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Stepped Care for Treating Obsessive-Compulsive Disorder
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), August 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00316355
  Purpose

This study will determine the effectiveness and cost-effectiveness of a stepped-care treatment program for people with obsessive-compulsive disorder.


Condition Intervention
Obsessive-Compulsive Disorder
Behavioral: Cognitive-Behavioral Therapy with EX/RP
Behavioral: Stepped-Care CBT

MedlinePlus related topics: Anxiety Obsessive-Compulsive Disorder
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Stepped Care for Obsessive-Compulsive Disorder

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) [ Time Frame: Measured at Months 1 and 3 post-treatment ] [ Designated as safety issue: Yes ]
  • Treatment-related cost estimates [ Time Frame: Measured at Months 1 and 3 post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinician's Global Impression (CGI) [ Time Frame: Measured at Months 1 and 3 post-treatment ] [ Designated as safety issue: Yes ]
  • Beck Depression Inventory-II (BDI-II) [ Time Frame: Measured at Months 1 and 3 post-treatment ] [ Designated as safety issue: Yes ]
  • Sheehan Disability Scale (SDS) [ Time Frame: Measured at Months 1 and 3 post-treatment ] [ Designated as safety issue: No ]
  • Quality of Life Inventory (QOLI) [ Time Frame: Measured at Months 1 and 3 post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: June 2006
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)
Behavioral: Cognitive-Behavioral Therapy with EX/RP
CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention.
2: Experimental
Stepped-care CBT
Behavioral: Stepped-Care CBT
In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP).

Detailed Description:

Obsessive-Compulsive Disorder (OCD) is a chronic and debilitating anxiety disorder. People with OCD often experience recurrent unwanted thoughts, called obsessions, and repetitive behaviors, called compulsions. These thoughts and behaviors interfere with everyday life to a great extent. Currently, the most frequently used psychosocial treatment for OCD is cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP). However, although effective, this treatment approach is largely inaccessible, time-consuming, labor-intensive, and expensive. A stepped-care approach to treating OCD may be more cost-effective and therefore more accessible for many individuals. Stepped-care CBT begins with the least expensive, least intrusive, most accessible option, and works up to the most expensive option if the less intrusive treatments do not work. This study will determine the benefits and cost-effectiveness of a stepped care treatment program for OCD.

Participants in this open label study will be randomly assigned to receive CBT for 6 to 14 weeks either through the stepped-care approach or immediately upon study entry. Participants will report to the study site for treatments and assessments on a regular basis, ranging from every 2 weeks to twice a week, depending on the stage of the study and the assigned treatment group. Stepped-care CBT will begin with self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement. If ineffective, this treatment will be followed by therapist-administered EX/RP. OCD symptoms will be assessed at Week 6. Participants who have responded to treatment after 6 weeks will not receive further treatment. All others will continue for an additional 8 weeks. These participants' OCD symptoms will be assessed again at Week 14. Participants assigned to the stepped-care approach whose OCD symptoms improved initially, but relapsed without further treatment by the Week 14 evaluation will receive full-scale CBT. Outcomes will be assessed again at 1- and 3-month follow-up visits.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary diagnosis of OCD of moderate or greater severity
  • Presence of OCD symptoms for at least 1 year

Exclusion Criteria:

  • History of psychotic or developmental disorder
  • Uncontrolled bipolar disorder
  • Serious suicide risk
  • Prior history of adequate CBT, including exposure and response prevention
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316355

Contacts
Contact: Christina Ryan, BA 860-545-7685 cryan02@harthosp.org
Contact: David F. Tolin, PhD 860-545-7685 dtolin@harthosp.org

Locations
United States, Connecticut
Institute of Living/Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06106
Contact: Sara Whiting, BA     860-545-7685     swhiting@harthosp.org    
Contact: David F. Tolin, PhD     860-545-7685     dtolin@harthosp.org    
Principal Investigator: David F. Tolin, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: David F. Tolin, PhD Institute of Living/Hartford Hospital
  More Information

Click here for the website of Research Studies at the Anxiety Disorders Center  This link exits the ClinicalTrials.gov site

Publications:
Tolin, D.F., Diefenbach, G.J., Maltby, N., & Hannan, S. (2005). Stepped care for obsessive-compulsive disorder: A pilot study. Cognitive and Behavioral Practice, 12, 403-414.

Responsible Party: Institute of Living ( David F. Tolin, PhD )
Study ID Numbers: R34 MH71464
Study First Received: April 18, 2006
Last Updated: August 20, 2008
ClinicalTrials.gov Identifier: NCT00316355  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Anxiety
Behavior therapy
Cognitive-behavioral therapy
Stepped care
Cost-effectiveness

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Obsessive-Compulsive Disorder

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 30, 2009