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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00045903
Other study ID # IRB #4734R
Secondary ID R01MH045436-01DS
Status Completed
Phase N/A
First received September 13, 2002
Last updated April 22, 2014
Start date August 2000
Est. completion date January 2007

Study information

Verified date October 2012
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 136
Est. completion date January 2007
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Exposure and Ritual Prevention (Cognitive Behavioral Therapy)

Stress Management Therapy (Cognitive Behavior Therapy)


Locations

Country Name City State
United States New York State Psychiactic Institute, Anxiety Disorders Clinic New York New York
United States University of Pennsylvania Center for the Treatment and Study of Anxiety Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
New York State Psychiatric Institute National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Obsessive-compulsive symptoms measured at Month 2 2 months No
Secondary General functioning measured at Month 2 2 months No
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