Self-help Lifestyle Medicine for Depression and Anxiety
Effect of a Culturally Adapted Self-help Smartphone-based Lifestyle Intervention in Reducing Depressive and Anxiety Symptoms: A Randomized Controlled Trial
1 other identifier
interventional
124
1 country
1
Brief Summary
This study will examine the effects of smartphone-based lifestyle medicine (LM) for alleviating depressive and anxiety symptoms in Chinese population. Since a range of lifestyle factors are involved in the pathogenesis and progression of depression and anxiety, modifying different lifestyle factors simultaneously, for example, diet, exercise, stress and sleep which are empirically supported by previous reviews, may be effective to reduce depressive and anxiety symptoms. Traditional Chinese medicine concepts will be integrated into the app to increase the acceptability towards mental health treatment. Through this study, we aim to promote evidence-based patient care and to improve help-seeking and access to evidence-based interventions for depression and anxiety.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2019
CompletedFirst Posted
Study publicly available on registry
November 5, 2019
CompletedStudy Start
First participant enrolled
February 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedMarch 11, 2020
March 1, 2020
5 months
November 4, 2019
March 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in the Patient Health Questionnaire (PHQ-9)
The PHQ-9, a 9-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-treatment and 1-month post treatment
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).
Baseline, immediately post-treatment and 1-month post treatment
Secondary Outcomes (8)
Change in the Insomnia Severity Index (ISI)
Baseline, immediately post-treatment and 1-month post treatment
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
Baseline, immediately post-treatment and 1-month post treatment
Change in the Health-Promoting Lifestyle Profile (HPLP II)
Baseline, immediately post-treatment and 1-month post treatment
Change in the Sheehan Disability Scale (SDS)
Baseline, immediately post-treatment and 1-month post treatment
Change in the Credibility-Expectancy Questionnaire (CEQ)
Baseline, immediately post-treatment and 1-month post treatment
- +3 more secondary outcomes
Study Arms (2)
Lifestyle Medicine Group
EXPERIMENTALWaitlist Control Group
NO INTERVENTIONParticipants in the waitlist control group will receive the intervention after the immediate post-treatment assessment
Interventions
Lifestyle intervention with components including physical activity, diet, relaxation/mindfulness, sleep and Traditional Chinese Medicine
Eligibility Criteria
You may qualify if:
- Hong Kong residents
- Aged ≥ 18 years
- Have a Patient Health Questionnaire (PHQ-9) score ≥ 10 or Generalized Anxiety Disorder 7-Item Scale (GAD-7) ≥ 8
- Able to read Chinese and type in Chinese or English
- Have an Internet-enabled mobile device (iOS or Android operating system)
- Are willing to provide informed consent and comply with the trial protocol
You may not qualify if:
- Current involvement in psychotherapy or unstable medication for depression and/or anxiety
- Beck Depression Inventory (BDI-II) Item 9 score of at least 2 indicating a current moderate suicidal risk that requires active crisis management (referral information to professional services will be provided to those with serious suicidal risk)
- Are having unsafe conditions and are not recommended for physical activity or a change in diet by physicians
- Having major psychiatric, medical or neurocognitive disorders that make participation infeasible or interfere with the adherence to the lifestyle modification
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Chinese University of Hong Kong
Shatin, Hong Kong
Related Publications (1)
Wong VW, Ho FY, Shi NK, Tong JT, Chung KF, Yeung WF, Ng CH, Oliver G, Sarris J. Smartphone-delivered multicomponent lifestyle medicine intervention for depressive symptoms: A randomized controlled trial. J Consult Clin Psychol. 2021 Dec;89(12):970-984. doi: 10.1037/ccp0000695.
PMID: 35025538DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
November 4, 2019
First Posted
November 5, 2019
Study Start
February 15, 2020
Primary Completion
July 1, 2020
Study Completion
September 1, 2020
Last Updated
March 11, 2020
Record last verified: 2020-03