Transdiagnostic CBT-I on Comorbid Depression and Insomnia

The Chinese University of Hong Kong

Status: Not yet enrolling

Conditions: Insomnia; Depression

Treatments: Behavioral: Self-help CBT-I; Behavioral: Self-help CBT-D

Study type: Interventional

Funder types: Other

Identifiers

NCT05630261

PSY026

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Self-help CBT-I

Experimental group

Description:

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).

Treatment:

Behavioral: Self-help CBT-I

Self-help CBT-D

Active Comparator group

Description:

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).

Treatment:

Behavioral: Self-help CBT-D