Clinical trial NCT05630261: Transdiagnostic CBT-I on Comorbid Depression and Insomnia
Official title: Efficacy of Internet-based Transdiagnostic Cognitive Behavioural Therapy Insomnia (CBT-I) on Comorbid Depression and Insomnia: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Depression
Keywords: Insomnia
Depression
Cognitive behavioral therapy
Transdiagnostic
Randomized controlled trial
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Hong Kong residents aged between 18 and 65;
2. Able to read and type in Chinese;
3. Have a Patient Health Questionnaire-9 (PHQ-9) score ≥ 10 indicating at least moderate level of depressive symptoms;
4. Have an Insomnia Severity Index (ISI) score ≥ 10 indicating clinical level of insomnia symptoms;
5. Have an Internet-enabled mobile device (iOS or Android operating system); and
6. Willing to provide informed consent and comply with trial protocol

Exclusion Criteria:

1. Received psychotherapy for depression and/or insomnia in the past 6 months;
2. 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);
3. Any medical or neurocognitive disorder(s) that makes participation unsuitable or interferes with adherence to the proposed interventions;
4. 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;
5. A change in psychotropic drugs or over-the-counter medications that target depression and/or insomnia within 2 weeks before the baseline assessment;
6. Shift work, pregnancy, or other commitments that interfere with regular sleep-wake patterns; and
7. Hospitalisation

Primary outcomes:
measure: Change in Patient Health Questionnaire
timeFrame: Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments
measure: Change in Insomnia Severity Index
timeFrame: Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments
Secondary outcomes:
measure: Change in Hospital Anxiety and Depression Scale
timeFrame: Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments
measure: Change in The Pittsburgh Sleep Quality Index
timeFrame: Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments
measure: Change in Sheehan Disability Scale
timeFrame: Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments
measure: Change in Multidimensional Fatigue Inventory
timeFrame: Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments
measure: Change in Short Form (Six-Dimension) Health Survey
timeFrame: Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments
measure: Change in Credibility-Expectancy Questionnaire
timeFrame: Baseline (Week 0) and Immediate post-intervention assessments (Week 7)
measure: Change in Treatment Acceptability/Adherence Scale
timeFrame: Baseline (Week 0) and Immediate post-intervention assessments (Week 7)
measure: Demographic survey
timeFrame: Baseline (Week 0)
Other outcomes:
Locations:
Study officials:
affiliation: Chinese University of Hong Kong
name: Fiona YY Ho, Ph.D
role: STUDY_CHAIR
References:
citation: Blom K, Jernelov S, Kraepelien M, Bergdahl MO, Jungmarker K, Ankartjarn L, Lindefors N, Kaldo V. Internet treatment addressing either insomnia or depression, for patients with both diagnoses: a randomized trial. Sleep. 2015 Feb 1;38(2):267-77. doi: 10.5665/sleep.4412.