Couple HOPES: Initial Development of a Guided, Internet-delivered Couple Intervention for Posttraumatic Stress Disorder (PTSD) and Relationship Enhancement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Couple Satisfaction Index (CSI-4) with change measured as mean change from baseline
研究概览
简要总结
Posttraumatic stress disorder (PTSD) is a common and disabling condition associated with intimate relationship problems and mental health problems in partners of those with PTSD. Recognizing the need to improve access to evidence-based interventions for those with PTSD and their families, our team has developed an Internet-delivered, self-help intervention to improve PTSD, enhance relationships, and improve partners' mental health: Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction). Couple HOPES presents text and video-based content across seven self-help intervention modules, with modest support from paraprofessional coaches. Although the Couple HOPES platform has been developed, it remains uncertain whether Couple HOPES is feasible, usable, and efficacious in reducing PTSD and enhancing intimate relationship functioning. The proposed project aims to refine and finalize Couple HOPES with couples that include a veteran, service member or first responder with significant PTSD symptoms. This project includes initial testing of the intervention's preliminary efficacy, safety, and feasibility in a series of 10 couples (Phase 1), then in an uncontrolled trial of 20 couples (Phase 2), and then a randomized clinical trial comparing its efficacy to a delayed intervention control condition in 70 couples. Potential benefits of this study include couples learning new skills to reduce PTSD symptoms and enhance relationship functioning, although this is not guaranteed. Risks include participants finding the assessments distressing, or possible worsening of PTSD symptoms or relationship functioning. These risks will be mitigated by continuous monitoring of PTSD symptoms, relationship functioning, and adverse events, and intervention by study staff.
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individual who is a Canadian military member, veteran, or first responder with clinically significant levels of PTSD symptoms
- •Must be willing to be audio-recorded for coaching sessions
- •Intimate partner willing to participant and complete intervention modules together
- •Access to high speed internet
排除标准
- •Elevated suicide risk
- •Severe physical aggression between partners in the past year
- •Clinically significant PTSD symptoms in both members of the dyad
结局指标
主要结局
Couple Satisfaction Index (CSI-4) with change measured as mean change from baseline
时间窗: Baseline, week 3, week 8, approximately once a week during treatment (for up to 8 weeks), after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up
Score on the CSI-4 range from 0 to 21, with 21 being the most satisfied.
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5) with change measured as mean change from baseline
时间窗: Baseline, week 3, week 8, approximately once a week during treatment (for up to 8 weeks), after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up
Scores on the PCL-5 range from 0 to 80, with 80 being the most severe PTSD symptoms.
次要结局
- Mean change from baseline on Ineffective Arguing Inventory(Baseline, week 3, week 8, after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up)
研究者
Candice Monson
Professor
Toronto Metropolitan University