- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00316355
Stepped Care for Treating Obsessive-Compulsive Disorder
Stepped Care for Obsessive-Compulsive Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Connecticut
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Hartford, Connecticut, United States, 06106
- Institute of Living/Hartford Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Traditional CBT
Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)
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CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention.
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Experimental: Stepped-Care CBT
Stepped-care CBT
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score
Time Frame: Pretreatment, Posttreatment, and 3-month follow-up
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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.
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Pretreatment, Posttreatment, and 3-month follow-up
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Treatment-related Total Cost Estimates
Time Frame: Posttreatment
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total estimated costs calculated based upon the fixed-dose schedule
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Posttreatment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David F. Tolin, PhD, Institute of Living/Hartford Hospital
Publications and helpful links
General 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34MH071464 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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