Internet-based Cognitive Behavioral Intervention for Adolescents With Anxiety Disorders

Anxiety Disorders Clinical Trial

Official title: Internet-based Cognitive Behavioral Intervention for Adolescents With Anxiety Disorders

Status Recruiting

Clinical Trial Summary

The goal of the randomized controlled trial is to find out if the internet-based therapy (iCBT) intervention CoolMinds, is effective in helping adolescents with anxiety. The adolescents in the study are aged between 12 and 17 years of age, who live in the region of Southern Denmark. They must have an anxiety diagnosis according to the

Diagnostic and Statistical Manual-5 (DSM-5) criteria. The main questions it aims to answer are:

1. If getting anxiety treatment with CoolMinds will lead to a greater reduction in anxiety symptoms, compared to a waitlist.

2. What effect different degrees of therapist support have on the treatment.

Participants will be getting 14 weeks of the iCBT intervention CoolMinds, and they will be asked to answer questionnaires about their mental health before and after the treatment.

Researchers will compare three different groups, with 56 adolescents in each group. The first group will receive iCBT with weekly scheduled feedback. The second group will get iCBT with feedback whenever the adolescents ask for it. The last group will be on a waiting list for 14 weeks, before receiving treatment.

Clinical Trial Description

Introduction

Among children and adolescents the most prevalent mental health conditions are anxiety disorders, with around 5-12% of youth in western countries fulfilling the criteria for an anxiety diagnosis. Evidence points to an increase in the prevalence of anxiety disorders during the transition from childhood to adolescence and from adolescence to adulthood up to age 30. Untreated anxiety disorders tend to chronify or become recurrent in the developmental course and persist into adulthood.

Cognitive behavioral therapy (CBT), in both individual and group format, is effective in treating young people with anxiety. Despite the existence of effective treatment options and the possible long-term consequences associated with untreated anxiety disorders in youth, it is estimated that less than 25% of children and adolescents with anxiety disorders receive professional help, with fewer receiving evidence-based treatment. Frequently mentioned barriers for adolescents opting to seek treatment include social stigma, shyness and fear of peer rejection, preference for self-reliance, confidentiality, privacy and anonymity concerns, worries concerning treatment costs, transportation or waiting times and limited availability of psychological treatment. Thus, it is of the utmost importance to consider these barriers when developing interventions to overcome these and thus increase treatment accessibility.

Internet-based cognitive behavioral therapy (iCBT) may be an effective alternative to face-to-face treatment, that can address some of the aforementioned barriers to treatment by providing greater flexibility, greater autonomy, reduced expenses, and eliminate travel time. To date, fourteen randomized controlled trials (RCTs) have evaluated iCBT programs in both children and adolescents with anxiety disorders. Four of these included predominantly or only adolescents and showed promising results with between group effect sizes ranging from d = 0.65-1.04 at follow-up.

Objectives

The primary aim of the present study is to examine the efficacy of an internet-delivered cognitive behavioral therapy intervention, CoolMinds, in adolescents aged 12-17 years, when delivered with planned feedback or on-demand feedback from a therapist compared to a waitlist control. Additionally, the study will explore the efficacy of delivering one booster session compared to none. It is hypothesized that:

1. CoolMinds will lead to a greater reduction in anxiety symptoms compared to the waitlist control.

2. The effect of CoolMinds will be independent of the degree of therapist support.

Design:

The study is designed as a superiority randomized controlled trial with the three conditions 1) iCBT with planned feedback 2) iCBT with on-demand feedback and 3) waitlist control. The allocation ratio is 1:1:1 for each condition. The participants will be stratified by aged into the age groups 12-14 years and 15-17 years respectively to secure an even age distribution across conditions. Additionally all participants that are active in the program for the first 8 weeks, will be randomized to receive or not receive a booster session 10 weeks after finishing the intervention with an allocation ratio of 1:1.

The study will be conducted at Center for Digital Psychiatry, an online clinic and research facility that is part of the psychiatric hospital in the region of southern Denmark, and at Center for Psychological Treatment of Children and Adolescents, a research and teaching center at Aarhus university, Denmark. All data will be collected from these two centers in Denmark.

Participants and recruitment:

All participants will have to register through a website to participate in the project. As part of the registration, the participants will have to fill out an initial screening questionnaire that assesses exclusion criteria. If an exclusion criteria is met, the participant will automatically be informed within the questionnaire that they are unable to participate and is given the choice to continue or discontinue their answering.

Data will be collected with a parent and adolescent questionnaire at five points:

pre-treatment (T1), post-treatment (T2) and at follow-ups after 3, 6 and 12 months (T3, T4, T5). Participants in the waitlist control group will be offered guided iCBT with planned feedback at post-treatment (T2). ;

Related Conditions & MeSH terms

• Anxiety Disorders

• NCT number: NCT06368557
• Study type: Interventional
• Source: Region of Southern Denmark
• Contact: Helene Skaarnes, MSc (Psych.)
• Phone: 0045 2964 9702
• Email: helene.skaarnes@rsyd.dk
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2023
• Completion date: June 2025