Psychoeducation (brief) for people with serious mental illness (Review)

Transcription

1 Psychoeducation (brief) for people with serious mental illness (Review) Zhao S, Sampson S, Xia J, Jayaram MB This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2015, Issue 4

2 T A B L E O F C O N T E N T S HEADER ABSTRACT PLAIN LANGUAGE SUMMARY SUMMARY OF FINDINGS FOR THE MAIN COMPARISON BACKGROUND OBJECTIVES METHODS RESULTS Figure Figure Figure ADDITIONAL SUMMARY OF FINDINGS DISCUSSION AUTHORS CONCLUSIONS ACKNOWLEDGEMENTS REFERENCES CHARACTERISTICS OF STUDIES DATA AND ANALYSES Analysis 1.1. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 1 Compliance: 1a. With medication - non-compliance Analysis 1.2. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 2 Compliance: 1b. With medication - partial compliance (medium term) Analysis 1.4. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 4 Compliance: 1d. With medication - very good/ good compliance (numberic compliance scale).. 86 Analysis 1.5. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 5 Compliance: 2a. With follow-up - loss to follow-up for any reason Analysis 1.6. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 6 Relapse: 1. Relapse for any reason Analysis 1.7. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 7 Relapse: 2. Relapse with readmission Analysis 1.8. Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 8 Knowledge: 1a. Average endpoint scale scores on various knowledge scales Analysis Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 11 Knowledge: 2. Average endpoint scores (SAUMD, high = poor) (short term) Analysis Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 12 Global state: 2. Average endpoint scale score Analysis Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 13 Service utilisation: rehospitalisation Analysis Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 14 Mental state: 1a. Global - average total endpoint scale scores (BPRS, high = poor) Analysis Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 15 Mental state: 1b. Global - average change scale scores (GWB/SES, high = good) (medium term). 96 Analysis Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 17 Mental state: 2a. Specific symptoms - short term Analysis Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 18 Mental state: 2b. specific symptoms - average total endpoint scale score (high = poor) (short term). 98 Analysis Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 20 Social functioning: 1a. Average change scores on various scales (high = poor) (medium term) Analysis Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 21 Expressed emotion: Participants with high EE relatives (FQ) i

3 Analysis Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 22 Expressed emotion for relatives: Average change scores on FQ scales (high = good) Analysis Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 23 Quality of life: 1a. Average endpoint scores (GQOLI-74, high = good) Analysis Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 24 Quality of life: 1b. Average endpoint scores (FAD, high = poor) Analysis Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 26 Satisfaction with mental health services: 1. Average change score (VSS, high = good) (short term). 102 Analysis Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 27 Satisfaction with mental health services: 2. Average change (VSS Scale, high = good) (long term at 1 year) Analysis Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 28 Patients satisfaction with mental health services: average endpoint scores (CSQ, high = good) (short term) Analysis Comparison 1 ANY FORM OF BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 29 Adverse event: Death Analysis 2.1. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 1 Compliance: With medication (numberic compliance scale, high = good) Analysis 2.2. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 2 Relapse: Relapse for any reason (medium term) Analysis 2.3. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 3 Service utilisation: hospitalisation (long term) Analysis 2.4. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 4 Mental state: Specific - average endpoint PANSS scores (high = poor) Analysis 2.5. Comparison 2 ANY FORM OF BRIEF PSYCHOEDUCATION vs CBT, Outcome 5 Quality of life: Average endpoint MSQoL-54 score (high = good) Analysis 3.1. Comparison 3 SUBGROUP ANALYSES 2. GROUP BRIEF PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 1 Compliance: 1a. With medication - non-compliance Analysis 3.2. Comparison 3 SUBGROUP ANALYSES 2. GROUP BRIEF PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 2 Compliance: 1b. With follow up - loss to follow-up for any reason Analysis 3.3. Comparison 3 SUBGROUP ANALYSES 2. GROUP BRIEF PSYCHOEDUCATION/INDIVIDUAL PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 3 Relapse: 1. Relapse for any reason. 111 Analysis 4.1. Comparison 4 SENSITIVITY ANALYSES 1 (without assumption for lost binary data): BRIEF PSYCHOEDUCATION vs CBT, Outcome 1 Relapse: Relapse for any reason (medium term) Analysis 4.2. Comparison 4 SENSITIVITY ANALYSES 1 (without assumption for lost binary data): BRIEF PSYCHOEDUCATION vs CBT, Outcome 2 Relapse: Relapse for any reason (medium term)-without assumption. 113 Analysis 5.1. Comparison 5 SENSITIVITY ANALYSES 2 (risk of bias): BRIEF PSYCHOEDUCATION vs ROUTINE CARE/INFORMATION, Outcome 1 Compliance: 1a. With medication - non-compliance ADDITIONAL TABLES CONTRIBUTIONS OF AUTHORS DECLARATIONS OF INTEREST SOURCES OF SUPPORT DIFFERENCES BETWEEN PROTOCOL AND REVIEW ii

4 [Intervention Review] Psychoeducation (brief) for people with serious mental illness Sai Zhao 1, Stephanie Sampson 2, Jun Xia 3, Mahesh B Jayaram 4 1 Tianjin University of Traditional Chinese Medicine, Tianjin, China, Systematic Review Solutions Ltd, Yan Tai, China. 2 The University of Nottingham, Nottingham, UK. 3 Cochrane Schizophrenia Group, The University of Nottingham, Nottingham, UK. 4 Department of Psychiatry, Melbourne Neuropsychiatry Centre, Melbourne, Australia Contact address: Sai Zhao, Tianjin University of Traditional Chinese Medicine, Tianjin, China, Systematic Review Solutions Ltd, 5-6 West Tashan Road, Yan Tai, , China. sai-zhao@review-solutions.cn. Editorial group: Cochrane Schizophrenia Group. Publication status and date: New, published in Issue 4, Review content assessed as up-to-date: 4 February Citation: Zhao S, Sampson S, Xia J, Jayaram MB. Psychoeducation (brief) for people with serious mental illness. Cochrane Database of Systematic Reviews 2015, Issue 4. Art. No.: CD DOI: / CD pub2. Background A B S T R A C T Those with serious/severe mental illness, especially schizophrenia and schizophrenic-like disorders, often have little to no insight regarding the presence of their illness. Psychoeducation may be defined as the education of a person with a psychiatric disorder regarding the symptoms, treatments, and prognosis of that illness. Brief psychoeducation is a short period of psychoeducation; although what constitutes brief psychoeducation can vary. A previous systematic review has shown that the median length of psychoeducation is around 12 weeks. In this current systematic review, we defined brief psychoeducation as programmes of 10 sessions or less. Objectives To assess the efficacy of brief psychoeducational interventions as a means of helping severely mentally ill people when added to standard care, compared with the efficacy of standard care alone. The secondary objective is to investigate whether there is evidence that a particular kind (individual/ family/group) of brief psychoeducational intervention is superior to others. Search methods We searched the Cochrane Schizophrenia Group register September 2013 using the phrase: [*Psychoeducat* in interventions of STUDY]. Reference lists of included studies were also inspected for further relevant studies. We also contacted authors of included study for further information regarding further data or details of any unpublished trials. Selection criteria All relevant randomised controlled trials (RCTs) comparing brief psychoeducation with any other intervention for treatment of people with severe mental illness. If a trial was described as double blind but implied randomisation, we entered such trials in a sensitivity analysis. 1

5 Data collection and analysis At least two review authors extracted data independently from included papers. We contacted authors of trials for additional and missing data. We calculated risk ratios (RR) and 95% confidence intervals (CI) of homogeneous dichotomous data. For continuous data, we calculated the mean difference (MD), again with 95% CIs. We used a fixed-effect model for data synthesis, and also assessed data using a random-effects model in a sensitivity analysis. We assessed risk of bias for each included study and created Summary of findings tables using GRADE (Grading of Recommendations Assessment, Development and Evaluation). Main results We included twenty studies with a total number of 2337 participants in this review. Nineteen studies compared brief psychoeducation with routine care or conventional delivery of information. One study compared brief psychoeducation with cognitive behavior therapy. Participants receiving brief psychoeducation were less likely to be non-compliant with medication than those receiving routine care in the short term (n = 448, 3 RCTs, RR 0.63 CI 0.41 to 0.96, moderate quality evidence) and medium term (n = 118, 1 RCT, RR 0.17 CI 0.05 to 0.54, low quality evidence). Compliance with follow-up was similar between the two groups in the short term (n = 30, 1 RCT, RR 1.00, CI 0.24 to 4.18), medium term (n = 322, 4 RCTs, RR 0.74 CI 0.50 to 1.09) and long term (n = 386, 2 RCTs, RR 1.19, CI 0.83 to 1.72). Relapse rates were significantly lower amongst participants receiving brief psychoeducation than those receiving routine care in the medium term (n = 406, RR 0.70 CI 0.52 to 0.93, moderate quality evidence), but not in the long term. Data from a few individual studies supported that brief psychoeducation: i) can improve the long-term global state (n = 59, 1 RCT, MD CI to -0.02, very low quality evidence); ii) promote improved mental state in short term (n = 60, 1 RCT, MD CI to -0.56,low quality evidence) and medium term; iii) can lower the incidence and severity of anxiety and depression. Social function such as rehabilitation status (n = 118, 1 RCT, MD CI to , low quality evidence) and social disability (n = 118, 1 RCT, MD CI to -1.83, low quality evidence) were also improved in the brief psychoeducation group. There was no difference found in quality of life as measured by GQOLI-74 in the short term (n = 62, 1 RCT, MD 0.63 CI to 2.05, low quality evidence), nor the death rate in either groups (n = 154, 2 RCTs, RR 0.99, CI 0.15 to 6.65, low quality evidence). Authors conclusions Based on mainly low to very low quality evidence from a limited number of studies, brief psychoeducation of any form appears to reduce relapse in the medium term, and promote medication compliance in the short term. A brief psychoeducational approach could potentially be effective, but further large, high-quality studies are needed to either confirm or refute the use of this approach. P L A I N L A N G U A G E S U M M A R Y The effectiveness of brief psychoeducation (10 sessions or less) for people with serious mental illness Review question. To investigate the effectiveness of brief psychoeducation compared with standard care as a means of helping people with serious mental illness. To investigate whether any kind (individual/ family/group) of brief psychoeducation is better than others. Background. Schizophrenia is a serious, long-term mental illness where people experience hallucinations and/or delusions and are often unable to distinguish these experiences from reality. Hearing voices and seeing things can be disturbing, confusing and frightening and can lead to changes in behaviour. It is suggested that insight into the illness can help people to understand the need for treatment and subsequently improve the prognosis. However, the nature of schizophrenia is such that it alters peoples thought processes and they are often unable to have insight into their illness. The stigma of having a mental illness can also influence a person s willingness to seek or take treatments. Effective education of people with schizophrenia can improve insight and understanding. Psychoeducation programmes have been developed, specifically aimed at people with mental health problems. It is not simply providing information to patients. Rather, it is a form of empowering training targeted at promoting awareness and providing tools to manage, cope and live with a mental illness. However, psychoeducation 2

6 can be time consuming; brief psychoeducation has been developed as a possible solution to this problem. In this review the authors defined brief psychoeducation to be a psychoeducation programme of 10 sessions or less. Study characteristics. The review authors searched for randomised trials in 2013 and found 20 relevant studies with 2337 participants. Half of the studies were carried out in China. These trials randomised people to receive either brief psychoeducation sessions (these ranged from one-day psychoeducation to eight sessions of psychoeducation over a period of one year) or routine care. Key results. Based on information from a limited number of studies, brief psychoeducation does seem to reduce relapse and encourage people to take their medication. Those receiving brief psychoeducation also have more favourable results for mental state and social functioning. Quality of the evidence. Although initial results are encouraging, most information and data for the main outcomes of interest, were rated as low or very low quality, and the number of trials providing useful data is small. Until further large, high-quality studies become available, the usefulness of brief psychoeducation remains debatable. Ben Gray, Senior Peer Researcher, McPin Foundation. 3

7 S U M M A R Y O F F I N D I N G S F O R T H E M A I N C O M P A R I S O N [Explanation] ANY FORM OF PSYCHOEDUCATION compared with ROUTINE CARE/INFORMATION for people with serious mental illness Patient or population: people with serious mental illness Settings: China(54%); Germany(14%); Denmark(8%); Pakistan(8%); Scotland(8%); Malaysia(8%). Intervention: ANY FORM OF PSYCHOEDUCATION Comparison: ROUTINE CARE/INFORMATION Outcomes Illustrative comparative risks*(95% CI) Relative effect (95% CI) Compliance: 1a. With medication - non-compliance- short term Follow-up: 12 weeks Assumed risk Corresponding risk ANY FORM OF BRIEF PSYCHOEDUCATION Study population RR 0.63 (0.41 to 0.96) 205per per1000 (84to197) Moderate No of Participants (studies) 448 (3 studies) Quality of the evidence (GRADE) moderate 2 Comments 137per per1000 (56to132) Relapse: 1. Relapse for any reason - medium term Follow-up: weeks Study population RR 0.7 (0.52 to 0.93) 354per per1000 (184to329) 406 (4 studies) moderate 4 Moderate 351per per1000 (183to326) 4

8 Global state: 2. Average endpoint scale score - medium term(gaf/gas, high=good) Follow-up: weeks Mental state: 1a. Global - average total endpoint scale scores (BPRS, high=poor)-shortterm Follow-up: up to 12 weeks Social functioning: 1a. Average change scores on various scales - medium term (high = poor)-sdss Follow-up: weeks The mean global state: medium term in the control groups was points The mean mental state: short term in the control group was points The mean social functioning: medium term in the control groups was points The mean global state: 2. average endpoint scale score - medium term (GAF/GAS, high = good) in the intervention groups was 0.5 lower (5.48 lower to 4.47 higher) The mean mental state: 1a. global - average total endpoint scale scores (BPRS, high = poor) - short term in the intervention groups was 2.7 lower (4.84 to 0.56 lower) The mean social functioning: medium term in the intervention groups was 1.96 lower (1.83 to 2.09 lower) 101 (2 studies) 60 (1 study) 118 (1 study) verylow 5,6,7 verylow 5,8,9 low 8,9 Quality of life: 1a. Average endpoint scores (GQOLI-74, high = good)-shortterm Follow-up: up to 12 weeks The mean quality of life: short term in the control groups was points The mean quality of life: short term in the intervention groups was 0.63 higher (0.79 lower to 2.05 higher) 62 (1 study) low 8,9 Adverse event: Death - medium term Follow-up: weeks Study population RR 0.99 (0.15 to 6.65) 154 (2 studies) low 5,7 5

9 13per Moderate 23per per1000 (2to85) 23per1000 (3to153) *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention(and its 95% CI). CI: Confidence interval; RR: Risk ratio; GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Lowquality:Furtherresearchisverylikelytohaveanimportantimpactonourconfidenceintheestimateofeffectandislikelytochangetheestimate. Very low quality: We are very uncertain about the estimate. 1 Assumedrisk:mediancontrolgroupriskpresentedfromstudies,aslittlevariationinbaselineriskacrossstudies(13.7%). 2 Risk of bias: rated serious - two included studies rated as a high risk of bias across at least one of the Risk of bias domains, including selective reporting and incomplete outcome data. 3 Assumedrisk:mediancontrolgroupriskpresentedfromstudies,aslittlevariationinbaselineriskacrossstudies(35.1%). 4 Riskof bias:rated serious -threeincludedstudiesratedas a unclear riskof biasacross at leastoneof the Riskof bias domains, including selective reporting and incomplete outcome data. 5 Riskofbias:rated serious -oneincludedstudyratedasa high riskofbiasacrossatleastoneoftheriskofbiasdomains,including incomplete outcome data. 6 Inconsistency:ratedas serious -aconsiderableheterogeneitywasdetected(i 2 =58%). 7 Imprecision:rated serious -confidenceintervalsforbestestimateofeffectincludebothnoeffectandappreciablebenefit/harm. 8 Imprecision:ratedas serious,toosmallsamplesize. 9 Westronglysuggestedapublicationbiasbecauseonlyonestudieswasincluded. 10 Assumedrisk:mediancontrolgroupriskpresentedfromstudies,aslittlevariationinbaselineriskacrossstudies(2.3%). 6

10 B A C K G R O U N D Description of the condition The term serious or severe mental illness is widely used by mental health professionals, but there is no internationally agreed definition for the term, and limited consistency between definitions. The definition of severe mental illness which is most representative of definitions used in research is that of the National Institute of Mental Health (NIMH) (Schinnar 1990), which has three dimensions. 1. Clinical diagnosis: a diagnosis of non-organic psychosis or personality disorder. 2. Chronicity: a two-year, or longer history of mental illness or treatment. 3. Disability: functional impairment, limiting one or more major life activities (National Institute of Mental Health 1987). The UK Quality and Outcomes Framework, which encourages General Practices to maintain registers of patients with severe mental illness, uses the following inclusion criteria, based on diagnosis alone: schizophrenia, bipolar disorder and other psychoses (QOF 2009). This is representative of definitions used by the UK Department of Health, and used in practice. Ruggeri 2000 suggested that the total worldwide population-based annual prevalence of serious mental illness is approximately two per thousand. Current mental health policy objectives include ensuring optimal quality of life for those with severe mental illness, and providing evidencebased approaches to give people the greatest choice and control over their own lives (DoH 2011). Those with severe mental illness, especially schizophrenia and schizophrenic-like disorders, often have little to no insight regarding the presence of their illness (McCormack 2013). This means that people with severe mental illness will not understand that they are ill in the same way that third party observers do. The lack of understanding of their illness, ultimately leads to poor treatment compliance and can result in relapse and repeated hospitalisation (Gerhardstein 2013). Some people may feel stigmatised by their illness and may deny its existence, whereas others have a true lack of understanding (Harvey 2013); both, ultimately increase noncompliance. Non-compliance is even more of a problem when people are living in the community and is also often related to the adverse effects of medication, as well as a lack of adequate knowledge about medication (Antai-Otong 1989). psychiatric condition, and changing behaviours and attitudes related to the condition (Colom 2011). Patient education can take a variety of forms and length. Some are as brief as one session (Razali 1997), others are as long as 18 months (Herz 2000). A previous systematic review has shown that the median length of psychoeducation is around 12 weeks (Xia 2011). Therefore, for psychoeducation to be considered brief we have used a cut-off of 10 sessions or less. The terms patient education, patient teaching, and patient instruction have also been used for this process. All imply that there is a focus on knowledge. The purpose of patient education, ultimately, is to enable the patient to engage in behaviour change and build skills for illness management (Chien 2013c). The goal may be to try to prevent hospitalisation or to manage the illness or condition to help the patient attain her/his maximum degree of health and well-being. How the intervention might work Education is a gradual process by which a person gains knowledge and understanding through learning. Learning, however, involves more than knowledge and, according to Rankin 1996, it can involve cognitive, affective and psychomotor processes. Learning implies changes in behaviour, skill or attitude (Falvo 1994). Patient education can take a variety of forms depending upon the abilities and interest of the patient and family. For example, the education may take place in small groups or on a one-to-one basis; it may involve the use of videotapes or pamphlets or a combination of these. Why it is important to do this review Proposed benefits of psychoeducation as a psychological intervention are that it is clinically focused, straightforward to deliver, and does not require long and complex training (Colom 2011). However, a key drawback is that psychoeducation traditionally places demands upon therapist time, with programmes often comprising many modules. A recent narrative literature review has suggested that shorter psychoeducation programmes or brief psychoeducation may have long-term positive outcomes in schizophrenia (Rummel-Kluge 2008). It is therefore important to look at brief psychoeducation programmes. Description of the intervention Psychoeducation may be defined as the education of a person with a psychiatric disorder regarding the symptoms, treatments, and prognosis of that illness. It is not simply providing information, but rather empowering training for patients targeted at promoting awareness, providing tools to manage, cope and live with a chronic O B J E C T I V E S To assess the efficacy of brief psychoeducational interventions as a means of helping severely mentally ill people when added to standard care, compared with the efficacy of standard care alone. 7

11 The secondary objective is to investigate whether there is evidence that a particular kind (individual/ family/group) of brief psychoeducational intervention is superior to others. M E T H O D S Criteria for considering studies for this review Types of studies All relevant randomised controlled trials. If a trial was described as double blind but implied randomisation, we included such trials in a sensitivity analysis (see Sensitivity analysis). If their inclusion did not result in a substantive difference, they remained in the analyses. If their inclusion did result in important clinically significant but not necessarily statistically significant differences, we did not add the data from these lower quality studies to the results of the better trials, but presented such data within a subcategory. We excluded quasi-randomised studies, such as those allocating by alternate days of the week. Where people were given additional treatments within brief psychoeducation, we only included data if the adjunct treatment was evenly distributed between groups and it was only the brief psychoeducation that was randomised. Types of participants Adults suffering from severe/serious mental illness as defined by National Institute of Mental Health In the absence of a formal diagnosis, we included people with illness such as schizophrenia, schizophrenia-like disorders, bipolar disorder, depression with psychotic features and/or personality disorder. Studies involving people with dual diagnosis of severe mental illness plus substance abuse were also included. However, trials involving participants with substance abuse alone were not included. Studies involving people with dementia or mental retardation were also excluded, as these illnesses are not considered as severe mental disorders. We included studies involving people with a range of severe mental illness diagnoses but only where the majority of people had a diagnosis of schizophrenia. A majority of the study participants were required to be within the age range 18 to 65 years. Types of interventions 1. All didactic interventions of psychoeducation or patient teaching, involving individuals or groups, considered to be brief were included. For the purpose of this review, programmes of 10 sessions or less were considered as brief. We defined psychoeducational interventions as any group or individual programme involving interaction between information provider and patient. These programmes addressed the illness from a multidimensional viewpoint, including familial, social, biological and pharmacological perspectives. Patients were provided with support, information and management strategies. Interventions including elements of behavioural training, such as social skills or life-skills training, as well as education, performed by patient peers, were excluded from this review. Staff education studies were also excluded. 2. Standard care was defined as the normal level of psychiatric care provided in the area where the trial was carried out. Types of outcome measures We divided all outcomes into short term (up to 12 weeks), medium term (13-52 weeks) or long term (over 52 weeks), and were interpreted as defined by each of the studies. Primary outcomes 1. Compliance 1.1 Compliance with medication 1.2 Compliance with follow-up 2. Relapse Secondary outcomes 3. Knowledge 3.1 Improvement of understanding of his/her illness and need for treatment - recipient/family member 3.2 Level of knowledge about expected and undesired effects of medication - recipient/family member 4. Behaviour 4.1 Level of psychiatric symptoms 4.2 Symptom control skills 4.3 Problem-solving skills 4.4 Social skills 5. Global state 5.1 Overall improvement 5.2 Use of additional medication 5.3 Average endpoint in global state score 5.4 Average change in global state scores 5.5 Average dose of drug 8

12 6. Global functioning 6.1 Clinically important change in general functioning 6.2 Any change in general functioning 6.3 Average endpoint in general functioning score 6.4 Average change in general functioning scores 7. Service utilisation 7.1 Use of outpatient treatment 7.2 Length of hospitalisation 8. Mental state 8.1 Clinically important change in general mental state 8.2 Any change in general mental state 8.3 Average endpoint in general mental state score 8.4 Average change in general mental state scores 9. Social functioning 9.1 Clinically important change in social functioning 9.2 Any change in social functioning 9.3 Average endpoint in social functioning score 9.4 Average change in social functioning scores 10. Expressed emotion 10.1 Clinically important change in expressed emotion 10.2 Any change in expressed emotion 10.3 Average endpoint general expressed emotion score 10.4 Average change in general expressed emotion scores 11. Quality of life 11.1 Clinically important change in quality of life 11.2 Any change in quality of life 11.3 Average endpoint quality of life score 11.4 Average change in quality of life scores 11.5 Clinically important change in specific aspects of quality of life 11.6 Any change in specific aspects of quality of life 11.7 Average endpoint specific aspects of quality of life 11.8 Average change in specific aspects of quality of life 12. Satisfaction with care 12.1 Clinically important change in satisfaction 12.2 Any change in satisfaction 12.3 Average endpoint in satisfaction score 12.4 Average change in satisfaction scores 13. Adverse effects/event 13.1 Clinically important general adverse effects 13.2 Any general adverse effects 13.3 Any serious, specific adverse effects 13.4 Average endpoint general adverse effect score 13.5 Average change in general adverse effect scores 13.6 Clinically important change in specific adverse effects 13.7 Any change in specific adverse effects 13.8 Average endpoint specific adverse effects 13.9 Average change in specific adverse effects 14. Health economic outcomes 14.1 Treatment costs 15. Summary of findings table We used the GRADE approach to interpret findings (Schünemann 2008) and used GRADE profiler (GRADEPRO) to import data from RevMan 5.1 (Review Manager) to create Summary of findings tables. These tables provided outcome-specific information concerning the overall quality of evidence from each included study in the comparison, the magnitude of effect of the interventions examined, and the sum of available data on all outcomes we rated as important to patient-care and decision making. We selected the following main outcomes for inclusion in the Summary of findings table: 1. Compliance - compliance with medication 2. Relapse - as defined in each study 3. Global state - overall improvement 4. Mental state - clinically important change in general mental state 5. Social function - clinically important change in social functioning 6. Quality of life - clinically important change in quality of life 7. Adverse effects - clinically important general adverse effects Search methods for identification of studies Electronic searches We searched the Cochrane Schizophrenia Group register September 2013 using the phrase: [*Psychoeducat* in interventions of STUDY]. This register is compiled by systematic searches of major databases, hand searches and conference proceedings (see Group Module). Searching other resources 1. Reference searching 9

13 We inspected references of all included studies for further relevant studies. 2. Personal contact We contacted the first author of each included study for information regarding unpublished trials. If authors responded we noted their responses in Characteristics of included studies. Data collection and analysis 2.2 Scale-derived data We included continuous data from rating scales only if: a) the psychometric properties of the measuring instrument have been described in a peer-reviewed journal (Marshall 2000); and b) the measuring instrument has not been written or modified by one of the trialists for that particular trial. Ideally, the measuring instrument should either be i. a self-report or ii. completed by an independent rater or relative (not the therapist). We realise that this is not often reported clearly, in Description of studies we noted if this was the case or not. Selection of studies Review author SZ inspected citations from the searches and identified relevant abstracts. A random 20% sample was independently re-inspected by JX to ensure reliability. Where disputes arose, the full report was acquired for more detailed scrutiny. Full reports of the abstracts meeting the review criteria were obtained and inspected by SZ. A random 20% of reports were re-inspected by JX in order to ensure reliable selection. Where it was not possible to resolve disagreement by discussion, we contacted the authors of the study for clarification. Data extraction and management 1. Extraction Review authors SS and AA (working as a team) extracted data from all included studies parallel to SZ. In addition, to ensure reliability, JX independently extracted data from a random sample of these studies, comprising 10% of the total. Again, any disagreement was discussed, decisions documented and, if necessary, authors of studies were contacted for clarification. We planned to consult MBJ for clarification of any remaining problems, but we did not request his assistance during this process Where data were presented only in graphs and figures, we attempted to extract the data whenever possible and include such data but only where the review authors independently found the same result. We attempted to contact authors through an open-ended request in order to obtain missing information or for clarification whenever necessary. Where studies were multi-centre, where possible, we extracted data relevant to each component centre separately. 2. Management 2.1 Forms We extracted data onto standard, simple forms. 2.3 Endpoint versus change data There are advantages of both endpoint and change data. Change data can remove a component of between-person variability from the analysis. On the other hand, calculation of change needs two assessments (baseline and endpoint), which can be difficult in unstable and difficult to measure conditions such as schizophrenia. We decided primarily to use endpoint data, and only use change data where the former were not available. Had we extracted endpoint and change data from the same scales, they would have been combined in the analysis through use of standardised mean differences (SMD) rather than mean differences (MD) throughout (Higgins 2011). 2.4 Skewed data Continuous data on clinical and social outcomes are often not normally distributed. To avoid the pitfall of applying parametric tests to non-parametric data, we aimed to apply the following standards to all data before inclusion: a) standard deviations (SDs) and means were reported in the paper or obtainable from the authors; b) when a scale starts from the finite number zero, the SD, when multiplied by two, is less than the mean (as otherwise the mean is unlikely to be an appropriate measure of the centre of the distribution, (Altman 1996); c) if a scale started from a positive value (such as the Positive and Negative Syndrome Scale (PANSS), (Kay 1986)), which can have values from 30 to 210), the calculation described above was modified to take the scale starting point into account. In these cases skew is present if 2 SD > (S-S min), where S is the mean score and S min is the minimum score. Endpoint scores on scales often have a finite start and end point and these rules can be applied. Skewed data pose less of a problem when looking at means if the sample size is large (> 200) and we entered these into the syntheses. We presented skewed endpoint data from studies of less than 200 participants as other data within the data and analyses section rather than enter such data into a statistical analyses. 10

14 When continuous data are presented on a scale that includes a possibility of negative values (such as change data), it is difficult to tell whether data are skewed or not. We presented and entered change data into analyses. 2.5 Common measure To facilitate comparison between trials, we intended to convert variables that can be reported in different metrics, such as days in hospital (mean days per year, per week or per month) to a common metric (e.g. mean days per month) - however, no such data were identified. 2.6 Conversion of continuous to binary Where possible, in future updates of this review, efforts will be made to convert outcome measures to dichotomous data. This can be done by identifying cut-off points on rating scales and dividing participants accordingly into clinically improved or not clinically improved. It is generally assumed that if there is a 50% reduction in a scale-derived score such as the Brief Psychiatric Rating Scale (BPRS, Overall 1962) or the PANSS (Kay 1986), this could be considered as a clinically significant response (Leucht 2005; Leucht 2005a). If data based on these thresholds are not available, we will use the primary cut-off presented by the original authors. 2.7 Direction of graphs Where possible, we entered data in such a way that the area to the left of the line of no effect indicates a favourable outcome for brief psychoeducation. Where keeping to this makes it impossible to avoid outcome titles with clumsy double-negatives (e.g. Not improved ), we reported data where the left of the line indicates an unfavourable outcome. This is noted in the relevant graphs. Assessment of risk of bias in included studies Review authors SZ and MJ worked independently to assess risk of bias by using criteria described in the Cochrane Handbook for Systemic reviews of Interventions (Higgins 2011) to assess trial quality. This set of criteria is based on evidence of associations between overestimate of effect and high risk of bias of the article such as sequence generation, allocation concealment, blinding, incomplete outcome data and selective reporting. If the raters disagreed, the final rating was made by consensus, with the involvement of another member of the review group. Where inadequate details of randomisation and other characteristics of trials were provided, we contacted the authors of the studies in order to obtain further information. Had non-concurrence in quality assessment been found, this would have been reported, and all disputes would have been resolved by discussion. The level of risk of bias was noted in both the text of the review and in the Summary of findings for the main comparison. Measures of treatment effect 1. Binary data For binary outcomes, we calculated a standard estimation of the risk ratio (RR) and its 95% confidence interval (CI). It has been shown that RR is more intuitive (Boissel 1999) than odds ratios and that odds ratios tend to be interpreted as RR by clinicians (Deeks 2000). The Number Needed to Treat/Harm (NNT/H) statistic with its CIs is intuitively attractive to clinicians but is problematic both in its accurate calculation in meta-analyses and interpretation (Hutton 2009). For binary data presented in the Summary of findings for the main comparison, where possible, we calculated illustrative comparative risks. 2. Continuous data For continuous outcomes, we estimated mean difference (MD) between groups. We preferred not to calculate effect size measures (standardised mean difference SMD). Had scales of very considerable similarity been used, we would have presumed there was a small difference in measurement, and we would have calculated effect size and transformed the effect back to the units of one or more of the specific instruments. Unit of analysis issues 1. Cluster trials Studies increasingly employ cluster randomisation (such as randomisation by clinician or practice) but analysis and pooling of clustered data poses problems. Firstly, authors often fail to account for intra-class correlation in clustered studies, leading to a unit of analysis error (Divine 1992) whereby P values are spuriously low, CIs unduly narrow and statistical significance overestimated. This causes type I errors (Bland 1997; Gulliford 1999). No cluster trials were identified in this review s trial search. In future versions, if cluster studies are included, where clustering is not accounted for in primary studies, we will present data in a table, with a (*) symbol to indicate the presence of a probable unit of analysis error and seek to contact first authors of studies to obtain intra-class correlation coefficients (ICCs) for their clustered data and to adjust for this by using accepted methods (Gulliford 1999). Where clustering has been incorporated into the analysis of primary studies, we will present these data as if from a non-cluster randomised study, but adjust for the clustering effect. We have sought statistical advice and have been advised that the binary data as presented in a report should be divided by a design effect. This is calculated using the mean number of participants per cluster (m) and the ICC [Design effect = 1+(m-1)*ICC] (Donner 2002). If the ICC is not reported we will assume it to be 0.1 (Ukoumunne 1999). 11

15 If cluster studies have been appropriately analysed taking into account ICCs and relevant data documented in the report, synthesis with other studies will be possible using the generic inverse variance technique. 2. Cross-over trials Due to the nature of the intervention, cross-over trials were not anticipated, nor identified in our search. However, in future versions of this review, it will be considered that a major concern of cross-over trials is the carry-over effect. It occurs if an effect (e.g. pharmacological, physiological or psychological) of the treatment in the first phase is carried over to the second phase. As a consequence, on entry to the second phase the participants can differ systematically from their initial state despite a wash-out phase. For the same reason cross-over trials are not appropriate if the condition of interest is unstable (Elbourne 2002). As both effects are very likely in severe mental illness, we will only use data of the first phase of cross-over studies. 3. Studies with multiple treatment groups Where a study involved more than two treatment arms, if relevant, the additional treatment arms were presented in the comparisons. If data were binary, these were simply added and combined within the two-by-two table. If data were continuous, we combined data following the formula in section (Combining groups) of the Cochrane Handbook for Systemic reviews of Interventions (Higgins 2011). Where the additional treatment arms are not relevant, we did not use these data. Dealing with missing data 1. Overall loss of credibility At some degree of loss of follow-up, data must lose credibility (Xia 2009). We chose that, for any particular outcome, should more than 50% of data have been unaccounted for, we would not reproduce these data or use them within analyses. If, however, more than 50% of those in one arm of a study were lost, but the total loss was less than 50%, we addressed this within the Summary of findings table by down-rating quality. Finally, we also downgraded quality within the Summary of findings table where loss was 25% to 50% in total. 2. Binary In the case where attrition for a binary outcome was between 0% and 50% and where these data were not clearly described, we presented data on a once-randomised-always-analyse basis (an intention-to-treat (ITT) analysis). Those leaving the study early were all assumed to have the same rates of negative outcome as those who completed, with the exception of the outcome of death and adverse effects. For these outcomes, the rate of those who stay in the study - in that particular arm of the trial - were used for those who did not. We undertook a sensitivity analysis to test how prone the primary outcomes were to change when data only from people who completed the study to that point were compared to the ITT analysis using the above assumptions. 3. Continuous 3.1 Attrition In the case where attrition for a continuous outcome was between 0% and 50%, and data only from people who complete the study to that point are reported, we reproduced these. 3.2 Standard deviations If standard deviations (SDs) were not reported, we first tried to obtain the missing values from the authors. If not available, where there were missing measures of variance for continuous data, but an exact standard error (SE) and CIs available for group means, and either a P value or t value available for differences in mean, we calculated them according to the rules described in the Cochrane Handbook for Systemic reviews of Interventions (Higgins 2011). When only the SE was reported, SDs were calculated by the formula SD = SE * square root (n). Chapters and of the Cochrane Handbook for Systemic reviews of Interventions (Higgins 2011) present detailed formulae for estimating SDs from P values, t or F values, CIs, ranges or other statistics. If these formulae did not apply, we calculated the SDs according to a validated imputation method, which was based on the SDs of the other included studies (Furukawa 2006). Although some of these imputation strategies can introduce error, the alternative would have been to exclude a given study s outcome and thus to lose information. We nevertheless examined the validity of the imputations in a sensitivity analysis excluding imputed values. 3.3 Last observation carried forward We anticipated that in some studies the method of last observation carried forward (LOCF) could be employed within the study report. As with all methods of imputation to deal with missing data, LOCF introduces uncertainty about the reliability of the results (Leucht 2007). Therefore, had LOCF data been used in the trial, if less than 50% of the data had been assumed, we planned to present and use these data and indicate that they were the product of LOCF assumptions. However, we did not come across data from trials employing LOCF. 12

16 Assessment of heterogeneity 1. Clinical heterogeneity We considered all included studies initially, without seeing comparison data, to judge clinical heterogeneity. We simply inspected all studies for clearly outlying people or situations which we had not predicted would arise. When such situations or participant groups arose, these were fully discussed. 2. Methodological heterogeneity We considered all included studies initially, without seeing comparison data, to judge methodological heterogeneity. We simply inspected all studies for clearly outlying methods which we had not predicted would arise. When such methodological outliers arose, these were fully discussed. 3. Statistical heterogeneity 3.1 Visual inspection We visually inspected graphs to investigate the possibility of statistical heterogeneity. 3.2 Employing the I 2 statistic Heterogeneity between studies was investigated by considering the I 2 method alongside the Chi 2 P value. The I 2 provides an estimate of the percentage of inconsistency thought to be due to chance (Higgins 2003). The importance of the observed value of I 2 depends on i. magnitude and direction of effects and ii. strength of evidence for heterogeneity (e.g. P value from Chi 2 test, or a confidence interval for I 2 ). An I 2 estimate greater than or equal to around 50% accompanied by a statistically significant Chi 2 statistic, was interpreted as evidence of substantial levels of heterogeneity (Section Higgins 2011). When substantial levels of heterogeneity were found in the primary outcome, we explored reasons for heterogeneity (Subgroup analysis and investigation of heterogeneity). Assessment of reporting biases 1. Protocol versus full study Reporting biases arise when the dissemination of research findings is influenced by the nature and direction of results (Egger 1997). These are described in section 10.1 of the Cochrane Handbook for Systemic reviews of Interventions (Higgins 2011). We tried to locate the protocols of included randomised trials. If the protocol was available, outcomes in the protocol and in the published report were compared. If the protocol was not available, outcomes listed in the methods section of the trial report were compared with actually reported results. 2. Funnel plot These are again described in Section 10 of the Cochrane Handbook for Systemic reviews of Interventions (Higgins 2011). We are aware that funnel plots may be useful in investigating reporting biases but are of limited power to detect small-study effects. We did not use funnel plots as no outcomes had more than 10 studies reporting data. Data synthesis We understand that there is no closed argument for preference for use of fixed-effect or random-effects models. The random-effects method incorporates an assumption that the different studies are estimating different, yet related, intervention effects. This often seems to be true to us and the random-effects model takes into account differences between studies even if there is no statistically significant heterogeneity. There is, however, a disadvantage to the random-effects model. It puts added weight onto small studies, which often are the most biased ones. Depending on the direction of effect, these studies can either inflate or deflate the effect size. We chose the fixed-effect model for all analyses. The reader is, however, able to choose to inspect the data using the randomeffects model. Subgroup analysis and investigation of heterogeneity 1. Subgroup analyses 1.1 Primary outcomes We planned to compare brief group psychoeducation and brief individual psychoeducation, for primary outcomes only. 1.2 Clinical state, stage or problem We proposed to undertake this review and provide an overview of the effects of brief psychoeducation for people with schizophrenia in general. In addition, however, we reported data on subgroups of people in the same clinical state, stage and with similar problems. 2. Investigation of heterogeneity If inconsistency was high, this was reported. First, we investigated whether data had been entered correctly. Second, if data were correct, we visually inspected the graph and outlying studies were successively removed to see if homogeneity was restored. For this review, we decided that should this occur with data contributing to the summary finding of no more than around 10% of the total 13

17 weighting, data would be presented. If not, data were not pooled and issues were discussed. We know of no supporting research for this 10% cut-off, but are investigating use of prediction intervals as an alternative to this unsatisfactory state. When unanticipated clinical or methodological heterogeneity were obvious, we simply stated hypotheses regarding these for future reviews or versions of this review. Sensitivity analysis 1. Implication of randomisation We aimed to include trials in a sensitivity analysis if they were described in some way as to imply randomisation. For the primary outcomes, we included these studies and if there was no substantive difference when the implied randomised studies were added to those with better description of randomisation, then all data were employed from these studies. or the precision of the effect estimates, then data from these trials were included in the analysis. 4. Imputed values We had planned to undertake a sensitivity analysis to assess the effects of including data from trials where we used imputed values for ICC in calculating the design effect in cluster-randomised trials. If substantial differences had been noted in the direction or precision of effect estimates in any of the sensitivity analyses listed above, we would not have pooled data from the excluded trials with the other trials contributing to the outcome, but presented them separately. However, no cluster-randomised trials were identified. 5. Fixed and random effects All data were synthesised using a fixed-effect model, however, we also synthesised data for the primary outcome using a randomeffects model to evaluate whether this altered the significance of the results. 2. Assumptions for lost binary data Where assumptions were made regarding people lost to followup (see Dealing with missing data), we compared the findings of the primary outcomes when we used our assumption/s and when we used data only from people who completed the study to that point. If there was a substantial difference, we reported results and discussed them, but continued to employ our assumption. Where assumptions were made regarding missing SDs data (see Dealing with missing data), we compared the findings of the primary outcomes when we used our assumption/s and when we used data only from people who completed the study to that point. A sensitivity analysis was undertaken to test how prone results were to change when completer-only data only were compared to the imputed data using the above assumption. If there was a substantial difference, we reported results and discussed them, but continued to employ our assumption. 3. Risk of bias We analysed the effects of excluding trials that were judged to be at high risk of bias across one or more of the domains of randomisation (implied as randomised with no further details available), allocation concealment, blinding and outcome reporting for the meta-analysis of the primary outcome. If the exclusion of trials at high risk of bias did not substantially alter the direction of effect R E S U L T S Description of studies Please also see Characteristics of included studies and Characteristics of excluded studies. Throughout this review, study ID s have received a prefix before the principal author s name and year of study (Xia 2011); the prefixes used include group, individual, both or unclear, and each correspond to whether the brief psychoeducation intervention was received either as a group, individually, a mixture of both group and individual, or whether lack of information renders how the intervention was received as unclear (e.g. see Both - Liu 2004; Group - Aguglia 2007; Individual - Cunningham 2001; Unclear - Li 2005). Results of the search The search of the Cochrane Schizophrenia Group Trials Register, carried out in 2013, identified 268 references (see Figure 1), of which 20 studies were included (Characteristics of included studies), 19 were excluded (Characteristics of excluded studies), and 18 are awaiting classification (Characteristics of studies awaiting classification). Please refer to Figure 1 for the study screening process. 14

18 Figure 1. Study flow diagram. 15

19 Included studies 1. Setting Ten of the 20 included studies were conducted in China, three studies were conducted in Germany, two in the UK, with the one each of the remaining studies conducted in either Italy, Malaysia, Pakistan, Denmark or Jamaica. Of the studies that described participant status, three studies included outpatients, and two conducted with hospital inpatients (one of which was an acute inpatient setting, Group - Bechdolf 2004). Three of the included studies were multi-centre (Group - Aguglia 2007; Group - Bauml 2007; Individual - Cunningham 2001). 2. Length of studies Length of studies ranged from one day/one session (Group - Razali 1995) to eight sessions delivered over a period of 12 months ( Group - Aguglia 2007). The mean length of study was calculated at 13 weeks. Follow-up periods ranged from six months (Group - Bechdolf 2004) to five years (Group - Hornung 1995). 3. Participants In total, there were 2337 participants included in this review; only 50% of studies reported individual male and female numbers in study populations, with 612 known males and 473 known females included in, at least, 10 of the included studies. All participants had a diagnosis of schizophrenia or schizoaffective disorder; the most frequently used diagnostic criteria were Diagnostic and Statistical Manual of Mental Disorders (DSM-III or DSM-IV) (in nine of the included studies), Chinese Classification of Mental Disorders (CCMD-2 or CCMD-3) (in six of the included studies), International Classification of Diseases (ICD-9/10) (in one of the included studies) and F20.2/ F20.9 (in one of the included studies conducted in Denmark). The remaining three studies did not specify diagnostic criteria, but stated that participants had schizophrenia. One of the included studies included acute patients (Group - Bechdolf 2004) 4. Trial size Trial sizes ranged from n = 30 (Both - Tom 1989) to n = 286 participants (Unclear - Li 2005), with the mean sample size calculated at n = Interventions Types of brief family intervention differed between studies and ranged from one-day delivery (Group - Razali 1995) to sessions delivered over a period 12 months (Group - Aguglia 2007). We compared our defined brief family intervention (10 sessions or less) to standard/ routine care or information (as defined in each study), which included interventions such as cognitive behavioural therapy (CBT, as in Group - Bechdolf 2004), medication treatment alone (as specified in Group - Aguglia 2007; Group - Coyle 1988) or other routine forms of health education (Both - Zhang 2004) or rehabilitation (Both - Liu 2004). The remaining majority of the included studies used either the terms standard care, routine care or simply no form of brief psychoeducation (however defined). 6. Outcome scales A variety of scales were used to assess clinical response and adverse events. We were, however, unable to use some of the scale-derived data due to poor reporting. Details of scales that provided usable data are shown below. 6.1 Compliance Schedule for Assessment of Insight - SAI (David 1990) The SAI rates three dimensions of insight: treatment adherence, recognition of illness and symptom re-labelling. These three subscales provide a summed total of insight score. High score indicates better insight. One study reported skewed data from this scale Compliance scale ( Kemp 1998) The compliance scale is a four-point rating scale used by Kemp 1998, starting from 1 up to 4. A higher score represents better compliance: 1, complete or partial refusal (refused depot or accepts only minimum dose); 2, takes medication irregularly (interruption of medication < four weeks), reluctant, requires persuasion, disagrees with psychiatrist in charge about dose; 3, takes medication regularly (interruption of medication < one week), agrees with psychiatrist-in-charge about dose; 4, active participation, readily accepts and shows some responsibility for regimen. 6.2 Mental state Brief Psychiatric Rating Scale - BPRS (Overall 1962) The BPRS is an 18-item scale measuring positive symptoms, general psychopathology and affective symptoms. The original scale has 16 items, but a revised 18-item scale is commonly used. Scores can range from 0 to 126. Each item is rated on a seven-point scale varying from not present to extremely severe, with high scores indicating more severe symptoms. Four studies reported data from this scale. 16

20 6.2.2 General Well-being Schedule - GWB (Taylor 2003) This is an 18-item, reliable measurement scale for psychological well-being. High scores indicate better outcome. One study reported data from this scale Positive and Negative Syndrome Scale - PANSS (Kay 1986) This is a 30-item scale, each of which can be defined on a sevenpoint scoring system from absent to extreme. It has three sub-scales for measuring the severity of general psychopathology, positive symptoms (PANSS-P), and negative symptoms (PANSS-N). A low score indicates lesser severity. One study reported data from this scale Rosenberg Self-esteem Scale - SES (Rosenberg 1965) The scale is a 10-item Likert scale with items answered on a fourpoint scale - from strongly agree to strongly disagree. High scores indicate better outcome. One study reported data from this scale Montgomery-Åsberg Depression Rating Scale - MADRS (Montgomery 1979) This is a 10-item, psychiatrist-administered scale to rate severity of depressive episodes in people with mood disorders. Overall scores range from 0 to 54 points, with a higher score indicating a worse outcome. One study reported skewed data using this scale Zung Self-Rating Anxiety Scale - SAS (Ramirez 2008) This scale is self-administered and has 20 questions. Each question is scored on a scale of one to four. High score indicates poor outcome. One study reported data from this scale Zung Self-Rating Depression Scale - SDS (Gregory 1994) High scores indicate a poor outcome. One study reported data from this scale. 6.3 Social functioning Morningside Rehabilitation Status Scale - MRSS ( McCreadie 1987) High scores indicates a worse outcome. One study reported data from this scale Social Disability Screening Schedule - SDSS (Tu 1997) High scores indicate a poor outcome. One study reported data from this scale. 6.4 Quality of life Family Assessment Device - FAD (Epstein 1983) High scores indicate unhealthy family functioning. One study reported data from this scale Family Burden Interview Schedule - FBIS (Pai 1981) High scores indicate a worse outcome. One study reported data from this scale General Quality of Life Inventory GQOLI-74 (Wang 1999) A 74-item quality of life assessment scale. It contains four subscales that assess physical functioning, psychological functioning, social functioning, and standard of living. High scores indicate better quality of life. One study reported data from this scale. 6.5 Knowledge Insight Treatment Attitude Questionnaire - ITAQ (McEvoy 1989) The ITAQ is a 11-item semi-structured interview that measures awareness of illness and attitude to medication and services, as well as follow-up evaluation. Its scores range from 0 to 22, with high scores indicating better insight. Two studies reported data from this scale The Scale to Assess Unawareness of Mental Disorder - SAUMD (Amador 1994) There is a total of 20 questions in SAUMD. Score range one to five points, a high score prompts a poor understanding and attribution. One study reported data from this scale Understanding of medication questionnaire - UMQ ( Macpherson 1996) UMQ measures knowledge of antipsychotic treatment. Fourteen stem questions generate eight sub-scale knowledge scores, relating to factual information, treatment practice, treatment rationale, effects of stopping treatment, side effects, precautions, tardive dyskinesia and risk/benefit evaluation.the UMQ is an extended version of scales measuring knowledge of illness and treatment and knowledge of tardive dyskinesia. Total knowledge score is 35. Knowledge scoring 0 = no understanding and 35 = full understanding. One study reported data from this scale. One study reported skewed data from this scale Knowlege About Schizophrenia Questionnaire-KSQ( Falloon 1983) KSQ is used to measure knowledge of mental illness and treatment, comprising of two parts.the first part consists of six openended questions and the second part contains 14 multiple-choice questions.the scores range from 0 to 44. A higher score prompts a better understanding of schizophrenia-related knowledge.one study reported data from this scale. 6.6 Global state Global Assessment of Functioning - GAF (APA 1994) The scale is a 90-point rating scale that assesses psychological, social and occupational functioning. GAF is included in DSMIII- R as axis V, but in spite of this there is little research on the reliability and validity of the instrument. A few reliability and validity assessments have been made, indicating that an acceptable interrater reliability can be attained and that modest validity in relation to a disability measure has been demonstrated. High scores indicate a better outcome. One study reported data from this scale Global Assessment Scale - GAS (Endicott 1976) GAS is a point rating scale, a global measure of overall functioning and symptomatology. High scores indicate better functioning. One study reported data from this scale. 6.7 Expressed emotion 17

21 6.7.1 Family Questionnaire - FQ (Feinstein 1989) The FQ is based on the Camberwell Family Interview and is a 20-item questionnaire developed to enable a less time-consuming evaluation of expressed emotion in relatives. It covers the two dimensions of criticism and emotional over-involvement and the items are scored on a four-point scale. The questionnaire is reliability tested and validated in the German language (Feinstein 1994 personal communication). One study reported skewed data using this scale. One study reported data using this scale. 6.8 Satisfaction with care Verona Service Satisfaction Scale - VSSS (Ruggeri 1993) The scale consists of 54 items in versions for patients and relatives. It is a questionnaire that covers seven dimensions of satisfaction with service: overall satisfaction, professionals skills and behaviour, information, access, efficacy, types of intervention and relatives involvement. (Ruggeri 1996) The VSSS satisfaction ratings are given on a five-point Likert scale. The instrument has been validated in community psychiatric samples (Ruggeri 1994; Ruggeri 1996). One study reported data from this scale Client Satisfaction Questionnaire-8 - CSQ-8 (Nguyen 1983) The CSQ-8 consists of eight items selected from the preliminary CSQ scale (Larsen 1979), which comprises 31 items in total.the eight questions could obtain a minimum score of eight to a maximum score of 32. A higher score will indicate a higher level of satisfaction. One study reported data from this scale. 6.9 Missing outcomes Most studies reported outcomes of interest as specified in our protocol; however, some relevant outcomes of significance were either not measured or not reported, including global state outcomes, specific or general adverse events or effects, and changes in behaviour. Economic outcomes, which would be of particular interest regarding the nature of the intervention, were either not reported or not measured in the studies and references we obtained. Excluded studies In total, 19 studies were excluded with reasons, including non-randomised studies, irrelevant interventions, or no identifiable usable data. These studies are best inspected by viewing Characteristics of excluded studies. Awaiting assessment Eighteen studies are await assessment - descriptions of these studies can be found in Characteristics of studies awaiting classification. Ongoing Studies There are currently no ongoing studies that we are aware of. Risk of bias in included studies See Figure 2 and Figure 3 as well as Characteristics of included studies for details as to each study s Risk of bias assessment. Figure 2. Risk of bias graph: review authors judgements about each risk of bias item presented as percentages across all included studies. 18

22 Figure 3. Risk of bias summary: review authors judgements about each risk of bias item for each included study. 19