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

August 3, 2012
December 2, 2015
August 2012
June 2014   (final data collection date for primary outcome measure)
  • Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) [ Time Frame: Baseline (pretreatment), 17-weeks (posttreatment), and 6 month-follow-up ] [ Designated as safety issue: No ]
    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.
  • Responder Status [ Time Frame: Week 17 (post-treatment) and 6-month follow-up ] [ Designated as safety issue: No ]
    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).
Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) [ Time Frame: Change in Y-BOCS will be assessed over the course of the 17 week treatment trial, then again three months and six months after the treatment. ] [ Designated as safety issue: No ]
The Y-BOCS is a semi-structured interview that assesses severity of obsessions and compulsions.
Complete list of historical versions of study NCT01659125 on ClinicalTrials.gov Archive Site
Not Provided
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Effectiveness and Neuropsychological Predictors of Guided Self-Help for Obsessive-Compulsive Disorder (OCD)
Effectiveness and Neuropsychological Predictors of Guided Self-Help for OCD
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).
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.
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obsessive-Compulsive Disorder
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
Experimental: OCFighter
OCFighter
Intervention: Behavioral: "OCFighter"
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01659125
DIEF003581HI
No
Not Provided
Not Provided
Hartford Hospital
Hartford Hospital
Not Provided
Principal Investigator: Gretchen Diefenbach, Ph.D. Hartford Hospital
Hartford Hospital
December 2015

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