Posttraumatic Stress Disorder
Conditions
Keywords
Self-help, Internet-delivered intervention
Brief 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.
Interventions
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.
Sponsors
Toronto Metropolitan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participating couples are either non-randomized in early phases of project or 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5) with change measured as mean change from baseline | 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 | Scores on the PCL-5 range from 0 to 80, with 80 being the most severe PTSD symptoms. |
| Couple Satisfaction Index (CSI-4) with change measured as mean change from baseline | 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 | Score on the CSI-4 range from 0 to 21, with 21 being the most satisfied. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline on Ineffective Arguing Inventory | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline on alcohol use as measured by the Alcohol Use Disorders Identification Test: Self-Report Version | 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. |
| Mean change from baseline in drug use based on the Drug Abuse Screen Test | 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. |
| Generalized Anxiety Disorder symptoms 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 | Scores range from 0 to 21, with 21 representing the highest level of anxiety. |
| State-Trait Anger Expression 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 | Scores range from 0 to 40, with 40 representing higher levels of anger. |
| Feasibility as measured by number of treatment sessions attended and rate of participant dropout | Once a week during treatment (for up to 8 weeks) | — |
| 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 | — |
| Mean change from baseline in perceived health measured with one item How satisfied are you with your health | 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. |
| Significant Others' Responses to Trauma Scale 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 | Scores range from 0 to 76, with 76 representing high partner accommodation. |
| Mean change from baseline on depression as measured by the Patient Health Questionnaire | 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. |
Countries
Canada
Outcome results
None listed