Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction)

Posttraumatic Stress Disorder Clinical Trial

— HOPES  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04763681
• Other study ID #: 2019-475
• Secondary ID: 173098CIHR-IRSC:
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2023
• Source: York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-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	York University	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
York 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	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 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, and 3 months after the intervention
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 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, and 3 months after the intervention
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
Secondary	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, 3 month post-treatment follow-up