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

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

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

Funding Information: The study was evaluated and funded by the Ministry of Ministry of Social Affairs, Health and Integration Baden Württemberg, Germany. The ministry was not involved in any other steps of the study, including the original design, study analyses, data interpretation, or the paper preparation. Open Access funding enabled and organized by Projekt DEAL. Open Access funding enabled and organized by Project DEAL and by Open Access Publishing Fund of University of Tübingen. Publisher Copyright: © 2022, The Author(s).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.govNCT05037344. Registered May 2019, last release August 13th, 2021.Peer reviewe

Internet-based cognitive behavioral therapy in children and adolescents with obsessive-compulsive disorder: A randomized controlled trial

OBJECTIVES: Obsessive-compulsive disorder (OCD) in childhood and adolescence often leads to significant impairment in various areas of life and has a high risk of becoming chronic. Cognitive behavioral therapy (CBT) is the recommended first-line treatment, but it is too rarely implemented in accordance with guidelines and is often not available close to the patient’s home. Importantly, internet-based CBT could help to reduce this gap in care. Having previously successfully demonstrated the feasibility of an internet-based CBT approach, we aimed to assess its effectiveness in a waiting list controlled randomized trial. METHODS: Children and adolescents aged 6–18 years with a principal diagnosis of OCD received 14 sessions of therapist-delivered CBT via videoconference distributed over 16 weeks. After inclusion, participants were randomly assigned to either the treatment or waiting list group. Participants in the treatment group began treatment immediately after baseline diagnostics, and participants in the waiting list group began treatment after a 16-week waiting period. The primary outcome was a pre-post comparison of OCD symptoms as measured with the Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Additionally, remission was an important outcome measure. Follow-up assessments were conducted for all measures 16 and 32 weeks after completion of treatment. RESULTS: A total of 60 children and adolescents were included into the analyses. Over the course of the treatment, OCD symptoms according to the CY-BOCS significantly decreased in the treatment group compared to the waiting-list control group. Cohen’s d between groups was 1.63. After the patients in the waiting list group also received the treatment, the OCD symptoms decreased significantly in this group as well. This improvement of symptoms increased over the course of the follow-up assessments. Remission rate peaked at the 32-week follow-up, with 68% in the treatment group and 79% in the waiting list group. Importantly, patient satisfaction with treatment was high to very high. CONCLUSION: In our study, OCD symptoms decreased significantly and remission rate was high after internet-based CBT. Those effects were comparable to those found in studies of face-to-face treatment. Although further evidence is needed, these are early indications that our approach may be a viable way to provide access to adequate treatment for children and adolescents affected by OCD. CLINICAL TRIAL REGISTRATION: [www.ClinicalTrials.gov], identifier [NCT05037344]