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

This study has been completed.
Sponsor:
Information provided by:
University of South Florida
ClinicalTrials.gov Identifier:
NCT00881465
First received: April 14, 2009
Last updated: August 5, 2010
Last verified: August 2010
  Purpose

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
Obsessive Compulsive Disorder
Behavioral: Cognitive-behavioral therapy
Behavioral: Wait-list control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Videophone Administered Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Screening, Baseline, Post-treatment, 3-month follow-up ] [ Designated as safety issue: No ]
  • 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"). [ Time Frame: Post-treatment, Follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive-behavioral therapy
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.
Behavioral: Cognitive-behavioral therapy
Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks.
Placebo Comparator: Waitlist
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.
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.

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.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881465

Locations
United States, Florida
University of South Florida
St. Petersburg, Florida, United States, 33701
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Eric Storch, Ph.D. University of South Florida
  More Information

No publications provided

Responsible Party: Eric Storch, Ph.D., University of South Florida
ClinicalTrials.gov Identifier: NCT00881465     History of Changes
Other Study ID Numbers: USF-09-0155
Study First Received: April 14, 2009
Last Updated: August 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Obsessive compulsive disorder

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on September 29, 2014