Effects of Multicomponent Lifestyle Intervention for Depression Supported With Digital Health Technologies to Promote Adherence: A Randomized Controlled Trial and a Process Evaluation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 141
- Locations
- 1
- Primary Endpoint
- Change in the Patient Health Questionnaire (PHQ-9)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •hospitalization
- •current participation in any other trial(s).
Arms & Interventions
Lifestyle medicine intervention with self-tracking tools
Lifestyle intervention including diet, sleep, exercise, relaxation, and mindfulness. Self-tracking tools including a smartphone application and an Actigraphy will be given.
Intervention: Group-based Lifestyle Medicine Program (Behavioral)
Pure lifestyle medicine intervention
Lifestyle intervention including diet, sleep, exercise, relaxation, and mindfulness.
Intervention: Group-based Lifestyle Medicine Program (Behavioral)
Care-As-Usual
continue receiving the routine care as usual and be given a smartphone-based LM intervention after the completion of follow-up assessments
Outcomes
Primary Outcomes
Change in the Patient Health Questionnaire (PHQ-9)
Time Frame: [Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
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 Outcomes
- Change in Insomnia Severity Index (ISI)([Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed])
- Change in Hospital Anxiety and Depression Scale (HADS)([Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed])
- Change in the Sheehan Disability Scale (SDS)([Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed])
- Change in the Health-Promoting Lifestyle Profile (HPLP II)([Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed])
- Change in Quality-adjusted Life Years - The Short Form Six-Dimension (SF-6D)([Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed])
Investigators
Fiona YY Ho
Assistant Professor
Chinese University of Hong Kong