Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368557
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2023-10-16
Brief Title:
Internet-based Cognitive Behavioral Intervention for Adolescents With Anxiety Disorders
Sponsor:
Region of Southern Denmark
Organization:
Region of Southern Denmark
Study Overview
Official Title:
Internet-based Cognitive Behavioral Intervention for Adolescents With Anxiety Disorders
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 065-104 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 111 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 11
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
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 065-104 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 111 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 11
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None