Stepped Care for Treating Obsessive-Compulsive Disorder
Primary Purpose
Obsessive-compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Traditional CBT
Stepped-Care CBT
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-compulsive Disorder focused on measuring Anxiety, Behavior therapy, Cognitive-behavioral therapy, Stepped care, Cost-effectiveness
Eligibility 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
Sites / Locations
- Institute of Living/Hartford Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Traditional CBT
Stepped-Care CBT
Arm Description
Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)
Stepped-care CBT
Outcomes
Primary Outcome Measures
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.
Treatment-related Total Cost Estimates
total estimated costs calculated based upon the fixed-dose schedule
Secondary Outcome Measures
Full Information
NCT ID
NCT00316355
First Posted
April 18, 2006
Last Updated
January 24, 2018
Sponsor
Hartford Hospital
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00316355
Brief Title
Stepped Care for Treating Obsessive-Compulsive Disorder
Official Title
Stepped Care for Obsessive-Compulsive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hartford Hospital
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will determine the effectiveness and cost-effectiveness of a stepped-care treatment program for people with obsessive-compulsive disorder.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-compulsive Disorder
Keywords
Anxiety, Behavior therapy, Cognitive-behavioral therapy, Stepped care, Cost-effectiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional CBT
Arm Type
Active Comparator
Arm Description
Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)
Arm Title
Stepped-Care CBT
Arm Type
Experimental
Arm Description
Stepped-care CBT
Intervention Type
Behavioral
Intervention Name(s)
Traditional CBT
Intervention Description
CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention.
Intervention Type
Behavioral
Intervention Name(s)
Stepped-Care CBT
Intervention Description
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 Measure Information:
Title
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score
Description
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.
Time Frame
Pretreatment, Posttreatment, and 3-month follow-up
Title
Treatment-related Total Cost Estimates
Description
total estimated costs calculated based upon the fixed-dose schedule
Time Frame
Posttreatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David F. Tolin, PhD
Organizational Affiliation
Institute of Living/Hartford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Living/Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
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Stepped Care for Treating Obsessive-Compulsive Disorder
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