Transdiagnostic CBT-I on Comorbid Depression and Insomnia

Study Overview
=================
Brief Summary
-----------------
This randomized control trial (RCT) aims at comparing the efficacy of self-help cognitive behavioural therapy for insomnia (CBT-I) and self-help cognitive behavioural therapy for depression (CBT-D) on comorbid depression and insomnia. It addresses the research gap of treating comorbid depression and insomnia with a transdiagnostic approach (i.e., CBT-I) rather than a disorder-specific approach (i.e., CBT-D). Insomnia is a transdiagnostic process that is common to many psychiatric disorders. It is not only a symptom for depression, but also a factor that contributes to the onset and maintenance of depression. There were limited studies comparing the efficacy of self-help CBT-I to self-help CBT-D among adults with comorbid insomnia and depression (e.g., Blom, 2015). Hence, this study will serve as one of the pioneering attempts to elucidate the role of self-help transdiagnostic insomnia therapy in reducing depressive symptoms. Prior to all study procedures, eligible participants will be required to complete an online informed consent. Around 100 eligible participants aged between 18 and 65 with a Patient Health Questionnaire-9 score ≥ 10 indicating at least moderate level of depressive symptoms and Insomnia Severity Index (ISI) score ≥ 10 indicating clinical level of insomnia symptoms will be randomly assigned to either Internet-based CBT-I (n = 50) or Internet-based CBT-D (n = 50) in a ratio of 1:1. Eligible participants in the CBT-I group will receive the intervention iSleepWell via the a digital mental health platform Next Stop, Wellness! for 6 consecutive weeks, whilst the CBT-D group will receive the intervention 'LIFE FLeX' via the same platform for 6 consecutive weeks. The outcomes of interest include depressive, anxiety, and insomnia symptoms, functional impairment, quality of life, intervention credibility and acceptability at baseline (Week 0), immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments.

Official Title
-----------------
Efficacy of Internet-based Transdiagnostic Cognitive Behavioural Therapy Insomnia (CBT-I) on Comorbid Depression and Insomnia: A Pilot Randomized Controlled Trial

Conditions
-----------------
Insomnia, Depression

Intervention / Treatment
-----------------
* Behavioral: Self-help CBT-I
* Behavioral: Self-help CBT-D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hong Kong residents aged between 18 and 65; Able to read and type in Chinese; Have a Patient Health Questionnaire-9 (PHQ-9) score ≥ 10 indicating at least moderate level of depressive symptoms; Have an Insomnia Severity Index (ISI) score ≥ 10 indicating clinical level of insomnia symptoms; Have an Internet-enabled mobile device (iOS or Android operating system); and Willing to provide informed consent and comply with trial protocol Exclusion Criteria: Received psychotherapy for depression and/or insomnia in the past 6 months; A Patient Health Questionnaire-9 (PHQ-9) item 9 score > 2, indicating a serious level of suicidal risk (referral information to professional mental health services will be provided); Any medical or neurocognitive disorder(s) that makes participation unsuitable or interferes with adherence to the proposed interventions; Other untreated sleep disorders, including narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS) / periodic leg movement disorder (PLMD) based on the SLEEP-50; A change in psychotropic drugs or over-the-counter medications that target depression and/or insomnia within 2 weeks before the baseline assessment; Shift work, pregnancy, or other commitments that interfere with regular sleep-wake patterns; and Hospitalisation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-help CBT-I<br>Participants assigned to the CBT-I group will receive the self-help CBT-I intervention for six weeks (i.e., participants will access the intervention every day, for 42 days). | Behavioral: Self-help CBT-I<br>* The intervention will cover the following topics: (a) physiological linkage between the brain and stress, (b) sleep hygiene, (c) stimulus control, (d) sleep restriction, (e) cognitive restructuring, and (f) positive psychology. Each weekly session will be divided into 6-8 chapters. Chapters are supported by short videos and interactive games. Homework activities will be assigned after each session.<br>|
| Active Comparator: Self-help CBT-D<br>Participants assigned to the CBT-D group will receive the self-help CBT-D intervention for six weeks (i.e., participants will access the intervention every day, for 42 days). | Behavioral: Self-help CBT-D<br>* The intervention will cover the following topics: (a) physiological linkage between the brain and stress, (b) emotion management, (c) cognitive restructuring, (d) behavioral activation, and (e) positive psychology. Each weekly session will be divided into 6-8 chapters. Some chapters are supported by short videos and e-worksheets. Homework activities will be assigned after each session, which include weekly record of emotions or between-session practice.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Health Questionnaire | The PHQ-9 is a 9-item questionnaire used for screening, diagnosing, monitoring, and measuring the severity of depression, which scores each of the nine DSM-IV criteria from 0 (not at all) to 3 (nearly every day). | Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments | 
| Change in Insomnia Severity Index | ISI is a 7-item scale designed to evaluate perceived insomnia severity. Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem. | Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hospital Anxiety and Depression Scale | HADS is a 14-item self-rated questionnaire used for measuring the presence of anxiety and depression symptoms on a 5-point-scale. | Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments | 
| Change in The Pittsburgh Sleep Quality Index | The PSQI-19 is a 19-item questionnaire used for measuring and identifying quality of sleep. It provides a measure of global sleep quality, including sleep latency, sleep duration, habitual sleep efficiency and sleep disturbances. | Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments | 
| Change in Sheehan Disability Scale | SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life. | Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments | 
| Change in Multidimensional Fatigue Inventory | A 20-item self-report instrument designed to measure fatigue. Ratings on a 5-point Likert scale are obtained on the dimensions of general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Scores on each subscale range from 4 to 20, with higher scores indicating greater fatigue. | Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments | 
| Change in Short Form (Six-Dimension) Health Survey | SF-6D is a preference-based single index measure of health. A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality. The SF-6D index, scored from 0.0 (worst health state) to 1.0 (best health state) | Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments | 
| Change in Credibility-Expectancy Questionnaire | The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success. | Baseline (Week 0) and Immediate post-intervention assessments (Week 7) | 
| Change in Treatment Acceptability/Adherence Scale | TAAS is a self-reported, ten-item questionnaire that is rated by a seven-point Likert scale from 1 to 7. It aims at evaluating treatment acceptability and anticipated treatment adherence of clients in the aspects of credibility, expectancy and distress. | Baseline (Week 0) and Immediate post-intervention assessments (Week 7) | 
| Demographic survey | The self-developed demographic survey will collect information including age, gender, level of education, working industry, relationship status, and location of residence, substance use, body mass index (BMI), rest-activity pattern, and social rhythms etc. | Baseline (Week 0) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insomnia, Depression, Cognitive behavioral therapy, Transdiagnostic, Randomized controlled trial