A Randomized Controlled Trial of Surf and Hike Therapy for Active-duty Service Members With Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
This study uses a randomized controlled trial design to compare the psychological effects of surf therapy to hike therapy in active duty service members who have been diagnosed with major depressive disorder.
详细描述
This prospective, longitudinal randomized controlled trial will enroll up to 86 active duty service members with major depressive disorder who are seeking surf or hike therapy as part of their standard medical care. Participants will be randomly assigned to receive 6 weeks of either surf or hike therapy. Assessor-administered and self-report measures will be completed at pre- and post-program, as well as three months following program completion. Participants also will complete brief, self-report assessments before and after each program activity session.
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)
盲法说明
The assessor will be blinded to participants' intervention condition.
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
- •Be a military service member seeking surf or hike therapy as part of the Wounded, Ill, and Injured Wellness program at Naval Medical Center San Diego;
- •Have medical clearance to participate in these programs;
- •Have a current diagnosis of Major Depressive Disorder based on DSM-5 criteria.
排除标准
- •Service members who are currently receiving surf or hike therapy (i.e., have already started attending program sessions);
- •Service members who are currently pregnant
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: 5 months
The MADRS is a widely used, semi-structured, clinical-interview assessment of depression symptom severity that is intended to be sensitive to change following an intervention.
次要结局
- PTSD Checklist (PCL-5)(5 months)
- Positive and Negative Affect scales (PANAS)(5 months)
- Insomnia Severity Index (ISI)(5 months)
- Patient Health Questionnaire (PHQ-9)(5 months)
- Short Form Health Survey - 36 Item, Version 2 (SF-36)(5 months)
- Generalized Anxiety Disorder (GAD-7)(5 months)
研究者
Kristen Walter
Clinical Research Psychologist
United States Naval Medical Center, San Diego