Zero-time Exercise for Depression: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 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
This study will examine the feasibility and effectiveness of a new lifestyle-integrated exercise, viz. Zero-time Exercise (ZTEx), for the management of depressive symptoms in Chinese adults in Hong Kong. ZTEx refers to the integration of simple strength- and stamina-enhancing physical activity into daily life, which can be done anytime, anywhere and by anyone. Depression is often accompanied by a tendency to sedentary behaviours and sleep disturbances, and sedentary lifestyles is associated with depression. The conventional psychological treatment approach for depression, viz. Cognitive Behavioural Therapy (CBT), emphasises the relationship between activity and mood. One of the treatment components in CBT for depression, viz. Behavioural Activation (BA), aims to promote activity engagement that are reinforcing and consistent with the long-term goals in reducing sedentary behaviour and increasing physical activity. The simple and brief ZTEx uses a foot-in-the-door approach to initiate simple behaviour change as an entry-level step for facilitating BA for participants with depression. A pilot randomized controlled trial (RCT) has shown some evidence on the effectiveness of ZTEx on improving insomnia. However, investigators have found no RCT on the effectiveness of ZTEx for the management of depressive symptoms.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hong Kong residents aged 18-65 years
- •Cantonese language fluency
- •Patient Health Questionnaire (PHQ-9) score ≥ 10 and ≤ 14; and
- •Willingness to provide informed consent and comply with the trial protocol.
排除标准
- •Pregnancy;
- •Have high levels of suicidal ideation (referral information to professional services will be provided);
- •Unstable psychotropic drugs within 2 weeks before study entry and throughout the treatment phase;
- •Current involvement in psychotherapy for depression;
- •Having unsafe conditions and are not recommended for exercising by physicians; and
- •Major psychiatric, medical or neurocognitive disorders that would make participation infeasible or interfere with the adherence to physical exercising.
结局指标
主要结局
Change in the Patient Health Questionnaire (PHQ-9)
时间窗: Baseline, 1-week post-treatment and 4-week post treatment
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). PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression
次要结局
- Change in Insomnia Severity Index (ISI)(Baseline, 1-week post-treatment and 4-week post treatment)
- Change in Multidimensional Fatigue Inventory (MFI)(Baseline, 1-week post-treatment and 4-week post treatment)
- Change in Hospital Anxiety and Depression Scale (HADS)(Baseline, 1-week post-treatment and 4-week post treatment)
- Change in Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version (SF-6D)(Baseline, 1-week post-treatment and 4-week post treatment)
- Change in International Physical Activities Questionnaire - Chinese version (IPAQ-C)(Baseline, 1-week post-treatment and 4-week post treatment)
- Change in Sheehan Disability Scale (SDS)(Baseline, 1-week post-treatment and 4-week post treatment)
- Change in Ecological momentary assessment (EMA)(Baseline, 1-week post-treatment and 4-week post treatment)
研究者
Fiona YY Ho
Assistant Professor
Chinese University of Hong Kong