Exposure and Response Prevention for Obsessive-Compulsive Disorder

Recruiting at 18 trial locations

Overseen By Terri L. Fletcher, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment, Psychosis, Mania, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 18

Duration: 16 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of Exposure and Response Prevention (ERP) therapy for Veterans with Obsessive-Compulsive Disorder (OCD), particularly those also experiencing post-traumatic stress disorder (PTSD). ERP involves gradually confronting feared situations to reduce anxiety and enhance daily life. Participants will receive either ERP therapy or stress management training. This trial suits Veterans diagnosed with OCD, with or without PTSD, who can access care through specific VA centers and are willing to participate in therapy sessions. As an unphased trial, it provides Veterans the chance to contribute to valuable research that may enhance therapeutic options for OCD and PTSD.

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 prior data suggests that Exposure and Response Prevention is safe for Veterans with OCD?

Research has shown that Exposure and Response Prevention (ERP) is a safe and effective treatment for obsessive-compulsive disorder (OCD). Many studies have demonstrated that ERP can greatly improve OCD symptoms and reduce depression and anxiety in people with OCD. These findings suggest that ERP is generally safe and beneficial for those with OCD. No major reports of negative effects have emerged, making it a promising option for anyone considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Exposure and Response Prevention (ERP) for Obsessive-Compulsive Disorder (OCD) because it offers a structured approach that is different from medications, which are the standard of care like SSRIs. ERP works by directly confronting and reducing the fear and anxiety associated with OCD triggers, helping patients build resilience through repeated exposure and response strategies. Delivered via video telehealth, it makes therapy more accessible and flexible, potentially reaching individuals who might not have easy access to in-person therapy. Additionally, the comprehensive nature of ERP, including psychoeducation and personalized hierarchies of feared situations, provides a robust framework that empowers patients to actively manage their OCD symptoms.

What evidence suggests that Exposure and Response Prevention is effective for OCD?

Research has shown that Exposure and Response Prevention (ERP), which participants in this trial may receive, effectively treats obsessive-compulsive disorder (OCD). Studies have found that ERP greatly reduces OCD symptoms. In fact, many consider ERP the best treatment for OCD due to its effectiveness in clinical settings. One study also found that ERP helps reduce depression and anxiety in people with OCD. Overall, patients who participate in ERP experience significant improvement in their quality of life. ^{1 3 4 6 7}

Who Is on the Research Team?

Terri L. Fletcher, PhD

Principal Investigator

Michael E. DeBakey VA Medical Center, Houston, TX

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Exposure and Response Prevention

Trial Overview

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.

How Is the Trial Designed?

Group I: Exposure and Response Prevention (ERP) Experimental Treatment 1 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 Condition Experimental Treatment 1 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)

Approved in European Union as Exposure and Response Prevention for:

• Obsessive-Compulsive Disorder (OCD)

Approved in Canada as Exposure and Response Prevention for:

• Obsessive-Compulsive Disorder (OCD)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Serious negative consequences (SNC) from exposure and response prevention (ERP) therapy for obsessive-compulsive disorder (OCD) are extremely rare, occurring in only 0.05% of adult clients and 0.01% of youth clients, indicating that ERP is a safe treatment option.

Despite some therapists' concerns, the study found that most therapists are willing to treat harm-related OCD, and improving communication about the safety and rationale of ERP could enhance access to this effective therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious negative consequences associated with exposure and response prevention for obsessive-compulsive disorder: A survey of therapist attitudes and experiences. Schneider, SC., Knott, L., Cepeda, SL., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Behavior therapy for obsessive-compulsive disorder (OCD), particularly through exposure and response prevention, is highly effective, with about 90% of patients experiencing significant improvements when they engage in these techniques.

Despite its effectiveness, about 25% of patients refuse behavior therapy, and the limited availability of such treatments poses a significant public health challenge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior therapy for obsessive compulsive disorder. Greist, JH.[2022]

In a study of 288 adults with OCD undergoing residential exposure and response prevention (ERP), those who showed greater willingness to experience unpleasant thoughts and feelings reported faster reductions in OCD symptoms during treatment.

This willingness was found to be a significant factor in treatment success, suggesting that embracing discomfort may enhance the effectiveness of ERP for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How willing are you? Willingness as a predictor of change during treatment of adults with obsessive-compulsive disorder. Reid, AM., Garner, LE., Van Kirk, N., et al.[2018]

A study involving 30 adults with OCD found that a stepped care approach to exposure and response prevention (ERP) was equally effective as standard ERP, with 67% of stepped care participants achieving significant improvement compared to 50% in the standard group.

The stepped care model significantly reduced treatment costs for patients and payers without compromising treatment efficacy or patient satisfaction, suggesting it could be a more accessible option for OCD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepped care versus standard cognitive-behavioral therapy for obsessive-compulsive disorder: a preliminary study of efficacy and costs. Tolin, DF., Diefenbach, GJ., Gilliam, CM.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Obsessive-compulsive disorders--inpatient behavior therapy]. Winkelmann, G., Hohagen, F.[2006]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Exposure with response prevention (ERP) for youth with obsessive-compulsive disorder (OCD) has a low attrition rate of 10.24%, which is significantly lower than other treatment modalities like pharmacotherapy (17.29%) and active controls (20.63%).

The study suggests that ERP is an effective first-line treatment for OCD, as attrition is primarily due to logistical issues rather than treatment distress, indicating that concerns about distress leading to dropout are unfounded.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of dropout rates from exposure with response prevention and pharmacological treatment for youth with obsessive compulsive disorder. Johnco, C., McGuire, JF., Roper, T., et al.[2022]

In a study involving 61 participants, both exposure and response prevention (ERP) and cognitive therapy (CT) were found to be equally effective in treating obsessive-compulsive disorder, with no significant differences in how they affected obsessions and compulsions over time.

The research indicated that changes in compulsive behaviors were more predictive of overall treatment success than changes in obsessive thoughts, suggesting that both therapies primarily facilitate change through the reduction of compulsions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive versus behavior therapy: processes of change in the treatment of obsessive-compulsive disorder. Anholt, GE., Kempe, P., de Haan, E., et al.[2019]

In a study of 377 in-patients with OCD, more frequent therapist-guided exposure and response prevention (ERP) sessions were linked to greater symptom reduction, emphasizing the importance of therapist involvement in treatment.

The effectiveness of self-guided ERP was found to be mediated by increased self-efficacy, suggesting that building patients' confidence can enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency and level of self-efficacy predict the effectiveness of therapist- and self-guided exposure in obsessive compulsive disorder. Voderholzer, U., Hilbert, S., Fischer, A., et al.[2020]

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