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Posttraumatic Stress DisorderHOPESNCT04231578

Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction)

A study testing Couple HOPES Guided, Internet-Delivered, Self-Help Intervention in people with Posttraumatic Stress Disorder, run by Toronto Metropolitan University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Posttraumatic Stress Disorder
What is being tested?
Couple HOPES Guided, Internet-Delivered, Self-Help Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
1 siteCanada
Study dates
31 Mar 2020to 15 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Elevated suicide risk
  • Severe physical aggression between partners in the past year
  • Clinically significant PTSD symptoms in both members of the dyad

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Candice M. Monson

    Toronto, Ontario, M5B 1Y3

Other trials in Canada

About this study

Official title: Couple HOPES: Initial Development of a Guided, Internet-delivered Couple Intervention for Posttraumatic Stress Disorder (PTSD) and Relationship Enhancement

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.

Being tested
Couple HOPES Guided, Internet-Delivered, Self-Help Intervention
Keywords
Self-help, Internet-delivered intervention
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Couple HOPES Guided, Internet-Delivered, Self-Help InterventionBehavioural

    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.

Study groups in NCT04231578
Study groupRoleWhat they receive
Immediate Couple HOPESExperimentalImmediately 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.
Receives: Behavioral: Couple HOPES Guided, Internet-Delivered, Self-Help Intervention
Delayed InterventionNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, week 3, week 8, approximately once a week during treatment (for up to 8 weeks), 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

  2. 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.

    Measured: Baseline, week 3, week 8, approximately once a week during treatment (for up to 8 weeks), 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

Secondary outcomes (1)

  1. Mean change from baseline on Ineffective Arguing Inventory

    Score range from 0 to 40, with 40 representing highly ineffective arguing.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2020
  2. Study start31 Mar 2020
  3. Primary completion15 Jan 2023
  4. Study completion15 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04231578
Sponsor's protocol ID
CIHR-IRSC:0525007697
Other IDs
CIHR-IRSC:0525007697, W7714-207266
Acronym
HOPES
Status last verified
Apr 2024
First submitted
18 Dec 2019
Last updated
12 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

  • 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.

    PubMed 40811121

  • 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.

    PubMed 36116104

  • 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.

    PubMed 35266773

Questions about this trial

What is this clinical trial studying?

A study testing Couple HOPES Guided, Internet-Delivered, Self-Help Intervention in people with Posttraumatic Stress Disorder, run by Toronto Metropolitan University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5) with change measured as mean change from baseline (time frame: Baseline, week 3, week 8, approximately once a week during treatment (for up to 8 weeks), 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04231578, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.

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