Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction)

Posttraumatic Stress Disorder Clinical Trial

— HOPES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04231578
• Other study ID #: CIHR-IRSC:0525007697
• Secondary ID: CIHR-IRSC:052500
• Status: Completed
• Phase: N/A
• Start date: March 31, 2020
• Est. completion date: January 15, 2023

Study information

• Verified date: April 2024
• Source: Toronto Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	Candice M. Monson	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Toronto Metropolitan University

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Significant Others' Responses to Trauma Scale with change measured as mean change from baseline	Scores range from 0 to 76, with 76 representing high partner accommodation.	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
Other	Mean change from baseline on depression as measured by the Patient Health Questionnaire	Scores range from 0 to 27, with 27 being the most depressed.	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
Other	Mean change from baseline on alcohol use as measured by the Alcohol Use Disorders Identification Test: Self-Report Version	Scores range from 0 to 40, with a higher score signifying an alcohol use disorder.	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
Other	Mean change from baseline in drug use based on the Drug Abuse Screen Test	Scores range from 0 to 10, with 10 being a severe level of problems related to drug abuse.	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
Other	Generalized Anxiety Disorder symptoms with change measured as mean change from baseline	Scores range from 0 to 21, with 21 representing the highest level of anxiety.	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
Other	State-Trait Anger Expression Inventory with change measured as mean change from baseline	Scores range from 0 to 40, with 40 representing higher levels of anger.	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
Other	Mean change from baseline in perceived health measured with one item "How satisfied are you with your health"	Scores range from 1 to 5, with 5 being the most satisfied.	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
Other	Trauma-Related Guilt Inventory with change measured as mean change from baseline		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
Other	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."		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
Other	Mean change from baseline in quality of life measured with one item "How would you rate your quality of life."		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
Other	Participant ratings of intervention satisfaction as indicated by the Client Satisfaction Questionnaire		After 7 modules are completed or 8 weeks into treatment
Other	Feasibility as measured by number of treatment sessions attended and rate of participant dropout		Once a week during treatment (for up to 8 weeks)
Primary	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.	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
Primary	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.	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	Mean change from baseline on Ineffective Arguing Inventory	Score range from 0 to 40, with 40 representing highly ineffective arguing.	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