Clinical trial NCT04763681: Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Self-help
Internet-delivered intervention
Couple satisfaction
COVID-19
Coronavirus
Lead sponsor: York University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5) with change measured as mean change from baseline
timeFrame: Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, and 3 months after the intervention
measure: Couple Satisfaction Index (CSI-4) with change measured as mean change from baseline
timeFrame: Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, and 3 months after the intervention
Secondary outcomes:
measure: Mean change from baseline on Ineffective Arguing Inventory
timeFrame: 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
measure: Significant Others' Responses to Trauma Scale with change measured as mean change from baseline
timeFrame: Baseline, week 3, week 8, 3 month post-treatment follow-up
Other outcomes:
measure: Mean change from baseline on depression as measured by the Patient Health Questionnaire
timeFrame: 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
measure: Mean change from baseline on alcohol use as measured by the Alcohol Use Disorders Identification Test: Self-Report Version
timeFrame: 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
measure: Mean change from baseline in drug use based on the Drug Abuse Screen Test
timeFrame: 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
measure: Generalized Anxiety Disorder symptoms with change measured as mean change from baseline
timeFrame: 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
measure: State-Trait Anger Expression Inventory with change measured as mean change from baseline
timeFrame: 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
measure: Mean change from baseline in perceived health measured with one item "How satisfied are you with your health"
timeFrame: 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
measure: Trauma-Related Guilt Inventory with change measured as mean change from baseline
timeFrame: 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
measure: 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."
timeFrame: 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
measure: Mean change from baseline in quality of life measured with one item "How would you rate your quality of life."
timeFrame: 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
measure: Participant ratings of intervention satisfaction as indicated by the Client Satisfaction Questionnaire
timeFrame: After 7 modules are completed or 8 weeks into treatment
measure: Feasibility as measured by number of treatment sessions attended and rate of participant dropout
timeFrame: Once a week during treatment (for up to 8 weeks)
Locations:
city: Toronto
country: Canada
facility: York University
state: Ontario
Study officials:
affiliation: York University
name: Dr. Skye Fitzpatrick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Monson, C. M., & Fredman, S. J. (2012). Cognitive-behavioral conjoint therapy for PTSD: Harnessing the healing power of relationships. New York, NY: Guilford.