CRITICALLY APPRAISED PAPER (CAP) Hasan, A. A., Callaghan, P., & Lymn, J. S. (2015). Evaluation of the impact of a psychoeducational intervention for people diagnosed with schizophrenia and their primary caregivers in Jordan: A randomized controlled trial. BMC Psychiatry, 15, 72. http://dx.doi.org/10.1186/s12888-015-0444-7 CLINICAL BOTTOM LINE: This study is the first adequately powered randomized controlled study to investigate the use of booklets internationally and with Arabic-speaking countries to address symptomatology, relapse, caregiver burden, and quality of life. This study evaluated the effectiveness of psychoeducational intervention methods for people diagnosed with schizophrenia (PDwS) and their caregivers, with the goals of increasing knowledge of schizophrenia, improving positive and negative symptoms, decreasing relapse of patients, and decreasing caregiver burden. Results showed an increase in knowledge of schizophrenia, a decrease in symptoms and relapse, and a decrease in caregiver burden. Given that as occupational therapists are increasingly called to educate clients and caregivers, this study provides a unique and practical methodology for using psychoeducational material as an effective intervention for clients with schizophrenia and their caregivers. This study demonstrates that less-intrusive methods than a face-to-face approach may be beneficial to this population. Practitioners can use the evidence to increase occupational engagement and self-efficacy for PDwS as well as their caregivers. RESEARCH OBJECTIVE(S): To compare the effectiveness of a psychoeducational intervention delivered as biweekly informational booklets about schizophrenia as well as follow-up phone calls after distribution of the booklets for adults diagnosed with schizophrenia or schizoaffective disorders. Results were compared with the control group, which received treatment as usual (TAU). The study examined whether the distribution of psychoeducational booklets changed knowledge of schizophrenia among caregivers and PDwS. The researchers also examined how education affected symptoms, relapse rates, hospitalizations, medication, and caregiver burden of care. DESIGN TYPE AND LEVEL OF EVIDENCE: Randomized controlled trial, Level I
SAMPLE SELECTION The participants were recruited on the basis of a primary diagnosis of schizophrenia or schizoaffective disorder, according to the Diagnostic and Statistical Manual of Mental Disorders (4th edition; DSM IV). Posters were placed in outpatient centers; both acute and chronic patients being treated in these clinics were targeted. Interested patients received further information about the study directly from a research student or mental health professional in these clinics. The patients then received a verbal explanation of the study and were provided with a written informed consent form. Inclusion Criteria PDwS ages 18 or older and their caregivers Able to read and write in English and Arabic Willing and able to consent Exclusion Criteria PDwS who had a learning disability, known organic mental disorder, or substance abuse disorder or who lived alone or without close contact with caregivers Participants currently receiving any formal psychoeducational intervention Primary caregivers involved in caring for more than one person diagnosed with mental health problems SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) 121 #/ (%) Male Ethnicity Patients: 84/(69.4%) Caregivers: 29/(24%) #/ (%) Female Patients: 37/(30.6%) Caregivers: 92/(76%) Schizophrenia: 65/(53.7%); schizoaffective disorders: 56/(46.3%) Disease/disability diagnosis INTERVENTION(S) AND CONTROL GROUPS 2
Group 1: Control Group Brief description of the intervention How many participants in the control group? Where did the intervention take place? Who Delivered? How often? All participants continued to receive TAU, which consisted of medication and laboratory investigations delivered by the mental health team. 63 Each participant received TAU from his or her respective outpatient mental health clinic in Amman, Jordan. Four clinics were used; all were state funded and provided similar care. Mental health team (no specification was provided) Not specified For how long? Not specified; study ran from September 2012 to July 2013 Group 2: Experimental Group Brief description of the intervention How many participants in the group? Where did the intervention take place? Who Delivered? How often? For how long? The experimental group received TAU, supported by psychoeducational booklets every 2 weeks for 12 weeks. The researchers also made follow-up phone calls to primary caregivers to ensure they had read and understood the booklet and were able to ask questions about content if needed. 58 Each participant received TAU from his or her respective outpatient mental health clinic in Amman, Jordan. Four clinics were used; all were state funded and provided similar care. Mental health team (no specification was provided) Every 2 weeks 12 weeks Intervention Biases: Check yes, no, or and explain, if needed. 3
Contamination: Co-intervention: Comments: Participants in both groups received TAU, which consisted of medication and laboratory investigations. Timing: Site: Comments: The study took place in the four outpatient centers where the patients receive their TAU. Use of different therapists to provide intervention: Comments: The role of the therapists was just to mail the psychoeducational pamphlets to the participants, so although the participants might have had different therapists, that should not have had an effect on the intervention. MEASURES AND OUTCOMES Measure 1: Knowledge about Schizophrenia Questionnaire (KASQ) Self-reported knowledge of schizophrenia: 25 items about management, etiology, prevalence, prognosis, and treatment Total scores range from 0 to 25 (a higher score indicates more knowledge of schizophrenia) Comment: Cronbach s alpha coefficient is between.85 and.89 (.88 4
for the Arabic version); test reliability is.83. Comment: High content validity At baseline, immediately postintervention, and at 3-month followup Measure 2: Positive and Negative Symptoms Scale (PANSS) for PDwS Positive and negative schizophrenia symptoms (30 clinical symptoms): Responses are scored on a 1 7 scale, where 1 indicates absence of psychopathology and 7 indicates severe psychopathology. Comment: Internal reliability:.77 for the Positive scale,.77 for the Negative scale, and.52 for the Clinical Global Impression scale Interrater reliability =.75.79 Comment: Criterion-related validity:.77 for the Positive scale,.77 for the Negative scale, and.52 for the Clinical Global Impression scale At baseline, immediately postintervention, and at 3-month followup Measure 3: Family Burden Interview Scale (FBIS) Family burden of care 24 items, focuses on six domains of primary caregivers burden: family finance, routine, leisure time, physical health, mental health, and family interaction Each item is rated on a 3-point Likert scale (0 = no burden, 2 = severe burden) Comment: Cronbach s α =.87, test retest reliability =.83; translated version, Cronbach s α =.87, interrater reliability =.86 5
At baseline, immediately postintervention, and at 3-month follow-up Measure 4: Schizophrenic Carers Quality of Life Scale (S-CQoL) for primary caregivers Quality of life 25 items looking at physical and psychological well-being, psychological burden and daily life, relationship with spouse, relationship with psychiatric team, relationship with family, relationship with friends, and material burden Total scores range from 25 to 125 (a higher score indicates a better quality of life) Comment: Cronbach s α =.79.92 for the English version. For the Arabic version, interrater reliability =.87, internal consistency =.87 At baseline, immediately postintervention, and at 3-month followup Measure 5: Relapse Relapse rates, defined by hospitalization and the number and dosage of antipsychotic medications prescribed to participants Comment: Moderate; interrater reliability (Kappa agreement) of.43 3 months before the study began, immediately postintervention, and at 3-month follow-up 6
Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or and if no, explain. Comment: Evaluators knew which group the participants had been allocated to, as did the participants. Recall or memory bias. Check yes, no, or, and if yes, explain. Comment: Participants provided information through structured interviews, recalling past events. This might have led to inaccurate reporting. Others (list and explain): The testing measures had not been used in Arabic-speaking countries before this study, so they had to be translated from English to Arabic for use and then back to English for scoring. RESULTS Knowledge of schizophrenia (measured with KASQ scores): At baseline, control and experimental groups showed no statistical significant difference in KASQ scores. After treatment, the experimental group scored statistically significantly higher on the KASQ (p <.001). The results for this measure were demonstrated with a large effect size (.62 and.52). These results show improvement in knowledge after intervention. Experience of positive and negative schizophrenic symptoms (measured with the PANSS for PDwS): Baseline scores indicated no statistically significant difference between control and experimental groups. After treatment, statistically significant differences (p <.001) were demonstrated, with a large effect size (.39) for the group over time. This indicates that there was a reduction in symptom severity after intervention. Relapse (measured by hospitalizations and medications): At posttreatment, the intervention group only experienced three relapses (5.2% of the 58 PDwS in the group) that required hospitalization, and at the 3-month follow-up, the group experienced four relapses (6.9% of PDwS). In contrast, the control group experienced 31 relapses posttreatment (49.2% of the group) and 32 relapses at the 3-month follow-up (50.8%). Significance values for group comparisons indicate a statistically significant difference (p <.001) for all hospitalization rate measurements. Medication use was also significantly higher in the intervention group compared with the control group at posttreatment (p <.002) and at 3-month follow-up (p <.001). These results show that the intervention affected the number of hospitalized relapses. Outcomes for primary caregivers (measured with KSQ, FBIS, and S-CQoL): At baseline, the scores for all three measurements indicated no statistically significant difference between groups. Group and time effect were statistically significant for all 7
primary caregiver outcomes. Although no significance values or effect sizes were reported, the researchers indicated that these results show how the intervention positively affected caregiver outcomes. Was this study adequately powered (large enough to show a measured difference)? Comment: The sample size was estimated on the basis of existing literature to show a 2-point posttreatment difference, along with a power of 80%, p <.05, and an attrition rate of 15%. Thus, a sample size of 144 was identified. Were appropriate analytic methods used? Check yes, no, or, and if no, explain. Comment: Analysis was done by intention to treat, with the last observation carried forward to handle missing data at posttreatment and 3-month follow-up. Demographic data were summarized by frequencies and percentages. A goodness-of-fit chi-square test was used for categorical variables, and independent samples t tests were used for continuous variables. Analysis of variance (between and within groups) was used to determine whether treatment produced between-groups, within-group, and interactive effects of treatment by time for each outcome. The McNemar test was used to identify the difference in relapse rates between groups from baseline, at posttreatment, and at 3-month followup. Were statistics appropriately reported (in written or table format)? Comment: Results for the chi-square test were appropriately reported in written format. The authors also used a chart format to report the analysis of variance test (Group Time) for the KASQ, PANSS, and FBIS with S- CQoL scores at pretest and posttests and results for repeat measures between the intervention and control group. Was the percent/number of subjects/participants who dropped out of the study reported? Limitations: Outcome measures were self reported. Medication compliance was not monitored. CONCLUSIONS 8
This study had several key conclusions: Interventions using psychoeducational booklets and TAU were more effective than TAU alone at improving PDwS s knowledge of schizophrenia and psychological outcomes. Adding a brief psychoeducational intervention to routine care in a psychiatric clinic was an effective way to ameliorate significant symptoms of schizophrenia. Relapse rate was reduced in both groups at both follow-up points; however, the difference was statistically significant in favor of the intervention group. In the light of secondary outcomes for primary caregivers (burden of care and quality of life), the study findings show a significant change in all outcomes in the intervention group at posttreatment and 3-month follow-up. The psychoeducational model adopted in this study suggests that improving knowledge about schizophrenia and its management among PDwS and their primary caregivers improves the relationship of PDwS and primary caregivers with mental health professionals and improves caregivers confidence in dealing with the PDwS s unexpected or challenging behavior. This work is based on the evidence-based literature review completed by Margaret A. Hammett, OTS; Jennifer Campbell, OTS; Anne Beckett-Fedarko, OTS; Lisa Prang, OTS; and Rochelle Mendonca, PhD, OTR/L, Faculty Advisor, Temple University. CAP Worksheet adapted from Critical Review Form Quantitative Studies. Copyright 1998 by M. Law, D. Stewart, N. Pollack, L. Letts, J. Bosch, and M. Westmorland, McMaster University. Used with permission. 9