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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obsessive Compulsive Disorder

Intervention / Treatment
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* Behavioral: Cognitive-behavioral therapy
* Behavioral: Wait-list control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive-behavioral therapy<br>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<br>* Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks.<br>|
| Placebo Comparator: Waitlist<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Scores on this scale range from 0 to 6 with higher scores corresponding to worse symptom severity. | 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). | 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. | within one week after treatment condition was concluded | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obsessive compulsive disorder