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Multicomponent Lifestyle Intervention for Depression Supported With Digital Health Technologies to Promote Adherence

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Group-based Lifestyle Medicine Program
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 Lifestyle Medicine, Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. at least 18 years of age
  2. Cantonese language fluency and readability
  3. a PHQ-9 score of at least 10, indicating a moderate level of depression
  4. current DSM-IV diagnostic criteria of major depressive episode based on the Mini International Neuropsychiatric Interview (MINI)
  5. possession of an internet-enabled mobile device (iOS or Android operating system)
  6. willingness to provide informed consent and comply with the trial protocol.

Exclusion Criteria:

  1. the presence of other current psychiatric disorders as assessed by the MINI
  2. any medical or neurocognitive disorder(s) that makes participation unsuitable based on the team's clinical experience or interferes with adherence to the lifestyle modification (e.g., where exercise or a change in diet are not recommended by physicians)
  3. current serious suicidal risk (non-fleeting intent or plan) as assessed by a PHQ-9 Item 9 score > 2 (referral information to professional mental health services will be provided)
  4. current involvement in lifestyle changes supervised by professionals
  5. intake of medication or current participation in any psychotherapy for depression
  6. pregnancy
  7. hospitalization
  8. current participation in any other trial(s).

Sites / Locations

  • The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Lifestyle medicine intervention with self-tracking tools

Pure lifestyle medicine intervention

Care-As-Usual

Arm Description

Lifestyle intervention including diet, sleep, exercise, relaxation, and mindfulness. Self-tracking tools including a smartphone application and an Actigraphy will be given.

Lifestyle intervention including diet, sleep, exercise, relaxation, and mindfulness.

continue receiving the routine care as usual and be given a smartphone-based LM intervention after the completion of follow-up assessments

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).

Secondary Outcome Measures

Change in Insomnia Severity Index (ISI)
ISI is 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.
Change in the Health-Promoting Lifestyle Profile (HPLP II)
The 52-item HPLPII is composed of a total scale and six subscales to measure behaviors in the theorized dimensions of health-promoting lifestyle: spiritual growth, interpersonal relations, nutrition, physical activity, health responsibility, and stress management.
Change in the Sheehan Disability Scale (SDS)
SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life
Change in Quality-adjusted Life Years - The Short Form Six-Dimension (SF-6D)
The Short Form Six-Dimension (SF-6D) is a self-report measure that assesses health-related quality of life to estimate participant's quality-adjusted life years (QALYs). This instrument was validated in the Chinese population and widely applied in previous mental health research.
Change in Hospital Anxiety and Depression Scale (HADS)
HADS is a 14-item self-rated questionnaire which consists of two 7-item subscales that measure the presence of anxiety and depression symptoms respectively. Each item is rated on a 4-point-scale (0-3) by the participant. The greater the score, the more psychologically distressed the respondent is.

Full Information

First Posted
July 8, 2022
Last Updated
July 11, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05454761
Brief Title
Multicomponent Lifestyle Intervention for Depression Supported With Digital Health Technologies to Promote Adherence
Official Title
Effects of Multicomponent Lifestyle Intervention for Depression Supported With Digital Health Technologies to Promote Adherence: A Randomized Controlled Trial and a Process Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

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

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
The proposed study will be a randomized, assessor-blind controlled trial embedding both outcome and process evaluations of a 6-week group LM intervention with/without self-tracking tools (Study I). The outcome evaluation will examine the effects of LM-S and LM alone vs. CAU, and the process evaluation will enhance the understanding of the causal assumptions that underpin LM to inform policy and clinical practice. Eligible participants with at least a moderate level of depression will be randomly assigned to the LM- S, LM alone, and CAU groups in a 1:1:1 allocation ratio. The study period will be 18 weeks. Assessments at baseline, week 7 (1-week post-intervention), and week 18 (12-week post-intervention) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Lifestyle Medicine, Depression

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lifestyle medicine intervention with self-tracking tools
Arm Type
Experimental
Arm Description
Lifestyle intervention including diet, sleep, exercise, relaxation, and mindfulness. Self-tracking tools including a smartphone application and an Actigraphy will be given.
Arm Title
Pure lifestyle medicine intervention
Arm Type
Experimental
Arm Description
Lifestyle intervention including diet, sleep, exercise, relaxation, and mindfulness.
Arm Title
Care-As-Usual
Arm Type
No Intervention
Arm Description
continue receiving the routine care as usual and be given a smartphone-based LM intervention after the completion of follow-up assessments
Intervention Type
Behavioral
Intervention Name(s)
Group-based Lifestyle Medicine Program
Intervention Description
Participants will receive four core modules that focus on lifestyle modifications. Core Module 1 will be Diets and Nutrition. This module aims to provide simple and evidence-based information regarding nutrition for improving and maintaining mental health. Core Module 2 will be Physical Activity. Participants will practice various types of gentle and adaptable exercises during the session and learn simple ways to incorporate exercise into their daily lives. Core Module 3 will be Sleep Management. This module will include basic facts about sleep, with a focus on psychoeducation on insomnia and how the relationship between circadian and social rhythms relate to sleep and mental health. Core Module 4 will be Stress Management. This module will include psychoeducation about stress, worry management, the cultivation of positive psychology, and relaxation techniques such as diaphragmatic breathing and progressive muscle relaxation.
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).
Time Frame
[Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
Secondary Outcome Measure Information:
Title
Change in Insomnia Severity Index (ISI)
Description
ISI is 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.
Time Frame
[Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
Title
Change in the Health-Promoting Lifestyle Profile (HPLP II)
Description
The 52-item HPLPII is composed of a total scale and six subscales to measure behaviors in the theorized dimensions of health-promoting lifestyle: spiritual growth, interpersonal relations, nutrition, physical activity, health responsibility, and stress management.
Time Frame
[Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
Title
Change in the Sheehan Disability Scale (SDS)
Description
SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life
Time Frame
[Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
Title
Change in Quality-adjusted Life Years - The Short Form Six-Dimension (SF-6D)
Description
The Short Form Six-Dimension (SF-6D) is a self-report measure that assesses health-related quality of life to estimate participant's quality-adjusted life years (QALYs). This instrument was validated in the Chinese population and widely applied in previous mental health research.
Time Frame
[Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
Title
Change in Hospital Anxiety and Depression Scale (HADS)
Description
HADS is a 14-item self-rated questionnaire which consists of two 7-item subscales that measure the presence of anxiety and depression symptoms respectively. Each item is rated on a 4-point-scale (0-3) by the participant. The greater the score, the more psychologically distressed the respondent is.
Time Frame
[Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
Other Pre-specified Outcome Measures:
Title
Change in the Credibility-Expectancy Questionnaire (CEQ)
Description
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
Time Frame
[Time Frame: Baseline and immediately after treatment]
Title
Treatment Acceptability Scale (TAS)
Description
An 8-item scale of the willingness to utilize or recommend the intervention.
Time Frame
[Time Frame: Baseline and immediately after treatment]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: at least 18 years of age Cantonese language fluency and readability a PHQ-9 score of at least 10, indicating a moderate level of depression current DSM-IV diagnostic criteria of major depressive episode based on the Mini International Neuropsychiatric Interview (MINI) possession of an internet-enabled mobile device (iOS or Android operating system) willingness to provide informed consent and comply with the trial protocol. Exclusion Criteria: the presence of other current psychiatric disorders as assessed by the MINI any medical or neurocognitive disorder(s) that makes participation unsuitable based on the team's clinical experience or interferes with adherence to the lifestyle modification (e.g., where exercise or a change in diet are not recommended by physicians) current serious suicidal risk (non-fleeting intent or plan) as assessed by a PHQ-9 Item 9 score > 2 (referral information to professional mental health services will be provided) current involvement in lifestyle changes supervised by professionals intake of medication or current participation in any psychotherapy for depression pregnancy hospitalization current participation in any other trial(s).
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Sha Tin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Wing-Hei Wong
Phone
+852 39436575
Email
vincentwongWH@link.cuhk.edu.hk

12. IPD Sharing Statement

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Multicomponent Lifestyle Intervention for Depression Supported With Digital Health Technologies to Promote Adherence

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