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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00316316
Other study ID # #5124
Secondary ID R34MH071570DAHBR
Status Completed
Phase Phase 1
First received April 18, 2006
Last updated March 15, 2012
Start date March 2006
Est. completion date March 2010

Study information

Verified date March 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 determine the effectiveness of adding motivational interviewing to cognitive behavioral therapy, consisting of exposure and ritual prevention, in improving treatment outcomes in people with obsessive-compulsive disorder.


Description:

Obsessive Compulsive Disorder (OCD) is a chronic and debilitating anxiety disorder. People with OCD often experience recurrent unwanted thoughts, or obsessions. Some examples of obsessions include the following: repetitive fears of causing harm or being harmed; fears of contamination and illness; fears of making mistakes; intrusive distressing sexual or religious imagery; and fears of losing things. In an effort to relieve anxiety about these obsessions, people with OCD develop repetitive behaviors called compulsions. Some examples of compulsions include the following: repetitive washing and cleaning; excessive checking; excessive ordering and arranging; and extreme hoarding and saving. These thoughts and behaviors interfere with everyday life to a great extent. Cognitive behavior therapy (CBT) with exposure and ritual prevention (EX/RP) is a standard treatment for OCD. EX/RP involves both imaginary and real exposure to situations or settings that may stimulate OCD behavior, and it requires that patients refrain from ritualizing. Motivational interviewing (MI) may help to enhance an individual's motivation to change by exploring and resolving ambivalence. This study will determine the effectiveness of adding MI to CBT that consists of EX/RP in improving treatment outcome in people with OCD.

Participants in this single-blind study will be randomly assigned to receive either standard CBT with EX/RP or CBT with EX/RP plus MI. All participants will report to the study site twice weekly for both therapy and assessments for a total of 2 months. Assessments will include interviews and self-rating forms. No medication will be administered during this study. However, participants will continue on any medication that they are taking at the time of study entry. All participants will be assessed for outcomes upon study completion. Participants who respond to therapy will be assessed again 6 months following study completion.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Primary diagnosis of OCD as defined by DSM-IV

- Obsessions and/or compulsions must have been present for at least one year

- At pre-treatment, a minimum on Y-BOCS on items 1-10 of 16

- If on psychiatric medication, patient has been on stable SRI dose for a minimum of 12 weeks (and four weeks for concomitant OCD meds,e.g., benzos and antipsychotics) and plans to remain on a stable dose for the duration of the EX/RP+MI treatment.

- Able to provide informed consent

- No prior adequate EX/RP treatment (defined as at least 8 exposure sessions that include response prevention instructions and between sessions assignments in a 2 month period)

- Based on hx, subject is unlikely to require a change in med during the course of EX/RP/EX/RP+MI treatment

Exclusion Criteria:

- Any additional medical or psychiatric conditions that could make participation in the study medically inadvisable

- Currently receiving psychotherapy at another clinic

Study Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational interviewing plus exposure and response prevention (MI plus EX/RP)
Participants will receive 18 sessions of MI plus EX/RP.
Exposure and response prevention (EX/RP)
Participants will receive 18 sessions of EX/RP.

Locations

Country Name City State
United States New York State Psychiatric Institute New York New York

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 Months 2 and 8 No
Secondary Adherence, depression, insight, and quality of life Measured at Months 2 and 8 No
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