Cognitive Behavioral Therapy Plus Drug Treatment for Obsessive Compulsive Disorder (Aug1)

April 22, 2014 updated by: New York State Psychiatric Institute

CBT Augmentation for SRI Pharmacotherapy in OCD

This study will evaluate the effectiveness of two cognitive behavioral therapies (CBTs) in treating obsessive compulsive disorder (OCD) in patients who are taking medication but still have residual symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiactic Institute, Anxiety Disorders Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Center for the Treatment and Study of Anxiety

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Behavioral: Exposure and Ritual Prevention (Cognitive Behavioral Therapy)
Active Comparator: Stress Management
Stress Management Therapy
Behavioral: Stress Management Therapy (Cognitive Behavior 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

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Michael Liebowitz, MD, New York State Psychiatric Institute
  • Principal Investigator: Edna Foa, MD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

September 13, 2002

First Submitted That Met QC Criteria

September 16, 2002

First Posted (Estimate)

September 17, 2002

Study Record Updates

Last Update Posted (Estimate)

April 23, 2014

Last Update Submitted That Met QC Criteria

April 22, 2014

Last Verified

October 1, 2012

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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