Feasibility, Acceptability, and Effectiveness of Enhanced Cognitive Behavioral Therapy (eCBT) for Children and Adolescents With Obsessive-Compulsive Disorder: Protocol for an Open Trial and Therapeutic Intervention
Authors: Wolters Lidewij H , Weidle Bernhard , Babiano-Espinosa Lucía , Skokauskas Norbert 
Published: November 2020

Background
Although the evidence base of cognitive behavioral therapy (CBT) for pediatric obsessive-compulsive disorder (OCD) has been broadly established, the treatment is hampered by limited access, poor compliance, and nonresponse. New technologies offer the opportunity to improve the accessibility, user friendliness, and effectiveness of traditional office-based CBT. By employing an integrated and age-appropriate technologically enhanced treatment package, we aim to execute a more focused and attractive application of CBT principles to increase the treatment effect for pediatric OCD.

Objective
The aim of this open study is to explore the acceptability, feasibility, and effectiveness of a newly developed enhanced CBT (eCBT) package for pediatric OCD.

Methods
This study is an open trial using a historical control design conducted at the outpatient clinic of the Department of Child and Adolescent Psychiatry at St. Olavs University Hospital (Trondheim) or at BUP Klinikk (Aalesund). Participants are 30 children (age 7-17 years) with a primary Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis of OCD, and their parents. All participants receive eCBT. eCBT consists of the usual evidence-based CBT for pediatric OCD in an “enhanced” format. Enhancements include videoconferencing sessions (supervision and guided exposure exercises at home) in addition to face-to-face sessions; an app system of interconnected apps for the child, the parents, and the therapist; psychoeducative videos; and frequent online self-assessments with direct feedback to patients and the therapist. Primary outcome measures are the Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS) (effectiveness), the Client Satisfaction Questionnaire-8 (acceptability), and treatment drop out (feasibility). Assessments are conducted pretreatment, posttreatment, and at 3- and 6-month follow-ups. A 12-month follow-up assessment is envisioned. The treatment outcome (CY-BOCS) will be compared to traditional face-to-face CBT (data collected in the Nordic Long-term OCD Treatment Study).

Results
Ethical approval has been obtained (2016/716/REK nord). Inclusion started on September 04, 2017. Data collection is ongoing.

Conclusions
This study is the first step in testing the acceptability, feasibility, and preliminary effectiveness of eCBT. In case of positive results, future steps include improving the eCBT treatment package based on feedback from service users, examining cost-effectiveness in a randomized controlled trial, and making the package available to clinicians and other service providers treating OCD in children and adolescents.

Trial Registration
ISRCTN, ISRCTN37530113; registered on January 31, 2020 (retrospectively registered); https://www.isrctn.com/ISRCTN37530113.

International Registered Report Identifier (IRRID)
DERR1-10.2196/24057