Stepped Care for Treating Obsessive-Compulsive Disorder

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

Detailed Description
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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.

Official Title
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Stepped Care for Obsessive-Compulsive Disorder

Conditions
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Obsessive-compulsive Disorder

Intervention / Treatment
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* Behavioral: Traditional CBT
* Behavioral: Stepped-Care CBT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional CBT<br>Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP) | Behavioral: Traditional CBT<br>* CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention.<br>|
| Experimental: Stepped-Care CBT<br>Stepped-care CBT | Behavioral: Stepped-Care CBT<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score | 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. | Pretreatment, Posttreatment, and 3-month follow-up | 
| Treatment-related Total Cost Estimates | total estimated costs calculated based upon the fixed-dose schedule | Posttreatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Behavior therapy, Cognitive-behavioral therapy, Stepped care, Cost-effectiveness