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

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ClinicalTrials.gov Identifier: NCT00045903
Recruitment Status : Completed
First Posted : September 17, 2002
Last Update Posted : April 23, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Behavioral: Exposure and Ritual Prevention (Cognitive Behavioral Therapy) Behavioral: Stress Management Therapy (Cognitive Behavior Therapy) Not Applicable

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  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: CBT Augmentation for SRI Pharmacotherapy in OCD
Study Start Date : August 2000
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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)



Primary Outcome Measures :
  1. Obsessive-compulsive symptoms measured at Month 2 [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. General functioning measured at Month 2 [ Time Frame: 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00045903


Locations
United States, New York
New York State Psychiactic Institute, Anxiety Disorders Clinic
New York, New York, United States, 10032
United States, Pennsylvania
University of Pennsylvania Center for the Treatment and Study of Anxiety
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
New York State Psychiatric Institute
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00045903     History of Changes
Other Study ID Numbers: IRB #4734R
R01MH045436-01 ( U.S. NIH Grant/Contract )
DSIR AT-CT
First Posted: September 17, 2002    Key Record Dates
Last Update Posted: April 23, 2014
Last Verified: October 2012

Keywords provided by New York State Psychiatric Institute:
Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders