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

NCT01659125 | Completed Results

• 1 other identifier: DIEF003581HI
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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).

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (pretreatment), 17-weeks (posttreatment), and 6 month-follow-up

• 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).

  Week 17 (post-treatment) and 6-month follow-up

Study Arms (1)

OCFighter

EXPERIMENTAL

OCFighter

Behavioral: "OCFighter"

Interventions

"OCFighter" BEHAVIORAL

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).

Also known as: OCFighter, Guided Self-help

OCFighter

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Gretchen J. Diefenbach
• Organization: Institute of Living

gretchen.diefenbach@hhchealth.org

860-545-7685

Study Officials

• Gretchen Diefenbach, Ph.D.

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2012
• First Posted: August 7, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 7, 2016
• Results First Posted: January 7, 2016

Record last verified: 2015-12

Locations

US (1)