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Self-help Lifestyle Medicine App and Booklets for Depression

Primary Purpose

Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Lifestyle medicine smartphone booklets
Lifestyle medicine smartphone app
Waitlist control
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 Depression, Self-help, Lifestyle Medicine, Well-being

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants with elevated depressive symptoms as defined by PHQ-9 score 10 or above
  • Hong Kong residents
  • Aged 18 or above
  • Able to read Chinese and type in Chinese or English
  • Have an Internet-enabled mobile device (iOS or Android operating system)

Exclusion Criteria:

  • Pregnancy;
  • Using medication or psychotherapy for depression;
  • Currently participating in other psychological intervention studies;
  • Cognitive impairment;
  • Having unsafe conditions and are not recommended for physical activity or a change in diet by physicians;
  • Self-disclosure of any major psychiatric, medical, or neurocognitive disorders that make participation unsuitable or may interfere with the adherence of the lifestyle modification;
  • Any suicidal ideation (scoring above 2 in item 9 in BDI-II) Participants with any urgent health necessity were excluded and referred.

Sites / Locations

  • The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Lifestyle medicine smartphone app

lifestyle medicine booklets

waitlist control

Arm Description

The app group will receive an app to facilitate lifestyle modification such as video demonstrations of physical activity, diet recommendations, stress and sleep management.

The booklet group will receive 8 lifestyle medicine and psychoeducation booklets with identical content with the lifestyle medicine app.

The waitlist control group will receive access to the lifestyle medicine app and booklets at the end of the study.

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

Self-developed survey
A self-developed survey will collect information including demographic information (e.g., age, gender, level of education, working industry, relationship status, and location of residence), substance use, body mass index (BMI), rest-activity pattern, and social rhythms, etc.
Change in the World Health Organization 5-item Well-Being Index
This is a 5-item measure of global subjective well-being. The internal consistency prior to treatment was 0.86.
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
SF-6D is a preference-based single index measure of health. A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality.
Change in the Perceived Stress Scale (PSS)
The PSS measures the perceived amount of stress experienced over the past month.
Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
The GAD-7, a 7-item questionnaire used for screening, diagnosing, monitoring and measuring the severity of anxiety over the past two weeks on a 4-point scale, "0" (not at all) to "4" (nearly every day).
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 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 International Physical Activities Questionnaire - Chinese version (IPAQ-C)
Participants' sitting time, walking time and moderate and vigorous physical activity are assessed by 5 questions from the short form of the International Physical Activity Questionnaire - Chinese version. Participants' engagement in brief strength and stamina-enhancing activity were assessed by asking the number of days they engaged in physical activity while seated and standing in the last seven days.
Change in the Insomnia Severity Index (ISI)
The 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.

Full Information

First Posted
October 9, 2021
Last Updated
November 2, 2021
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05086913
Brief Title
Self-help Lifestyle Medicine App and Booklets for Depression
Official Title
A Comparison of Self-help Lifestyle Modification Delivered by a Smartphone App and Booklets in Managing Depressive Symptoms: a Pilot Randomised Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2021 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
December 2022 (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
This study aims to compare self-help lifestyle medicine (LM) delivered by a smartphone app and booklets in managing depressive symptoms in a Chinese population. This study is a randomised controlled trial. First, informed consent will be obtained from potential participants. Around 90 eligible participants will be randomly assigned to either the LM app group, the LM booklet group, and the waitlist control group, in a ratio of 1:1:1. The app group will receive an app to facilitate lifestyle modification such as video demonstrations of physical activity, diet recommendations, stress and sleep management. The booklet group will receive 8 LM booklets with identical content with the LM app. The waitlist control group will receive access to the app and booklets at the end of the study. The whole intervention lasts 8 weeks. Participants will also receive 2 messages per week from the researcher to check and prompt motivation and adherence. Participants will complete assessment before, immediately after intervention, at one month and 12-week follow up.
Detailed Description
As lifestyle plays an important role in the pathogenesis of depression, lifestyle medicine (LM) emerges as a new way to alleviate depressive symptoms (Sarris & O'Neil, 2016). Booklets have been shown as an inexpensive and effective delivery modality of lifestyle modification among individuals with physical conditions (Wong, Chair & Wong, 2017). Meanwhile, a recent meta-analysis supports the efficacy of mobile applications in improving depressive symptoms (Linardon, Cujipers, Carlbring, Messer & Fuller-Tyszkiewicz, 2019). Notably, the efficacy of lifestyle intervention using booklets and app have not been compared. This pilot study can inform the field about the efficacy of lifestyle intervention using two self-help delivery modalities and offer new ways to better managing depressive symptoms. This study will be a randomised controlled trial comparing self-help LM delivered by a smartphone app and booklets in improving depression. For a pilot study, a sample size of 12 per group is recommended (Julious, 2005). Considering an estimation of 20% attrition at the three assessment time points, the final sample size is 90, with 30 participants in each group. The LM booklet group will receive a pocket size 6-page booklet weekly that covers 8 lifestyle medicine themes including stress, relaxation, diet, exercise, sleep hygiene, worry management, mindfulness, and positive psychology. Exercises based on cognitive behavioural therapy and guidance to set and meet short term and long-term goals are featured in the booklets. The booklet series is reviewed by a panel of experts including clinical psychologists, psychiatrists, dietitians, physical trainers, and traditional Chinese Medicine practitioners. The app group will receive access to a mobile app that offers 8 modules with identical content as the wellness booklets, in addition to videos, relaxation, exercise and cooking demonstrations, daily challenges and record of goals. The waitlist control group will receive access to the app and booklets at the end of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Self-help, Lifestyle Medicine, Well-being

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lifestyle medicine smartphone app
Arm Type
Experimental
Arm Description
The app group will receive an app to facilitate lifestyle modification such as video demonstrations of physical activity, diet recommendations, stress and sleep management.
Arm Title
lifestyle medicine booklets
Arm Type
Experimental
Arm Description
The booklet group will receive 8 lifestyle medicine and psychoeducation booklets with identical content with the lifestyle medicine app.
Arm Title
waitlist control
Arm Type
Sham Comparator
Arm Description
The waitlist control group will receive access to the lifestyle medicine app and booklets at the end of the study.
Intervention Type
Other
Intervention Name(s)
Lifestyle medicine smartphone booklets
Intervention Description
Participants will receive a pocket size 6-page booklet weekly over 8 weeks that covers 8 lifestyle medicine, mental health and CBT themes including stress, relaxation, diet, exercise, sleep hygiene, worry management, mindfulness, and positive psychology, and guides participants to set and meet short term and long-term goals.
Intervention Type
Other
Intervention Name(s)
Lifestyle medicine smartphone app
Intervention Description
The lifestyle medicine app offers 8 modules with identical content as the wellness booklets, in addition to videos, relaxation, exercise and cooking demonstrations, daily challenges, record of goals, and ecological momentary assessments of diet, physical activity, sleep, stress and mood.
Intervention Type
Other
Intervention Name(s)
Waitlist control
Intervention Description
The waitlist control group will receive access to the lifestyle medicine app and booklets at the end of the study.
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
baseline, immediately post-intervention, 4-week and 12-week follow-up
Secondary Outcome Measure Information:
Title
Self-developed survey
Description
A self-developed survey will collect information including demographic information (e.g., age, gender, level of education, working industry, relationship status, and location of residence), substance use, body mass index (BMI), rest-activity pattern, and social rhythms, etc.
Time Frame
Baseline
Title
Change in the World Health Organization 5-item Well-Being Index
Description
This is a 5-item measure of global subjective well-being. The internal consistency prior to treatment was 0.86.
Time Frame
baseline, immediately post-intervention, 4-week and 12-week follow-up
Title
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
Description
SF-6D is a preference-based single index measure of health. A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality.
Time Frame
baseline, immediately post-intervention, 4-week and 12-week follow-up
Title
Change in the Perceived Stress Scale (PSS)
Description
The PSS measures the perceived amount of stress experienced over the past month.
Time Frame
baseline, immediately post-intervention, 4-week and 12-week follow-up
Title
Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Description
The GAD-7, a 7-item questionnaire used for screening, diagnosing, monitoring and measuring the severity of anxiety over the past two weeks on a 4-point scale, "0" (not at all) to "4" (nearly every day).
Time Frame
baseline, immediately post-intervention, 4-week and 12-week follow-up
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
baseline, immediately post-intervention, 4-week and 12-week follow-up
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
baseline, immediately post-intervention, 4-week and 12-week follow-up
Title
Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
Description
Participants' sitting time, walking time and moderate and vigorous physical activity are assessed by 5 questions from the short form of the International Physical Activity Questionnaire - Chinese version. Participants' engagement in brief strength and stamina-enhancing activity were assessed by asking the number of days they engaged in physical activity while seated and standing in the last seven days.
Time Frame
baseline, immediately post-intervention, 4-week and 12-week follow-up
Title
Change in the Insomnia Severity Index (ISI)
Description
The 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
baseline, immediately post-intervention, 4-week and 12-week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants with elevated depressive symptoms as defined by PHQ-9 score 10 or above Hong Kong residents Aged 18 or above Able to read Chinese and type in Chinese or English Have an Internet-enabled mobile device (iOS or Android operating system) Exclusion Criteria: Pregnancy; Using medication or psychotherapy for depression; Currently participating in other psychological intervention studies; Cognitive impairment; Having unsafe conditions and are not recommended for physical activity or a change in diet by physicians; Self-disclosure of any major psychiatric, medical, or neurocognitive disorders that make participation unsuitable or may interfere with the adherence of the lifestyle modification; Any suicidal ideation (scoring above 2 in item 9 in BDI-II) Participants with any urgent health necessity were excluded and referred.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chung Yan Chow, Undergraduate
Phone
39436575
Email
pmhlab@cuhk.edu.hk
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Sha Tin
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fiona Ho
Phone
+852 39436575
Email
pmhlab@cuhk.edu.hk

12. IPD Sharing Statement

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Self-help Lifestyle Medicine App and Booklets for Depression

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