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

• ClinicalTrials.gov Identifier: NCT04763681
• Recruitment Status: Recruiting
• First Posted: February 21, 2021
• Last Update Posted: February 8, 2022
• Sponsor: York University
• Information provided by (Responsible Party): Skye Fitzpatrick, York University

Study Description

Brief Summary:

Posttraumatic Stress Disorder (PTSD) will be a severe problem in Canada in the wake of COVID-19, especially for Military Members, Veterans, First Responders, and Healthcare Workers (MVFH). However, gold standard face-to-face PTSD treatments do not meet current MVFH needs, which requires virtual interventions and minimal healthcare resources. Recognizing the need for a virtual, low-resource PTSD intervention for MVFH with PTSD and their loved ones, the investigators developed Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction). Couple HOPES is a secure, online self-help intervention for those with PTSD and their partners (www.couplehopes.com). However, MVFH are now particularly likely to be exposed to traumas related to COVID-19. It is essential to identify if Couple HOPES is safe and helpful for couples involving MVFH with COVID-19-related PTSD specifically. This project will therefore test the efficacy of Couple HOPES compared to a delayed waitlist control in 70 couples wherein one member is a MVFH with COVID-19-related PTSD. The investigators will examine if Couple HOPES is helpful in improving PTSD symptoms and relationship satisfaction for such couples, and if it is more or less helpful to this end for these couples compared to those with other forms of trauma exposure. 70 couples including a MVFH with COVID-19-related PTSD, will be randomly assigned to receive Couple HOPES or to a waitlist. PTSD symptoms and relationship satisfaction will be measured ~weekly during the intervention and one month after it. Related problems (e.g., depression, anxiety, healthcare use) will be measured before, in the middle of, after, and one month after, the intervention.

Condition or disease	Intervention/treatment	Phase
Posttraumatic Stress Disorder	Behavioral: Couple HOPES Guided, Internet-Delivered, Self-Help Intervention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participating couples are 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 (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Expanding a Randomized Controlled Trial of a Couple Internet-Delivered PTSD Intervention to Reach Military Members, Veterans, and First Responders With COVID-19-Related Trauma Exposure
• Actual Study Start Date: January 1, 2021
• Estimated Primary Completion Date: August 31, 2022
• Estimated Study Completion Date: March 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, and 3 months after the intervention ]
   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 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, and 3 months after the intervention ]
   Score on the CSI-4 range from 0 to 21, with 21 being the most satisfied.

Secondary Outcome Measures :

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.
2. Significant Others' Responses to Trauma Scale with change measured as mean change from baseline [ Time Frame: Baseline, week 3, week 8, 3 month post-treatment follow-up ]
   Scores range from 0 to 76, with 76 representing high partner accommodation.

Other Outcome Measures:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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 ]
8. 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 ]
9. 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 ]
10. Participant ratings of intervention satisfaction as indicated by the Client Satisfaction Questionnaire [ Time Frame: After 7 modules are completed or 8 weeks into treatment ]
11. 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) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Individual who is a Canadian military member, veteran, first responder or healthcare worker with clinically significant levels of PTSD symptoms related to COVID-19
• Individual who is an American healthcare worker with clinically significant levels of PTSD symptoms related to COVID-19
• 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

Contacts and Locations

Contacts

Contact: Caitlin M Martin Newnham, BSc; 6472449539; caitmn@yorku.ca

Contact: Dr. Skye Fitzpatrick, PhD; skyefitz@yorku.ca

Locations

Canada, Ontario

York University; Recruiting

Toronto, Ontario, Canada, M3J 1P3

Contact: Caitlin M Martin Newnham, BSc caitmn@yorku.ca

Contact: Skye Fitzpatrick, PhD skyefitz@yorku.ca

Principal Investigator: Skye Fitzpatrick, PhD

Sponsors and Collaborators

York University

Investigators

• Principal Investigator: Dr. Skye Fitzpatrick, PhD; York University

More Information

Publications:

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

• Responsible Party: Skye Fitzpatrick, Assistant Professor, York University
• ClinicalTrials.gov Identifier: NCT04763681
• Other Study ID Numbers: 2019-475; 173098 ( Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR) ); CIHR-IRSC:0525007697 ( Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR) ); W7714-207266 ( Other Grant/Funding Number: National Defence Security Orders and Directives )
• First Posted: February 21, 2021
• Last Update Posted: February 8, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Skye Fitzpatrick, York University:

Self-help; Internet-delivered intervention; Couple satisfaction; COVID-19; Coronavirus

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders