Self-help Lifestyle Medicine App and Booklets for Depression

NCT05086913 | Unknown

• 1 other identifier: PSY017
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; Self-help; Lifestyle Medicine; Well-being

Outcome Measures

Primary Outcomes (1)

• 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).

  baseline, immediately post-intervention, 4-week and 12-week follow-up

Secondary Outcomes (9)

• Self-developed survey

  Baseline

• Change in the World Health Organization 5-item Well-Being Index

  baseline, immediately post-intervention, 4-week and 12-week follow-up

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

  baseline, immediately post-intervention, 4-week and 12-week follow-up

• Change in the Perceived Stress Scale (PSS)

  baseline, immediately post-intervention, 4-week and 12-week follow-up

• Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)

  baseline, immediately post-intervention, 4-week and 12-week follow-up

Study Arms (3)

Lifestyle medicine smartphone app

EXPERIMENTAL

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

Other: Lifestyle medicine smartphone app

lifestyle medicine booklets

EXPERIMENTAL

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

Other: Lifestyle medicine smartphone booklets

waitlist control

SHAM COMPARATOR

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

Other: Waitlist control

Interventions

Lifestyle medicine smartphone booklets OTHER

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 booklets

Lifestyle medicine smartphone app OTHER

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 smartphone app

Waitlist control OTHER

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

waitlist control

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

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

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Chung Yan Chow, Undergraduate

CONTACT

39436575; pmhlab@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 9, 2021
• First Posted: October 21, 2021
• Study Start: November 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 3, 2021

Record last verified: 2021-11

Locations

HK (1)