ERP to Improve Functioning in Veterans With OCD

NCT05240924 | Recruiting

• 1 other identifier: D3677-R
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Work and Social Adjustment Scale (WSAS) - Change

  The WSAS is a 5-item, self-report measure of impairment and functioning across five domains: work, household tasks, relationships, social, and leisure functioning. Respondents rate the impairment due to a specified problem; study participants will be directed to respond regarding impairment caused by OCD. Each item is rated on a 0-8 scale; total scores range from 0 to 40. The WSAS has good internal consistency reliability and validity and has been used to assess changes in functioning in OCD and anxiety disorders in psychotherapy trials. A score of 0-9 (Low impairment), 10-19 (Moderate impairment), and 20-40 (Severe impairment).

  Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment

Secondary Outcomes (2)

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

  Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment

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

  Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment

Other Outcomes (7)

• Obsessive-Compulsive Inventory, Revised (OCI-R) - Change

  Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment

• Adult OCD Impact Scale (AOIS) - Change

  Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment

• Patient Health Questionnaire (PHQ-9) - Depression - Change

  Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment

Study Arms (2)

Exposure and Response Prevention (ERP)

EXPERIMENTAL

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.

Behavioral: Exposure and Response Prevention

Control Condition

OTHER

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.

Other: Stress Management Training

Interventions

Exposure and Response Prevention 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.

Also known as: ERP

Exposure and Response Prevention (ERP)

Stress Management Training 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.

Control Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (18)

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

East Orange, New Jersey, 07018, United States

RECRUITING

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, 14215-1129, United States

RECRUITING

VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010-5011, United States

RECRUITING

Northport VA Medical Center, Northport, NY

Northport, New York, 11768-2200, United States

RECRUITING

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468-3904, United States

RECRUITING

Asheville VA Medical Center, Asheville, NC

Asheville, North Carolina, 28805-2576, United States

RECRUITING

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

RECRUITING

Fayetteville VA Medical Center, Fayetteville, NC

Fayetteville, North Carolina, 28301-3856, United States

RECRUITING

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

Salisbury, North Carolina, 28144, United States

RECRUITING

VA Roseburg Healthcare System, Roseburg, OR

Roseburg, Oregon, 97471, United States

RECRUITING

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

White City, Oregon, 97503, United States

RECRUITING

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

RECRUITING

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

RECRUITING

Hampton VA Medical Center, Hampton, VA

Hampton, Virginia, 23667, United States

RECRUITING

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249-0001, United States

RECRUITING

Salem VA Medical Center, Salem, VA

Salem, Virginia, 24153-6404, United States

RECRUITING

Spokane VA Medical Center, Spokane, WA

Spokane, Washington, 99205-6185, United States

RECRUITING

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

Walla Walla, Washington, 99362-3975, United States

RECRUITING

Related Publications (1)

• Ponzini GT, Hundt NE, Christie IC, Chen PV, Ecker AH, Lindsay JA, Teng EJ, Storch EA, Myers US, Roussev MS, Fletcher TL. A protocol for a randomized controlled trial of exposure and response prevention for veterans with obsessive compulsive disorder. Contemp Clin Trials. 2024 Mar;138:107445. doi: 10.1016/j.cct.2024.107445. Epub 2024 Jan 17.

  PMID: 38237674 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Stress Disorders, Post-Traumatic; Compulsive Behavior

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Impulsive Behavior; Behavior

Study Officials

• Terri L. Fletcher, PhD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew G Escamilla, BS

CONTACT

(713) 440-4461; matthew.escamilla@va.gov

Terri L Fletcher, PhD

CONTACT

(713) 440-4400; Terri.Fletcher@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 15, 2022
• Study Start: October 3, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)