NCT00316316

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

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

March 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

Enrollment Period

4 years

First QC Date

April 18, 2006

Last Update Submit

March 15, 2012

Conditions

Keywords

OCD

Outcome Measures

Primary Outcomes (1)

  • Obsessive-compulsive symptoms

    Measured at Months 2 and 8

Secondary Outcomes (1)

  • Adherence, depression, insight, and quality of life

    Measured at Months 2 and 8

Study Arms (2)

1

ACTIVE COMPARATOR

Participants will receive motivational interviewing plus exposure and response prevention

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

2

ACTIVE COMPARATOR

Participants will receive exposure and response prevention only

Behavioral: Exposure and response prevention (EX/RP)

Interventions

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

Also known as: MI plus EX/RP
1

Participants will receive 18 sessions of EX/RP.

Also known as: EX/RP
2

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Any additional medical or psychiatric conditions that could make participation in the study medically inadvisable
  • Currently receiving psychotherapy at another clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Helen Blair Simpson, MD, PhD

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2006

First Posted

April 20, 2006

Study Start

March 1, 2006

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 16, 2012

Record last verified: 2012-03

Locations