Transdiagnostic CBT-I on Comorbid Depression and Insomnia

NCT ID: NCT05630261

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2023-12-31

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.

Conditions

Insomnia; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Self-help CBT-I

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).

Group Type: EXPERIMENTAL

Self-help CBT-I

Intervention Type: BEHAVIORAL

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.

Self-help CBT-D

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).

Group Type: ACTIVE_COMPARATOR

Self-help CBT-D

Intervention Type: BEHAVIORAL

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.

Interventions

Self-help CBT-I

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.

Intervention Type: BEHAVIORAL

Self-help CBT-D

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Fiona YY Ho

Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fiona YY Ho, Ph.D

Role: STUDY_CHAIR

Chinese University of Hong Kong

Central Contacts

Basilia Louie

Role: CONTACT

1155143060@link.cuhk.edu.hk

39436575

References

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.

Reference Type: BACKGROUND

PMID: 25337948 (View on PubMed)

Other Identifiers

PSY026

Identifier Type: -

Identifier Source: org_study_id