ERP to Improve Functioning in Veterans With OCD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-03

Study Completion Date

2026-05-31

Brief Summary

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Obsessive compulsive disorder (OCD) is a debilitating psychiatric illness impacting work, social, and family functioning. Exposure and Response Prevention (ERP) is the sole evidence-based psychotherapy for OCD; however, no randomized controlled trials (RCTs) have examined the effectiveness of ERP among Veterans or individuals with both OCD and posttraumatic stress disorder (PTSD). This 4-year Hybrid Type I trial will compare outcomes of ERP to those of a control condition among Veterans with OCD. Primary and secondary aims will examine whether Veterans' functioning, quality of life, and OCD symptoms differ between the ERP and control in the full sample of Veterans with OCD, and in the half of the sample with both OCD and PTSD. The tertiary aim is to conduct a mixed-methods formative evaluation of the implementation potential of ERP in VA mental health settings.

Detailed Description

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The proposed 4-year multisite RCT will compare outcomes of VTH-delivered ERP to those of a stress management training control condition among 160 Veterans with OCD. Half of the sample with have comorbid PTSD. The primary aim will examine whether participants' functioning, quality of life, and OCD symptoms differ as a function of the intervention (ERP vs. control). The secondary aim will examine these outcomes among the half of the sample with comorbid OCD and PTSD. The tertiary aim is to conduct a mixed-methods formative evaluation of the implementation potential of ERP in VA mental health settings.

Eligible Veteran participants will be randomized to ERP or to the control condition. Veterans randomized to ERP will receive 16 weekly ERP sessions delivered via VTH. Control participants will receive 16 weekly sessions of a stress management training intervention delivered via VTH. Participants in both conditions will complete assessments at post-treatment and 6 months after completing treatment. Participants in the ERP condition will also complete an assessment of treatment satisfaction and a qualitative exit interview assessing the Veterans' perceptions of the impact of treatment on multiple domains of functioning, including the impact on PTSD symptoms. Providers and VA administrators will participate in qualitative interviews regarding the implementation potential of ERP in VA.

Conditions

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Obsessive Compulsive Disorder (OCD) Comorbid Post-Traumatic Stress Disorder and OCD

Keywords

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Obsessive Compulsive Disorder OCD Post-Traumatic Stress Disorder PTSD Worry Compulsion Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A hybrid type 1 effectiveness-implementation trial evaluating the effectiveness of ERP in Veterans while also assessing the implementation context. This two-arm, participant-level randomized trial will compare ERP to a stress management training control. All participants will receive treatment via video telehealth (VTH). Because one of the primary unanswered questions is whether ERP is effective in individuals with comorbid PTSD, the investigators considered only testing ERP in patients with comorbid PTSD. However, given that the investigators could find no published treatment trials of OCD in Veterans, or trials of OCD delivered via VTH, the investigators believe the effectiveness of ERP in this population must also be tested. Effect sizes in the OCD-only group will serve as comparators for those in the OCD+PTSD group. Implementation context will be evaluated using a mixed-methods formative evaluation guided by the RE-AIM Quest framework.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Immediately following the baseline assessment, Veterans who meet inclusion criteria will be randomized to either ERP or stress management training. Randomization will be conducted by the study biostatistician. Given that one of the primary reasons ERP must be tested in the Veteran population specifically is the potentially confounding role of comorbid PTSD, allocation to ERP or stress management training will be stratified by the presence or absence of PTSD in order to ensure 50% comorbid PTSD in each group. Block randomization with randomly selected block sizes will be carried out to ensure that the outcome assessor is masked to condition.

Study Groups

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Exposure and Response Prevention (ERP)

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 Type EXPERIMENTAL

Exposure and Response Prevention

Intervention Type BEHAVIORAL

ERP is a specialized cognitive behavioral intervention conducted over the course of 8-16 therapy sessions. ERP is based upon exposure principles and the idea that people can habituate to the distress caused by OCD triggers and learn to cope with anxiety about feared consequences without engaging in compulsive behaviors to 'neutralize' the obsession. ERP begins with psychoeducation about OCD and exposure, followed by construction of a hierarchy, or list, of situations that are feared, avoided, or trigger OCD rituals such as washing or checking. Then, the therapist and client begin in-session exposures to hierarchy items utilizing response or ritual prevention techniques to avoid reinforcing the ritual. Exposures can be in vivo, such as touching a contaminated item, or imaginal, such as visualizing a feared consequence happening.

Control Condition

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.

Group Type OTHER

Stress Management Training

Intervention Type OTHER

The stress management training intervention will be based on that delivered by Simpson in an ERP trial. It will be delivered by PhD and Master's level therapists from each site's clinics. The stress management training intervention will begin with an introductory session providing psychoeducation about OCD, followed by 15 sessions covering stress management skills such as deep breathing progressive muscle relaxation, positive imagery, assertiveness training, and problem solving. Each session will contain an extended practice of the selected skill and will end with homework assignments to practice the stress management skills and monitor symptoms.

Interventions

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Exposure and Response Prevention

ERP is a specialized cognitive behavioral intervention conducted over the course of 8-16 therapy sessions. ERP is based upon exposure principles and the idea that people can habituate to the distress caused by OCD triggers and learn to cope with anxiety about feared consequences without engaging in compulsive behaviors to 'neutralize' the obsession. ERP begins with psychoeducation about OCD and exposure, followed by construction of a hierarchy, or list, of situations that are feared, avoided, or trigger OCD rituals such as washing or checking. Then, the therapist and client begin in-session exposures to hierarchy items utilizing response or ritual prevention techniques to avoid reinforcing the ritual. Exposures can be in vivo, such as touching a contaminated item, or imaginal, such as visualizing a feared consequence happening.

Intervention Type BEHAVIORAL

Stress Management Training

The stress management training intervention will be based on that delivered by Simpson in an ERP trial. It will be delivered by PhD and Master's level therapists from each site's clinics. The stress management training intervention will begin with an introductory session providing psychoeducation about OCD, followed by 15 sessions covering stress management skills such as deep breathing progressive muscle relaxation, positive imagery, assertiveness training, and problem solving. Each session will contain an extended practice of the selected skill and will end with homework assignments to practice the stress management skills and monitor symptoms.

Intervention Type OTHER

Other Intervention Names

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ERP

Eligibility Criteria

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Inclusion Criteria

* Veterans having a primary diagnosis of Obsessive Compulsive Disorder (OCD)(50% of sample) and comorbid OCD and Post-traumatic stress disorder (PTSD) (50% of sample) who are receiving care from the Michael E. DeBakey VA Medical Center (MEDVAMC) in Houston, TX; the Ralph H. Johnson VA Medical Center in Charleston, SC; the VISN 20 Clinical Resource Hub which provides telehealth services to Washington, Oregon, and Alaska: the VISN 2 Clinical Resource Hub which provides telehealth services to New Jersey, New York, and northern Pennsylvania, and the VISN 6 Clinical Resource Hub which provides telehealth services to North Carolina and Virginia.
* Willingness to participate in Exposure and Response Prevention(ERP)

Exclusion Criteria

* 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).
* Potential participants taking psychotropic medications must be on a stable dose of these medications for at least 6 weeks prior to study enrollment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Terri L. Fletcher, PhD

Role: PRINCIPAL_INVESTIGATOR

Michael E. DeBakey VA Medical Center, Houston, TX

Reach out to these primary contacts for questions about participation or study logistics.

Matthew G Escamilla, BS

Role: CONTACT

Phone: (713) 440-4461

Reference Type DERIVED

PMID: 38237674 (View on PubMed)

Other Identifiers

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D3677-R

Identifier Type: -

Identifier Source: org_study_id

ERP to Improve Functioning in Veterans With OCD

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Exposure and Response Prevention (ERP)

Exposure and Response Prevention

Control Condition

Stress Management Training

Interventions

Exposure and Response Prevention

Stress Management Training

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

VA Office of Research and Development

Responsible Party

Principal Investigators

Terri L. Fletcher, PhD

Locations

East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

VA Western New York Healthcare System, Buffalo, NY

VA NY Harbor Healthcare System, New York, NY

Northport VA Medical Center, Northport, NY

James J. Peters VA Medical Center, Bronx, NY

Asheville VA Medical Center, Asheville, NC

Durham VA Medical Center, Durham, NC

Fayetteville VA Medical Center, Fayetteville, NC

Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC

VA Roseburg Healthcare System, Roseburg, OR

VA Southern Oregon Rehabilitation Center and Clinics, White City, OR

Ralph H. Johnson VA Medical Center, Charleston, SC

Michael E. DeBakey VA Medical Center, Houston, TX

Hampton VA Medical Center, Hampton, VA

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Salem VA Medical Center, Salem, VA

Spokane VA Medical Center, Spokane, WA

Jonathan M. Wainwright Memorial VA Medical Center, Walla Walla, WA

Countries

Central Contacts

Matthew G Escamilla, BS

Terri L Fletcher, PhD

Facility Contacts

Jennifer Schneider, PhD

Matthew G Escamilla, BS

Jennifer Schneider, PhD

Matthew G Escamilla, BS

Jennifer Schneider, PhD

Matthew, BS

Jennifer Schneider, PhD

Matthew Escamilla, BS

Jennifer Schneider, PhD

Matthew G Escamilla, BS

Holly Hunley, PhD

Matthew G Escamilla, BS

Holly Hunley, PhD

Matthew G Escamilla, BS

Holly Hunley, PhD

Matthew G Escamilla, BS

Holly Hunley, PhD

Matthew G Escamilla, BS

Milena S Roussev, PhD

Matthew G Escamilla, BS

Milena S Roussev, PhD

Matthew G Escamilla, BS

Ursula S Myers, PhD

Matthew G Escamilla, BS

Matthew G Escamilla, BS

Holly Hunley, PhD

Matthew G Escamilla, BS

Holly Hunley, PhD

Matthew Escamilla, BS

Holly Hunley, PhD

Matthew G Escamilla, BS