Cognitive Behavioral Therapy Plus Drug Treatment for Obsessive Compulsive Disorder

NCT ID: NCT00045903

Last Updated: 2014-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2007-01-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Exposure and Ritual Prevention

Exposure and Ritual Prevention Therapy

Group Type EXPERIMENTAL

Exposure and Ritual Prevention (Cognitive Behavioral Therapy)

Intervention Type BEHAVIORAL

Stress Management

Stress Management Therapy

Group Type ACTIVE_COMPARATOR

Stress Management Therapy (Cognitive Behavior Therapy)

Intervention Type BEHAVIORAL

Interventions

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Exposure and Ritual Prevention (Cognitive Behavioral Therapy)

Intervention Type BEHAVIORAL

Stress Management Therapy (Cognitive Behavior Therapy)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Liebowitz, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Edna Foa, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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New York State Psychiactic Institute, Anxiety Disorders Clinic

New York, New York, United States

Site Status

University of Pennsylvania Center for the Treatment and Study of Anxiety

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23945445 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23759449 (View on PubMed)

Other Identifiers

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R01MH045436-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DSIR AT-CT

Identifier Type: -

Identifier Source: secondary_id

IRB #4734R

Identifier Type: -

Identifier Source: org_study_id

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