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

This study has been completed.
Sponsor:
Collaborators:
University of South Florida
Fordham University
Information provided by (Responsible Party):
Stephen Whiteside, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01194076
First received: August 31, 2010
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Obsessive Compulsive Disorder
Behavioral: 5-day intensive treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Wait-list Feasibility Study of One-Week Intensive Cognitive-Behavioral Therapy for Pediatric OCD

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Children's Yale Brown Obsessive Compulsive Scale (CYBOCS) [ Time Frame: 1 month before tx, pre-tx, post-tx, 3 month follow-up ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Spence children's anxiety scale [ Time Frame: baseline, pre-tx, post-tx, 3 month follow-up ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: May 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194076

Locations
United States, Florida
University of South Florida
Tampa, Florida, United States, 33620
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Fordham University
Bronx, New York, United States, 10458
Sponsors and Collaborators
Mayo Clinic
University of South Florida
Fordham University
Investigators
Principal Investigator: Stephen P Whiteside, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Stephen Whiteside, PHD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01194076     History of Changes
Other Study ID Numbers: 09-0082590
Study First Received: August 31, 2010
Last Updated: May 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
cognitive behavior therapy
exposure and response prevention
pediatric
obsessive compulsive disorder
child
anxiety
intensive
OCD
CBT

Additional relevant MeSH terms:
Compulsive Personality Disorder
Disease
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Pathologic Processes
Personality Disorders

ClinicalTrials.gov processed this record on November 24, 2014