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

NCT ID: NCT00316316

Last Updated: 2012-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2010-03-31

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.

Conditions

Obsessive-Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Participants will receive motivational interviewing plus exposure and response prevention

Group Type: ACTIVE_COMPARATOR

Motivational interviewing plus exposure and response prevention (MI plus EX/RP)

Intervention Type: BEHAVIORAL

Participants will receive 18 sessions of MI plus EX/RP.

2

Participants will receive exposure and response prevention only

Group Type: ACTIVE_COMPARATOR

Exposure and response prevention (EX/RP)

Intervention Type: BEHAVIORAL

Participants will receive 18 sessions of EX/RP.

Interventions

Motivational interviewing plus exposure and response prevention (MI plus EX/RP)

Participants will receive 18 sessions of MI plus EX/RP.

Intervention Type: BEHAVIORAL

Exposure and response prevention (EX/RP)

Participants will receive 18 sessions of EX/RP.

Intervention Type: BEHAVIORAL

Other Intervention Names

MI plus EX/RP; EX/RP

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helen Blair Simpson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23945445 (View on PubMed)

Related Links

http://www.Columbia-OCD.org

Click here for the Obsessive-Compulsive Disorder Research Clinic website.

Other Identifiers

R34MH071570

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DAHBR 96-BHA

Identifier Type: -

Identifier Source: secondary_id

#5124

Identifier Type: -

Identifier Source: org_study_id