Internet-based Cognitive Behavioral Intervention for Adolescents With Anxiety Disorders

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety Disorders
• Intervention / Treatment: Behavioral: CoolMinds: Internet-based cognitive behavioral therapy (iCBT)

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 = 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).

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helene Skaarnes, MSc (Psych.); Phone Number: 0045 2964 9702; Email: helene.skaarnes@rsyd.dk
• Study Contact Backup: Name: Nikita M Sørensen, MSc (Psych.); Phone Number: 0045 87159439; Email: nikita@psy.au.dk

Study Locations

• Denmark
  • Region Of Southern Denmark
    • Odense, Region Of Southern Denmark, Denmark, 5000
      • Recruiting
      • Centre for Digital Psychiatry
      • Contact: Helene Skaarnes, MSc (psych)); Phone Number: +4529649702; Email: helene.skaarnes@rsyd.dk
      • Contact: Kim Mathiasen, Ph.d.; Phone Number: +4561677747; Email: kmathiasen@health.sdu.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Between 12 and 17 years of age.
• Have a principal anxiety diagnosis according to DSM-5 criteria.
• The ability to read and write Danish.
• Internet access.
• A parent able to participate in treatment alongside the adolescent.

Exclusion Criteria:

• Autism spectrum disorder.
• Attention deficit hyperactivity disorder.
• Psychotic symptoms.
• Bipolar disorder.
• Current suicidal ideation or self-mutilating behavior.
• Current alcohol or substance abuse.
• A score of 5 or above on ADIS
• Current eating disorder.
• Received CBT for an anxiety disorder within the past 12 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iCBT with planned feedback; Participants in this iCBT condition will receive written feedback from their therapist on assignments weekly. The participants will also be able to contact their assigned therapist through messages within the program and receive asynchronous support if needed. Participant depression and suicidality will also be continuously monitored using weekly questionnaires.	Behavioral: CoolMinds: Internet-based cognitive behavioral therapy (iCBT); The intervention consists of 14 weeks of iCBT, where the main treatment components are psychoeducation, cognitive restructuring, exposure therapy, and relapse prevention. The program comprises eleven sessions for adolescents and ten sessions for parents to be completed simultaneously. The participants will have the opportunity to get therapist feedback during the treatment period, the therapist may spend a maximum of 15 minutes giving feedback per week per participant.
Experimental: iCBT with on-demand feedback; Participants in the on-demand iCBT condition will not receive any planned contact with the therapist. However, the participants will be able to contact the therapist through messages within the program and receive asynchronous support if needed. The therapist will also be monitoring the participants' answers on questionnaires and assignments to ensure progress. Participant depression and suicidality will also be continuously monitored using weekly questionnaires.	Behavioral: CoolMinds: Internet-based cognitive behavioral therapy (iCBT); The intervention consists of 14 weeks of iCBT, where the main treatment components are psychoeducation, cognitive restructuring, exposure therapy, and relapse prevention. The program comprises eleven sessions for adolescents and ten sessions for parents to be completed simultaneously. The participants will have the opportunity to get therapist feedback during the treatment period, the therapist may spend a maximum of 15 minutes giving feedback per week per participant.
No Intervention: waitlist control; A waitlist control is included to compare the treatment conditions to a no-treatment condition and serves as a control for the effects of time and assessment on efficacy. Participants in the waitlist condition will be instructed to wait 14 weeks. After the 14-week period, participants will be offered iCBT treatment with planned therapist feedback and with elective modules. If participants do not wish to receive the iCBT treatment, they will receive help in finding another relevant treatment if needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Youth Online Diagnostic Assessment - Child and Parent Versions	An online diagnostic assessment tool that assesses DSM-5 anxiety disorders and specific phobias based on the Anxiety and Related Disorders Interview Schedule for DSM-5, which is considered the golden standard.	Pre-treatment, immediately after treatment and at 3-month follow-up
Spence Children's Anxiety Scale- Child and Parent Versions	A 44-item self-report questionnaire assessing anxiety symptoms of six different anxiety disorders in DSM-IV. The responses are scored on a 4 point scale ranging from 0 to 3, with a minimum score of 0 and a maximum score of 114, higher scores mean a higher level of anxiety.	Pre-treatment, immediately after treatment and at 3- 6- 12-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Anxiety Life Interference Scale- Child and Parent Version	A 10-item self-report questionnaire assessing the impact of youth anxiety on various areas of life functioning such as school, extracurricular activities, family life and friendships. The responses are scored on a likert scale ranging from 0 to 4, with higher scores indicating higher anxiety life interference, minimum score is 0, maximum score is 36.	Pre-treatment, immediately after treatment and at 3- 6- 12-month follow-up
The Mood and Feelings Questionnaire- Child and Parent Version	A 33-item self-report questionnaire assessing depression in youth, The responses are scored from 0 to 2, with higher scores suggest more severe depressive symptoms. Minimum score is 0, maximum score is 66.	Pre-treatment, immediately after treatment and at 3- 6- 12-month follow-up
Working Alliance Inventory - Short Form	A 12-item self-report questionnaire assessing the therapeutic alliance, the responses are scored from 1 to 7, minimum total score 12 to maximum total score of 84, higher scores reflect a more positive rating of working alliance.	Immediately after treatment and every 14 days during the treatment period
Working Alliance Inventory for Online Interventions	A 36- items self-report questionnaire assessing the technical alliance, the responses are scored from 1 to 7, minimum total score 36 to maximum total score of 252, higher scores reflect a more positive rating of working alliance.	Immediately after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children´s Anxiety Scale	A 8-item abbreviated version of the Spence Children's Anxiety Scale containing 8 of the original 44-items. The responses are scored from 0 to 3, with a minimum total score of 0, to a maximum total score of 24. Higher scores mean a higher level of anxiety.	weekly questionnaire
The Short Mood and Feelings questionnaire	A 13-items self-report questionnaire with an added item about suicidal thoughts and ideation will assess the level of depressive symptoms and risk of suicide. The responses are scored from 0 to 2, with a minimum total score of 0, to a maximum total score of 26. with higher scores suggest more severe depressive symptoms.	Weekly questionnaire
EuroQol-5 Dimension Youth	A 5-item self-report questionnaire assessing quality of life and self-rated health. The items cover five domains: mobility, selfcare, usual activities, pain/discomfort, and anxiety and depression. The responses are scored from 1 to 5, with a minimum total score of 5, to a maximum total score of 25. Higher score suggest problems with the different dimensions.	Pre-treatment, immediately after treatment and at 3- 6- 12-month follow-up
Client Satisfaction Questionnaire-8	An 8-item questionnaire used to measure general satisfaction with a received treatment.The responses are scored from 1 to 4, with a minimum total score of 8, to a maximum total score of 32, with higher scores indicating greater satisfaction.	Immediately after treatment
Systems Usability Scale	A 10-item questionnaire used to assess the subjective experience of usability of a higher score computer system. The responses are scored from 1 to 5, the participant´s scores for each question are converted to a new number, added together and then multiplied by 2.5 to make a scale with a minimum total score of 0, to a maximum total score of 100. A higher score indicates greater system usability.	Immediately after treatment
Negative Effects Questionnaire	A 20-item questionnaire used to monitor the occurrence of negative effects in psychological treatments. The responses are scored from 0-4, with a minimum total score of 0, to a maximum total score of 80. A higher score indicates, more negative effects.	Immediately after treatment
Sociodemographic measures	s will be gathered on parents regarding age, level of education, civil status, gender and primary caregiver in case of single parents. For the adolescents, information will be gathered regarding age and gender	pre-treatment
Engagement	with the treatment will be measured objectively using the number of logins to the treatment program as well as number of words per message sent to the therapist and number of words per text box in the modules. This will be registered for both adolescents and parents.	Immediately after treatment
Cost-effectiveness	Will be measured by self-report questionnaire about the number of days absent from school, if they have been in contact with self-paid psychiatrist or psychologist during the study and the use of communal services.	Immediately after treatment
Cost-effectiveness	Will be measured by the time the parent and adolescent spent in the program, as well the therapists time spent on each patient.	Immediately after treatment
The Anxiety Disorders Interview Schedule for Children	Depression will be measured oral during the clinical interview, with The Anxiety Disorders Interview Schedule for Children as The Youth Online Diagnostic Assessment depression module is not translated to Danish.	pre-treatment

Collaborators and Investigators

• Sponsor: Region of Southern Denmark
• Collaborators: University of Aarhus
• Investigators: Principal Investigator: Kim Mathiasen, P.hd, Centre for Digital Psychiatry, Mental Health Services in the Region of Southern Denmark

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Cognitive behavioral therapy; Digital health; Anxiety Disorders; Internet-based
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 22/59602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data will be available for researches at Aarhus University, center for psychological treatment of children and adolescents. They will have access to study protocol, statistical analysis plan, informed consent form, clinical study report and analytical code.

Data will also be stored on a server located in the Region of Southern Denmark. When the study is finished the data will be transferred to The Danish National Archives. Data are available upon reasonable request. Restrictions apply to the availability of data and approval is needed from Danish Data Protection Agency and or The Danish National Archives.

IPD Sharing Time Frame

The data is available for researchers from Aarhus University, center for psychological treatment of children and adolescents during and after the study is finished.

For other the data will become available after the study is finished

IPD Sharing Access Criteria

There have been made an data sharing agreement between Aarhus University, center for psychological treatment of children and adolescents and the region of southern Denmark, the agreement must be followed

Restrictions apply to the availability of data and approval is needed from Danish Data Protection Agency and or The Danish National Archives.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No