160 Participants Needed

Exposure and Response Prevention for Obsessive-Compulsive Disorder

Recruiting at 17 trial locations
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MG
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Overseen ByTerri L. Fletcher, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial will test a therapy called ERP, which helps people face their fears and stop doing habits that make them feel temporarily better but keep the problem going. It will focus on Veterans with OCD, including those who also have PTSD. The goal is to see if this therapy improves their daily functioning and quality of life.

Will I have to stop taking my current medications?

If you are taking psychotropic medications, you need to be on a stable dose for at least 6 weeks before joining the study. This means you don't have to stop your current medications, but they should not be changed right before or during the trial.

What data supports the effectiveness of the treatment Exposure and Response Prevention for Obsessive-Compulsive Disorder?

Research shows that Exposure and Response Prevention (ERP) is the most effective treatment for obsessive-compulsive disorder (OCD), with about 90% of patients who undergo ERP experiencing significant improvements. ERP is also effective in reducing symptoms in related conditions like Tourette syndrome.12345

Is exposure and response prevention (ERP) therapy safe for humans?

Some therapists have concerns about the safety of ERP, especially for certain types of OCD symptoms, but there is no strong evidence of serious negative consequences. ERP is generally considered safe, though it can be distressing for some people, which may lead to them stopping treatment early.26789

How is the treatment Exposure and Response Prevention (ERP) unique for obsessive-compulsive disorder (OCD)?

Exposure and Response Prevention (ERP) is unique because it involves gradually facing fears and resisting the urge to perform compulsive behaviors, which is different from medication-based treatments. It is the most supported psychological treatment for OCD and can be used alone or with cognitive therapy to potentially enhance its effectiveness.123810

Research Team

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Terri L. Fletcher, PhD

Principal Investigator

Michael E. DeBakey VA Medical Center, Houston, TX

Eligibility Criteria

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.

Inclusion Criteria

I am a veteran diagnosed with OCD, possibly also with PTSD, and am treated at specific VA centers.
I am willing to undergo ERP therapy.

Exclusion Criteria

I have been on a stable dose of my mental health medication for at least 6 weeks.
Significant cognitive impairment or conditions that threaten safety (current psychosis, mania, imminent suicidality including plan or intent, and treatment-interfering moderate to severe substance use)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 16 weekly sessions of ERP or stress management training via VTH

16 weeks
16 visits (virtual)

Post-Treatment Assessment

Participants complete assessments to evaluate treatment outcomes

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness 6 months after treatment

6 months
2 visits (virtual)

Treatment Details

Interventions

  • Exposure and Response Prevention
Trial OverviewThe 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.
Participant Groups
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.

Exposure and Response Prevention is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Exposure and Response Prevention for:
  • Obsessive-Compulsive Disorder (OCD)
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Approved in European Union as Exposure and Response Prevention for:
  • Obsessive-Compulsive Disorder (OCD)
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Approved in Canada as Exposure and Response Prevention for:
  • Obsessive-Compulsive Disorder (OCD)

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Findings from Research

Exposure therapy with response prevention is considered the most effective treatment for obsessive-compulsive disorder (OCD), highlighting its importance in managing this condition.
This therapy has been successfully applied to both outpatient and inpatient settings, demonstrating its versatility and effectiveness across different patient populations.
[Obsessive-compulsive disorders--inpatient behavior therapy].Winkelmann, G., Hohagen, F.[2006]
Exposure and response prevention (ERP) therapy shows a small-to-medium effect size in reducing symptoms for patients with obsessive-compulsive disorder (OCD) and Tourette syndrome (TS), based on a meta-analysis of 18 studies involving 1057 OCD patients and 267 TS patients.
The study suggests that while ERP is effective, combining it with other therapies and developing online ERP services could enhance treatment outcomes, as the exact neurological mechanisms behind its efficacy remain unclear.
The Efficacy and Neural Correlates of ERP-based Therapy for OCD & TS: A Systematic Review and Meta-Analysis.Yan, J., Cui, L., Wang, M., et al.[2022]
A study involving 127 participants with OCD found that integrating cognitive therapy with exposure and response prevention (ERP) significantly improved treatment outcomes compared to ERP alone, leading to greater reductions in symptoms and obsessive beliefs.
More patients in the ERP + cognitive therapy group were classified as treatment responders, indicating that combining these approaches can enhance the effectiveness of OCD treatment.
Does the addition of cognitive therapy to exposure and response prevention for obsessive compulsive disorder enhance clinical efficacy? A randomized controlled trial in a community setting.Rector, NA., Richter, MA., Katz, D., et al.[2022]

References

[Obsessive-compulsive disorders--inpatient behavior therapy]. [2006]
The Efficacy and Neural Correlates of ERP-based Therapy for OCD & TS: A Systematic Review and Meta-Analysis. [2022]
Does the addition of cognitive therapy to exposure and response prevention for obsessive compulsive disorder enhance clinical efficacy? A randomized controlled trial in a community setting. [2022]
Cognitive versus behavior therapy: processes of change in the treatment of obsessive-compulsive disorder. [2019]
Behavior therapy for obsessive compulsive disorder. [2022]
A meta-analysis of dropout rates from exposure with response prevention and pharmacological treatment for youth with obsessive compulsive disorder. [2022]
Serious negative consequences associated with exposure and response prevention for obsessive-compulsive disorder: A survey of therapist attitudes and experiences. [2020]
How willing are you? Willingness as a predictor of change during treatment of adults with obsessive-compulsive disorder. [2018]
Stepped care versus standard cognitive-behavioral therapy for obsessive-compulsive disorder: a preliminary study of efficacy and costs. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Frequency and level of self-efficacy predict the effectiveness of therapist- and self-guided exposure in obsessive compulsive disorder. [2020]