DepressionNCT06181110
Sleep-Wake Patterns on Illness Trajectories and Treatment Response in MDD
A study testing Transdiagnostic Intervention for Sleep and Circadian Dysfunction in people with Depression and Sleep Disorders, Circadian Rhythm, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The proposed study will include a longitudinal ecological study (Study 1) and a randomised controlled trial (Study 2). The aims will be to (1) identify the sleep-wake profiles in individuals with MDD through clustering; (2) examine the associations between sleep-wake features/profiles and the prognosis of MDD; and (3)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Sleep Disorders, Circadian Rhythm
- What is being tested?
- Transdiagnostic Intervention for Sleep and Circadian Dysfunction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteHong Kong
- Study dates
- Jun 2024to Jan 2026
- 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
- Adults aged 18-65 years living in Hong Kong
- Being fluent and literate in Cantonese
- A Patient Health Questionnaire-9 (PHQ-9) score of at least 10, indicating a moderate level of depression.
- Meeting the DSM diagnostic criteria for current MDD according to the Mini International Neuropsychiatric Interview (MINI)
- Experiencing ≥ 1 sleep or circadian problem in the past 3 months according to the sleep and circadian problems checklist (i.e., time needed to fall asleep ≥ 30 minutes, wake after sleep onset ≥ 30 minutes, < 6-hour sleep per night or ≥ 9-hour sleep per night per 24-hour period, and falling asleep after 2:00 AM ≥ 3 nights per week; and variability in the sleep-wake schedule ≥ 2.78 hours within a week)
- Access to an Internet-enabled mobile device (iOS or Android operating system)
- Willingness to provide informed consent and comply with the trial protocol.
Who cannot join
- Severe medical or neurocognitive disorder(s) that make participation unsuitable based on the team's clinical experience
- Presence of other psychiatric disorders as assessed by MINI
- A history of electroconvulsive therapy (ECT)
- Current involvement in any psychological treatment programme that targets depression and/or sleep and circadian problems
- A change in the class or dose of any prescribed psychotropic drugs within 6 weeks before the baseline assessment
- Shift work, pregnancy, or work, family, or other commitments that interfere with regular sleep-wake patterns
- Presence of other untreated sleep disorders, including narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)/periodic leg movement disorder (PLMD) based on the cut-off scores of SLEEP-50 (narcolepsy ≥ 7; OSA ≥ 15; RLS/PLMD ≥ 7)
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Chinese University of Hong Kong
Shatin
Chun-Yin Poon, +852 39436575, evanpcy99@link.cuhk.edu.hk
About this study
Official title: Associations Between Actigraphy-Derived Sleep-Wake Patterns and Illness Trajectories and Treatment Response in Major Depressive Disorder
The proposed study will include a longitudinal ecological study (Study 1) and a randomised controlled trial (Study 2). The aims will be to (1) identify the sleep-wake profiles in individuals with MDD through clustering; (2) examine the associations between sleep-wake features/profiles and the prognosis of MDD; and (3) investigate the anti-depressant effects of sleep- and circadian-targeted intervention in those with MDD and whether sleep-wake features/profiles may moderate the treatment outcomes. 70 depressed participants from Study 1 will be randomized to Study 2 for the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) group and the care-as-usual (CAU) group in a 1:1 allocation ratio. The study period will be 8 weeks. Major assessments at baseline and immediate post-treatment will be managed by an independent assessor (a research assistant, RA) who is blind to the group allocation. The proposed trial and the nested pilot study will follow the CONSORT and STROBE guidelines, respectively. The intervention will be provided free of charge.The current registration is only for Study 2 of the current research project.
- Conditions
- Depression, Sleep Disorders, Circadian Rhythm
- Being tested
- Transdiagnostic Intervention for Sleep and Circadian Dysfunction
- Keywords
- Actigraphy, Transdiagnostic Intervention, Depression, Rest-Activity Rhythm
- Medical subject headings
- Depression, Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdiagnostic Intervention for Sleep and Circadian DysfunctionBehavioural
Also called TranS-C
This intervention is a non-pharmacological approach that targets various factors contributing to sleep and circadian problems. It incorporates evidence-based elements such as CBT for insomnia, IPSRT, chronotherapy, and motivation enhancement. The treatment consists of 8 sessions with 4 cross-cutting modules: case formulation, sleep and circadian education, motivational interviewing, and goal setting. Participants also receive 4 core modules addressing sleep-wake regularity, daytime functioning, correcting beliefs, and maintaining behavioral change. Additionally, 6 optional modules cater to specific sleep-wake patterns, addressing sleep efficiency, excessive time in bed, delayed/advanced sleep phase, sleep-related worry, complex sleep environments, and nightmares. Modules are delivered based on individual needs. Sessions include agenda setting, homework review, treatment content delivery, goal assignment, and session summarization.
| Study group | Role | What they receive |
|---|---|---|
| TranS-C Group | Experimental | TranS-C is a personalized, non-pharmacological transdiagnostic intervention that addresses psychosocial, behavioural, and cognitive contributors to sleep and circadian dysfunction. It references the sleep health framework and integrates evidence-based elements, including CBT for insomnia, interpersonal and social rhythm therapy (IPSRT), chronotherapy, and motivation enhancement. Receives: Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction |
| Care-As-Usual Group | No intervention | The participants in this group will not receive the TranS-C treatment but will have access to usual care based on their needs and preferences, including but not limited to pharmacological interventions, psychological interventions, and complementary and alternative medicine. A treatment tracking log will be used to monitor the care the participants receive during the study period. The CAU group will receive self-help TranS-C materials after completing all of the assessments. We will monitor the participants' weekly depression severity using PHQ-9 and refer those who have serious suicidal risk to the PI for further assessment and professional mental health services if deemed necessary. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire-9 (PHQ-9)
A 9-item questionnaire used for screening, diagnosing, and monitoring the severity of depression.
Measured: Baseline, 8 weekly survey across study 2, and 2 weekly immediate post treatment assessments
Secondary outcomes (7)
Change in Hospital Anxiety and Depression Scale (HADS)
A 14-item scale measuring anxiety and depression in both hospital and community settings.
Measured: Baseline, and immediate post treatment assessment
Change in Insomnia Severity Index (ISI)
A 7-item scale used to assess the perceived severity of insomnia.
Measured: Baseline, and immediate post treatment assessment
Change in Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD) and Sleep-Related Impairment (PROMIS-SRI)
8-item scales to assess sleep and circadian functions.
Measured: Baseline, 8 weekly survey across study 2, and 2 weekly immediate post treatment assessments
Change in Multidimensional Fatigue Inventory (MFI)
A 20-item scale used to assess five dimensions of fatigue.
Measured: Baseline, and immediate post treatment assessment
Change in Short Form (6-Dimension) Health Survey (SF-6D)
A health survey used for measuring the quality of life on six dimensions.
Measured: Baseline, and immediate post treatment assessment
Change in Sheehan Disability Scale (SDS)
A 5-item scale used to assess functional impairments in work/ school, social life, and family life.
Measured: Baseline, and immediate post treatment assessment
Change in Core Consensus Standardized Sleep Diary
A 9-item scale used to record sleep time, wake time, perceived sleeping quality, and use of hypnotics.
Measured: 10-week daily survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study startJun 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- 70 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181110
- Sponsor's protocol ID
- PSY032
- Status last verified
- May 2024
- First submitted
- 13 Dec 2023
- Last updated
- 30 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Actigraphy-Derived Sleep-Wake Patterns and Illness Trajectories and Treatment Response in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06181110
- Acronym / sponsor ID
- PSY032
- Conditions
- Depression, Sleep Disorders, Circadian Rhythm
- Keywords
- Actigraphy, Transdiagnostic Intervention, Depression, Rest-Activity Rhythm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 26 Dec 2023 (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.
The proposed study will include a longitudinal ecological study (Study 1) and a randomised controlled trial (Study 2). The aims will be to (1) identify the sleep-wake profiles in individuals with MDD through clustering; (2) examine the associations between sleep-wake features/profiles and the prognosis of MDD; and (3) investigate the anti-depressant effects of sleep- and circadian-targeted intervention in those with MDD and whether sleep-wake features/profiles may moderate the treatment outcomes. 70 depressed participants from Study 1 will be randomized to Study 2 for the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) group and the care-as-usual (CAU) group in a 1:1 allocation ratio. The study period will be 8 weeks. Major assessments at baseline and immediate post-treatment will be managed by an independent assessor (a research assistant, RA) who is blind to the group allocation. The proposed trial and the nested pilot study will follow the CONSORT and STROBE guidelines, respectively. The intervention will be provided free of charge.The current registration is only for Study 2 of the current research project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TranS-C Group | Experimental | Behavioral: Transdiagnostic Intervention for Sleep and Circadian DysfunctionTranS-C is a personalized, non-pharmacological transdiagnostic intervention that addresses psychosocial, behavioural, and cognitive contributors to sleep and circadian dysfunction. It references the sleep health framework and integrates evidence-based elements, including CBT for insomnia, interpersonal and social rhythm therapy (IPSRT), chronotherapy, and motivation enhancement. |
| Care-As-Usual Group | No intervention | –The participants in this group will not receive the TranS-C treatment but will have access to usual care based on their needs and preferences, including but not limited to pharmacological interventions, psychological interventions, and complementary and alternative medicine. A treatment tracking log will be used to monitor the care the participants receive during the study period. The CAU group will receive self-help TranS-C materials after completing all of the assessments. We will monitor the participants' weekly depression severity using PHQ-9 and refer those who have serious suicidal risk to the PI for further assessment and professional mental health services if deemed necessary. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18-65 years living in Hong Kong
- Being fluent and literate in Cantonese
- A Patient Health Questionnaire-9 (PHQ-9) score of at least 10, indicating a moderate level of depression.
- Meeting the DSM diagnostic criteria for current MDD according to the Mini International Neuropsychiatric Interview (MINI)
- Experiencing ≥ 1 sleep or circadian problem in the past 3 months according to the sleep and circadian problems checklist (i.e., time needed to fall asleep ≥ 30 minutes, wake after sleep onset ≥ 30 minutes, < 6-hour sleep per night or ≥ 9-hour sleep per night per 24-hour period, and falling asleep after 2:00 AM ≥ 3 nights per week; and variability in the sleep-wake schedule ≥ 2.78 hours within a week)
Key exclusion criteria (7 listed)
- Severe medical or neurocognitive disorder(s) that make participation unsuitable based on the team's clinical experience
- Presence of other psychiatric disorders as assessed by MINI
- A history of electroconvulsive therapy (ECT)
- Current involvement in any psychological treatment programme that targets depression and/or sleep and circadian problems
- A change in the class or dose of any prescribed psychotropic drugs within 6 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 |
|---|---|---|
| Transdiagnostic Intervention for Sleep and Circadian DysfunctionAlso: TranS-CThis intervention is a non-pharmacological approach that targets various factors contributing to sleep and circadian problems. It incorporates evidence-based elements such as CBT for insomnia, IPSRT, chronotherapy, and motivation enhancement. The treatment consists of 8 sessions with 4 cross-cutting modules: case formulation, sleep and circadian education, motivational interviewing, and goal setting. Participants also receive 4 core modules addressing sleep-wake regularity, daytime functioning, correcting beliefs, and maintaining behavioral change. Additionally, 6 optional modules cater to specific sleep-wake patterns, addressing sleep efficiency, excessive time in bed, delayed/advanced sleep phase, sleep-related worry, complex sleep environments, and nightmares. Modules are delivered based on individual needs. Sessions include agenda setting, homework review, treatment content delivery, goal assignment, and session summarization. | Behavioural | TranS-C Group |
Primary outcome
Change in Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, 8 weekly survey across study 2, and 2 weekly immediate post treatment assessments
A 9-item questionnaire used for screening, diagnosing, and monitoring the severity of depression.
7 secondary outcomes
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, and immediate post treatment assessment
Change in Insomnia Severity Index (ISI)
Time frame: Baseline, and immediate post treatment assessment
Change in Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD) and Sleep-Related Impairment (PROMIS-SRI)
Time frame: Baseline, 8 weekly survey across study 2, and 2 weekly immediate post treatment assessments
Change in Multidimensional Fatigue Inventory (MFI)
Time frame: Baseline, and immediate post treatment assessment
Change in Short Form (6-Dimension) Health Survey (SF-6D)
Time frame: Baseline, and immediate post treatment assessment
Change in Sheehan Disability Scale (SDS)
Time frame: Baseline, and immediate post treatment assessment
Change in Core Consensus Standardized Sleep Diary
Time frame: 10-week daily survey
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdiagnostic Intervention for Sleep and Circadian Dysfunction in people with Depression and Sleep Disorders, Circadian Rhythm, run by Chinese University of Hong Kong at 1 site in 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 7 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 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire-9 (PHQ-9) (time frame: Baseline, 8 weekly survey across study 2, and 2 weekly immediate post treatment assessments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2024.