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A Transdiagnostic Sleep and Circadian Treatment for Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03786731
Recruitment Status : Active, not recruiting
First Posted : December 25, 2018
Last Update Posted : February 18, 2019
Sponsor:
Collaborator:
University of California, Berkeley
Information provided by (Responsible Party):
Fiona YY Ho, Chinese University of Hong Kong

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Sleep Disturbance Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Transdiagnostic Sleep and Circadian Treatment for Major Depressive Disorder: A Randomised Controlled Trial
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TranS-C Group
Transdiagnostic Sleep and Circadian Treatment
Behavioral: 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.

No Intervention: CAU group
Care-As-Usual group



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Pre-treatment, 1-week post-treatment and 12-week post treatment ]
    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.

  2. Change in Insomnia Severity Index (ISI) [ Time Frame: Pre-treatment, 1-week post-treatment and 12-week post treatment ]
    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)

  3. Change in 7-Day Sleep Diary [ Time Frame: Pre-treatment, 1-week post-treatment and 12-week post treatment ]
    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.

  4. Change in Multidimensional Fatigue Inventory (MFI) [ Time Frame: Pre-treatment, 1-week post-treatment and 12-week post treatment ]
    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.

  5. 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 ]
    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)

  6. Change in Sheehan Disability Scale (SDS) [ Time Frame: Pre-treatment, 1-week post-treatment and 12-week post treatment ]
    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

  7. Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD) [ Time Frame: Pre-treatment, 1-week post-treatment and 12-week post treatment ]
    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.

  8. Patient-Reported Outcomes Measurement Information System-Sleep-Related Impairment (PROMIS-SRI) [ Time Frame: Pre-treatment, 1-week post-treatment and 12-week post treatment ]
    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


Other Outcome Measures:
  1. Change in Credibility-Expectancy Questionnaire (CEQ) [ Time Frame: Pre-treatment, 1-week post-treatment and 12-week post treatment ]

    The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success. it measures how much the one believe that the therapy will help to improve one's lifestyle, functioning ranging from 1 to 9 with 1 representing the lowest value and the 9 representing the highest value. Two questions asking how much improvement in the functioning the one thinks and feels that it will occur ranging 0% to 100%. 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Hong Kong Citizen who is able to speak Cantonese and read Chinese;
  2. Aged ≥ 18 years;
  3. Presence of the DSM-IV diagnostic criteria of MDD based on Chinese-bilingual Structured Clinical Interview for DSM-IV (SCID);
  4. Score on PHQ-9 is 10 or above;
  5. 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;
  6. Adequate opportunity and circumstances for sleep to occur; and
  7. Willing to give informed consent and comply with the trial protocol.

Exclusion Criteria:

  1. Presence of other psychiatric disorders as defined by the DSM-IV diagnostic criteria using SCID;
  2. Major medical or neurocognitive disorders that make participation infeasible;
  3. Have suicidal ideation based on Beck Depression Inventory (BDI-II) Item 9 score ≥ 2;
  4. Untreated sleep disorders based on SLEEP-50 (≥ 7 on narcolepsy; ≥ 15 on OSA; ≥ 7 on RLS/PLMD);
  5. Past or current involvement in a psychological treatment programme for depression and/or sleep problems;
  6. Shift work, pregnancy, work, family, or other commitments that interfere with regular night-time sleep patterns;
  7. Hospitalization; and
  8. A change in psychotropic drugs within 2 weeks before baseline assessment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786731


Locations
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Hong Kong
The Chinese University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
University of California, Berkeley

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Responsible Party: Fiona YY Ho, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03786731     History of Changes
Other Study ID Numbers: PSY004
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fiona YY Ho, Chinese University of Hong Kong:
Major Depressive Disorder
Sleep
Transdiagnostic Sleep and Circadian Treatment

Additional relevant MeSH terms:
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Dyssomnias
Sleep Wake Disorders
Parasomnias
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms