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Sponsored by: |
University of South Florida |
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Information provided by: | University of South Florida |
ClinicalTrials.gov Identifier: | NCT00881465 |
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.
Condition | Intervention | Phase |
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Obsessive Compulsive Disorder |
Behavioral: Cognitive-behavioral therapy Behavioral: Wait-list control |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Videophone Administered Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder |
Estimated Enrollment: | 30 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Cognitive-behavioral therapy: Experimental
Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.
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Behavioral: Cognitive-behavioral therapy
Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks.
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Waitlist: Placebo Comparator
Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.
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Behavioral: Wait-list control
Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.
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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.
Ages Eligible for Study: | 7 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eric A Storch, Ph.D. | 727-767-8230 | rothmanctr@health.usf.edu |
Contact: Jane Mutch, Ph.D. | 727-767-8230 | pmutch@health.usf.edu |
United States, Florida | |
University of South Florida | Recruiting |
St. Petersburg, Florida, United States, 33701 | |
Contact: Eric Storch, Ph.D. 727-767-8230 rothmanctr@health.usf.edu | |
Contact: Jane Mutch, Ph.D. 727-767-8230 pmutch@health.usf.edu | |
Principal Investigator: Eric Storch, Ph.D. | |
Sub-Investigator: Tanya Murphy, MD | |
Sub-Investigator: Jane Mutch, Ph.D. |
Principal Investigator: | Eric Storch, Ph.D. | University of South Florida |
Responsible Party: | University of South Florida ( Eric Storch, Ph.D. ) |
Study ID Numbers: | USF-09-0155 |
Study First Received: | April 14, 2009 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00881465 History of Changes |
Health Authority: | United States: Institutional Review Board |
Obsessive compulsive disorder |
Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder |
Pathologic Processes Disease Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder |