Internet-based cognitive behavioral intervention for adolescents with anxiety disorders: a study protocol for a parallel three armed randomized controlled trial

Helene Skaarnes; Nikita Marie Sørensen; Anders House Wisnewski; Johanne Jeppesen Lomholt; Mikael Thastum; Lauren McLellan; Kim Mathiasen

doi:10.1186/s13063-024-08511-0

Internet-based cognitive behavioral intervention for adolescents with anxiety disorders: a study protocol for a parallel three armed randomized controlled trial

Helene Skaarnes^*, Nikita Marie Sørensen, Anders House Wisnewski, Johanne Jeppesen Lomholt, Mikael Thastum, Lauren McLellan, Kim Mathiasen

^*Corresponding author for this work

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Abstract

Background: Anxiety disorders are among the most prevalent mental health concerns affecting children and adolescents. Despite their high prevalence, statistics indicate that fewer than 25% of individuals in this demographic seek professional assistance for their condition. Consequently, there is a pressing need to develop innovative interventions aimed at improving treatment accessibility. Objectives: This study aims to assess the effectiveness of Internet-delivered Cognitive Behavioral Therapy (iCBT) for adolescents with anxiety, with a specific emphasis on involving parents in the treatment process. Methods: The study is structured as a parallel three-armed randomized controlled trial, comparing Internet-delivered Cognitive Behavioral Therapy (iCBT) with planned feedback, iCBT with on-demand feedback, and a waitlist control group, each group including 56 participants. Participants in the two iCBT conditions will undergo a 14-week treatment regimen, while those in the waitlist control group will wait for 14 weeks before starting iCBT with planned feedback. Additionally, participants in the iCBT groups will be randomly assigned to receive a booster session or not. The study design is factorial including two factors: type of therapist feedback (factor 1) and booster or no booster (factor 2). The study population comprises adolescents aged between 12 and 17 years, residing in Denmark, diagnosed with an anxiety disorder according to DSM-5 criteria. The primary outcome measures are the Youth Online Diagnostic Assessment and the Spence Children’s Anxiety Scale. Assessments will occur at baseline, post-treatment, and at 3-, 6-, and 12-month follow-ups post-treatment. Discussion: The findings of this study are anticipated to contribute to improving the accessibility of evidence-based treatments for adolescents with anxiety. Trial registration: The study is registered at clinicalTrials.gov, under protocol ID 22/59602. The Initial release was the 16.10.2023, first posted due to technical problems 16.04.2024. https://clinicaltrials.gov/study/NCT06368557?locStr=Odense,%20Denmark&country=Denmark&city=Odense&page=2&rank=13.

Original language	English
Article number	674
Pages (from-to)	1-15
Number of pages	15
Journal	Trials
Volume	25
Issue number	1
DOIs	https://doi.org/10.1186/s13063-024-08511-0
Publication status	Published - Dec 2024

Bibliographical note

Copyright the Author(s) 2024. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

adolescents
anxiety disorders
cognitive behavioral therapy
digital health
internet-based
study protocol

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10.1186/s13063-024-08511-0Licence: CC BY

Publisher version (open access)Final published version, 1.32 MBLicence: CC BY

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title = "Internet-based cognitive behavioral intervention for adolescents with anxiety disorders: a study protocol for a parallel three armed randomized controlled trial",

abstract = "Background: Anxiety disorders are among the most prevalent mental health concerns affecting children and adolescents. Despite their high prevalence, statistics indicate that fewer than 25% of individuals in this demographic seek professional assistance for their condition. Consequently, there is a pressing need to develop innovative interventions aimed at improving treatment accessibility. Objectives: This study aims to assess the effectiveness of Internet-delivered Cognitive Behavioral Therapy (iCBT) for adolescents with anxiety, with a specific emphasis on involving parents in the treatment process. Methods: The study is structured as a parallel three-armed randomized controlled trial, comparing Internet-delivered Cognitive Behavioral Therapy (iCBT) with planned feedback, iCBT with on-demand feedback, and a waitlist control group, each group including 56 participants. Participants in the two iCBT conditions will undergo a 14-week treatment regimen, while those in the waitlist control group will wait for 14 weeks before starting iCBT with planned feedback. Additionally, participants in the iCBT groups will be randomly assigned to receive a booster session or not. The study design is factorial including two factors: type of therapist feedback (factor 1) and booster or no booster (factor 2). The study population comprises adolescents aged between 12 and 17 years, residing in Denmark, diagnosed with an anxiety disorder according to DSM-5 criteria. The primary outcome measures are the Youth Online Diagnostic Assessment and the Spence Children{\textquoteright}s Anxiety Scale. Assessments will occur at baseline, post-treatment, and at 3-, 6-, and 12-month follow-ups post-treatment. Discussion: The findings of this study are anticipated to contribute to improving the accessibility of evidence-based treatments for adolescents with anxiety. Trial registration: The study is registered at clinicalTrials.gov, under protocol ID 22/59602. The Initial release was the 16.10.2023, first posted due to technical problems 16.04.2024. https://clinicaltrials.gov/study/NCT06368557?locStr=Odense,%20Denmark&country=Denmark&city=Odense&page=2&rank=13.",

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doi = "10.1186/s13063-024-08511-0",

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AU - Wisnewski, Anders House

AU - Lomholt, Johanne Jeppesen

AU - Thastum, Mikael

AU - McLellan, Lauren

AU - Mathiasen, Kim

N1 - Copyright the Author(s) 2024. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

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Internet-based cognitive behavioral intervention for adolescents with anxiety disorders: a study protocol for a parallel three armed randomized controlled trial

Abstract

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Keywords

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