Internet-based psychotherapy in children with obsessive-compulsive disorder (OCD): protocol of a randomized controlled trial

Annette Conzelmann, Karsten Hollmann, Anna Haigis, Heinrich Lautenbacher, Verena Bizu, Rehan App, Matthias Nickola, Gunilla Wewetzer, Christoph Wewetzer, Tord Ivarsson, Norbert Skokauskas, Lidewij H Wolters, Gudmundur Skarphedinsson, Bernhard Weidle, Else de Haan, Nor Christian Torp, Scott N Compton, Rosa Calvo, Sara Lera-Miguel, Annika Alt, Carolin Sarah Hohnecker, Katharina Allgaier, Tobias J Renner, Annette Conzelmann, Karsten Hollmann, Anna Haigis, Heinrich Lautenbacher, Verena Bizu, Rehan App, Matthias Nickola, Gunilla Wewetzer, Christoph Wewetzer, Tord Ivarsson, Norbert Skokauskas, Lidewij H Wolters, Gudmundur Skarphedinsson, Bernhard Weidle, Else de Haan, Nor Christian Torp, Scott N Compton, Rosa Calvo, Sara Lera-Miguel, Annika Alt, Carolin Sarah Hohnecker, Katharina Allgaier, Tobias J Renner

Abstract

Background: Obsessive-compulsive disorder (OCD) in children can lead to a huge burden on the concerned patients and their family members. While successful state-of-the art cognitive behavioral interventions exist, there is still a lack of available experts for treatment at home, where most symptoms manifest. Internet-based cognitive behavioral therapy (iCBT) could overcome these restrictions; however, studies about iCBT in children with OCD are rare and mostly target computerized self-help resources and only email contact with the therapist. Therefore, we intended to build up and to evaluate an iCBT approach for children with OCD, replacing successful elements of traditional in-office face-to-face CBT, with face-to-face teleconferences, online materials, and apps.

Methods: With the help of a pilot feasibility study, we developed the iCBT consisting of 14 teleconference sessions with the child and parents. The sessions are supported by an app assessing daily and weekly symptoms and treatment course completed by children and parents. Additionally, we obtain heart rate and activity scores from the child via wristbands during several days and exposure sessions. Using a waiting list randomized control trial design, we aim to treat and analyze 20 children with OCD immediately after a diagnostic session whereas the control group of another set of 20 OCD patients will be treated after waiting period of 16 weeks. We will recruit 30 patients in each group to take account for potential dropouts. Outcomes for the treatment group are evaluated before randomization (baseline, t0), 16 weeks (end of treatment, t1), 32 weeks (follow-up 1, t2), and 48 weeks after randomization (follow-up 2, t3). For the waiting list group, outcomes are measured before the first randomization (baseline), at 16 weeks (waiting list period), 32 weeks (end of treatment), 48 weeks after the first randomization (follow-up I), and 64 weeks after the first randomization (follow-up II).

Discussion: Based on our experience of feasibility during the pilot study, we were able to develop the iCBT approach and the current study will investigate treatment effectiveness. Building up an iCBT approach, resembling traditional in-office face-to-face therapy, may ensure the achievement of well-known therapy effect factors, the acceptance in both patients and clinicians, and the wide distribution within the health system.

Trial registration: ClinicalTrials.gov NCT05037344 . Registered May 2019, last release August 13th, 2021.

Keywords: App; Children; Internet psychotherapy; Obsessive-compulsive disorder; Randomized controlled TRIAL.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Schedule of enrolment, interventions, and assessments. Information about the diagnostic measures can be found in themanuscript text. Time points: -t1 = First contact and enrolment to the study; t0 = Baseline assessment; tx = Appassessments; t1 = After 16 weeks, Assessment at the end of intervention treatment group/begin treatment waiting group; t2= After 32 weeks, Follow-up I for treatment group/end of intervention waiting group; t3 = After 48 weeks, Follow-up IItreatment group/follow-up waiting group; t4 = After 48 weeks, Follow-up II waiting group. X means assessment in thetreatment and waiting group unless it is indicated that the assessment is only carried out in one specific group. TG=treatment group; WG = waiting group. p=assessed in parents, c = assessed in children, t =assessed in therapist. * only TG,** only WG

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