Longitudinal Ecological Study on Sleep-Wake Patterns in MDD Using Actigraphy

NCT06233422 | Not Yet Recruiting

• 1 other identifier: PSY033
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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 Major Depressive Disorder (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. In Study 1, a total of 140 participants comprising 70 participants with MDD and 70 age- and gender-matched healthy controls will be recruited. Sleep-wake patterns will be collected for 4 consecutive weeks using actigraphy devices and one-off self-report measures will be collected via an in-house smartphone application, PsyHub. Study 1 and 2 will follow the CONSORT and STROBE guidelines, respectively. The current registration is only for Study 1 of the current research project.

Conditions

Depression; Sleep Disorders, Circadian Rhythm

Keywords

Actigraphy; Transdiagnostic Intervention; Depression; Rest-Activity Rhythm

Outcome Measures

Primary Outcomes (21)

• Change in Patient Health Questionnaire-9 (PHQ-9)

  A 9-item questionnaire used for screening, diagnosing, and monitoring the severity of depression, by scoring each item from "0" (not at all) to "3" (nearly everyday), total severity scale ranging from 0 to 27.

  1 at baseline, 4 weekly assessment across study 1, and 1 at the end of study 1

• Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - sleep onset latency (SOL)

  Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, SOL is one of the sleep parameters which will be measured by Actigraphy.

  24-hour wear time for 4 consecutive weeks

• Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - wake after sleep onset (WASO)

  Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, WASO is one of the sleep parameters which will be measured by Actigraphy.

  24-hour wear time for 4 consecutive weeks

• Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - total sleep time (TST)

  Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, TST is one of the sleep parameters which will be measured by Actigraphy.

  24-hour wear time for 4 consecutive weeks

• Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - sleep efficiency (SE)

  Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, SE is one of the sleep parameters which will be measured by Actigraphy.

  24-hour wear time for 4 consecutive weeks

• Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - fragmentation index (FI)

  Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, FI is one of the sleep parameters which will be measured by Actigraphy.

  24-hour wear time for 4 consecutive weeks

• Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - time in bed (TIB)

  Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, TIB is one of the sleep parameters which will be measured by Actigraphy.

  24-hour wear time for 4 consecutive weeks

• Change in Actigraphy (Actiwatch Spectrum Plus; USA Philips Respironics Inc.) - number of awakenings (NOA)

  Participants will be instructed to wear a wrist-worn actigraphy device to record their physiological patterns for 4 consecutive weeks, NOA is one of the sleep parameters which will be measured by Actigraphy.

  24-hour wear time for 4 consecutive weeks

• Variability in sleep-wake variables using non-parametric approach - interdaily stability (IS)

  IS is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach.

  24-hour wear time for 4 consecutive weeks

• Variability in sleep-wake variables using non-parametric approach - intradaily variability (IV)

  IV is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach.

  24-hour wear time for 4 consecutive weeks

• Variability in sleep-wake variables using non-parametric approach - relative amplitude (RA)

  RA is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach.

  24-hour wear time for 4 consecutive weeks

• Variability in sleep-wake variables using non-parametric approach - the least active 5 hours (L5)

  L5 is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach.

  24-hour wear time for 4 consecutive weeks

• Variability in sleep-wake variables using non-parametric approach - the most active 10 hours (M10)

  M10 is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the non-parametric approach.

  24-hour wear time for 4 consecutive weeks

• Variability in sleep-wake variables using extended cosinor approach - amplitude

  Rhythm height (amplitude) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. It tells the difference between the peak and nadir of the rhythm.

  24-hour wear time for 4 consecutive weeks

• Variability in sleep-wake variables using extended cosinor approach - mesor

  Rhythm height (mesor) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the 24-hour adjusted mean rhythm activity,

  24-hour wear time for 4 consecutive weeks

• Variability in sleep-wake variables using extended cosinor approach - acrophase

  Rhythm timing (acrophase) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. It tells the time of peak rhythm activity.

  24-hour wear time for 4 consecutive weeks

• Variability in sleep-wake variables using extended cosinor approach - up-mesor

  Rhythm timing (up-mesor) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the activity initiation time.

  24-hour wear time for 4 consecutive weeks

• Variability in sleep-wake variables using extended cosinor approach - down-mesor

  Rhythm timing (down-mesor) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the time of activity offset.

  24-hour wear time for 4 consecutive weeks

• Variability in sleep-wake variables using extended cosinor approach - alpha

  Rhythm shape (alpha) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the width of the rhythm.

  24-hour wear time for 4 consecutive weeks

• Variability in sleep-wake variables using extended cosinor approach - beta

  Rhythm shape (beta) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. It tells the steepness of the fitted curve.

  24-hour wear time for 4 consecutive weeks

• Variability in sleep-wake variables using extended cosinor approach - pseudo F-statistic

  Rhythm robustness (pseudo F-statistic) is one of the sleep-wake variables which will be collected through Actigraphy, and quantified using the extended cosinor approach. This tells the goodness of extended cosine fit.

  24-hour wear time for 4 consecutive weeks

Secondary Outcomes (7)

• Change in Hospital Anxiety and Depression Scale (HADS)

  1 at baseline, and 1 at the end of study 1

• Change in Insomnia Severity Index (ISI)

  1 at baseline, and 1 at the end of study 1

• Change in Patient-Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD) and Sleep-Related Impairment (PROMIS-SRI)

  1 at baseline, 4 weekly assessment across study 1, and 1 at the end of study 1

• Change in Multidimensional Fatigue Inventory (MFI)

  1 at baseline, and 1 at the end of study 1

• Change in Short Form (6-Dimension) Health Survey (SF-6D)

  1 at baseline, and 1 at the end of study 1

Study Arms (2)

Major Depressive Disorder (MDD) Group

MDD group will consist of 70 participants with MDD, aged between 18-65, with a Patient Health Questionnaire-9 (PHQ-9) score of at least 10; who are also experiencing at least 1 sleep or circadian problem in the past 3 months.

Other: No intervention involved

Healthy Control Group

Healthy control group will consist of 70 healthy control participants, aged between 18-65, with a Patient Health Questionnaire-9 (PHQ-9) score of below 5, indicating minimal or no depressive symptoms.

Other: No intervention involved

Interventions

No intervention involved OTHER

No intervention involved

Healthy Control Group; Major Depressive Disorder (MDD) Group

Eligibility Criteria

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

Study Population

Community sample, if recruitment in the community is insufficient, we will recruit participants from our collaborating outpatient clinics, non-governmental organizations, and community centers

You may qualify if:

• Adults aged 18 to 65 years living in Hong Kong
• Being fluent and literate in Cantonese
• A Patient Health Questionnaire-9 (PHQ-9) score of below 5, indicating minimal or no depressive symptoms
• Accessibility to an Internet-enabled mobile device (iOS or Android operating system)
• Willingness to provide informed consent and comply with the trial protocol.

You may not qualify if:

• Presence of any psychiatric disorder(s) as assessed by MINI
• Shift work, pregnancy, or work, family, or other commitments that interfere with regular sleep-wake patterns
• Presence of other untreated sleep disorders based on cut-off scores of individual sections in SLEEP-50.
• We will not exclude those with current suicidal risks (i.e., non-fleeting intent or plan), which is a common symptom of MDD. However, if serious suicidal risk (i.e., PHQ-9 Item 9 score \> 2) is identified, the participant will be referred to the PI (a clinical psychologist) for further assessment and professional mental health services if deemed necessary.
• Adults aged 18-65 years living in Hong Kong
• Being fluent and literate in Cantonese
• A PHQ-9 score of at least 10, indicating a moderate level of depression.
• Meeting the DSM diagnostic criteria for current MDD according to the Mini International Neuropsychiatric Interview (MINI)
• 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)
• Access to an Internet-enabled mobile device (iOS or Android operating system)
• Willingness to provide informed consent and comply with the trial protocol.
• Severe medical or neurocognitive disorder(s) that make participation unsuitable based on the team's clinical experience
• Presence of other psychiatric disorders as assessed by MINI
• A history of electroconvulsive therapy (ECT)
• Current involvement in any psychological treatment programme that targets depression and/or sleep and circadian problems

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Depression; Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: January 31, 2024
• Study Start: June 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: January 1, 2026
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

HK (1)