Wait-list Study of One-Week Intensive Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder (OCD)

NCT01194076 | Completed

• 1 other identifier: 09-0082590
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to examine how well intensive cognitive-behavioral therapy (CBT) delivered over 5 days works in reducing Obsessive-Compulsive Disorder (OCD) symptoms in children and adolescents. Treatment will consist of exposure and response prevention with an added focus on teaching parents to be exposure coaches.

Conditions

Obsessive Compulsive Disorder

Keywords

cognitive behavior therapy; exposure and response prevention; pediatric; obsessive compulsive disorder; child; anxiety; intensive; OCD; CBT

Outcome Measures

Primary Outcomes (1)

• Children's Yale Brown Obsessive Compulsive Scale (CYBOCS)

  The CYBOCS is the gold standard measure of OCD symptoms. The primary outcome is the decrease in CYBOCS scores from pre-tx to post-tx, and post-tx to follow-up, compared to the change from 1 month before tx to pre-tx.

  1 month before tx, pre-tx, post-tx, 3 month follow-up

Secondary Outcomes (1)

• Spence children's anxiety scale

  baseline, pre-tx, post-tx, 3 month follow-up

Study Arms (1)

5day intensive treatment

EXPERIMENTAL

Behavioral: 5-day intensive treatment

Interventions

5-day intensive treatment BEHAVIORAL

Exposure Based Cognitive Behavioral Therapy administered in 10 appointments over 5 days with an added focus on training parents to be exposure coaches

5day intensive treatment

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Principal diagnosis of OCD on the ADIS-IV-P and CY-BOCS Total Score ≥ 16
• No change in psychotropic medication (if applicable) for at least 8 weeks prior to study entry
• to 17 years old
• Availability of at least one parent to accompany the child to all assessment sessions and be present for videophone assessments
• Have a computer and high-speed internet within their home
• English speaking.

You may not qualify if:

• Patients will be excluded from the study if they meet any of the following criteria:
• History of and/or current psychosis, autism, bipolar disorder, or current suicidality, oppositional defiant disorder, or eating disorder measured by the ADIS-IV-P and all available clinical information
• Principal diagnosis other than OCD
• Current a positive diagnosis in the caregiver of mental retardation, psychosis, or other psychiatric disorders or conditions that would limit their ability to understand CBT (based on clinical interview).
• Participants can be included if they are taking a selective serotonin reuptake inhibitor, SNRI, tricyclic, or antipsychotic provided that no medication changes were made 8 weeks prior to initiation of CBT or during treatment.

Sponsors & Collaborators

• Mayo Clinic: lead
• University of South Florida: collaborator
• Fordham University: collaborator

Study Sites (3)

University of South Florida

Tampa, Florida, 33620, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Fordham University

The Bronx, New York, 10458, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Stephen P Whiteside, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 2, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 30, 2012

Record last verified: 2012-05

Locations

US (3)