Self-help Lifestyle Medicine App and Booklets for Depression
NCT ID: NCT05086913
Last Updated: 2021-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2021-11-30
2022-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Lifestyle medicine smartphone app
The app group will receive an app to facilitate lifestyle modification such as video demonstrations of physical activity, diet recommendations, stress and sleep management.
Lifestyle medicine smartphone app
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.
lifestyle medicine booklets
The booklet group will receive 8 lifestyle medicine and psychoeducation booklets with identical content with the lifestyle medicine app.
Lifestyle medicine smartphone booklets
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.
waitlist control
The waitlist control group will receive access to the lifestyle medicine app and booklets at the end of the study.
Waitlist control
The waitlist control group will receive access to the lifestyle medicine app and booklets at the end of the study.
Interventions
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Lifestyle medicine smartphone booklets
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.
Lifestyle medicine smartphone app
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.
Waitlist control
The waitlist control group will receive access to the lifestyle medicine app and booklets at the end of the study.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Fiona YY Ho
Assistant Professor
Locations
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The Chinese University of Hong Kong
Shatin, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Fiona Ho
Role: primary
Other Identifiers
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PSY017
Identifier Type: -
Identifier Source: org_study_id