ERP to Improve Functioning in Veterans With OCD

Obsessive Compulsive Disorder (OCD) Clinical Trial

Official title:

Exposure and Response Prevention to Improve Functioning in Veterans With Obsessive Compulsive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05240924
• Other study ID #: D3677-R
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: May 31, 2026

Study information

• Verified date: March 2024
• Source: VA Office of Research and Development
• Contact: Matthew G Escamilla, BS
• Phone: (713) 440-4461
• Email: matthew.escamilla[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: May 31, 2026
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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; and the VISN 20 Clinical Resource Hub which provides telehealth services to Washington, Oregon, and Alaska.

• 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.

Related Conditions & MeSH terms

• Obsessive Compulsive Disorder (OCD)
• Obsessive-Compulsive Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina
United States	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas
United States	VA Roseburg Healthcare System, Roseburg, OR	Roseburg	Oregon
United States	Spokane VA Medical Center, Spokane, WA	Spokane	Washington
United States	Jonathan M. Wainwright Memorial VA Medical Center, Walla Walla, WA	Walla Walla	Washington
United States	VA Southern Oregon Rehabilitation Center and Clinics, White City, OR	White City	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Obsessive-Compulsive Inventory, Revised (OCI-R) - Change	The OCI-R is included as a secondary assessment of OCD symptoms. It contains 18 items rated on a 0-4 scale from "not at all" to "extremely." The recommended cutoff for a likely OCD diagnosis is 21, and it has excellent internal consistency and validity.	Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment
Other	Adult OCD Impact Scale (AOIS) - Change	The AOIS is a 48-item measure that assesses level of difficulty completing activities due to OCD in four different areas: work/school, home/family, intimate relationships, and social situations. Questions are rated on a five-point scale; total scores range from 0 - 182 with higher scores indicating greater functional impairment due to OCD. This scale has excellent internal consistency (alpha = .96) and scores correlation with other measures of general functioning and disability.	Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment
Other	Patient Health Questionnaire (PHQ-9) - Depression - Change	The PHQ-9 is a psychometrically strong, 9-item measure of depressive symptoms that taps each of the DSM-5 depression symptoms. Scores range from 0-27 with scores greater than or equal to 10 suggesting the presence of clinically significant depression. PHQ-9 comprises five categories, where a cut-off point of 0-4 indicates no depressive symptoms, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, 15-19 moderately-severe depressive symptoms, and 20-27 severe depressive symptoms. The PHQ-9 has excellent internal consistency and validity with other measures of depression.	Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment
Other	Quality of Life and Functional Status (SF-12V) - Change	The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. Physical and mental health composite scores are computed using the score of 12 questions and range from 0 to 100, where are zero score indicates the lowest level of health measure by the scales and 100 indicates the highest level of health. The investigators will assess quality of life using the 12-tiem short form health survey for Veterans, an instrument adopted by VHA as a measure of functional status. SF-12V responses can be summarized in component scores for physical (PCS) and mental (MCS) functioning.	Baseline, Post Treatment (4-6 months after randomization), 6 Months Post Treatment
Other	PTSD Checklist (PCL-5) - PTSD Symptoms - Change	The PCL-5 will be used to determine severity of PTSD symptoms. This 20-item questionnaire assesses each DSM-5 criterion for PTSD. The recommended cutoff for probable PTSD is 33. It has excellent internal consistency and correlation with other measures of PTSD.	Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment
Other	Generalized Anxiety Disorder-7 scale (GAD-7) - Anxiety Symptoms - Change	The GAD-7 is a 7-item measure of generalized anxiety symptoms. Scores range from 0 to 21, with scores greater than or equal to 10 suggesting the presence of generalized anxiety disorder. Cut points of 5, 10, and 15 might be interpreted as representing mild, moderate, and severe levels of anxiety on the GAD-7. The GAD-7 has good internal consistency reliability and validity.	Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment
Other	Columbia Suicide Severity Rating Scale (C-SSRS) - Suicidality - Change	The C-SSRS assesses severity of suicidal ideation, intensity of ideation, behaviors such as preparation, and lethality of attempts. Internal consistency is very good (alpha = .94) and the scale shows good convergent validity with other scales assessing suicidality. For the current study, the investigators use the 'current' version which assesses suicide risk in the past month.	Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment
Primary	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	Quality of Life Enjoyment and Satisfaction Questionnaire, short form (QLESQ-SF) - Change	The QLESQ-SF is a 16-item scale assessing quality of life, enjoyment, and satisfaction across a broad range of domains, including physical health, mood, leisure activities, relationships, and overall sense of well-being. Respondents rate each item on a scale of 1-5. Because the last two items, about medication and overall life enjoyment, are scored separately, scores range from 14 to 70. The QLESQ-SF has good internal consistency reliability and validity and has been used to examine quality of life in OCD and anxiety disorders. Each item uses a 5-point scale ranging from 1 (very poor) to 5 (very good). A total score is derived from 14 items with a maximum score of 70 and with higher scores indicating greater life satisfaction and enjoyment.	Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment
Secondary	Yale-Brown Obsessive Compulsive Scale, self-report form (Y-BOCS) - Change	This 10-item questionnaire asks about the frequency and severity of obsessions and compulsions, ability to resist them, and interference from symptoms. Scores can range from 0-40. A score of 8-15 represents mild OCD; 16-23, moderate; 24-31, severe, and above 32, extreme. The self-report Y-BOCS has excellent reliability and validity, and correlates highly with the original clinician-administered interview version. It is frequently used as an outcome measure in randomized controlled trials of ERP. A clinically significant improvement in Y-BOCS score is a 35% reduction.	Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment