Wait-list Study of One-Week Intensive Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder (OCD) (5dayOCD)

Wait-list Feasibility Study of One-Week Intensive Cognitive-Behavioral Therapy for Pediatric OCD

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.

Study Overview

• Status: Completed
• Conditions: Obsessive Compulsive Disorder
• Intervention / Treatment: Behavioral: 5-day intensive treatment

Detailed Description

Although cognitive-behavioral therapy (CBT) is the most effective intervention for pediatric obsessive-compulsive disorder (OCD), many people do not receive CBT initially due, in part, to the lack of trained providers and geographic barriers (e.g., distance to such providers). Rather, the majority of youth with OCD receive psychiatric medication alone or together with unproven forms of psychotherapy. While some serotonergic medications have demonstrated utility in pediatric OCD, side effects can be common, response rates are modest at best, and symptom remission is rare. Storch et al. have shown that CBT can be delivered effectively in an intensive format over a 3-week time-span; however, even this shortened treatment approach involves considerable time and financial expenditure for those who do not have local access to CBT, including three week's time off from work and the cost of local room and board. Given this, more efficient ways of providing CBT need to be identified and tested to increase the number of people with access to this form of treatment. With this in mind, the proposed feasibility study examines the use of videophone technology to evaluate a 5-day cognitive-behavioral intervention for youth with OCD administered at multiple sites. A total of 30 youth will receive 10 60-75-minute sessions of CBT over 5 days (two sessions a day). Cognitive-behavioral therapy will be based on a demonstrated effective treatment protocol, and adapted for administration over a one-week time-span. We will utilize a month-long waitlist control to estimate treatment efficacy. Comprehensive assessments will be conducted by trained clinicians at relevant time-points (i.e., baseline, post-waitlist, post-treatment, follow-up) to assess symptom severity and impairment. Should supporting data be found, CBT delivered in a 5-day format would have the potential to help many more families who would otherwise remain untreated or inadequately treated.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33620
      • University of South Florida
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • Bronx, New York, United States, 10458
      • Fordham University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients must meet the following inclusion criteria to be eligible for study participation:

  • 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
  • 7 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 5day intensive treatment	Behavioral: 5-day intensive treatment; Exposure Based Cognitive Behavioral Therapy administered in 10 appointments over 5 days with an added focus on training parents to be exposure coaches

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Spence children's anxiety scale	baseline, pre-tx, post-tx, 3 month follow-up

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: University of South Florida; Fordham University
• Investigators: Principal Investigator: Stephen P Whiteside, PhD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): May 1, 2012
• Study Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: August 31, 2010
• First Submitted That Met QC Criteria: September 1, 2010
• First Posted (ESTIMATE): September 2, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): May 30, 2012
• Last Update Submitted That Met QC Criteria: May 29, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: OCD; pediatric; anxiety; cognitive behavior therapy; child; CBT; exposure and response prevention; obsessive compulsive disorder; intensive
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 09-0082590