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Behavioral Intervention

Exposure and Response Prevention for Obsessive-Compulsive Disorder

N/A
Recruiting
Led By Terri L. Fletcher, 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
Veterans having a primary diagnosis of Obsessive Compulsive Disorder (OCD) and comorbid OCD and Post-traumatic stress disorder (PTSD) who are receiving care from specific VA Medical Centers and Clinical Resource Hub
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post treatment (4-6 months after randomization), 6 months post treatment
Awards & highlights

Study Summary

This trial will compare the outcomes of exposure and response prevention (ERP), the sole evidence-based psychotherapy for OCD, to those of a control condition among Veterans with OCD.

Who is the study for?
This trial is for Veterans diagnosed with OCD, and half of the participants will also have PTSD. They must be receiving care from specific VA medical centers or via telehealth in certain states and willing to undergo ERP therapy. Those with severe cognitive issues, psychosis, mania, high suicide risk, or substance abuse problems cannot join.Check my eligibility
What is being tested?
The study tests how well Exposure and Response Prevention (ERP) improves functioning and quality of life compared to a control condition in Veterans with OCD alone or both OCD and PTSD. It's a randomized controlled trial that also evaluates ERP's potential for wider use in VA mental health settings.See study design
What are the potential side effects?
Since ERP is a type of psychotherapy involving exposure to anxiety-provoking stimuli without engaging in compulsive behaviors, side effects may include temporary increases in anxiety and emotional distress during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a veteran diagnosed with OCD, possibly also with PTSD, and am treated at specific VA centers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post treatment (4-6 months after randomization), 6 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post treatment (4-6 months after randomization), 6 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Work and Social Adjustment Scale (WSAS) - Change
Secondary outcome measures
Quality of Life Enjoyment and Satisfaction Questionnaire, short form (QLESQ-SF) - Change
Yale-Brown Obsessive Compulsive Scale, self-report form (Y-BOCS) - Change
Other outcome measures
Adult OCD Impact Scale (AOIS) - Change
Columbia Suicide Severity Rating Scale (C-SSRS) - Suicidality - Change
Generalized Anxiety Disorder-7 scale (GAD-7) - Anxiety Symptoms - Change
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Exposure and Response Prevention (ERP)Experimental Treatment1 Intervention
ERP will be based upon the Treatments That Work series, which contains both a provider manual and client workbook. Sessions will last 90 minutes and occur weekly for 16 sessions. All ERP treatment will be delivered via VTH. Participants will receive instructions on accessing the VTH platform and take part in a brief practice run connecting to the VTH appointment with guidance from an RA. ERP treatment content includes psychoeducation about OCD, assessment of OCD symptoms, the rationale for treatment, construction of a hierarchy or a list of feared or avoided situations, and in-session in-vivo and imaginal exposures. Weekly homework assignments will include self-monitoring, reading chapters about the treatment, and practicing exposures daily. All therapy sessions will be audio-recorded. Although sessions are expected to occur weekly, accounting for delays due to scheduling, holidays, and missed appointments, the investigators will allow up to 6 months to complete the treatment.
Group II: Control ConditionExperimental Treatment1 Intervention
Participants randomized to the control condition will receive 16 weekly sessions of stress management training via video telehealth. This control condition was chosen because it is expected to provide the therapeutic alliance and common factors associated with therapy generally and some specific effects in anxiety reduction.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exposure and Response Prevention
2013
Completed Phase 4
~260

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,444 Total Patients Enrolled
1 Trials studying Obsessive-Compulsive Disorder
105 Patients Enrolled for Obsessive-Compulsive Disorder
Terri L. Fletcher, PhDPrincipal InvestigatorMichael E. DeBakey VA Medical Center, Houston, TX
1 Previous Clinical Trials
225 Total Patients Enrolled

Media Library

Exposure and Response Prevention (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05240924 — N/A
Obsessive-Compulsive Disorder Research Study Groups: Exposure and Response Prevention (ERP), Control Condition
Obsessive-Compulsive Disorder Clinical Trial 2023: Exposure and Response Prevention Highlights & Side Effects. Trial Name: NCT05240924 — N/A
Exposure and Response Prevention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05240924 — N/A

Frequently Asked Questions

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

How many participants are currently undergoing this therapeutic trial?

"Indeed, clinicaltrials.gov reveals that this trial is currently enrolling participants. Starting on October 3rd 2022, the study has been actively searching for 160 patients from a single medical centre."

Answered by AI

Are investigators still signing up participants for this research endeavor?

"Affirmative. Data hosted on clinicaltrials.gov attests to the current recruitment of participants for this medical trial, which was first announced on October 3rd 2022 and last amended five days later. In total, 160 people are being sought after at one location."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
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?
2
~57 spots leftby Feb 2025