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ERP to Improve Functioning in Veterans With OCD

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exposure and Response Prevention
Stress Management Training
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder (OCD) focused on measuring Obsessive Compulsive Disorder, OCD, Post-Traumatic Stress Disorder, PTSD, Worry, Compulsion, Stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Roseburg Healthcare System, Roseburg, ORRecruiting
  • VA Southern Oregon Rehabilitation Center and Clinics, White City, ORRecruiting
  • Ralph H. Johnson VA Medical Center, Charleston, SCRecruiting
  • Michael E. DeBakey VA Medical Center, Houston, TXRecruiting
  • Spokane VA Medical Center, Spokane, WARecruiting
  • Jonathan M. Wainwright Memorial VA Medical Center, Walla Walla, WARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Exposure and Response Prevention (ERP)

Control Condition

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 2, 2022
Last Updated
September 6, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05240924
Brief Title
ERP to Improve Functioning in Veterans With OCD
Official Title
Exposure and Response Prevention to Improve Functioning in Veterans With Obsessive Compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder (OCD), Comorbid Post-Traumatic Stress Disorder and OCD
Keywords
Obsessive Compulsive Disorder, OCD, Post-Traumatic Stress Disorder, PTSD, Worry, Compulsion, Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exposure and Response Prevention (ERP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Condition
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exposure and Response Prevention
Other Intervention Name(s)
ERP
Intervention Description
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
Other
Intervention Name(s)
Stress Management Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Work and Social Adjustment Scale (WSAS) - Change
Description
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 Treatment
Secondary Outcome Measure Information:
Title
Quality of Life Enjoyment and Satisfaction Questionnaire, short form (QLESQ-SF) - Change
Description
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 Treatment
Title
Yale-Brown Obsessive Compulsive Scale, self-report form (Y-BOCS) - Change
Description
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 Treatment
Other Pre-specified Outcome Measures:
Title
Obsessive-Compulsive Inventory, Revised (OCI-R) - Change
Description
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 Treatment
Title
Adult OCD Impact Scale (AOIS) - Change
Description
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 Treatment
Title
Patient Health Questionnaire (PHQ-9) - Depression - Change
Description
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 Treatment
Title
Quality of Life and Functional Status (SF-12V) - Change
Description
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 Treatment
Title
PTSD Checklist (PCL-5) - PTSD Symptoms - Change
Description
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.
Time Frame
Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment
Title
Generalized Anxiety Disorder-7 scale (GAD-7) - Anxiety Symptoms - Change
Description
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.
Time Frame
Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment
Title
Columbia Suicide Severity Rating Scale (C-SSRS) - Suicidality - Change
Description
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.
Time Frame
Baseline, Post Treatment (4-6 Months after Randomization), 6 Months Post Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew G Escamilla, BS
Phone
(713) 440-4461
Email
matthew.escamilla@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Terri L Fletcher, PhD
Phone
(713) 440-4400
Email
Terri.Fletcher@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terri L. Fletcher, PhD
Organizational Affiliation
Michael E. DeBakey VA Medical Center, Houston, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Roseburg Healthcare System, Roseburg, OR
City
Roseburg
State/Province
Oregon
ZIP/Postal Code
97471
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milena S Roussev, PhD
Phone
206-303-8274
Email
Milena.Roussev@va.gov
First Name & Middle Initial & Last Name & Degree
Matthew G Escamilla, BS
Email
matthew.escamilla@va.gov
Facility Name
VA Southern Oregon Rehabilitation Center and Clinics, White City, OR
City
White City
State/Province
Oregon
ZIP/Postal Code
97503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milena S Roussev, PhD
Phone
206-303-8274
Email
Milena.Roussev@va.gov
First Name & Middle Initial & Last Name & Degree
Matthew G Escamilla, BS
Email
Matthew.Escamilla@va.gov
Facility Name
Ralph H. Johnson VA Medical Center, Charleston, SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5703
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ursula S Myers, PhD
Phone
843-252-3880
Email
ursula.myers@va.gov
First Name & Middle Initial & Last Name & Degree
Matthew G Escamilla, BS
Phone
7137948601
Email
matthew.escamilla@va.gov
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew G Escamilla, BS
Phone
713-440-4461
Email
matthew.escamilla@va.gov
First Name & Middle Initial & Last Name & Degree
Terri L. Fletcher, PhD
Facility Name
Spokane VA Medical Center, Spokane, WA
City
Spokane
State/Province
Washington
ZIP/Postal Code
99205-6185
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milena S Roussev, PhD
Phone
206-303-8274
Email
Milena.Roussev@va.gov
First Name & Middle Initial & Last Name & Degree
Matthew G Escamilla, BS
Email
matthew.escamilla@va.gov
Facility Name
Jonathan M. Wainwright Memorial VA Medical Center, Walla Walla, WA
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362-3975
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milena S Roussev, PhD
Phone
206-303-8274
Email
Milena.Roussev@va.gov
First Name & Middle Initial & Last Name & Degree
Matthew G Escamilla, BS
Email
Matthew.Escamilla@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No

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ERP to Improve Functioning in Veterans With OCD

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