Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction)

NCT ID: NCT04231578

Last Updated: 2024-04-12

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

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-31

Study Completion Date

2023-01-15

Brief Summary

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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

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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 either non-randomized in early phases of project or 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, 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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Toronto Metropolitan University

OTHER

Sponsor Role lead

Responsible Party

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Candice Monson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Candice M Monson, PhD

Role: PRINCIPAL_INVESTIGATOR

Toronto Metropolitan University

Locations

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Candice M. Monson

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)

Crenshaw AO, Whitfield KM, Collins A, Valela R, Varma S, Landy MSH, Ip J, Donkin V, Earle E, Siegel A, Samonas C, Bushe J, Mensah DH, Xiang A, Doss BD, Morland L, Wagner AC, Fitzpatrick S, Monson CM. Partner outcomes from an uncontrolled trial of Couple HOPES: A guided online couple intervention for posttraumatic stress disorder and relationship enhancement. J Trauma Stress. 2023 Feb;36(1):230-238. doi: 10.1002/jts.22878. Epub 2022 Sep 18.

Reference Type DERIVED
PMID: 36116104 (View on PubMed)

Monson CM, Wagner AC, Crenshaw AO, Whitfield KM, Newnham CM, Valela R, Varma S, Di Bartolomeo AA, Fulham L, Collins A, Donkin V, Mensah DH, Landy MSH, Samonas C, Morland L, Doss BD, Fitzpatrick S. An uncontrolled trial of couple HOPES: A guided online couple intervention for PTSD and relationship enhancement. J Fam Psychol. 2022 Sep;36(6):1036-1042. doi: 10.1037/fam0000976. Epub 2022 Mar 10.

Reference Type DERIVED
PMID: 35266773 (View on PubMed)

Other Identifiers

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CIHR-IRSC:0525007697

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

W7714-207266

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CIHR-IRSC:0525007697

Identifier Type: -

Identifier Source: org_study_id

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