Stepped Care for Treating Obsessive-Compulsive Disorder

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
David Tolin, Hartford Hospital
ClinicalTrials.gov Identifier:
NCT00316355
First received: April 18, 2006
Last updated: May 5, 2016
Last verified: May 2016

April 18, 2006
May 5, 2016
June 2006
January 2010   (final data collection date for primary outcome measure)
  • Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score [ Time Frame: Pretreatment, Posttreatment, and 3-month follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    total estimated costs calculated based upon the fixed-dose schedule
  • Measured 1 and 3 months post-intervention: Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
  • Treatment-related cost estimates
Complete list of historical versions of study NCT00316355 on ClinicalTrials.gov Archive Site
Not Provided
  • Measured 1 and 3 months post-intervention: Clinician's Global Impression (CGI)
  • Beck Depression Inventory-II (BDI-II)
  • Sheehan Disability Scale (SDS)
  • Quality of Life Inventory (QOLI)
Not Provided
Not Provided
 
Stepped Care for Treating Obsessive-Compulsive Disorder
Stepped Care for Obsessive-Compulsive Disorder
This study will determine the effectiveness and cost-effectiveness of a stepped-care treatment program for people with obsessive-compulsive disorder.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obsessive-compulsive Disorder
  • Behavioral: Traditional CBT
    CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention.
  • 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).
  • Active Comparator: Traditional CBT
    Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)
    Intervention: Behavioral: Traditional CBT
  • Experimental: Stepped-Care CBT
    Stepped-care CBT
    Intervention: Behavioral: Stepped-Care CBT
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 69 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00316355
R34MH071464, R34MH071464
Yes
No
Not Provided
David Tolin, Hartford Hospital
Hartford Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: David F. Tolin, PhD Institute of Living/Hartford Hospital
Hartford Hospital
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP