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

NCT00881465 | Completed Phase 2 Results

• 1 other identifier: USF-09-0155
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive Compulsive Disorder

Keywords

Obsessive compulsive disorder

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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 Arms (2)

Cognitive-behavioral therapy

EXPERIMENTAL

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

Waitlist

PLACEBO COMPARATOR

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

Interventions

Cognitive-behavioral therapy BEHAVIORAL

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

Cognitive-behavioral therapy

Wait-list control BEHAVIORAL

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.

Waitlist

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

St. Petersburg, Florida, 33701, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Use of a non-active control condition.

Results Point of Contact

• Title: Eric Storch, Ph.D.
• Organization: University of South Florida

estorch@health.usf.edu

7277678230

Study Officials

• Eric Storch, Ph.D.

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 14, 2009
• First Posted: April 15, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 11, 2015
• Results First Posted: May 15, 2015

Record last verified: 2015-05

Locations

US (1)