Effectiveness and Neuropsychological Predictors of Guided Self-Help for Obsessive-Compulsive Disorder (OCD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01659125
First received: August 3, 2012
Last updated: December 2, 2015
Last verified: December 2015
Results First Received: April 8, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Obsessive-Compulsive Disorder
Intervention: Behavioral: "OCFighter"

  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
OCFighter Participants

OCFighter

"OCFighter": OCFighter™ s an interactive, internet guided self-help (GSH) treatment program for obsessive-compulsive disorder (OCD). It uses the evidence based approach known as Cognitive Behavioral Therapy (CBT) and was adapted from the previously validated BT STEPS program for OCD. The program teaches the best practice CBT technique to help with OCD called exposure with ritual prevention (ERP).


Participant Flow:   Overall Study
    OCFighter Participants  
STARTED     26  
Initiated Treatment     24  
Completed the Posttreatment Assessment     17  
Completed 3-month Follow-up     16  
Completed 6-month Follow-up     12  
COMPLETED     12  
NOT COMPLETED     14  
Withdrawal by Subject                 2  
Lost to Follow-up                 7  
Technical Problem                 1  
Time Constraints                 2  
Failed to Start Treatment                 2  



  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.
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Reporting Groups
  Description
OCFighter Participants

OCFighter

"OCFighter": OCFighter™ s an interactive, internet guided self-help (GSH) treatment program for obsessive-compulsive disorder (OCD). It uses the evidence based approach known as Cognitive Behavioral Therapy (CBT) and was adapted from the previously validated BT STEPS program for OCD. The program teaches the best practice CBT technique to help with OCD called exposure with ritual prevention (ERP).


Baseline Measures
    OCFighter Participants  
Number of Participants  
[units: participants]
  26  
Age  
[units: years]
Mean (Standard Deviation)
  37.08  (12.57)  
Gender  
[units: participants]
 
Female     17  
Male     9  
Region of Enrollment  
[units: participants]
 
United States     26  



  Outcome Measures
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1.  Primary:   Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)   [ Time Frame: Baseline (pretreatment), 17-weeks (posttreatment), and 6 month-follow-up ]

2.  Primary:   Responder Status   [ Time Frame: Week 17 (post-treatment) and 6-month follow-up ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Gretchen J. Diefenbach
Organization: Institute of Living
phone: 860-545-7685
e-mail: gretchen.diefenbach@hhchealth.org



Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01659125     History of Changes
Other Study ID Numbers: DIEF003581HI
Study First Received: August 3, 2012
Results First Received: April 8, 2015
Last Updated: December 2, 2015
Health Authority: United States: Institutional Review Board