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Couple HOPES Guided, Internet-Delivered, Self-Help Intervention for Post-Traumatic Stress Disorder (HOPES Trial)

N/A
Waitlist Available
Led By Dr. Skye Fitzpatrick, PhD
Research Sponsored by York University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, and 3 months after the intervention
Awards & highlights

HOPES Trial Summary

This trial will test the efficacy of an online self-help intervention, 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.

Eligible Conditions
  • Post Traumatic Stress Disorder

HOPES Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, and 3 months after the intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, and 3 months after the intervention 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
Significant Others' Responses to Trauma Scale with change measured as mean change from baseline
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
+8 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?

York UniversityLead Sponsor
58 Previous Clinical Trials
17,336 Total Patients Enrolled
Dr. Skye Fitzpatrick, PhDPrincipal InvestigatorYork University
1 Previous Clinical Trials
42 Total Patients Enrolled

Frequently Asked Questions

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

Is this research encompassing participants who are below seventieth year of age?

"According to the prerequisites of this study, only individuals between the age 18 and 64 can participate."

Answered by AI

Are there any specific prerequisites for enrollment in this clinical experiment?

"To participate in this medical trial, potential patients must have been diagnosed with PTSD and be within the ages of 18-64. Currently, approximately 140 individuals are being sought to join."

Answered by AI

Are any participants currently being accepted for this research endeavor?

"Affirmative, according to the details hosted on clinicaltrials.gov this experiment is currently recruiting patients. The trial was opened for recruitment on January 1st 2021 and last updated February 7th 2022; 140 individuals need to be enrolled from one location."

Answered by AI

How many people are participating in the research experiment?

"Affirmative. Clinicaltrials.gov contains information verifying that this clinical trial, which was first launched on January 1st 2021 is actively recruiting participants. The research team needs to enlist 140 test subjects from a single medical site."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Oregon
How old are they?
18 - 65
What site did they apply to?
York University
What portion of applicants met pre-screening criteria?
Met criteria
~33 spots leftby Apr 2025