Wait-list Study of One-Week Intensive Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder (OCD) (5dayOCD)
Primary Purpose
Obsessive Compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
5-day intensive treatment
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring cognitive behavior therapy, exposure and response prevention, pediatric, obsessive compulsive disorder, child, anxiety, intensive, OCD, CBT
Eligibility 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.
Sites / Locations
- University of South Florida
- Mayo Clinic
- Fordham University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
5day intensive treatment
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Spence children's anxiety scale
Full Information
NCT ID
NCT01194076
First Posted
August 31, 2010
Last Updated
May 29, 2012
Sponsor
Mayo Clinic
Collaborators
University of South Florida, Fordham University
1. Study Identification
Unique Protocol Identification Number
NCT01194076
Brief Title
Wait-list Study of One-Week Intensive Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder (OCD)
Acronym
5dayOCD
Official Title
Wait-list Feasibility Study of One-Week Intensive Cognitive-Behavioral Therapy for Pediatric OCD
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
University of South Florida, Fordham University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
cognitive behavior therapy, exposure and response prevention, pediatric, obsessive compulsive disorder, child, anxiety, intensive, OCD, CBT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
5day intensive treatment
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
5-day intensive treatment
Intervention Description
Exposure Based Cognitive Behavioral Therapy administered in 10 appointments over 5 days with an added focus on training parents to be exposure coaches
Primary Outcome Measure Information:
Title
Children's Yale Brown Obsessive Compulsive Scale (CYBOCS)
Description
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.
Time Frame
1 month before tx, pre-tx, post-tx, 3 month follow-up
Secondary Outcome Measure Information:
Title
Spence children's anxiety scale
Time Frame
baseline, pre-tx, post-tx, 3 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen P Whiteside, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33620
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Fordham University
City
Bronx
State/Province
New York
ZIP/Postal Code
10458
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Wait-list Study of One-Week Intensive Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder (OCD)
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