Skip to main content
OpenTrials
Completed

NCT Number: NCT04231578

Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Posttraumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Candice M. Monson

Toronto, Ontario, M5B 1Y3, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. 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

    Scores on the PCL-5 range from 0 to 80, with 80 being the most severe PTSD symptoms.

  2. Couple Satisfaction Index (CSI-4) 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

    Score on the CSI-4 range from 0 to 21, with 21 being the most satisfied.

Secondary outcomes

  1. Mean change from baseline on Ineffective Arguing Inventory

    Time frame: 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

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

Other outcomes

  1. Significant Others' Responses to Trauma Scale with change measured as mean change from baseline

    Time frame: 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

    Scores range from 0 to 76, with 76 representing high partner accommodation.

  2. Mean change from baseline on depression as measured by the Patient Health Questionnaire

    Time frame: 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

    Scores range from 0 to 27, with 27 being the most depressed.

  3. Mean change from baseline on alcohol use as measured by the Alcohol Use Disorders Identification Test: Self-Report Version

    Time frame: 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

    Scores range from 0 to 40, with a higher score signifying an alcohol use disorder.

  4. Mean change from baseline in drug use based on the Drug Abuse Screen Test

    Time frame: 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

    Scores range from 0 to 10, with 10 being a severe level of problems related to drug abuse.

  5. Generalized Anxiety Disorder symptoms with change measured as mean change from baseline

    Time frame: 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

    Scores range from 0 to 21, with 21 representing the highest level of anxiety.

  6. State-Trait Anger Expression Inventory with change measured as mean change from baseline

    Time frame: 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

    Scores range from 0 to 40, with 40 representing higher levels of anger.

  7. Mean change from baseline in perceived health measured with one item "How satisfied are you with your health"

    Time frame: 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

    Scores range from 1 to 5, with 5 being the most satisfied.

  8. Trauma-Related Guilt Inventory with change measured as mean change from baseline

    Time frame: 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

  9. Mean change from baseline in work functioning measured with one item "Please rate your ability to function at work. If you do not work outside the home, please rate your ability to complete household tasks."

    Time frame: 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

  10. Mean change from baseline in quality of life measured with one item "How would you rate your quality of life."

    Time frame: 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

  11. Participant ratings of intervention satisfaction as indicated by the Client Satisfaction Questionnaire

    Time frame: After 7 modules are completed or 8 weeks into treatment

  12. Feasibility as measured by number of treatment sessions attended and rate of participant dropout

    Time frame: Once a week during treatment (for up to 8 weeks)

Sponsors and collaborators

Lead sponsor

Toronto Metropolitan University

Other

Registry information

Official study title

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

Acronym: HOPES

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2020
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.