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Stepped Care for Treating Obsessive-Compulsive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00316355
Recruitment Status : Completed
First Posted : April 20, 2006
Results First Posted : June 6, 2016
Last Update Posted : February 22, 2018
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
David Tolin, Hartford Hospital

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

Condition or disease Intervention/treatment Phase
Obsessive-compulsive Disorder Behavioral: Traditional CBT Behavioral: Stepped-Care CBT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stepped Care for Obsessive-Compulsive Disorder
Study Start Date : June 2006
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Traditional CBT
Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)
Behavioral: Traditional CBT
CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention.

Experimental: Stepped-Care CBT
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).

Primary Outcome Measures :
  1. Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score [ Time Frame: Pretreatment, Posttreatment, and 3-month follow-up ]
    The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score was used as the outcome measure. The Y-BOCS is a clinician-rated scale assessing obsession (5 items) and compulsion (5 items) symptom severity on a 0 to 4 scale. All 10 items are added for the total score, with total scores ranging from 0 to 40, and higher numbers indicating more severe symptoms.

  2. Treatment-related Total Cost Estimates [ Time Frame: Posttreatment ]
    total estimated costs calculated based upon the fixed-dose schedule

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00316355

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United States, Connecticut
Institute of Living/Hartford Hospital
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Hartford Hospital
National Institute of Mental Health (NIMH)
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Principal Investigator: David F. Tolin, PhD Institute of Living/Hartford Hospital
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.

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Responsible Party: David Tolin, Principal Investigator, Hartford Hospital Identifier: NCT00316355    
Other Study ID Numbers: R34MH071464 ( U.S. NIH Grant/Contract )
R34MH071464 ( U.S. NIH Grant/Contract )
First Posted: April 20, 2006    Key Record Dates
Results First Posted: June 6, 2016
Last Update Posted: February 22, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by David Tolin, Hartford Hospital:
Behavior therapy
Cognitive-behavioral therapy
Stepped care
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders