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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Effectiveness and Neuropsychological Predictors of Guided Self-Help for OCD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01659125
• Other study ID #: DIEF003581HI
• Status: Completed
• Phase: N/A
• First received: August 3, 2012
• Last updated: December 2, 2015
• Start date: August 2012
• Est. completion date: June 2014

Study information

• Verified date: December 2015
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

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).

Locations

Country	Name	City	State
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No