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

Depression Clinical Trial

Official title:

Associations Between Actigraphy-Derived Sleep-Wake Patterns and Illness Trajectories and Treatment Response in Major Depressive Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06181110
• Other study ID #: PSY032
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: January 2026

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: January 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Change in Patient Health Questionnaire-9 (PHQ-9)	A 9-item questionnaire used for screening, diagnosing, and monitoring the severity of depression.	Baseline (4 weekly assessments), 8 weekly survey across study 2, and immediate post treatment assessment
Secondary	Change in Hospital Anxiety and Depression Scale (HADS)	A 14-item scale measuring anxiety and depression in both hospital and community settings.	Baseline (4 weekly assessments), 8 weekly survey across study 2, and immediate post treatment assessment
Secondary	Change in Insomnia Severity Index (ISI)	A 7-item scale used to assess the perceived severity of insomnia.	Baseline, and immediate post treatment assessment
Secondary	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 (4 weekly assessments), 8 weekly survey across study 2, and 1 immediate post treatment assessment
Secondary	Change in Multidimensional Fatigue Inventory (MFI)	A 20-item scale used to assess five dimensions of fatigue.	Baseline, and immediate post treatment assessment
Secondary	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
Secondary	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
Secondary	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.	8-week daily survey