Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction)

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder
• Interventions: Behavioral: Couple HOPES Guided, Internet-Delivered, Self-Help Intervention

• Registration Number: NCT04231578
• Lead Sponsor: Toronto Metropolitan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-18
• Study Start: 2020-03-31
• Primary Completion: 2023-01-15
• Study Completion: 2023-01-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Couple HOPES	Couple HOPES Guided, Internet-Delivered, Self-Help Intervention	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.

Primary Outcome Measures

Name	Time	Method
Couple Satisfaction Index (CSI-4) with change measured as mean change from baseline	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	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.

Secondary Outcome Measures

Name	Time	Method
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	Score range from 0 to 40, with 40 representing highly ineffective arguing.

Trial Locations

Locations (1)

Candice M. Monson; 🇨🇦 Toronto, Ontario, Canada