Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction)

Study Overview
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Brief Summary
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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.

Official Title
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Expanding a Randomized Controlled Trial of a Couple Internet-Delivered PTSD Intervention to Reach Military Members, Veterans, and First Responders With COVID-19-Related Trauma Exposure

Conditions
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Posttraumatic Stress Disorder

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participating couples are randomized to either immediately receive the Internet-delivered Couple HOPES intervention or to a delayed intervention group, where they receive access to Couple HOPES 8 weeks later.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Couple HOPES<br>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. | Behavioral: Couple HOPES Guided, Internet-Delivered, Self-Help Intervention<br>* Couple HOPES is a guided self-help intervention for individuals with PTSD and their partners based on Cognitive-Behavioral Conjoint Therapy for PTSD (Monson & Fredman, 2012). This intervention consists of text and video-based content across seven intervention modules and phone and online-based coaching sessions with a paraprofessional. Participants are able to complete these modules in their own home or private location of their choosing. The primary outcomes are PTSD symptoms, relationship satisfaction, and the mental health and wellbeing of partners of those with PTSD.<br>|
| No Intervention: Delayed Intervention<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5) with change measured as mean change from baseline | Scores on the PCL-5 range from 0 to 80, with 80 being the most severe PTSD symptoms. | Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, and 3 months after the intervention | 
| Couple Satisfaction Index (CSI-4) with change measured as mean change from baseline | Score on the CSI-4 range from 0 to 21, with 21 being the most satisfied. | Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, and 3 months after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline on Ineffective Arguing Inventory | Score range from 0 to 40, with 40 representing highly ineffective arguing. | 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 | 
| Significant Others' Responses to Trauma Scale with change measured as mean change from baseline | Scores range from 0 to 76, with 76 representing high partner accommodation. | Baseline, week 3, week 8, 3 month post-treatment follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-help, Internet-delivered intervention, Couple satisfaction, COVID-19, Coronavirus