Development of a Behavioral Team Intervention for Obsessive Compulsive Disorder

NCT ID: NCT02616341

Last Updated: 2017-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-02-29

Brief Summary

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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).

Detailed Description

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Conditions

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Obsessive Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Team ERP (T-ERP) Intervention

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type BEHAVIORAL

Interventions

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Team ERP (T-ERP) Intervention

Intervention Type BEHAVIORAL

Treatment as Usual (TAU)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Butler Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Mancebo, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital, Providence RI 02906

Other Identifiers

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1005-008

Identifier Type: -

Identifier Source: org_study_id

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