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

Obsessive Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00881465
• Other study ID #: USF-09-0155
• Status: Completed
• Phase: Phase 2
• First received: April 14, 2009
• Last updated: May 15, 2015
• Start date: March 2009
• Est. completion date: June 2010

Study information

• Verified date: May 2015
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Cognitive-behavioral therapy
Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks.
• 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.

Locations

Country	Name	City	State
United States	University of South Florida	St. Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	within one week after treatment condition was concluded	No
Secondary	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.	Scores on this scale range from 0 to 6 with higher scores corresponding to worse symptom severity.	within one week after treatment condition was concluded	No
Secondary	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").	Scores on this scale range from 1 to 7. Scores of 1 (very much improved) and 2 (much improved) are grouped together to indicate if a participate has had a beneficial response to the interview. The data represents participants who had a beneficial response to the treatment condition. Scores of 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse) are grouped together to indicate that a participant has not had a positive treatment response.	within one week after treatment condition was concluded	No