Stepped Care for Treating Obsessive-Compulsive Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Tolin, Hartford Hospital
ClinicalTrials.gov Identifier:
NCT00316355
First received: April 18, 2006
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Obsessive-compulsive Disorder
Behavioral: Cognitive-Behavioral Therapy with EX/RP
Behavioral: Stepped-Care CBT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stepped Care for Obsessive-Compulsive Disorder

Resource links provided by NLM:


Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) [ Time Frame: Measured at Months 1 and 3 post-treatment ] [ Designated as safety issue: Yes ]
  • Treatment-related cost estimates [ Time Frame: Measured at Months 1 and 3 post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinician's Global Impression (CGI) [ Time Frame: Measured at Months 1 and 3 post-treatment ] [ Designated as safety issue: Yes ]
  • Beck Depression Inventory-II (BDI-II) [ Time Frame: Measured at Months 1 and 3 post-treatment ] [ Designated as safety issue: Yes ]
  • Sheehan Disability Scale (SDS) [ Time Frame: Measured at Months 1 and 3 post-treatment ] [ Designated as safety issue: No ]
  • Quality of Life Inventory (QOLI) [ Time Frame: Measured at Months 1 and 3 post-treatment ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: June 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)
Behavioral: Cognitive-Behavioral Therapy with EX/RP
CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention.
Experimental: 2
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316355

Locations
United States, Connecticut
Institute of Living/Hartford Hospital
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Hartford Hospital
Investigators
Principal Investigator: David F. Tolin, PhD Institute of Living/Hartford Hospital
  More Information

Additional Information:
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.

Responsible Party: David Tolin, Principal Investigator, Hartford Hospital
ClinicalTrials.gov Identifier: NCT00316355     History of Changes
Other Study ID Numbers: R34 MH071464, R34MH071464
Study First Received: April 18, 2006
Last Updated: February 24, 2014
Health Authority: United States: Federal Government

Keywords provided by Hartford Hospital:
Anxiety
Behavior therapy
Cognitive-behavioral therapy
Stepped care
Cost-effectiveness

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders

ClinicalTrials.gov processed this record on April 23, 2014