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Development of a Behavioral Team Intervention for Obsessive Compulsive Disorder

Primary Purpose

Obsessive Compulsive Disorder

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Team ERP (T-ERP) Intervention

Treatment as Usual (TAU)

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 Years to 65 Years
English speaking
Primary DSM-IV OCD (identified by the patient and therapist as the most problematic disorder over the past year)
At least moderate severity OCD (YBOCS > 16)
Not currently on psychotropic medications or on the same psychotropic medications for at least 4 weeks prior to screening
Have never received 10 or more sessions of ERP
Not currently attending psychotherapy for OCD
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:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Team ERP (T-ERP) Intervention

Treatment as Usual (TAU)

Arm Description

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

Treatment as Usual (TAU) includes standard community treatment consisting of a personalized treatment plan and assistance with treatment referrals to available community resources

Outcomes

Primary Outcome Measures

Changes in OCD symptom severity as measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

Secondary Outcome Measures

Full Information

NCT ID

NCT02616341

First Posted

November 18, 2015

Last Updated

August 9, 2017

Sponsor

Butler Hospital

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT02616341

Brief Title

Development of a Behavioral Team Intervention for Obsessive Compulsive Disorder

Official Title

Development of a Behavioral Team Intervention for Obsessive Compulsive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Butler Hospital

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive Compulsive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Team ERP (T-ERP) Intervention

Arm Type

Experimental

Arm Description

Arm Title

Treatment as Usual (TAU)

Arm Type

Active Comparator

Arm Description

Treatment as Usual (TAU) includes standard community treatment consisting of a personalized treatment plan and assistance with treatment referrals to available community resources

Intervention Type

Behavioral

Intervention Name(s)

Team ERP (T-ERP) Intervention

Intervention Type

Behavioral

Intervention Name(s)

Treatment as Usual (TAU)

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 Years to 65 Years English speaking Primary DSM-IV OCD (identified by the patient and therapist as the most problematic disorder over the past year) At least moderate severity OCD (YBOCS > 16) Not currently on psychotropic medications or on the same psychotropic medications for at least 4 weeks prior to screening Have never received 10 or more sessions of ERP Not currently attending psychotherapy for OCD 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: Significant cognitive impairment (MMSE < 25) Prominent suicidal ideation Current psychosis, mania, alcohol or drug dependence as assessed by the SCID-P. Prominent Hoarding

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Mancebo, Ph.D.

Organizational Affiliation

Butler Hospital, Providence RI 02906

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Development of a Behavioral Team Intervention for Obsessive Compulsive Disorder

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