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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01659125
Recruitment Status : Completed
First Posted : August 7, 2012
Results First Posted : January 7, 2016
Last Update Posted : January 7, 2016
Sponsor:
Information provided by (Responsible Party):
Hartford Hospital

Study Description
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Brief Summary:
The primary aim of this study is to learn about who is most likely to benefit from guided self-help (GSH) for obsessive-compulsive disorder (OCD).

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Behavioral: "OCFighter" Not Applicable

Detailed Description:
40 Participants with OCD will be recruited. They will be given access to OC Fighter, an internet OCD treatment program. During the 17 week program, participants will meet with a therapist 9 times. Assessments will occur at pretreatment, post-treatment, 3-month follow up and 6-month follow up.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Neuropsychological Predictors of Guided Self-Help for OCD
Study Start Date : August 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: OCFighter
OCFighter
 Behavioral: "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).
Other Names:
  • OCFighter
  • Guided Self-help


Outcome Measures
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Primary Outcome Measures :
  1. Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) [ Time Frame: Baseline (pretreatment), 17-weeks (posttreatment), and 6 month-follow-up ]
    The Y-BOCS is a semi-structured interview that assesses severity of obsessions and compulsions. The total score is reported here and ranges from 0 to 40 with higher scores indicating more severe OCD symptoms.

  2. Responder Status [ Time Frame: Week 17 (post-treatment) and 6-month follow-up ]
    Participants who experienced a clinically significant change in Y-BOCS score defined as posttreatment YBOCS score that (a) has decreased by a reliable level (at least 1.96 times the standard deviation of that measure, taking into account the reliability of the measure itself; in this case, a decrease of 5 points or more), and (b) is within the nonclinical range of scores (in this case, a score of 13 or below).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Principal or co-principal diagnosis of OCD
  • Clinical global impression score greater than or equal to 4
  • Y-BOCS score great than or equal to 8
  • Fluency in English
  • Capacity to understand the nature of the study and willingness to sign informed consent form

Exclusion Criteria:

  • Active manic episode, psychosis, pervasive developmental disorder, mental retardation
  • Concurrent OCD psychotherapy
  • Current threat of harm to self or others
  • Previous adequate trial of therapist-administered or self-administered exposure and response prevention for OCD
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659125


Locations
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United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Hartford Hospital
Investigators
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Principal Investigator: Gretchen Diefenbach, Ph.D. Hartford Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01659125    
Other Study ID Numbers: DIEF003581HI
First Posted: August 7, 2012    Key Record Dates
Results First Posted: January 7, 2016
Last Update Posted: January 7, 2016
Last Verified: December 2015
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders