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: NCT04763681
• Lead Sponsor: York University

Brief Summary

Posttraumatic Stress Disorder (PTSD) will be a severe problem in Canada in the wake of COVID-19, especially for Military Members, Veterans, First Responders, and Healthcare Workers (MVFH). However, gold standard face-to-face PTSD treatments do not meet current MVFH needs, which requires virtual interventions and minimal healthcare resources. Recognizing the need for a virtual, low-resource PTSD intervention for MVFH with PTSD and their loved ones, the investigators developed Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction). Couple HOPES is a secure, online self-help intervention for those with PTSD and their partners (www.couplehopes.com). However, MVFH are now particularly likely to be exposed to traumas related to COVID-19. It is essential to identify if Couple HOPES is safe and helpful for couples involving MVFH with COVID-19-related PTSD specifically. This project will therefore test the efficacy of Couple HOPES compared to a delayed waitlist control in 70 couples wherein one member is a MVFH with COVID-19-related PTSD. The investigators will examine if Couple HOPES is helpful in improving PTSD symptoms and relationship satisfaction for such couples, and if it is more or less helpful to this end for these couples compared to those with other forms of trauma exposure. 70 couples including a MVFH with COVID-19-related PTSD, will be randomly assigned to receive Couple HOPES or to a waitlist. PTSD symptoms and relationship satisfaction will be measured \~weekly during the intervention and one month after it. Related problems (e.g., depression, anxiety, healthcare use) will be measured before, in the middle of, after, and one month after, the intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-02-13
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-21
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Individual who is a Canadian military member, veteran, first responder or healthcare worker with clinically significant levels of PTSD symptoms related to COVID-19
• Individual who is an American healthcare worker with clinically significant levels of PTSD symptoms related to COVID-19
• 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 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, and 3 months after the intervention	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 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, and 3 months after the intervention	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.
Significant Others' Responses to Trauma Scale with change measured as mean change from baseline	Baseline, week 3, week 8, 3 month post-treatment follow-up	Scores range from 0 to 76, with 76 representing high partner accommodation.

Trial Locations

Locations (1)

York University; 🇨🇦 Toronto, Ontario, Canada