Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction)

Toronto Metropolitan University

Status: Completed

Conditions: Posttraumatic Stress Disorder

Treatments: Behavioral: Couple HOPES Guided, Internet-Delivered, Self-Help Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04231578

W7714-207266 (Other Grant/Funding Number)

CIHR-IRSC:0525007697 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Elevated suicide risk
• Severe physical aggression between partners in the past year
• Clinically significant PTSD symptoms in both members of the dyad

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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152 participants in 2 patient groups

Immediate Couple HOPES

Experimental group

Description:

Immediately assigned to receive seven modules of an Internet-delivered self-help intervention with paraprofessional coaching for PTSD completed at the participant's own pace within 8 weeks.

Treatment:

Behavioral: Couple HOPES Guided, Internet-Delivered, Self-Help Intervention

Delayed Intervention

No Intervention group

Description:

Participants will not receive Couple HOPES for the first 8 weeks, and complete assessments at the beginning, middle, and end of this period. After this 8-week delay, participants will then receive seven modules of an Internet-delivered self-help intervention with paraprofessional coaching for PTSD completed at the participant's own pace within 8 weeks.