Videophone Administered Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder
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ClinicalTrials.gov Identifier: NCT00881465 |
Recruitment Status
:
Completed
First Posted
: April 15, 2009
Results First Posted
: May 15, 2015
Last Update Posted
: June 11, 2015
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Sponsor:
University of South Florida
Information provided by:
University of South Florida
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Tracking Information | ||||
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First Submitted Date ICMJE | April 14, 2009 | |||
First Posted Date ICMJE | April 15, 2009 | |||
Results First Submitted Date | April 7, 2015 | |||
Results First Posted Date | May 15, 2015 | |||
Last Update Posted Date | June 11, 2015 | |||
Study Start Date ICMJE | March 2009 | |||
Actual Primary Completion Date | June 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997). The CY-BOCS is a 10-item Semi-structured Measure of Obsession and Compulsion Severity Over the Previous Week. This Measure Will Serve as the Primary Outcome Index. [ Time Frame: within one week after treatment condition was concluded ] Items on this scale are summed to arrive at a total score. Scores on this scale range from 0 to 40 with higher scores corresponding to worse symptom severity.
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Original Primary Outcome Measures ICMJE |
Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997). The CY-BOCS is a 10-item Semi-structured Measure of Obsession and Compulsion Severity Over the Previous Week. This Measure Will Serve as the Primary Outcome Index. [ Time Frame: Screening, Baseline, Post-treatment, Follow-up at 3 months ] | |||
Change History | Complete list of historical versions of study NCT00881465 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Videophone Administered Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder | |||
Official Title ICMJE | Videophone Administered Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder | |||
Brief Summary | Although cognitive-behavioral therapy (CBT) is the most effective intervention for pediatric obsessive-compulsive disorder (OCD), many people do receive CBT initially. Given this, alternative ways of providing CBT need to be identified and tested. With this in mind, the proposed study examines the efficacy of a videophone based cognitive-behavioral intervention for youth with OCD. A total of 30 youth will be randomly assigned to either videophone administered CBT or an abbreviated wait-list control arm. Comprehensive assessments will be conducted by trained clinicians at relevant time-points to assess symptom severity and impairment. | |||
Detailed Description | Although cognitive-behavioral therapy (CBT) is the most effective intervention for pediatric obsessive-compulsive disorder (OCD), many people do 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. Given this, alternative 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 study examines the efficacy of a videophone based cognitive-behavioral intervention for youth with OCD. A total of 30 youth will be randomly assigned to either videophone administered CBT or an abbreviated wait-list control arm. Cognitive-behavioral therapy will be based on a demonstrated effective treatment protocol, and adapted for videophone administration. Comprehensive assessments will be conducted by trained clinicians at relevant time-points (e.g., baseline, post-treatment, follow-up) to assess symptom severity and impairment. Should supporting data be found, videophone-administered CBT would have the potential to help many more families who would otherwise remain untreated or inadequately treated. On a societal level, evaluation and dissemination of telehealth interventions such as this will lessen costs related to sustained treatment and OCD related impairment. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Obsessive Compulsive Disorder | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
31 | |||
Original Estimated Enrollment ICMJE |
30 | |||
Actual Study Completion Date | June 2010 | |||
Actual Primary Completion Date | June 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 7 Years to 17 Years (Child) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00881465 | |||
Other Study ID Numbers ICMJE | USF-09-0155 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Eric Storch, Ph.D., University of South Florida | |||
Study Sponsor ICMJE | University of South Florida | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | University of South Florida | |||
Verification Date | May 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |