A Transdiagnostic Sleep and Circadian Treatment for Depression

NCT03775148 | Completed

• 1 other identifier: PSY002
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Insomnia

Keywords

Depression; Insomnia; Transdiagnostic Sleep and Circadian Treatment

Outcome Measures

Primary Outcomes (1)

• 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

  Pre-treatment, 1-week post-treatment and 12-week post treatment

Secondary Outcomes (6)

• Change in Hospital Anxiety and Depression Scale (HADS)

  Pre-treatment, 1-week post-treatment and 12-week post treatment

• Change in Insomnia Severity Index (ISI)

  Pre-treatment, 1-week post-treatment and 12-week post treatment

• Change in 7-Day Sleep Diary

  Pre-treatment, 1-week post-treatment and 12-week post treatment

• Change in Multidimensional Fatigue Inventory (MFI)

  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)

  Pre-treatment, 1-week post-treatment and 12-week post treatment

Other Outcomes (1)

• Change in Credibility-Expectancy Questionnaire (CEQ)

  Pre-treatment, 1-week post-treatment and 12-week post treatment

Study Arms (2)

TranS-C Group

EXPERIMENTAL

Transdiagnostic Sleep and Circadian Treatment

Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)

CAU Group

NO INTERVENTION

Care-As-Usual group

Interventions

Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) BEHAVIORAL

TranS-C integrates elements of evidence-based interventions, namely cognitive-behavioural therapy for insomnia, delayed sleep phase type, and interpersonal and social rhythm therapy.

TranS-C Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• University of California, Berkeley: collaborator

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Depression; Sleep Initiation and Maintenance Disorders

Interventions

Sleep

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 13, 2018
• Study Start: January 1, 2019
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: November 5, 2019

Record last verified: 2019-11

Locations

HK (1)