- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00045903
Cognitive Behavioral Therapy Plus Drug Treatment for Obsessive Compulsive Disorder (Aug1)
CBT Augmentation for SRI Pharmacotherapy in OCD
Study Overview
Status
Conditions
Detailed Description
Participants remain on their current OCD medication and are randomly assigned to receive one of two CBTs: exposure and ritual prevention or stress management therapy. Exposure and ritual prevention involves imaginal and in-vivo exposure and requires that participants refrain from ritualizing. Stress management involves relaxation, assertiveness training, and structured problem-solving. Therapy occurs twice per week for 2 months. Participants are assessed verbally by an independent evaluator and are asked to complete self-rating forms. Patients who respond are followed for up to 1 additional year. Participants continue to take the same medication and the same monthly therapy for the first 6 months of follow-up. During the second 6 months of follow-up, participants discontinue therapy but continue taking the same medication.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00389493
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- New York State Psychiactic Institute, Anxiety Disorders Clinic
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Center for the Treatment and Study of Anxiety
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Obsessive-Compulsive Disorder (OCD) diagnosis
- Currently taking a serotonin reuptake inhibitor (SRI, i.e. clomipramine, fluoxetine, fluvoxamine, paroxetine, sertraline, or citalopram) for OCD
Exclusion Criteria:
- Medical or psychiatric conditions that would make participation in the study hazardous
- Intensive cognitive-behavioral therapy while on an adequate dose and duration of an SRI for OCD
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exposure and Ritual Prevention
Exposure and Ritual Prevention Therapy
|
|
Active Comparator: Stress Management
Stress Management Therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Obsessive-compulsive symptoms measured at Month 2
Time Frame: 2 months
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
General functioning measured at Month 2
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michael Liebowitz, MD, New York State Psychiatric Institute
- Principal Investigator: Edna Foa, MD, University of Pennsylvania
Publications and helpful links
General Publications
- Farris SG, McLean CP, Van Meter PE, Simpson HB, Foa EB. Treatment response, symptom remission, and wellness in obsessive-compulsive disorder. J Clin Psychiatry. 2013 Jul;74(7):685-90. doi: 10.4088/JCP.12m07789.
- Foa EB, Simpson HB, Liebowitz MR, Powers MB, Rosenfield D, Cahill SP, Campeas R, Franklin M, Hahn CG, Hembree EA, Huppert JD, Schmidt AB, Vermes D, Williams MT. Six-month follow-up of a randomized controlled trial augmenting serotonin reuptake inhibitor treatment with exposure and ritual prevention for obsessive-compulsive disorder. J Clin Psychiatry. 2013 May;74(5):464-9. doi: 10.4088/JCP.12m08017.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB #4734R
- DSIR AT-CT
- R01MH045436-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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