Back to resultsEffectiveness and Neuropsychological Predictors of Guided Self-Help for Obsessive-Compulsive Disorder (OCD)
Primary Purpose
Obsessive-Compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
"OCFighter"
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder
Eligibility 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
Sites / Locations
- Hartford Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OCFighter
Arm Description
OCFighter
Outcomes
Primary Outcome Measures
Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
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
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01659125
Brief Title
Effectiveness and Neuropsychological Predictors of Guided Self-Help for Obsessive-Compulsive Disorder (OCD)
Official Title
Effectiveness and Neuropsychological Predictors of Guided Self-Help for OCD
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hartford Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OCFighter
Arm Type
Experimental
Arm Description
OCFighter
Intervention Type
Behavioral
Intervention Name(s)
"OCFighter"
Other Intervention Name(s)
OCFighter, Guided Self-help
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
Description
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.
Time Frame
Baseline (pretreatment), 17-weeks (posttreatment), and 6 month-follow-up
Title
Responder Status
Description
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).
Time Frame
Week 17 (post-treatment) and 6-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gretchen Diefenbach, Ph.D.
Organizational Affiliation
Hartford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effectiveness and Neuropsychological Predictors of Guided Self-Help for Obsessive-Compulsive Disorder (OCD)
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