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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00316316
First received: April 18, 2006
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Obsessive-Compulsive Disorder
Behavioral: Motivational interviewing plus exposure and response prevention (MI plus EX/RP)
Behavioral: Exposure and response prevention (EX/RP)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy Plus Motivational Interviewing for Obsessive Compulsive Disorder

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Obsessive-compulsive symptoms [ Time Frame: Measured at Months 2 and 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adherence, depression, insight, and quality of life [ Time Frame: Measured at Months 2 and 8 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: March 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Participants will receive motivational interviewing plus exposure and response prevention
Behavioral: Motivational interviewing plus exposure and response prevention (MI plus EX/RP)
Participants will receive 18 sessions of MI plus EX/RP.
Other Name: MI plus EX/RP
Active Comparator: 2
Participants will receive exposure and response prevention only
Behavioral: Exposure and response prevention (EX/RP)
Participants will receive 18 sessions of EX/RP.
Other Name: EX/RP

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316316

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Helen Blair Simpson, MD, PhD New York State Psychiatric Institute
  More Information

Additional Information:
No publications provided by New York State Psychiatric Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00316316     History of Changes
Other Study ID Numbers: #5124, R34MH071570, DAHBR 96-BHA
Study First Received: April 18, 2006
Last Updated: March 15, 2012
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
OCD

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Disease
Personality Disorders
Mental Disorders
Anxiety Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014