Stepped Care for Treating Obsessive-Compulsive Disorder
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|ClinicalTrials.gov Identifier: NCT00316355|
Recruitment Status : Completed
First Posted : April 20, 2006
Results First Posted : June 6, 2016
Last Update Posted : February 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obsessive-compulsive Disorder||Behavioral: Traditional CBT Behavioral: Stepped-Care CBT||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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).
- 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.
- Treatment-related Total Cost Estimates [ Time Frame: Posttreatment ]total estimated costs calculated based upon the fixed-dose schedule
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 ClinicalTrials.gov identifier (NCT number): NCT00316355
|United States, Connecticut|
|Institute of Living/Hartford Hospital|
|Hartford, Connecticut, United States, 06106|
|Principal Investigator:||David F. Tolin, PhD||Institute of Living/Hartford Hospital|