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Cognitive Behavioral Therapy Plus Motivational Interviewing for Treatment of Obsessive-Compulsive Disorder

Primary Purpose

Obsessive-Compulsive Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Motivational interviewing plus exposure and response prevention (MI plus EX/RP)
Exposure and response prevention (EX/RP)
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 OCD

Eligibility Criteria

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

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive motivational interviewing plus exposure and response prevention

Participants will receive exposure and response prevention only

Outcomes

Primary Outcome Measures

Obsessive-compulsive symptoms

Secondary Outcome Measures

Adherence, depression, insight, and quality of life

Full Information

First Posted
April 18, 2006
Last Updated
March 15, 2012
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00316316
Brief Title
Cognitive Behavioral Therapy Plus Motivational Interviewing for Treatment of Obsessive-Compulsive Disorder
Official Title
Cognitive Behavioral Therapy Plus Motivational Interviewing for Obsessive Compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (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
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Participants will receive motivational interviewing plus exposure and response prevention
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive exposure and response prevention only
Intervention Type
Behavioral
Intervention Name(s)
Motivational interviewing plus exposure and response prevention (MI plus EX/RP)
Other Intervention Name(s)
MI plus EX/RP
Intervention Description
Participants will receive 18 sessions of MI plus EX/RP.
Intervention Type
Behavioral
Intervention Name(s)
Exposure and response prevention (EX/RP)
Other Intervention Name(s)
EX/RP
Intervention Description
Participants will receive 18 sessions of EX/RP.
Primary Outcome Measure Information:
Title
Obsessive-compulsive symptoms
Time Frame
Measured at Months 2 and 8
Secondary Outcome Measure Information:
Title
Adherence, depression, insight, and quality of life
Time Frame
Measured at Months 2 and 8

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Blair Simpson, MD, PhD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
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
Links:
URL
http://www.Columbia-OCD.org
Description
Click here for the Obsessive-Compulsive Disorder Research Clinic website.

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Cognitive Behavioral Therapy Plus Motivational Interviewing for Treatment of Obsessive-Compulsive Disorder

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