Development of a Behavioral Team Intervention for Obsessive Compulsive Disorder

NCT02616341 | Completed DMC

• 1 other identifier: 1005-008
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Obsessive Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Team ERP (T-ERP) Intervention

EXPERIMENTAL

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

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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)

Interventions

Team ERP (T-ERP) Intervention BEHAVIORAL

Team ERP (T-ERP) Intervention

Treatment as Usual (TAU) BEHAVIORAL

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Butler Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Methods; Therapeutics

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Maria Mancebo, Ph.D.

  Butler Hospital, Providence RI 02906

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 26, 2015
• Study Start: November 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: August 10, 2017

Record last verified: 2017-08