Major Depressive DisorderNCT03786731
A Transdiagnostic Sleep and Circadian Treatment for Major Depressive Disorder
A study testing Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in people with Major Depressive Disorder and Sleep Disturbance, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study will examine the use of a transdiagnostic Sleep and Circadian Treatment (TranS-C) in treating Major Depressive Disorder (MDD) in Chinese adults. Sleep disturbance is highly comorbid with a range of psychological disorders, especially MDD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Sleep Disturbance
- What is being tested?
- Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2019to Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hong Kong Citizen who is able to speak Cantonese and read Chinese;
- Aged ≥ 18 years;
- Presence of the DSM-IV diagnostic criteria of MDD based on Chinese-bilingual Structured Clinical Interview for DSM-IV (SCID);
- Score on PHQ-9 is 10 or above;
- More than 1 sleep or circadian problem according to the Sleep and Circadian Problem Checklist, including time needed to fall asleep more than 30 minutes for more than 3 nights per week, less than 6 hours of sleep per night or at least 9 hour of sleep per night per 24 hour period for at least 3 nights per week, variability in the sleep-wake schedule at least 2.78 hours within a week, and falling asleep after 2 am on at least 3 nights per week;
- Adequate opportunity and circumstances for sleep to occur; and
- Willing to give informed consent and comply with the trial protocol.
Who cannot join
- Presence of other psychiatric disorders as defined by the DSM-IV diagnostic criteria using SCID;
- Major medical or neurocognitive disorders that make participation infeasible;
- Have suicidal ideation based on Beck Depression Inventory (BDI-II) Item 9 score ≥ 2;
- Untreated sleep disorders based on SLEEP-50 (≥ 7 on narcolepsy; ≥ 15 on OSA; ≥ 7 on RLS/PLMD);
- Past or current involvement in a psychological treatment programme for depression and/or sleep problems;
- Shift work, pregnancy, work, family, or other commitments that interfere with regular night-time sleep patterns;
- Hospitalization; and
- A change in psychotropic drugs within 2 weeks before baseline assessment
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Eliz Lam, +852 39436575, pmhlab@cuhk.edu.hk
About this study
Official title: A Transdiagnostic Sleep and Circadian Treatment for Major Depressive Disorder: A Randomised Controlled Trial
This study will examine the use of a transdiagnostic Sleep and Circadian Treatment (TranS-C) in treating Major Depressive Disorder (MDD) in Chinese adults. Sleep disturbance is highly comorbid with a range of psychological disorders, especially MDD. MDD is a major public health concern and a leading cause of disability worldwide. A shift in treatment perspectives, from a disorder-specific approach to a transdiagnostic approach, has been proposed. While the disorder-specific approach tends to understand and treat different mental disorders as independent psychological problems, the transdiagnostic approach aims to identify common clinical features (e.g. sleep disturbances) across a range of psychological disorders. The transdiagnostic approach would potentially facilitate timely dissemination of evidence-based psychological treatments and contribute to significant public health implications.
This study will be a randomized controlled trial on the efficacy of TranS-C for MDD. TranS-C integrates elements of evidence-based interventions, namely cognitive-behavioral therapy for insomnia, delayed sleep phase type, and interpersonal and social rhythm therapy. Prior to all study procedures, an online informed consent (with phone support) will be obtained from potential participants. Around 150 eligible participants will be randomly assigned to the TranS-C group or the care-as-usual control group (CAU group) in a ratio of 1:1. The randomization will be performed by an independent assessor using a computer-generated list of numbers. No deception is necessary. Participants in the TranS-C group will receive TranS-C once per week for 6 consecutive weeks respectively. The group treatment will be delivered by a clinical psychology trainee under the supervision of a clinical psychologist. The TranS-C group will complete a set of online/paper-and-pencil questionnaires before the treatment commences, 1-week, and 12-week after the treatment sessions are completed. The CAU group will complete the same set of online/paper-and-pencil questionnaires during the same periods.
- Conditions
- Major Depressive Disorder, Sleep Disturbance
- Being tested
- Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)
- Keywords
- Major Depressive Disorder, Sleep, Transdiagnostic Sleep and Circadian Treatment
- Medical subject headings
- Depressive Disorder, Major, Parasomnias
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 Dysfunction (TranS-C)Behavioural
TranS-C integrates elements of evidence-based interventions, namely cognitive-behavioural therapy for insomnia, delayed sleep phase type, and interpersonal and social rhythm therapy.
| Study group | Role | What they receive |
|---|---|---|
| TranS-C Group | Experimental | Transdiagnostic Sleep and Circadian Treatment Receives: Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) |
| CAU group | No intervention | Care-As-Usual group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Patient Health Questionnaire (PHQ-9)
The PHQ-9, a 20-item questionnaire used for screening, diagnosing, monitoring and measuring the severity of depression, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression
Measured: Pre-treatment, 1-week post-treatment and 12-week post treatment]
Secondary outcomes (8)
Change in Hospital Anxiety and Depression Scale (HADS)
A 14-item self-rating scale that measures anxiety and depression in both hospital and community settings. It is divided into an Anxiety subscale (HADS-A) and a Depression subscale (HADS-D) both containing seven intermingled items. It is for screening purpose and not meant to be a diagnostic tool. HADS scores of 8-10, 11-14, and 15-21 represent mild, moderate, and severe anxiety and depression separately.
Measured: Pre-treatment, 1-week post-treatment and 12-week post treatment
Change in Insomnia Severity Index (ISI)
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. Total score categories: 0-7 is no clinically significant insomnia, 8-14 is subthreshold insomnia,15-21 is clinical insomnia (moderate severity), and 22-28 is clinical insomnia (severe)
Measured: Pre-treatment, 1-week post-treatment and 12-week post treatment
Change in 7-Day Sleep Diary
The standardized sleep diary records sleep-onset latency (SOL; min), wake after sleep onset (WASO; min), total wake time (TWT; min), total sleep time (TST; min), time in bed (TIB; min); sleep efficiency (SE; calculated as TST/TIB * 100%), etc. Severity of sleep disturbances: sleep latency of time awake after sleep onset greater than 30 min; or last awakening occurring more than 30 min before desired time and before total sleep time reaches 6.5 hours; sleep efficiency is lower than 85%. Frequency: sleep difficulties present three or more nights per week.
Measured: Pre-treatment, 1-week post-treatment and 12-week post treatment
Change in Multidimensional Fatigue Inventory (MFI)
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: Pre-treatment, 1-week post-treatment and 12-week post treatment
Change in Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version (SF-6D)
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: Pre-treatment, 1-week post-treatment and 12-week post treatment
Change in Sheehan Disability Scale (SDS)
A 5-item self-report tool for assessing functional impairment in work/school, social life, and family life. Representation of scores in terms of functional impairment: 0: not at all, 1-3: mildly, 4-6: moderately, 7-9: markedly, 10: extremely
Measured: Pre-treatment, 1-week post-treatment and 12-week post treatment
Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD)
PROMIS-SD item bank consists of 27 items and assesses perceptions of sleep quality, sleep depth, and restoration associated with sleep; perceived difficulties and concerns with getting to sleep or staying asleep; and perceptions of the adequacy of and satisfaction with sleep. PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. Scores 0.5 - 1.0 SD worse than the mean = mild symptoms/impairment. Scores 1.0 - 2.0 SD worse than the mean = moderate symptoms/impairment. Scores 2.0 SD or more worse than the mean = severe symptoms/impairment.
Measured: Pre-treatment, 1-week post-treatment and 12-week post treatment
Patient-Reported Outcomes Measurement Information System-Sleep-Related Impairment (PROMIS-SRI)
The PROMISSRI item bank contains 16 items and assesses perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. Scores 0.5 - 1.0 SD worse than the mean = mild symptoms/impairment. Scores 1.0 - 2.0 SD worse than the mean = moderate symptoms/impairment. Scores 2.0 SD or more worse than the mean = severe symptoms/impairment
Measured: Pre-treatment, 1-week post-treatment and 12-week post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start1 Jan 2019
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (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 Major Depressive DisorderStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Berkeley
- Responsible party
- Principal investigator, Fiona YY Ho, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786731
- Sponsor's protocol ID
- PSY004
- Status last verified
- Mar 2020
- First submitted
- 21 Dec 2018
- Last updated
- 11 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yau AY, Ng KY, Lau WY, Poon CY, Yeung WF, Chung KF, Chan CS, Harvey AG, Ho FY. A group-based transdiagnostic sleep and circadian treatment for major depressive disorder: A randomized controlled trial. J Consult Clin Psychol. 2024 Mar;92(3):135-149. doi: 10.1037/ccp0000869. Epub 2024 Jan 25.
PubMed 38271019
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Transdiagnostic Sleep and Circadian Treatment for Major Depressive Disorder: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03786731
- Acronym / sponsor ID
- PSY004
- Conditions
- Major Depressive Disorder, Sleep Disturbance
- Keywords
- Major Depressive Disorder, Sleep, Transdiagnostic Sleep and Circadian Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- University of California, Berkeley
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 26 Dec 2018 (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 study will examine the use of a transdiagnostic Sleep and Circadian Treatment (TranS-C) in treating Major Depressive Disorder (MDD) in Chinese adults. Sleep disturbance is highly comorbid with a range of psychological disorders, especially MDD. MDD is a major public health concern and a leading cause of disability worldwide. A shift in treatment perspectives, from a disorder-specific approach to a transdiagnostic approach, has been proposed. While the disorder-specific approach tends to understand and treat different mental disorders as independent psychological problems, the transdiagnostic approach aims to identify common clinical features (e.g. sleep disturbances) across a range of psychological disorders. The transdiagnostic approach would potentially facilitate timely dissemination of evidence-based psychological treatments and contribute to significant public health implications.
This study will be a randomized controlled trial on the efficacy of TranS-C for MDD. TranS-C integrates elements of evidence-based interventions, namely cognitive-behavioral therapy for insomnia, delayed sleep phase type, and interpersonal and social rhythm therapy. Prior to all study procedures, an online informed consent (with phone support) will be obtained from potential participants. Around 150 eligible participants will be randomly assigned to the TranS-C group or the care-as-usual control group (CAU group) in a ratio of 1:1. The randomization will be performed by an independent assessor using a computer-generated list of numbers. No deception is necessary. Participants in the TranS-C group will receive TranS-C once per week for 6 consecutive weeks respectively. The group treatment will be delivered by a clinical psychology trainee under the supervision of a clinical psychologist. The TranS-C group will complete a set of online/paper-and-pencil questionnaires before the treatment commences, 1-week, and 12-week after the treatment sessions are completed. The CAU group will complete the same set of online/paper-and-pencil questionnaires during the same periods.
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 Dysfunction (TranS-C)Transdiagnostic Sleep and Circadian Treatment |
| CAU group | No intervention | –Care-As-Usual group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hong Kong Citizen who is able to speak Cantonese and read Chinese;
- Aged ≥ 18 years;
- Presence of the DSM-IV diagnostic criteria of MDD based on Chinese-bilingual Structured Clinical Interview for DSM-IV (SCID);
- Score on PHQ-9 is 10 or above;
- More than 1 sleep or circadian problem according to the Sleep and Circadian Problem Checklist, including time needed to fall asleep more than 30 minutes for more than 3 nights per week, less than 6 hours of sleep per night or at least 9 hour of sleep per night per 24 hour period for at least 3 nights per week, variability in the sleep-wake schedule at least 2.78 hours within a week, and falling asleep after 2 am on at least 3 nights per week;
Key exclusion criteria (8 listed)
- Presence of other psychiatric disorders as defined by the DSM-IV diagnostic criteria using SCID;
- Major medical or neurocognitive disorders that make participation infeasible;
- Have suicidal ideation based on Beck Depression Inventory (BDI-II) Item 9 score ≥ 2;
- Untreated sleep disorders based on SLEEP-50 (≥ 7 on narcolepsy; ≥ 15 on OSA; ≥ 7 on RLS/PLMD);
- Past or current involvement in a psychological treatment programme for depression and/or sleep problems;
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 Dysfunction (TranS-C)TranS-C integrates elements of evidence-based interventions, namely cognitive-behavioural therapy for insomnia, delayed sleep phase type, and interpersonal and social rhythm therapy. | Behavioural | TranS-C Group |
Primary outcome
Change in the Patient Health Questionnaire (PHQ-9)
Time frame: Pre-treatment, 1-week post-treatment and 12-week post treatment]
The PHQ-9, a 20-item questionnaire used for screening, diagnosing, monitoring and measuring the severity of depression, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression
8 secondary outcomes
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: Pre-treatment, 1-week post-treatment and 12-week post treatment
Change in Insomnia Severity Index (ISI)
Time frame: Pre-treatment, 1-week post-treatment and 12-week post treatment
Change in 7-Day Sleep Diary
Time frame: Pre-treatment, 1-week post-treatment and 12-week post treatment
Change in Multidimensional Fatigue Inventory (MFI)
Time frame: Pre-treatment, 1-week post-treatment and 12-week post treatment
Change in Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version (SF-6D)
Time frame: Pre-treatment, 1-week post-treatment and 12-week post treatment
Change in Sheehan Disability Scale (SDS)
Time frame: Pre-treatment, 1-week post-treatment and 12-week post treatment
Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD)
Time frame: Pre-treatment, 1-week post-treatment and 12-week post treatment
Patient-Reported Outcomes Measurement Information System-Sleep-Related Impairment (PROMIS-SRI)
Time frame: Pre-treatment, 1-week post-treatment and 12-week post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Derived from this study: PubMed 38271019Yau AY, Ng KY, Lau WY, Poon CY, Yeung WF, Chung KF, Chan CS, Harvey AG, Ho FY. A group-based transdiagnostic sleep and circadian treatment for major depressive disorder: A randomized controlled trial. J Consult Clin Psychol. 2024 Mar;92(3):135-149. doi: 10.1037/ccp0000869. Epub 2024 Jan 25.
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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 (TranS-C) in people with Major Depressive Disorder and Sleep Disturbance, 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 8 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 11 Mar 2020. 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?
Contact Fiona Ho (39433469 ext. 852, pmhlab@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 the Patient Health Questionnaire (PHQ-9) (time frame: Pre-treatment, 1-week post-treatment and 12-week post treatment]). 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 NCT03786731, 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 11 Mar 2020.