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Clinical Trials/NCT00881465
NCT00881465
Completed
Phase 2

Videophone Administered Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder

University of South Florida1 site in 1 country31 target enrollmentMarch 2009

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Obsessive Compulsive Disorder
Sponsor
University of South Florida
Enrollment
31
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
June 2010
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Principal diagnosis of OCD on the ADIS-IV-C/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 sessions
  • Have a computer within their home

Exclusion Criteria

  • History of and/or current psychosis, autism, bipolar disorder, or current suicidality
  • Principal diagnosis other than OCD
  • 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)
  • The child requires a higher level of psychiatric and/or medical care (e.g., inpatient hospitalization)
  • Child receptive vocabulary \< 80.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Clinical Global Impression - Severity (CGI-S; National Institute of Mental Health, 1985). The CGI-S is a 7-point Clinician Rating of Severity of Psychopathology.(within one week after treatment condition was concluded)
  • Clinical Global Improvement (CGI; Guy, 1976). The CGI is a 7-point Rating of Treatment Response Anchored by 1 ("Very Much Improved) and 7 ("Very Much Worse").(within one week after treatment condition was concluded)

Study Sites (1)

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