Abstract of dissertation entitled. Internet-based Cognitive Behavioural Therapy to Improve Sleep Efficiency. in Adults with Insomnia.

Transcription

1 Abstract of dissertation entitled Internet-based Cognitive Behavioural Therapy to Improve Sleep Efficiency in Adults with Insomnia Submitted by Yao Cheuk Ni for the Degree of Master of Nursing at The University of Hong Kong in August 2014 Insomnia is a common health problem among adults in Hong Kong. It can adversely impact the patients physiologically, behaviorally, emotionally and socially, and add burdens to the healthcare system. A new form of treatment for insomnia is the Internet-based or computerized cognitive behavioral therapy for insomnia (CCBT-I). However, it had not been systematically reviewed. The purposes of this dissertation are (1) to evaluate current evidence on the

2 effectiveness of CCBT-I in improving sleep efficiency in adults with insomnia; (2) to develop an evidence-based guideline for the CCBT-I programme; (3) to assess the implementation potential of a CCBT-I programme in a special observation ward of a local hospital in Hong Kong (Ward A); and (4) to develop an implementation and evaluation plan of the CCBT-I programme. A systematic search on the electronic databases Pubmed and PsycINFO revealed six randomized controlled trials that assessed the effectiveness of CCBT-I in patients with insomnia. Data of the identified studies was extracted and the methodological quality was assessed using the Scottish Intercollegiate Guidelines Network (SIGN) methodology checklist for randomized controlled trials (SIGN, 2013). The transferability of the findings of the identified studies, feasibility of implementing CCBT-I in Ward A, and the cost and benefit were assessed. An evidence-based guideline for CCBT-I, with seven recommendations regarding the programme duration, contents, and features, was developed. Strategies for communicating with the stakeholders, plans for pilot testing and evaluation of outcomes were described. The primary outcome measure of the programme evaluation is the patients sleep efficiency (SE). Other study outcomes include patients total sleep time (TST) and wake time after sleep onset (WASO),

3 nurses satisfaction with the CCBT-I programme and confidence in educating the patients to access to the CCBT-I website, Ward A s readmission rate of the insomnia patients and the annual healthcare cost of managing the readmitted patients. It was found that there are six randomized controlled trials supporting the effectiveness of CCBT-I in improving SE in adults with insomnia. The evidence suggests that the target patients for the proposed programme should be adults who report sleep difficulties, have regular Internet access, and have stable mental and medical conditions. The duration of the programme can be set for 6 weeks. It should contain main components like sleep restriction, stimulus control, sleep hygiene and cognitive restructuring. It can be designed with highly interactive elements. Automated reminders by can also be used. The evidence is applicable for Ward A in terms of setting, target patients and philosophy of care. Determinants such as support from ward nurses and administrators, staff training and collaboration between disciplines were considered to draw a conclusion that a CCBT-I programme is feasible in Ward A. The proposed programme is cost-effective and may help to generate an annual saving of over HK$ The preparation, implementation and evaluation of the proposed programme will take a total of 30 months. Before the 6-week programme is carried out, a pilot test will

4 be conducted and completed in 3 months. Data collection will be done immediately after the programme and 48 weeks after the programme. A final period of 4 months will be required for data analysis and reporting. The evaluation results will determine whether the CCBT-I programme is justified for a change of practice in Ward A.

5 Internet-based Cognitive Behavioural Therapy to Improve Sleep Efficiency in Adults with Insomnia By Yao Cheuk Ni Bachelor of Nursing A dissertation submitted in partial fulfillment of the requirements for the Degree of Master of Nursing at The University of Hong Kong August 2014

6 i Declaration I declare that this dissertation represents my own work, except where due acknowledge is made, and that it has not been previously included in a thesis, dissertation or report submitted to this University or to any other institution for a degree, diploma or other qualifications. Signed Yao Cheuk Ni

7 ii Acknowledgements I would like to express my gratitude to my supervisors Dr. Patsy Pui-Hing Chau, Assistant Professor, and Dr. Daniel Yee-Tak Fong, Associate Professor, for their guidance and concern throughout the learning process of this translational nursing research. Besides, I would like to thank my colleagues for the encouragement and accommodating my duty request in the past two years.

8 iii Contents Declaration.. i Acknowledgements. ii Contents iii Chapter 1: Introduction 1.1 Background Affirming the needs Objectives and significance... 6 Chapter 2: Critical appraisal 2.1 Search and appraisal strategies Selection criteria Search strategy Appraisal strategy Results Systematic search Study characteristics 11

9 iv Methodological quality Summary and synthesis Summary of data Synthesis of data.. 18 Chapter 3: Translation and application 3.1 Implementation potential Transferability Feasibility Cost-to-benefit assessment Evidence-based practice guideline.. 33 Chapter 4: Implementation and evaluation plans 4.1 Communication plan Stakeholders Strategies for communicating with the stakeholders Plan for pilot testing Preparation of the pilot test Subject recruitment.. 39

10 v Data collection Data evaluation Evaluation plan Outcomes Nature and number of patients to be involved Timing and frequency of data collection Data analysis Basis for recommendation of the CCBT-I programme Conclusion References. 47 Appendices Appendix A: Search history 53 Appendix B: Table of evidence 54 Appendix C: Quality appraisal using Scottish Intercollegiate Guidelines Network (SIGN) methodology checklist for randomized controlled trials.. 58 Appendix D: Schedule for the CCBT-I programme 61

11 vi Appendix E: Estimated setup cost of the CCBT-I programme (material cost) 62 Appendix F: Estimated setup cost of the CCBT-I programme (non-material cost) 63 Appendix G: Estimated annual running cost of the CCBT-I programme (material cost) 64 Appendix H: Estimated annual running cost of the CCBT-I programme (non-material cost). 65 Appendix I: Annual saved cost.. 66 Appendix J: Guideline on Internet-based cognitive behavioural therapy for adults with insomnia.. 67 Appendix K: Grading of recommendations 73 Appendix L: Example of a sleep diary Appendix M: Questionnaire for Nurses... 76

12 1 Chapter 1: Introduction 1.1 Background Insomnia is a highly prevalent disorder among adults in not only Hong Kong but also the world. Approximately 1 in 4 people reported to have poor sleep in a worldwide cross-sectional survey (Soldatos, Allaert, Ohta, & Dikeos, 2005). The prevalence of insomnia was found to be 39.4% in a cross-sectional study conducted in Hong Kong (Wong & Fielding, 2011). The prevalence may be higher than reported because not all the insomnia-sufferers recognize that they have the problem and seek medical attention. According to Roth (2001), insomnia is often under-diagnosed and under-treated. Insomnia can be diagnosed as a primary disorder. According to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR), primary insomnia can be defined as having predominant complaints like difficulty initiating sleep, maintaining sleep, or non-restorative sleep, for at least one month (American Psychiatric Association, 2000). Co-morbid insomnia is diagnosed instead if the sleep disturbances coexist with medical or psychiatric disorders. The International Classification of Sleep Disorders (American Academy of Sleep Medicine, 2005) defines the severity of insomnia

13 2 according to the degree to which the patients social, occupational or other important aspects of functioning are adversely affected. Mild insomnia can be associated with feelings of restlessness, irritability, mild anxiety, daytime fatigue and tiredness but it causes little or no impairment of social or occupational functioning. Moderate insomnia, however, can cause mild or moderate impairment of social or occupational functioning. Severe insomnia can cause severe impairment. Insomnia may be linked to significant morbidity and have detrimental effects on the patients general health. Persistent sleep loss can adversely impact the patients physiologically, behaviorally, emotionally and socially (Ward, 2011). Physiologically, immune function and endocrine function can be altered. Problems like hypertension and impaired healing can be caused. Behaviorally, fatigue, impaired daytime functioning, impaired short-term memory and impaired coping can be resulted. The emotional health outcomes include altered mood and low motivation. The social health outcomes include worsened social and family interactions. Insomnia is found to have negatively affected patients quality of life (IsHak et al., 2012) Insomnia can increase the burden to the society because it leads to greater use of general medical facilities (Kuppermann et al., 1995). In a cross-sectional study

14 3 conducted in Hong Kong (Fielding & Wong, 2012), healthcare utilization for those with chronic insomnia is found to be as high as 49%. About 30.2% of the respondents had attended the western medicine practitioners. About 17.6% of the respondents had consulted at least one type of therapists among which Chinese medicine practitioners were the most frequently consulted. Besides the great use of medical facilities, which increases the healthcare cost, insomnia may also be associated with the high rates of work absenteeism (Kuppermann et al., 1995) and accidents or injuries (Yee, Campbell, Beasley, & Neill, 2002). Therefore, managing insomnia can indirectly help to alleviate those problems. One of the treatment options for insomnia is pharmacotherapy. Short-intermediate acting benzodiazepine receptor agonists and sedating antidepressants are commonly prescribed by the physicians. Some people may purchase over-the-counter antihistamine or herbal substances to aid in sleeping. However, they have insufficient efficacy and safety data, thereby are not recommended to treat chronic insomnia (Schutte-Rodin, Broch, Buysee, Dorsey, & Sateia, 2008). Another treatment option is the cognitive behavioural therapy for insomnia (CBT-I). It includes components like stimulus control, sleep restriction, sleep hygiene and cognitive restructuring. CBT-I was found to be effective and have more long-lasting therapeutic effect than pharmacotherapy (Riemann &

15 4 Perlis, 2009). Internet-based or computerized CBT-I (CCBT-I) is a new form of CBT-I but it had not been systematically reviewed. This new approach of using the Internet is more accessible and available than the traditional one which is delivered face-to-face by trained therapists (Griffiths, Lindenmeyer, Powell, Lowe, & Thorogood, 2006). In addition to the accessibility, the cost-effectiveness of CCBT also contributes to the increasing use of the new approach (Andersson, 2009). In this way, Espie s model of stepped care for insomnia has suggested the use of the Internet as a first line treatment for insomnia (Espie, 2009). The treatment goals of the CCBT-I are improving sleep quality and quantity, and reducing insomnia associated daytime impairment. Common outcome indicators for sleep include sleep efficiency (SE), total sleep time (TST), wake time after sleep onset (WASO), sleep onset latency (SOL), formation of a positive and clear association between the bed and sleeping, and level of sleep-related psychological distress. 1.2 Affirming the Needs Many patients attend the hospitals or outpatient clinics to seek treatment for insomnia, regardless of whether it is primary or co-morbid with other mental or

16 5 medical conditions. In a local publicly funded hospital, a special observation ward (Ward A), which is operated by the Department of Medicine, was set up to hospitalize patients who are emotionally, psychologically or mentally unstable. Excluding those with acute psychiatric diagnoses, more than one-tenth of the patients suffer from insomnia. The number of admission to Ward A is about 250 per month, meaning that the number of insomnia patients admitted to Ward A is about 25 per month or 300 per year. They have reported to have difficulties falling asleep or maintaining sleep. Insufficient sleep also causes them daytime tiredness and mood disturbances. Some of the patients have to rely on hypnotics in order to get into sleep. Overdose may occur in some occasions. These correspond to the literature findings. Studies have shown that prolonged use of hypnotics is associated with drawbacks like psychological dependence, tolerance and addiction (Van Straten & Cuijpers, 2009). Definitely it is not just about administrating the drugs prescribed by the physicians in the management of insomnia. Non-pharmacological interventions can be effective to tackle persistent insomnia (Smith et al., 2002) and nurses can play an important role in it. Nurses in Ward A do recognize that both pharmacological and non-pharmacological therapies are important in managing insomnia. For pharmacological approach, the prescribed hypnotics are administered to the

17 6 patients whenever necessary. The drug effects are observed and reported to the physicians for adjustment of the dosage. For non-pharmacological approach, one of the daytime routines is to arrange some patients, who have poor sleep at night, to get out of beds and sit on the chairs. This aims to limit their time in bed during daytime and avoid too many naps. At bedtime, the televisions are switched off and the lights are dimmed so as to provide the patients with a sleep-promoting environment. Nursing procedures are minimized to avoid disruptions to their sleep. Junior ward staffs learn to do these practices with verbal instructions. There is no black-and-white guideline to explain these practices. Since they are based on experience but not evidence, their actual effects are uncertain. Moreover, the patients in Ward A usually have short length of stay in the hospital and may be referred to the outpatient clinics on discharge. The current ward practices may not really help them, especially in the long run. Some of them may even be readmitted because of persistent insomnia. There is a need to construct an empowering and efficacious evidence-based programme for those insomnia-suffering patients so they can learn to sleep healthily when they return home. A CCBT-I programme can be a solution to this. 1.3 Objectives and Significance

18 7 In this dissertation, a translational nursing research approach is used to develop an evidence-based CCBT-I programme. The objectives of this dissertation are listed as follows: (1) to systematically evaluate the current evidence on the effectiveness of CCBT-I in improving sleep efficiency in adults with insomnia; (2) to develop an evidence-based guideline for the CCBT-I programme; (3) to assess the implementation potential of a CCBT-I programme in a special observation ward of a local hospital in Hong Kong (Ward A); and (4) to develop an implementation and evaluation plan of the CCBT-I programme. Managing insomnia is significant to the patients, healthcare workers, hospitals as well as the society. If the patients are empowered to manage insomnia, the chance of having insomnia-associated health problems will be lowered. The rates of outpatient clinic attendance, admission and re-admission to the hospitals, especially to Ward A, due to insomnia can be lowered too. The reduced healthcare utilization can result in reduction of the workload of the healthcare workers and the healthcare cost, i.e. lessening the burden of the society.

19 8 Chapter 2: Critical Appraisal 2.1 Search and Appraisal Strategies Selection criteria. Studies were included if their study populations were adults aged 18 or above who (1) had a clinical diagnosis of insomnia; or (2) had subjective complaint of sleep difficulties and daytime impairments. The intervention should be a CCBT-I programme delivered via the Internet. It should comprise the main components of a traditional CBT-I including sleep hygiene, stimulus control, sleep restriction and cognitive restructuring, but should not be limited to them. The outcomes should at least involve objective measures like sleep efficiency, sleep onset latency, and total sleep time. Randomized controlled trials (RCTs) were included. Studies were excluded if the study population (1) were shift workers who were unable to establish a regular sleeping schedule; (2) had unstable medical conditions; or (3) had an acute manic or psychotic disorder Search strategy. A systematic search was conducted using the electronic databases Pubmed and PsycINFO. The studies were selected according to a set of criteria listed in the following paragraphs. Key search terms include: (1) internet/ web/ online/ computer-aided/ computer-assisted/ computer-guided/

20 9 computerized; AND (2) CBT/ cognitive therapy/ behavioural therapy; AND (3) insomnia/ sleep disorders/ sleep problem. The titles and abstracts of the identified studies were then screened manually for potential studies. The full texts of the potential studies were screened for eligible studies. The reference lists of the eligible studies were also examined. Data including study type, quality, patient characteristics, intervention, comparison, length of follow-up, outcome measures and effect size, was extracted and summarized in the table of evidence according to the Scottish Intercollegiate Guidelines Network (SIGN) (SIGN, n.d.) Appraisal strategy. To assess the methodological quality of the identified studies, the SIGN methodology checklist for randomized controlled trials (SIGN, 2013) was used as the assessment tool. The checklist is divided into 2 sections. The first one examines how well the studies are designed to minimize risk of bias. It assesses areas like: (1) whether the research question is clearly defined; (2) randomization strategy; (3) concealment method; (4) presence of blinding; (5) whether there is significant difference between study groups; (6) whether the study groups are treated equally; (7) reliability of outcome measures; (8) dropout rate; (9) whether intention-to-treat analysis is performed; and (10) whether results obtained in different sites are similar. The second section is about the overall assessment of the study. It evaluates the overall rating on the

21 10 methodological quality, as well as the certainty and applicability of the study finding. The methodological quality is rated according to the extent to which the risk of bias is minimized. High quality (++) means the majority of the listed criteria are met. There is little or no risk of bias. It is unlikely that the results will be changed by further study. Acceptable (+) means most of the listed criteria are met but there are some flaws in the study, causing some risk of bias. Further study may change the conclusions. Low quality (0) means most of the listed criteria are not met or there are significant flaws in the study design. Further study is likely to change the conclusions. 2.2 Results Systematic search. The systematic search was conducted in the period from 13th March to 22nd July After the search terms were entered into the two electronic databases Pubmed and PsycINFO, 141 and 148 citations were retrieved respectively. After screening the titles and abstracts, 7 and 8 potential studies were selected respectively. The next step was screening the full texts of the potential studies and only 5 and 6 studies in the respective databases met the selection criteria. The reference lists of those studies were examined but no extra

22 11 study was found. Among those 11 studies, five of them were duplicated, thus were removed. Finally six relevant studies were identified (Strom, Pettersson, & Andersson, 2004; Ritterband et al., 2009; Vincent & Lewycky, 2009; Espie et al., 2012; Lancee, van den Bout, van Straten, & Spoormaker, 2012; Ritterband et al., 2012). The search history is shown in Appendix A Study characteristics. The data of the studies were summarized in the table of evidence (Appendix B). The six RCTs were published from 2004 to Two of the studies were conducted in the US (Ritterband et al., 2009; Ritterband et al., 2012). The other four were conducted in Sweden, Canada, UK and the Netherlands (Strom et al., 2004; Vincent & Lewycky, 2009; Espie et al., 2012; Lancee et al., 2012). One of the studies just stated that the participants were adults but it did not report the participants exact age, and did not report any formal diagnosis of insomnia (Vincent & Lewycky, 2009). The participants in the rest of the studies were reported to have mean age of 44.1 to 56.7, and had formal diagnoses of insomnia based on the DSM-IV, DSM-IV-TR or DSM-V criteria. The participants reported to have subjective complaint of sleep difficulties and daytime impairment for over 3 months (Strom et al., 2004; Espie et al., 2012) or over 6 months (Ritterband et al., 2009; Vincent & Lewycky, 2009; Ritterband et al., 2012). The

23 12 study by Lancee et al. (2012) did not specify the duration of symptoms. One of the studies (Ritterband et al., 2012) stated clearly that the participants should have less than 6.5 hours of sleep per night on average over the past month while the other five studies did not. The participants state of illness was described in two of the studies. Vincent and Lewycky (2009) recruited participants who had stable condition if a comorbid sleep or psychiatric disorder was present. Ritterband et al. (2012) recruited participants who were in remission from any stage or type of cancer, and had completed active treatment for more than a month Methodological quality. The methodological quality of the identified studies was assessed using the SIGN methodology checklist for randomized controlled trials (SIGN, 2013) (Appendix C). All selected studies could clearly define the research questions. Random assignment of subjects were performed and reported in all except one study which did not specify the randomization strategy (Strom et al., 2004). Only one study (Espie et al., 2012) had used an adequate concealment method. However, no concealment was reported in the other five studies. Presence of blinding was not mentioned in four studies (Strom et al., 2004; Ritterband et al., 2009; Vincent & Lewycky, 2009; Ritterband et al., 2012) but it was mentioned in the study of Espies et al. (2012). Both the participants and investigators were not kept blind in the study of Lancee et al. (2012). Four studies

24 13 reported that the treatment and control groups had similar demographic characteristics at the start of the trials (Ritterband et al., 2009; Vincent & Lewycky, 2009; Espie et al., 2012; Lancee et al., 2012). One study reported significant differences in sex (p=0.03) and cancer type (p=0.002). The other one (Strom et al., 2004) did not state whether there was significant difference between groups. In all study, the only difference between groups was the treatment under investigation. The outcome measures were standard, valid and reliable in all studies. The dropout rates in the treatment groups ranged from 4.5% (Ritterband et al., 2009) to 44.4% (Strom et al., 2004) while those in the control or alternative groups ranged from 4.3% (Ritterband et al., 2009) to 33.9% (Vincent & Lewycky, 2009). The dropout rate in Strom et al. (2004) was high but no explanation was reported. Sensitivity analysis on the possible influence of missing values was not reported either. Four of the studies used intention-to-treat (ITT) analysis (Ritterband et al., 2009; Espies et al., 2012; Lancee et al., 2012; Ritterband et al., 2012). But ITT was not mentioned in the other two studies (Strom et al., 2004; Vincent & Lewycky, 2009). Five of the studies were rated to have acceptable (+) methodological quality (Ritterband et al., 2009; Vincent & Lewycky, 2009; Espies et al., 2012; Lancee et al., 2012; Ritterband et al., 2012) but the other one was rated to have low quality

25 14 (0) (Strom et al., 2004). It was likely that the overall effects could be attributed to the study interventions in three of the studies (Ritterband et al., 2009; Espies et al., 2012; Lancee et al., 2012) but not in the study of Strom et al. (2004). It was uncertain whether it was true in Vincent and Lewycky s study (2009) because ITT was not mentioned but it seemed to have dealt with the missing data. It was also uncertain in the study by Ritterband et al. (2012) as the sample size was small and there were imbalance of sex and cancer type. The generalizability is in doubt. Despite different level of risk of bias, results in all of the six studies could be applicable to the local population. 2.3 Summary and Synthesis Summary of data. Six RCTs that examined the effectiveness of CCBT-I were identified (Appendix B). The target participants in these studies were adults who were diagnosed to have insomnia or had symptoms of insomnia. The interventions under investigation were all CCBT-I programmes but with different durations, contents and characteristics. They were compared to either a wait-list control or an alternative treatment. Sleep data was collected and analyzed. The following paragraphs sum up the interventions, comparisons, follow-ups, outcome measures, data analysis and effect sizes.

26 Interventions. All the six studies employed Internet-based (or online) CBT-I programme. Ritterband et al. (2009) and Ritterband et al. (2012) used exactly the same programme called SHUTi (Sleep Healthy Using the Internet) but on different subjects. In the studies, it was required that the participants had access to a computer (Strom et al., 2004; Vincent & Lewycky, 2009; Espie et al., 2012;), a modem (Strom et al., 2004; Espie et al., 2012), the Internet (Strom et al., 2004; Ritterband et al., 2009; Vincent & Lewycky, 2009; Espie et al., 2012; Ritterband et al., 2012), and a valid address (Lancee et al., 2012). In all the six studies, the duration of the intervention ranged from 5 weeks to 9 weeks. They all comprised components like sleep restriction, stimulus control, sleep hygiene and cognitive restructuring. Besides, psychoeducation was included in three studies (Vincent & Lewycky, 2009; Espie et al., 2012; Lancee et al., 2012). Relaxation was included in two studies (Strom et al., 2004; Espie et al., 2012). Relapse prevention was included in two studies (Ritterband et al., 2009; Ritterband et al., 2012). Paradoxical intention was included in one study only (Lancee et al., 2012). The CCBT-I programmes in the six studies had different features. For example, four of the studies used automated reminders (Strom et al., 2004; Ritterband et al., 2009; Espie et al., 2012; Ritterband et al., 2012). The CCBT-I

27 16 programmes contained interactive elements in three studies (Ritterband et al., 2009; Espie et al., 2012; Ritterband et al., 2012). Among the above three studies, Espie et al. (2012) was found to have the most interactive features, including an automatic calculation of sleep data as well as an online forum moderated by experts. One study only used an audio-visual mode with occasional text material (Vincent & Lewycky, 2009). Another study used a simple website which had no interactive element (Lancee et al., 2012) Comparisons. In all the six studies, the CCBT-I was compared with a wait-list control. Participants in the control group were able to gain access to the CCBT-I programmes after the trials had ended. Two of the studies also employed alternative interventions for comparison. In the study of Espie et al. (2012), an online imaginary relief therapy (IRT) acted as a placebo. It contained very brief information about sleep, relaxation, breathing control and pseudo-desensitization. It had the same duration and similar features as the CCBT-I programme. Participants in this placebo group could also access to the CCBT-I after the trial. Another study (Lancee et al., 2012) used paper-and-pencil CBT-I as an alternative. The contents and the duration were the same as the CCBT-I programme Follow-ups. The length of follow-up period differed among the studies. One of the studies did not mention any follow-up investigation

28 17 (Ritterband et al., 2012). Among the remaining five studies, the shortest follow-up period lasted for 8 weeks (Espie et al., 2012), while the longest follow-up period lasted for 48 weeks (Lancee et al., 2012) Outcome measures. All studies used sleep diaries for assessing the outcomes. The common outcomes included sleep efficiency (SE), total sleep time (TST), sleep onset latency (SOL) and wake time after sleep onset (WASO). Other particular outcomes included number of nocturnal awakenings (NWAK), total time in bed (TIB), sleep quality (SQ) and the Insomnia Severity Index (ISI) Data analysis and effect sizes. Multilevel regression analyses were used to analyze the sleep data in one of the studies (Lancee et al., 2012) while analyses of variance (ANOVA) were used in the other five studies (Strom et al., 2004; Ritterband et al., 2009; Vincent & Lewycky, 2009; Espie et al., 2012; Ritterband et al., 2012). In the study of Lancee et al. (2012), significant improvement (p<0.01) was found in both online CBT and paper-and-pencil CBT at 4-week follow-up on SE ( d= ), TST ( d= ), SOL ( d= ), and WASO ( d= ). Of the five remaining studies, four reported significant interaction between time and group in SE (Strom et al., 2004; Ritterband et al., 2009; Espie et al., 2012; Ritterband et al., 2012); two reported significant interaction between time and group (p<0.05) in TST (Strom et al.,

29 ; Espie et al., 2012); two reported significant interaction between time and group (p<0.05) in SOL (Espie et al., 2012; Ritterband et al., 2012); two reported significant interaction between time and group (p<0.05) in WASO (Ritterband et al., 2009; Espie et al., 2012); and three reported significant interaction between time and group (p<0.05) in ISI (Ritterband et al., 2009; Vincent & Lewycky, 2009; Ritterband et al., 2012). All studies demonstrated that CCBT-I was an effective intervention in improving sleep in adults with insomnia. The effect sizes were defined as the differences in means (CCBT - wait-list control). Regarding the post-treatment effect, SE ranged from (Strom et al., 2004) to (Espie et al., 2012). TST ranged from +0.6 min (Strom et al., 2004) to min (Espie et al., 2012). SOL ranged from min (Espie et al., 2012) to -8.6 min (Strom et al., 2004). WASO ranged from -51 min (Espie et al., 2012) to min (Strom et al., 2004). ISI ranged from (Ritterband et al., 2009) to (Vincent & Lewycky, 2009) Synthesis of data. One of the six identified studies was found to have low methodological quality (Strom et al., 2004). It had several flaws in the study design. The major ones included uncertainty about the randomization strategy, concealment method and ITT analysis. The dropout rate in the treatment group

30 19 was high but no explanation was provided. No sensitivity analysis on the possible influence of noncompliance and missing values was reported either. These reduced the strength of evidence of this study. Nevertheless, it was the first study in which the Internet was used to deliver self-help CBT for insomnia. It is worth paying attention to despite low methodological quality. The CCBT-I programmes in all the six studies were common in the main treatment components including sleep restriction, stimulus control, sleep hygiene and cognitive restructuring. They were found to be effective in improving sleep (Strom et al., 2004; Ritterband et al., 2009; Vincent & Lewycky, 2009; Espie et al., 2012; Lancee et al., 2012; Ritterband et al., 2012). There were some additional features in different programmes which may explain the difference in results. Among the six studies, the increase in SE in the study by Espie et al. (2012) seemed to be the greatest and the statistical analysis had shown that the result was significant. The CCBT-I programme of Espie et al. (2012) had the greatest number of additional features such as pre-programmed interactive sessions with the animated virtual therapist. It also had a support/motivation system including text reminders by the virtual therapist, an online social community or forum moderated by experts, and a graduation ceremony on completion of the course. These can be important to encourage

31 20 participants to move on, adhere to the treatment and benefit from it in the long run. The increase in SE in the studies by Ritterband et al. (2009) and Ritterband et al. (2012) was smaller than the previous study. These two studies showed similar results probably because they used the same CCBT-I programme (SHUTi). This programme was reported to have interactive elements such as quizzes and games (Ritterband et al., 2009; Ritterband et al., 2012). Besides, automated reminders were sent to the participants via so as to promote their compliance to the treatment. The increase in SE in the studies by Vincent and Lewycky (2009) and Lancee et al. (2012) seemed to be the smallest. The post-treatment SE means were not given in the article of Lancee et al. (2012). However, when comparing the 4-week-follow-up effect size in the study by Lancee et al. (2012) with that by Vincent and Lewycky (2009), it can be assumed that the interventions in both the studies had similar effect in terms of SE. The CCBT-I programme of Lancee et al. (2012) was delivered in a simple website without any interaction while that of Vincent and Lewycky (2009) was delivered in audiovisual mode with small amount of texts to highlight particular points. In view of the evidence, interactive elements and automated reminder

32 21 are thus recommended for the CCBT-I programme. When a CCBT-I programme is to be constructed, more detailed presentation and the use of technology must be considered. The CCBT-I programmes differed from each other regarding the programme duration. Five-week programmes were launched in two studies (Strom et al., 2004; Vincent & Lewycky, 2009). Six-week programmes were launched in two studies (Espie et al., 2012; Lancee et al., 2012). Nine-week programmes were launched in the other two studies (Ritterband et al., 2009; Ritterband et al., 2012). All of them were found effective in improving sleep. Taking the effect size into account, the shortest intervention time can be taken as six weeks. To conclude, there is sufficient evidence to support the effectiveness of CCBT-I in improving sleep efficiency in adults with insomnia. A CCBT-I programme can be developed and applied in Ward A. The target patients for this intervention should be adults who are aged 18 or above and have regular Internet access. They should report sleep difficulties, such as difficulty initiating sleep and difficulty remaining sleep. They should have stable mental and medical conditions. The duration of the programme can be set for six weeks. It should contain main components like sleep restriction, stimulus control, sleep hygiene and cognitive restructuring. It can be designed with highly interactive elements. Automated

33 22 reminders by can also be used. Sleep diary should be adopted to collect patients sleep data.

34 23 Chapter 3: Translation and Application As described in the previous chapters, insomnia is found to be a prevalent disorder among adults in Hong Kong. Internet-based or computerized cognitive behavioral therapy for insomnia (CCBT-I) is a relatively new self-help treatment found to be effective in improving patients sleep efficiency. Therefore, a CCBT-I programme is proposed for the Ward A as an innovative intervention. In this chapter, the transferability of the previous research findings, feasibility of implementing CCBT-I in Ward A, and cost-to-benefit assessment will be discussed. 3.1 Implementation Potential Transferability. Ward A is a special observation ward of the Department of Medicine of a publicly funded hospital. It hospitalizes patients who have psychological, emotional or mental problems. Insomnia is a common suffering among them. At least 10% of the admitted adult patients report difficulties falling asleep and maintaining sleep. They also report to feel fatigue at daytime. Sleeping pills are prescribed for most of them. Some of them may be too reliant on medical help, adding burdens to the healthcare system. A self-help insomnia management is thus necessary to change the situation. In the proposed

35 24 programme, patients are not required to receive the intervention during their stay in Ward A but they can do it at home, as the programme will be launched online. They can be instructed to access to the online programme before they are discharged. The target populations in the identified studies are similar to that in Ward A. In the identified studies, the participants were adults who either had a clinical diagnosis of insomnia (Strom et al., 2004; Ritterband et al., 2009; Espie et al., 2012; Lancee et al., 2012; Ritterband et al., 2012) or had subjective complaint of sleep difficulties and daytime impairments (Vincent & Lewycky, 2009). These are, to a certain extent, like the characteristics of the insomnia patients in Ward A. Furthermore, the participants took part in the programmes wherever they had access to the computers and the Internet. There was no geographical limit. Same in the proposed programme, patients can receive the intervention wherever they have access to the Internet. It will be necessary to consider whether the philosophy of care underlying the proposed CCBT-I programme is consistent with the philosophy of the Hospital Authority (HA) because the programme will be managed by a HA hospital. The HA strives to help all members in the community to avoid the need to hospital admissions whenever possible. It provides them with high-quality services to cure

36 25 their health problems and prevent readmission. It aims at enhancing best possible health and quality of life outside the hospitals (Hospital Authority, n.d.). The proposed programme is a self-help intervention and can be carried out in the community. If people can effectively manage sleep problem by themselves, the chance for them to seek both inpatient and outpatient services will possibly be reduced. The proposed programme can promote sleep, meaning that it will also help patients to prevent many sleep-loss-linked adverse health outcomes, as stated in Chapter 1. It will help to improve patients quality of life too. Therefore, it seems that the philosophy of care underlying the programme is fundamentally consistent with the philosophy of the HA. It is expected that 300 patients will join the proposed programme in each year and can benefit from it. It is estimated that the preparation, implementation and evaluation of the proposed CCBT-I programme will take a total of 30 months. Before the 6-week programme is carried out, there will be a preparatory period including 2 months for proposal preparation, 2 months for obtaining approval and setting up the communication team, 2 months for website development, 1 month for staff training, 3 months for pilot study, 2 months for content modification and 3 months for patient recruitment. There will be a follow-up period of 48 weeks. A final period of 4 months will be required for data analysis and reporting. The

37 26 programme schedule is shown in Appendix D Feasibility. The implementation of the CCBT-I programme should fit smoothly with the current staff function. Usually when the patients are discharged, nurses in Ward A may give them brief education on medications and health advices regarding their own physical or emotional conditions. Explaining the new CCBT-I programme to them should take the nurses little extra time. It is sufficiently possible to introduce the programme to the patients during discharge education. Support from nurses is a factor for evaluating the feasibility of the programme. Nurses in Ward A may be hesitant to support the programme at first because CCBT-I may be a relatively new idea to the current practice. They may doubt its efficiency and efficacy. The advantages or the short-term effects of CCBT-I may not be visible to them, as the patients will have to receive the actual intervention at home. Seemingly the programme will not bring them any benefit in the short period. However, their workload can actually be reduced if the admission and readmission rates of insomnia patients are lowered. This is why it is important to illustrate to them the benefits of CCBT-I with evidences, in order to gain their support and cooperation. The proposed programme will be feasible as the nurses attitude can be changed by promoting their understanding.

38 27 Nurses in Ward A may not have enough training on the CCBT-I. However, the proposed programme will be carried out on the Internet. The nurses will be responsible for the introduction only. The actual contents of the website will be constructed by the programme in-charge nurse and a work group, and reviewed by the psychiatrists for opinions. Still, nurses in Ward A should have a basic understanding of the mode of therapy. To enhance their understanding and to facilitate them to execute the programme, a brief education on CCBT-I will be delivered to them in advance. A 2-hour training session will be arranged for them. They are also encouraged to try to access to the website before they introduce it to the patients. It is likely that they have to be released from the routine practice or spend their off-duty time to attend the training. The training will help to increase the feasibility of the programme. Support from the administrators is crucial. The HA has been conducive to evidence-based practice. It promotes the use of the ekg (e-knowledge gateway), a database with substantial literatures and the HA s own study reports. It sometimes organizes workshops on research method and data analysis. These show that the HA supports research and the development of evidence-based practice. Research findings especially the advantages of CCBT-I should be clearly presented to them. The HA administrators will possibly be supportive to the proposed programme.

39 28 The proposed CCBT-I programme will need the collaboration between nurses in Ward A and the psychiatric consultation liaison team (CLT). The CLT s daily routines are assessing patients mental conditions, making diagnoses and treatment suggestions. In the proposed programme, the CLT s role is to comment on the website contents and help to screen for eligible patients. Since nurses in Ward A have been working closely with the CLT in their usual patient care, and they have a good relationship, it will not be too difficult to invite them to participate in the programme. Sleep diaries were used as the assessment tool in the identified studies (Strom et al., 2004; Ritterband et al., 2009; Vincent & Lewycky, 2009; Espie et al., 2012; Lancee et al., 2012; Ritterband et al., 2012). A sleep diary is used to record subjective quantitative estimates of sleep onset, duration, latency, etc. It is a reliable tool to collect sleep data (Rogers, Caruso, & Aldrich, 1993). It is not available in Ward A at present. However, it can be created easily during the preparatory period of the programme. The technical issues with the online platform can be dealt with by cooperation with a web design company which can be easily selected by launching a tender Cost-to-benefit assessment Potential risk and benefits of the implementation. The proposed

40 29 CCBT-I programme can cause little risk to the patients. The major shortcoming of CCBT-I is the absence of a therapist who can provide timely information and emotional support (Cheng & Dizon, 2012). In case the patients have unstable emotion or suicidal ideation, the computer-based programme will be unable to manage it like a therapist does. This may probably be the only risk of the programme. Otherwise, the patients are not exposed to any physical harm. The primary benefit of the proposed CCBT-I programme is improving sleep in insomnia patients (Strom et al., 2004; Ritterband et al., 2009; Vincent & Lewycky, 2009; Espie et al., 2012; Lancee et al., 2012; Ritterband et al., 2012). They will learn to sleep healthily at home. The chance for them to seek medical attention due to sleep problem and the related emotional or physical consequences can be lowered. The readmission rate may thus drop, lessening the workload of nurses and other healthcare workers. The prescription and use of hypnotics may also be reduced (Espie et al., 2012; Lancee et al., 2012). This may help to prevent hypnotic-associated problems such as dependence, tolerance and addiction. Considering the fact that insomnia can be associated with some significant morbidity and detrimental effects on the patients general health (as discussed in Chapter 1), not implementing the CCBT-I programme for improving patients sleep may finally lead to increased healthcare use and expenses. In addition,

41 30 patients as well as nurses in Ward A may have less chance to improve their knowledge in non-pharmacological interventions in managing insomnia Cost of implementing the programme. The material cost of setting up the CCBT-I programme consists of the costs of website setup (HK$5388; quotation from a web design company), a web content management system (CMS) for uploading images and text (HK$4000; quotation from a web design company), and poster printing (HK$30). The sum will be HK$9418. The photocopying of the guidelines, agendas and minutes will be free because the ward photocopier can be used. The venue for training and meeting, and computer and audio-visual equipment are free of charge because they can be provided by the department. Detailed descriptions and calculation are shown in Appendix E. The non-material cost of setting up the CCBT-I programme refers to the labour cost for monthly meetings, training or briefing sessions, and data analysis and report preparation. The hourly rates for the ward nurses and the CLT Advanced Practice Nurses (APNs) are HK$156 (point 20) and HK$248 (point 30) respectively (Hospital Authority, 2013a). The estimated hourly rates for the Ward Manager and the CLT Medical Officers (MOs) are around HK$300. The total non-material setup cost is HK$ Detailed descriptions and calculation are shown in Appendix F.

42 31 The total setup cost of the CCBT-I programme equals the sum of the material cost (HK$9418) and the non-material cost (HK$45692). A sum of HK$55110 is obtained. The annual material cost of running the CCBT-I programme involves two items, the web hosting service provided by the web design company (HK$816) and printing of pamphlets (HK$1000). It will be HK$1816 in total. Appendix G shows the details. The annual non-material cost of running the CCBT-I programme only involves the labour cost for patient education by nurses. Assume the annual number of insomnia patients in Ward A is 300 and 0.25 hour will be spent on each of them during discharge education, man-hour of 75 will be needed. This costs HK$ Appendix H shows the calculation. The CLT do not need to spend extra time for patient screening because they can assess the patients mental fitness during consultation as usual. The total annual running cost of the CCBT-I programme is equal to the sum of the material cost (HK$1816) and the non-material cost (HK$11700). A sum of HK$13516 is obtained Savings from implementing the programme. If the CCBT-I programme effectively reduces the number of insomnia patients readmitted to

43 32 Ward A, money can certainly be saved. Currently, the readmission rate of insomnia patients to Ward A is approximately 10%. The estimated mean length of stay for each readmitted patient is 1.5 days. The hospital maintenance cost per patient per day is HK$4680 (Hospital Authority, 2013b). Since no data about the reduction rate of the readmission of insomnia patients can be found from the literatures, a rate of 35% will be used for assumption. About 35% of respondents in Vincent and Lewycky s study (2009) reported to have much or very much improvement in sleep. It is assumed that patients with much improved sleep may have less chance to seek medical attention. If implementing the programme will reduce 35% of the readmission, HK$70200 will be saved form reduced admission. Appendix I shows the calculation. The annual saved cost from implementing the CCBT-I programme is equal to the estimated annual saved cost from reduced readmission minus the estimated total annual running cost of the CCBT-I programme. That is HK$70200 minus HK$13516, meaning that an amount of HK$56684 can be saved per year Balancing cost and benefit. Implementing the CCBT-I programme can result in important benefits and saved cost. The setup cost of the programme is only paid once and will soon be paid off in one year. The CCBT-I programme is definitely a cost-effective intervention.

44 Evidence-based Practice Guideline An evidence-based practice guideline titled Guideline on Internet-based Cognitive Behavioural Therapy for Adults with Insomnia is developed. The background, purpose and readers of the guideline, and target patients of the CCBT-I programme are stated in it. Seven recommendations, regarding the programme duration, contents and features, are made with support of evidence. The SIGN system (2011) is used for grading the recommendations and levels of evidence. Three of the identified studies (Ritterband et al., 2009; Espie et al., 2012; Lancee et al., 2012) are graded as level 1+ evidence. The other three studies (Strom et al., 2004; Vincent & Lewycky, 2009; Ritterband et al., 2012) are graded as level 1- evidence. Four of the recommendations are Grade A recommendations and three of them are Grade B recommendations. Appendix J and Appendix K show the details of the guideline and the SIGN grading of recommendations respectively.