Sleep-Wake Patterns on Illness Trajectories and Treatment Response in MDD

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Sleep Disorders, Circadian Rhythm
• Intervention / Treatment: Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Sha Tin, Hong Kong
    • The Chinese University of Hong Kong
    • Contact: Chun-Yin Poon; Phone Number: +852 39436575; Email: evanpcy99@link.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for the MDD group:

1. Adults aged 18-65 years living in Hong Kong
2. Being fluent and literate in Cantonese
3. A Patient Health Questionnaire-9 (PHQ-9) score of at least 10, indicating a moderate level of depression.
4. Meeting the DSM diagnostic criteria for current MDD according to the Mini International Neuropsychiatric Interview (MINI)
5. 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)
6. Access to an Internet-enabled mobile device (iOS or Android operating system)
7. Willingness to provide informed consent and comply with the trial protocol.

Exclusion Criteria for the MDD group:

1. Severe medical or neurocognitive disorder(s) that make participation unsuitable based on the team's clinical experience
2. Presence of other psychiatric disorders as assessed by MINI
3. A history of electroconvulsive therapy (ECT)
4. Current involvement in any psychological treatment programme that targets depression and/or sleep and circadian problems
5. A change in the class or dose of any prescribed psychotropic drugs within 6 weeks before the baseline assessment
6. Shift work, pregnancy, or work, family, or other commitments that interfere with regular sleep-wake patterns
7. 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TranS-C Group; 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.	Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction; 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.; Other Names: TranS-C
No Intervention: Care-As-Usual Group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Health Questionnaire-9 (PHQ-9)	A 9-item questionnaire used for screening, diagnosing, and monitoring the severity of depression.	Baseline, 8 weekly survey across study 2, and 2 weekly immediate post treatment assessments

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Insomnia Severity Index (ISI)	A 7-item scale used to assess the perceived severity of insomnia.	Baseline, and immediate post treatment assessment
Change in Multidimensional Fatigue Inventory (MFI)	A 20-item scale used to assess five dimensions of fatigue.	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.	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.	Baseline, and immediate post treatment assessment
Change in Hospital Anxiety and Depression Scale (HADS)	A 14-item scale measuring anxiety and depression in both hospital and community settings.	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.	10-week daily survey
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.	Baseline, 8 weekly survey across study 2, and 2 weekly immediate post treatment assessments

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Treatment Acceptability/ Adherence Scale (TAAS)	A 10-item scale of the willingness to utilize or recommend the intervention.	Baseline, and immediate post treatment assessment
Change in Credibility-Expectancy Questionnaire (CEQ)	A 6-item scale used to rate the treatment's credibility, satisfaction, and expectation for success.	Baseline, and immediate post treatment assessment

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 22, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Actigraphy; Transdiagnostic Intervention; Rest-Activity Rhythm
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Dyssomnias; Neurologic Manifestations; Occupational Diseases; Chronobiology Disorders; Depression; Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
• Other Study ID Numbers: PSY032

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No