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Couple HOPES and COVID-19

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04763681
Acronym
HOPES
Enrollment
54
Registered
2021-02-21
Start date
2021-01-01
Completion date
2024-01-31
Last updated
2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

Keywords

Self-help, Internet-delivered intervention, Couple satisfaction, COVID-19, Coronavirus

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.

Interventions

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.

Sponsors

York University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5) with change measured as mean change from baselineBaseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, and 3 months after the interventionScores on the PCL-5 range from 0 to 80, with 80 being the most severe PTSD symptoms.
Couple Satisfaction Index (CSI-4) with change measured as mean change from baselineBaseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, and 3 months after the interventionScore on the CSI-4 range from 0 to 21, with 21 being the most satisfied.

Secondary

MeasureTime frameDescription
Mean change from baseline on Ineffective Arguing InventoryBaseline, 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-upScore range from 0 to 40, with 40 representing highly ineffective arguing.
Significant Others' Responses to Trauma Scale with change measured as mean change from baselineBaseline, week 3, week 8, 3 month post-treatment follow-upScores range from 0 to 76, with 76 representing high partner accommodation.

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORDr. Skye Fitzpatrick, PhD

York University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026