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
Results First Received: March 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Obsessive-compulsive Disorder
Interventions: Behavioral: Traditional CBT
Behavioral: Stepped-Care CBT

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Traditional CBT

Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)

Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention.

Stepped-Care CBT

Stepped-care CBT

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).


Participant Flow:   Overall Study
    Traditional CBT     Stepped-Care CBT  
STARTED     15     19  
Started Treatment     12     18  
COMPLETED     10     12  
NOT COMPLETED     5     7  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants randomized to treatment conditions

Reporting Groups
  Description
Traditional CBT

Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)

Traditional CBT: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention.

Stepped-Care CBT

Stepped-care CBT

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).

Total Total of all reporting groups

Baseline Measures
    Traditional CBT     Stepped-Care CBT     Total  
Number of Participants  
[units: participants]
  15     19     34  
Age  
[units: years]
Mean (Standard Deviation)
  31.33  (10.50)     35.95  (16.16)     33.74  (13.10)  
Gender  
[units: participants]
     
Female     7     13     20  
Male     8     6     14  
Region of Enrollment  
[units: participants]
     
United States     15     19     34  



  Outcome Measures
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1.  Primary:   Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score   [ Time Frame: Pretreatment, Posttreatment, and 3-month follow-up ]

2.  Primary:   Treatment-related Total Cost Estimates   [ Time Frame: Posttreatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: David Tolin
Organization: Hartford Hospital
phone: 860-545-7685
e-mail: david.tolin@hhchealth.org


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, Hartford Hospital
ClinicalTrials.gov Identifier: NCT00316355     History of Changes
Other Study ID Numbers: R34MH071464 ( US NIH Grant/Contract Award Number )
Study First Received: April 18, 2006
Results First Received: March 29, 2016
Last Updated: May 5, 2016
Health Authority: United States: Federal Government