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

December 2, 2015 updated by: Hartford Hospital

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Hartford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (pretreatment), 17-weeks (posttreatment), and 6 month-follow-up
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).
Week 17 (post-treatment) and 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hartford Hospital

Investigators

  • Principal Investigator: Gretchen Diefenbach, Ph.D., Hartford Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

August 3, 2012

First Submitted That Met QC Criteria

August 6, 2012

First Posted (Estimate)

August 7, 2012

Study Record Updates

Last Update Posted (Estimate)

January 7, 2016

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIEF003581HI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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