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Internet-Based Couples Therapy for PTSD (HOPES Trial)

N/A
Waitlist Available
Led By Candice M Monson, PhD
Research Sponsored by Toronto Metropolitan University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

HOPES Trial Summary

This trial is testing a new internet-based intervention to help improve PTSD symptoms, relationship functioning, and mental health in partners of people with PTSD. The trial will test the feasibility, safety, and efficacy of the intervention in 10 couples, then 20 couples, and then compare it to a control condition in 70 couples.

Who is the study for?
This trial is for Canadian military members, veterans, or first responders with PTSD and their intimate partners willing to participate. They must have significant PTSD symptoms but not both in the couple, no severe partner aggression in the past year, nor elevated suicide risk.Check my eligibility
What is being tested?
Couple HOPES is an online self-help program designed to reduce PTSD symptoms and improve relationships. It includes seven modules with text and video content plus support from coaches. The study will test its effectiveness through three phases involving different numbers of couples.See study design
What are the potential side effects?
Participants may experience distress during assessments or a potential worsening of PTSD symptoms or relationship issues. However, continuous monitoring by staff aims to mitigate these risks.

HOPES Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Couple Satisfaction Index (CSI-4) with change measured as mean change from baseline
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5) with change measured as mean change from baseline
Secondary outcome measures
Mean change from baseline on Ineffective Arguing Inventory
Other outcome measures
Feasibility as measured by number of treatment sessions attended and rate of participant dropout
Generalized Anxiety Disorder symptoms with change measured as mean change from baseline
Mean change from baseline in drug use based on the Drug Abuse Screen Test
+9 more

HOPES Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate Couple HOPESExperimental Treatment1 Intervention
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.
Group II: Delayed InterventionActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Couple HOPES Guided, Internet-Delivered, Self-Help Intervention
2020
N/A
~160

Find a Location

Who is running the clinical trial?

Toronto Metropolitan UniversityLead Sponsor
84 Previous Clinical Trials
10,815 Total Patients Enrolled
Ryerson UniversityLead Sponsor
76 Previous Clinical Trials
7,747 Total Patients Enrolled
Candice M Monson, PhDPrincipal InvestigatorToronto Metropolitan University
2 Previous Clinical Trials
97 Total Patients Enrolled

Media Library

Couple HOPES Guided, Internet-Delivered, Self-Help Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04231578 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Immediate Couple HOPES, Delayed Intervention
Post-Traumatic Stress Disorder Clinical Trial 2023: Couple HOPES Guided, Internet-Delivered, Self-Help Intervention Highlights & Side Effects. Trial Name: NCT04231578 — N/A
Couple HOPES Guided, Internet-Delivered, Self-Help Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04231578 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the largest number of individuals participating in this investigation?

"Affirmative. Analysis of the clinicaltrials.gov database suggests that this investigation is currently recruiting, having been initially published on March 31st 2020 and most recently updated on July 7th 2021. 1 medical centre needs to recruit 140 individuals for this trial."

Answered by AI

Is recruitment still ongoing for this research endeavor?

"Affirmative. Information hosted on clinicaltrials.gov notes that this medical trial is currently enrolling volunteers and was originally posted on March 31st 2020. 140 participants are required for the study, which will be carried out at one site."

Answered by AI
~30 spots leftby Apr 2025