Effects of Multicomponent Lifestyle Intervention for Depression Supported With Digital Health Technologies to Promote Adherence: A Randomized Controlled Trial and a Process Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Change in the Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Change in the Patient Health Questionnaire (PHQ-9)
时间窗: [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).
次要结局
- 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])
研究者
Fiona YY Ho
Assistant Professor
Chinese University of Hong Kong