Clinical trial NCT00881465: Videophone Administered Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder
Official title: Videophone Administered Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obsessive Compulsive Disorder
Keywords: Obsessive compulsive disorder
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2009-04-15
Enrollment: 31
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: within one week after treatment condition was concluded
Secondary outcomes:
measure: 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.
timeFrame: within one week after treatment condition was concluded
measure: 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").
timeFrame: within one week after treatment condition was concluded
Other outcomes:
Locations:
city: St. Petersburg
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Eric Storch, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: