ERP to Improve Functioning in Veterans With OCD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Exposure and Response Prevention
BehavioralERP 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.
Stress Management Training
Other interventionThe 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Exposure and Response Prevention (ERP)Experimental treatment 1 intervention
Group B: Control ConditionOther 1 intervention
Trial outcomes
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).
Time frame
Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post TreatmentSecondary outcomes
1
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.
Time frame
Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment2
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.
Time frame
Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post TreatmentOther outcomes
1
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.
Time frame
Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment2
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.
Time frame
Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment3
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.
Time frame
Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment4
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.
Time frame
Baseline, Post Treatment (4-6 months after randomization), 6 Months Post TreatmentSponsors and contacts
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Source ClinicalTrials.gov