Feasibility, Acceptability and Effectiveness of Enhanced Cognitive Behavioral Therapy (eCBT) for Children and Adolescents With Obsessive-Compulsive Disorder: Therapeutic Intervention and Trial Protocol (Preprint)

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 non-response. New technologies offer the opportunity to improve accessibility, user friendliness, and effectiveness of traditional office-based CBT. By employing an integrated and age appropriate technological enhanced treatment package, we aim to execute a more focused and attractive application of CBT principles to increase treatment effect for pediatric OCD. OBJECTIVE The aim of this open study is to explore acceptability, feasibility and effectiveness of a newly developed enhanced CBT (eCBT) package for pediatric OCD. METHODS The present 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 Olav's University Hospital (Trondheim), or at BUP Klinikk (Aalesund). Participants are 30 children (7-17 years) with a primary 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 pre-treatment, post-treatment and at 3- and 6-months follow-up. A 12-month follow-up assessment is envisioned. 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 (reference "2016/716/REK nord"). Inclusion has started on 04-09-2017. Data collection is ongoing. CONCLUSIONS The present study is a first step in testing the acceptability, feasibility, and preliminary effectiveness of eCBT. In case of positive results, future steps include improvement of the eCBT treatment package based on feedback from service users, to examine (cost-)effectiveness in a randomized controlled trial, and making the package available for clinicians and other service providers treating OCD in children and adolescents. CLINICALTRIAL ISRCTN, ISRCTN37530113. Registered 31 January 2020 (retrospectively registered), https://www.isrctn.com/ISRCTN37530113.