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

Primary Purpose

Obsessive-Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exposure and Ritual Prevention (Cognitive Behavioral Therapy)
Stress Management Therapy (Cognitive Behavior Therapy)
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Cognitive Behavioral Therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiactic Institute, Anxiety Disorders Clinic
  • University of Pennsylvania Center for the Treatment and Study of Anxiety

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exposure and Ritual Prevention

Stress Management

Arm Description

Exposure and Ritual Prevention Therapy

Stress Management Therapy

Outcomes

Primary Outcome Measures

Obsessive-compulsive symptoms measured at Month 2

Secondary Outcome Measures

General functioning measured at Month 2

Full Information

First Posted
September 13, 2002
Last Updated
April 22, 2014
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00045903
Brief Title
Cognitive Behavioral Therapy Plus Drug Treatment for Obsessive Compulsive Disorder
Acronym
Aug1
Official Title
CBT Augmentation for SRI Pharmacotherapy in OCD
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exposure and Ritual Prevention
Arm Type
Experimental
Arm Description
Exposure and Ritual Prevention Therapy
Arm Title
Stress Management
Arm Type
Active Comparator
Arm Description
Stress Management Therapy
Intervention Type
Behavioral
Intervention Name(s)
Exposure and Ritual Prevention (Cognitive Behavioral Therapy)
Intervention Type
Behavioral
Intervention Name(s)
Stress Management Therapy (Cognitive Behavior Therapy)
Primary Outcome Measure Information:
Title
Obsessive-compulsive symptoms measured at Month 2
Time Frame
2 months
Secondary Outcome Measure Information:
Title
General functioning measured at Month 2
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Liebowitz, MD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edna Foa, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiactic Institute, Anxiety Disorders Clinic
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Pennsylvania Center for the Treatment and Study of Anxiety
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23945445
Citation
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.
Results Reference
derived
PubMed Identifier
23759449
Citation
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.
Results Reference
derived

Learn more about this trial

Cognitive Behavioral Therapy Plus Drug Treatment for Obsessive Compulsive Disorder

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