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

NCT ID: NCT00881465

Last Updated: 2015-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-06-30

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.

Conditions

Obsessive Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive-behavioral therapy

Intervention Type: BEHAVIORAL

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.

Group Type: PLACEBO_COMPARATOR

Wait-list control

Intervention Type: 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.

Interventions

Cognitive-behavioral therapy

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

University of South Florida

Principal Investigators

Eric Storch, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

University of South Florida

St. Petersburg, Florida, United States

Countries

United States

Other Identifiers

USF-09-0155

Identifier Type: -

Identifier Source: org_study_id