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STEP-Home Workshop for Post-Traumatic Stress Disorder (STEP-Home Trial)

N/A
Waitlist Available
Led By Catherine B Fortier, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-75 years old (to avoid outcomes being affected by aging)
Be older than 18 years old
Must not have
Neurological diagnosis prohibiting appropriate group participation (excluding TBI)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post 12-week treatment, post treatment (24 week follow-up)
Awards & highlights

Summary

This trial will test the efficacy of STEP-Home, a novel therapy targeting the needs of post-9/11 Veterans, in a randomized controlled design. The intervention is designed to improve functional skills central to community participation: emotional regulation, problem solving, and attention functioning.

Who is the study for?
This trial is for post-9/11 Veterans aged 18-75 who are experiencing difficulties reintegrating into civilian life, including issues with anger or readjustment. Participants must speak English and agree to the study's consent process. It excludes those in crisis, currently in other behavioral therapies, with bipolar disorder, active substance dependence, certain neurological conditions excluding TBI, schizophreniform disorder/active psychosis, or severe psychiatric disorders.Check my eligibility
What is being tested?
The STEP-Home workshop is being tested against PCGT (a control group therapy) to see if it helps Veterans improve emotional regulation, problem-solving skills and attention functioning for better community reintegration. This transdiagnostic skill-based intervention focuses on whole-person care rather than specific mental health diagnoses.See study design
What are the potential side effects?
As this is a psychological skills workshop rather than a medical treatment, traditional side effects like you'd expect from medication are not applicable. However participants may experience discomfort when discussing personal experiences or learning new coping strategies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have a neurological condition that prevents me from participating in group activities, except for TBI.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post 12-week treatment, post treatment (24 week follow-up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post 12-week treatment, post treatment (24 week 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
Attention-Related Cognitive Errors Scale (ARCES) (Change)
Difficulties in Emotion Regulation Scale (DERS) (Change)
Military to Civilian Questionnaire (Change)
+3 more
Secondary outcome measures
Average number of hours worked (Change)
Barriers to Employment Success Inventory (BESI) (Change)
Depression Anxiety and Stress Scale (DASS-21) (Change)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: STEP-HomeExperimental Treatment1 Intervention
The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
Group II: PCGTActive Control1 Intervention
The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
STEP-Home
2019
N/A
~230

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,628 Previous Clinical Trials
3,325,758 Total Patients Enrolled
Catherine B Fortier, PhDPrincipal InvestigatorVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

STEP-Home Clinical Trial Eligibility Overview. Trial Name: NCT03868930 — N/A
Post-Traumatic Stress Disorder Research Study Groups: STEP-Home, PCGT
Post-Traumatic Stress Disorder Clinical Trial 2023: STEP-Home Highlights & Side Effects. Trial Name: NCT03868930 — N/A
STEP-Home 2023 Treatment Timeline for Medical Study. Trial Name: NCT03868930 — N/A
~36 spots leftby Jul 2025
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