Development of a Behavioral Team Intervention for Obsessive Compulsive Disorder

August 9, 2017 updated by: Butler Hospital
The overall aim of this study is to determine modifications to Exposure and Response Prevention (ERP) therapy that are needed in order to effectively deliver treatment for Obsessive Compulsive Disorder (OCD) in a community mental health center. This study is the final study in a series of three projects executed to adapt and pilot-test a team ERP (T-ERP) intervention that will optimize therapist time by utilizing paraprofessionals to assist with group-ERP treatment plans. The intervention will be tailored to meet the unique needs of low-SES individuals with OCD and be implemented in a community mental health center (CMHC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18 Years to 65 Years
  2. English speaking
  3. Primary DSM-IV OCD (identified by the patient and therapist as the most problematic disorder over the past year)
  4. At least moderate severity OCD (YBOCS > 16)
  5. Not currently on psychotropic medications or on the same psychotropic medications for at least 4 weeks prior to screening
  6. Have never received 10 or more sessions of ERP
  7. Not currently attending psychotherapy for OCD
  8. Low-income based on the U.S. Housing and Urban Development (HUDs) threshold for RI (less than $41,000 per year for individuals).

Exclusion Criteria:

  1. Significant cognitive impairment (MMSE < 25)
  2. Prominent suicidal ideation
  3. Current psychosis, mania, alcohol or drug dependence as assessed by the SCID-P.
  4. Prominent Hoarding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Team ERP (T-ERP) Intervention
The ERP team intervention (T-ERP) consists of 25 sessions over 20 weeks with four components: (a) 3-4 pretherapy individual session with therapist, (b) 12 weekly group sessions (90-mins) led by a therapist and, (c) 10 individual coaching sessions with a case manager during weeks 2-11 of the group, and (d) 2 booster group sessions to reinforce relapse prevention
Behavioral: Team ERP (T-ERP) Intervention
ACTIVE_COMPARATOR: Treatment as Usual (TAU)
Treatment as Usual (TAU) includes standard community treatment consisting of a personalized treatment plan and assistance with treatment referrals to available community resources
Behavioral: Treatment as Usual (TAU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in OCD symptom severity as measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time Frame: Baseline, 6th week of treatment, 12th week of treatment, 3 months post-treatment, 6 months post-treatment
Baseline, 6th week of treatment, 12th week of treatment, 3 months post-treatment, 6 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Butler Hospital

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Maria Mancebo, Ph.D., Butler Hospital, Providence RI 02906

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 25, 2015

First Posted (ESTIMATE)

November 26, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 10, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1005-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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