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Completed

NCT Number: NCT04763681

Couple HOPES and COVID-19

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.

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Key information

Conditions

Posttraumatic Stress Disorder COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mental Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Virus Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

York University

Toronto, Ontario, M3J 1P3, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

York University

Other

Registry information

Official study 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

Acronym: HOPES

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2021
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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