NCT00045903

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2002

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

April 23, 2014

Status Verified

October 1, 2012

Enrollment Period

6.4 years

First QC Date

September 13, 2002

Last Update Submit

April 22, 2014

Conditions

Keywords

Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

  • Obsessive-compulsive symptoms measured at Month 2

    2 months

Secondary Outcomes (1)

  • General functioning measured at Month 2

    2 months

Study Arms (2)

Exposure and Ritual Prevention

EXPERIMENTAL

Exposure and Ritual Prevention Therapy

Behavioral: Exposure and Ritual Prevention (Cognitive Behavioral Therapy)

Stress Management

ACTIVE COMPARATOR

Stress Management Therapy

Behavioral: Stress Management Therapy (Cognitive Behavior Therapy)

Interventions

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obsessive-Compulsive Disorder (OCD) diagnosis
  • Currently taking a serotonin reuptake inhibitor (SRI, i.e. clomipramine, fluoxetine, fluvoxamine, paroxetine, sertraline, or citalopram) for OCD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New York State Psychiactic Institute, Anxiety Disorders Clinic

New York, New York, 10032, United States

Location

University of Pennsylvania Center for the Treatment and Study of Anxiety

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Michael Liebowitz, MD

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR
  • Edna Foa, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2002

First Posted

September 17, 2002

Study Start

August 1, 2000

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

April 23, 2014

Record last verified: 2012-10

Locations