Posttraumatic Stress Disorder Clinical Trial
Official title:
Couple HOPES: Initial Development of a Guided, Internet-delivered Couple Intervention for Posttraumatic Stress Disorder (PTSD) and Relationship Enhancement
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.
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