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

August 31, 2010
May 29, 2012
May 2010
May 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01194076 on ClinicalTrials.gov Archive Site
Spence children's anxiety scale [ Time Frame: baseline, pre-tx, post-tx, 3 month follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Wait-list Study of One-Week Intensive Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder (OCD)
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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obsessive Compulsive Disorder
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
Experimental: 5day intensive treatment
Intervention: Behavioral: 5-day intensive treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
7 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01194076
09-0082590
No
Stephen Whiteside, Mayo Clinic
Mayo Clinic
  • University of South Florida
  • Fordham University
Principal Investigator: Stephen P Whiteside, PhD Mayo Clinic
Mayo Clinic
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP