What side effects are associated with this type of intervention?

Exposure and Response Prevention (ERP) is generally well-tolerated but can cause temporary increases in anxiety and distress as patients confront their fears. Pharmacotherapy for OCD, particularly with SSRIs and SNRIs, can have side effects such as nausea, headache, insomnia, sexual dysfunction, and increased anxiety, especially at the beginning of treatment. Combining ERP with medication can enhance treatment efficacy but may also combine the side effects of both approaches.

What prior FDA approvals exist?

The FDA has approved several selective serotonin reuptake inhibitors (SSRIs) for the treatment of Obsessive-Compulsive Disorder (OCD), including fluoxetine, fluvoxamine, sertraline, and paroxetine. Clomipramine, a tricyclic antidepressant, is also approved for OCD. These medications help reduce OCD symptoms by increasing serotonin levels in the brain. Common side effects include gastrointestinal issues, sleep disturbances, and sexual dysfunction. In addition to pharmacotherapy, Cognitive Behavioral Therapy (CBT) with Exposure and Response Prevention (ERP) is a highly effective non-pharmacological treatment for OCD. ERP involves exposing patients to their fears and preventing the associated compulsive response, which helps reduce anxiety and compulsive behaviors over time.

What other types of research exist?

Promising novel alternatives to ERP for OCD treatment in 2024 include: 1) Deep Brain Stimulation (DBS) targeting the ventral internal capsule/ventral striatum, which has shown efficacy in treatment-refractory OCD cases. 2) Pharmacotherapy with memantine or riluzole as augmentation strategies for treatment-resistant OCD. 3) Cognitive-Behavioral Therapy (CBT) combined with serotonin reuptake inhibitors (SRIs) for severe OCD or partial responders to monotherapy. These alternatives offer new avenues for patients who do not respond to traditional ERP.

← Back to Search

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

No Placebo-Only Group

Summary

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.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post treatment (4-6 months after randomization), 6 months post treatment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Work and Social Adjustment Scale (WSAS) - Change

Secondary study objectives

Quality of Life Enjoyment and Satisfaction Questionnaire, short form (QLESQ-SF) - Change

Yale-Brown Obsessive Compulsive Scale, self-report form (Y-BOCS) - Change

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Obsessive-Compulsive Disorder (OCD) include Exposure and Response Prevention (ERP) and pharmacotherapy with selective serotonin reuptake inhibitors (SSRIs). ERP, a form of cognitive-behavioral therapy, works by exposing patients to their fears or obsessions and preventing the compulsive behaviors that usually follow, thereby reducing anxiety and breaking the cycle of compulsions. SSRIs, on the other hand, increase serotonin levels in the brain, which helps alleviate OCD symptoms. These treatments are essential for OCD patients as they address both the behavioral and neurochemical aspects of the disorder, providing a comprehensive approach to symptom management.