Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction)

NCT04763681 | Completed

• 4 other identifiers: 2019-475173098CIHR-IRSC:0525007697W7714-207266
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• 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

• Significant Others' Responses to Trauma Scale with change measured as mean change from baseline

  Baseline, week 3, week 8, 3 month post-treatment follow-up

Other Outcomes (11)

• 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

• 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

• 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

Study Arms (2)

Immediate Couple HOPES

EXPERIMENTAL

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

Delayed Intervention

NO 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.

Interventions

Couple HOPES Guided, Internet-Delivered, Self-Help Intervention BEHAVIORAL

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.

Immediate Couple HOPES

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Elevated suicide risk
• Severe physical aggression between partners in the past year
• Clinically significant PTSD symptoms in both members of the dyad

Sponsors & Collaborators

• York University: lead

Study Sites (1)

York University

Toronto, Ontario, M3J 1P3, Canada

Location

Related Publications (2)

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

  BACKGROUND

• Fitzpatrick S, Crenshaw AO, Valela R, Samonas C, Earle EA, Goss S, Hernandez KM, Bushe J, Varma S, Proctor D, Wagner AC, Goenka K, Luxor O, Collins A, Morland L, Shields N, Roth M, Doss BD, Schumm J, Monson CM. A randomized controlled trial testing couple HOPES: An online, self-help couples' intervention for posttraumatic stress disorder. J Consult Clin Psychol. 2025 Aug;93(8):580-594. doi: 10.1037/ccp0000965.

  PMID: 40811121 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dr. Skye Fitzpatrick, PhD

  York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 13, 2021
• First Posted: February 21, 2021
• Study Start: January 1, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)