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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post 12-week treatment, post treatment (24 week follow-up)
Awards & highlights

STEP-Home Trial 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.

STEP-Home Trial 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.

STEP-Home Trial 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

STEP-Home 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
1,609 Previous Clinical Trials
3,306,208 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

Frequently Asked Questions

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

Are there any age restrictions for enrolment in this experiment?

"This trial is open to participants aged between 18 and 75. Separately, there are 723 studies for those younger than 18 years old and 2388 trials that accept applicants over 65."

Answered by AI

What are the primary objectives of this investigative endeavor?

"The primary endpoint of this clinical trial, assessed at Screening, Baseline, Post 12-Week Treatment and Post Treatment (24 week follow-up) is to appraise the Problem Solving Inventory (PSI). Secondary endpoints are PTSD Checklist for DSM-5 (PCL-5), Satisfaction with Life Scale (SWLS), and Neurobehavioral Symptoms Inventory (NSI). These assessments will measure change in scores across a range from 0 to 80 for PCL-5, 5 to 35 SWLS, and 0 to 88 NSI; lower numbers being preferable."

Answered by AI

What criteria must one fulfill in order to participate in this clinical experiment?

"This clinical trial is recruiting 300 participants, aged between 18 and 75 years old, who have been diagnosed with depression. Additionally, they must be Post-9/11 Veterans that report some degree of difficulty related to reintegration, readjustment or anger (as assessed by the M2CQ; PDRI; STAXI-2). Furthermore, all patients should demonstrate fluency in English as sessions will only be conducted in this language. Lastly, those interested are required to agree to participate and complete the Informed Consent Form (ICF) & Health Insurance Portability and Accountability Act (HIPAA)."

Answered by AI

Does this experiment currently have capacity for additional participants?

"According to clinicaltrials.gov, this particular trial initiated on June 17th 2019 and ended its recruitment phase as of April 14th 2022. Unfortunately, it is not enrolling any participants at the present moment; however, there are 3372 other medical trials actively seeking patients."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
Texas
How old are they?
18 - 65
What site did they apply to?
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Michael E. DeBakey VA Medical Center, Houston, TX
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

If it can help with PTSD and I can help to make that happen is one of the reasons why I’m reaching out.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

What is it in its entirety?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop
2019. "Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03868930.
~38 spots leftby Apr 2025
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