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NCT02616341 Clinical Trial

Development of a Behavioral Team Intervention for Obsessive Compulsive Disorder

Obsessive Compulsive Disorder Clinical Trial

Official title:
Development of a Behavioral Team Intervention for Obsessive Compulsive Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02616341
Other study ID # 1005-008
Secondary ID
Status Completed
Phase N/A
First received November 18, 2015
Last updated August 9, 2017
Start date November 2012
Est. completion date February 2016

Study information
Verified date August 2017
Source Butler Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Team ERP (T-ERP) Intervention

• Treatment as Usual (TAU)

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Butler Hospital National Institute of Mental Health (NIMH)

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