Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction) (HOPES)

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.

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Couple HOPES Guided, Internet-Delivered, Self-Help Intervention

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen M Whitifeld, B.A.; Phone Number: 1+2369 416-979-5000; Email: impact.lab@ryerson.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1Y3
      • Candice M. Monson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
Participant ratings of intervention satisfaction as indicated by the Client Satisfaction Questionnaire		After 7 modules are completed or 8 weeks into treatment
Feasibility as measured by number of treatment sessions attended and rate of participant dropout		Once a week during treatment (for up to 8 weeks)

Collaborators and Investigators

• Sponsor: Toronto Metropolitan University
• Investigators: Principal Investigator: Candice M Monson, PhD, Toronto Metropolitan University

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2020
• Primary Completion (Actual): January 15, 2023
• Study Completion (Actual): January 15, 2023

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Self-help; Internet-delivered intervention
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: CIHR-IRSC:0525007697 (Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR) 2018-2019 Foundation Grant); W7714-207266 (Other Grant/Funding Number: National Defence Security Orders and Directives)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No