Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction)

NCT ID: NCT04763681

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-01-31

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.

Detailed Description

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Conditions

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Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Immediate Couple HOPES

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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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.

Delayed Intervention

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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York University

OTHER

Sponsor Role lead

Responsible Party

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Skye Fitzpatrick

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Skye Fitzpatrick, PhD

Role: PRINCIPAL_INVESTIGATOR

York University

Locations

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York University

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Monson, C. M., & Fredman, S. J. (2012). Cognitive-behavioral conjoint therapy for PTSD: Harnessing the healing power of relationships. New York, NY: Guilford.

Reference Type BACKGROUND

Fitzpatrick S, Crenshaw AO, Valela R, Samonas C, Earle EA, Goss S, Hernandez KM, Bushe J, Varma S, Proctor D, Wagner AC, Goenka K, Luxor O, Collins A, Morland L, Shields N, Roth M, Doss BD, Schumm J, Monson CM. A randomized controlled trial testing couple HOPES: An online, self-help couples' intervention for posttraumatic stress disorder. J Consult Clin Psychol. 2025 Aug;93(8):580-594. doi: 10.1037/ccp0000965.

Reference Type DERIVED
PMID: 40811121 (View on PubMed)

Other Identifiers

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173098

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CIHR-IRSC:0525007697

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

W7714-207266

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2019-475

Identifier Type: -

Identifier Source: org_study_id

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