search
Back to results

A Transdiagnostic Sleep and Circadian Treatment for Depression

Primary Purpose

Depression, Insomnia

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Insomnia, Transdiagnostic Sleep and Circadian Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Hong Kong Citizen who is able to speak Cantonese and read Chinese
  2. Aged ≥ 18 years;
  3. Score on PHQ-9 is 10 or above
  4. 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
  5. Adequate opportunity and circumstances for sleep to occur
  6. Willing to give informed consent and comply with the trial protocol.

Exclusion Criteria:

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

Sites / Locations

  • The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TranS-C Group

CAU Group

Arm Description

Transdiagnostic Sleep and Circadian Treatment

Care-As-Usual group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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)
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.
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.
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)
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

Full Information

First Posted
December 11, 2018
Last Updated
November 4, 2019
Sponsor
Chinese University of Hong Kong
Collaborators
University of California, Berkeley
search

1. Study Identification

Unique Protocol Identification Number
NCT03775148
Brief Title
A Transdiagnostic Sleep and Circadian Treatment for Depression
Official Title
A Transdiagnostic Sleep and Circadian Treatment for Depression: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
University of California, Berkeley

4. Oversight

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

5. Study Description

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 pilot 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 40 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Insomnia
Keywords
Depression, Insomnia, Transdiagnostic Sleep and Circadian Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TranS-C Group
Arm Type
Experimental
Arm Description
Transdiagnostic Sleep and Circadian Treatment
Arm Title
CAU Group
Arm Type
No Intervention
Arm Description
Care-As-Usual group
Intervention Type
Behavioral
Intervention Name(s)
Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)
Intervention Description
TranS-C integrates elements of evidence-based interventions, namely cognitive-behavioural therapy for insomnia, delayed sleep phase type, and interpersonal and social rhythm therapy.
Primary Outcome Measure Information:
Title
Change in the Patient Health Questionnaire (PHQ-9)
Description
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
Time Frame
Pre-treatment, 1-week post-treatment and 12-week post treatment
Secondary Outcome Measure Information:
Title
Change in Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
Pre-treatment, 1-week post-treatment and 12-week post treatment
Title
Change in Insomnia Severity Index (ISI)
Description
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)
Time Frame
Pre-treatment, 1-week post-treatment and 12-week post treatment
Title
Change in 7-Day Sleep Diary
Description
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.
Time Frame
Pre-treatment, 1-week post-treatment and 12-week post treatment
Title
Change in Multidimensional Fatigue Inventory (MFI)
Description
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.
Time Frame
Pre-treatment, 1-week post-treatment and 12-week post treatment
Title
Change in Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version (SF-6D)
Description
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)
Time Frame
Pre-treatment, 1-week post-treatment and 12-week post treatment
Title
Change in Sheehan Disability Scale (SDS)
Description
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
Time Frame
Pre-treatment, 1-week post-treatment and 12-week post treatment
Other Pre-specified Outcome Measures:
Title
Change in Credibility-Expectancy Questionnaire (CEQ)
Description
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%.
Time Frame
Pre-treatment, 1-week post-treatment and 12-week post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Hong Kong Citizen who is able to speak Cantonese and read Chinese Aged ≥ 18 years; 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 Willing to give informed consent and comply with the trial protocol. Exclusion Criteria: 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 A change in psychotropic drugs within 2 weeks before baseline assessment
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Learn more about this trial

A Transdiagnostic Sleep and Circadian Treatment for Depression

We'll reach out to this number within 24 hrs