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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00881465

First Posted: April 15, 2009

Last Update Posted: June 11, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

University of South Florida

Tracking Information

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

Start Date ^ICMJE

March 2009

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.

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

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: within one week after treatment condition was concluded ]
Scores on this scale range from 0 to 6 with higher scores corresponding to worse symptom severity.
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: within one week after treatment condition was concluded ]
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.

Original Secondary Outcome Measures ^ICMJE

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 ]
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 ]

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

Condition ^ICMJE

Obsessive Compulsive Disorder

Intervention ^ICMJE

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

Study Arms

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.

Intervention: Behavioral: Cognitive-behavioral therapy
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.

Intervention: Behavioral: Wait-list control

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2010

Primary Completion Date

June 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

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

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

Principal Investigator:

Eric Storch, Ph.D.

University of South Florida

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

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