Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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: May 15, 2015
Last verified: May 2015
Results First Received: April 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Obsessive Compulsive Disorder
Interventions: Behavioral: Cognitive-behavioral therapy
Behavioral: Wait-list control

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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

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.

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.


Participant Flow:   Overall Study
    Cognitive-behavioral Therapy     Waitlist  
STARTED     16     15  
COMPLETED     14     15  
NOT COMPLETED     2     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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

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.

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.

Total Total of all reporting groups

Baseline Measures
    Cognitive-behavioral Therapy     Waitlist     Total  
Number of Participants  
[units: participants]
  16     15     31  
Age  
[units: participants]
     
<=18 years     16     15     31  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  11  (2.5)     11.2  (2.81)     11.1  (2.59)  
Gender  
[units: participants]
     
Female     6     6     12  
Male     10     9     19  
Region of Enrollment  
[units: participants]
     
United States     16     15     31  



  Outcome Measures
  Show All Outcome Measures

1.  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.   [ Time Frame: within one week after treatment condition was concluded ]

2.  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.   [ Time Frame: within one week after treatment condition was concluded ]

3.  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”).   [ Time Frame: within one week after treatment condition was concluded ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Use of a non-active control condition.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Eric Storch, Ph.D.
Organization: University of South Florida
phone: 7277678230
e-mail: estorch@health.usf.edu



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
Results First Received: April 7, 2015
Last Updated: May 15, 2015
Health Authority: United States: Institutional Review Board