InsomniaNCT05630261
Transdiagnostic CBT-I on Comorbid Depression and Insomnia
A study testing Self-help CBT-I and Self-help CBT-D in people with Insomnia and Depression, run by Chinese University of Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia, Depression
- What is being tested?
- Self-help CBT-I and Self-help CBT-D
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Internet-based Transdiagnostic Cognitive Behavioural Therapy Insomnia (CBT-I) on Comorbid Depression and Insomnia: A Pilot Randomized Controlled Trial
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
- Being tested
- Self-help CBT-I, Self-help CBT-D
- Keywords
- Insomnia, Depression, Cognitive behavioral therapy, Transdiagnostic, Randomized controlled trial
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-help CBT-IBehavioural
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-DBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-help CBT-I | Experimental | 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). Receives: Behavioral: Self-help CBT-I |
| Self-help CBT-D | Active comparator | 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). Receives: Behavioral: Self-help CBT-D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Week 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study startDec 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona YY Ho, Chinese University of Hong Kong
- Investigators
- Fiona YY Ho, Ph.D, Study chair, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630261
- Sponsor's protocol ID
- PSY026
- Status last verified
- Nov 2022
- First submitted
- 20 Nov 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25337948
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Internet-based Transdiagnostic Cognitive Behavioural Therapy Insomnia (CBT-I) on Comorbid Depression and Insomnia: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05630261
- Acronym / sponsor ID
- PSY026
- Conditions
- Insomnia, Depression
- Keywords
- Insomnia, Depression, Cognitive behavioral therapy, Transdiagnostic, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-help CBT-I | Experimental | Behavioral: Self-help CBT-IParticipants 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). |
| Self-help CBT-D | Active comparator | Behavioral: Self-help CBT-DParticipants 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-help CBT-IThe 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. | Behavioural | Self-help CBT-I |
| Self-help CBT-DThe 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. | Behavioural | Self-help CBT-D |
Primary outcome
Change in Patient Health Questionnaire
Time frame: Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments
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).
Change in Insomnia Severity Index
Time frame: Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments
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.
8 secondary outcomes
Change in Hospital Anxiety and Depression Scale
Time frame: Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments
Change in The Pittsburgh Sleep Quality Index
Time frame: Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments
Change in Sheehan Disability Scale
Time frame: Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments
Change in Multidimensional Fatigue Inventory
Time frame: Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments
Change in Short Form (Six-Dimension) Health Survey
Time frame: Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments
Change in Credibility-Expectancy Questionnaire
Time frame: Baseline (Week 0) and Immediate post-intervention assessments (Week 7)
Change in Treatment Acceptability/Adherence Scale
Time frame: Baseline (Week 0) and Immediate post-intervention assessments (Week 7)
Demographic survey
Time frame: Baseline (Week 0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Background: PubMed 25337948Blom 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona YY Ho, Ph.D study chair
Chinese University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Self-help CBT-I and Self-help CBT-D in people with Insomnia and Depression, run by Chinese University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Basilia Louie (39436575, 1155143060@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire (time frame: Baseline (Week 0), Immediate post-treatment (Week 7), and 12 weeks follow-up (Week 19) assessments). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05630261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.