protocolSection identificationModule nctId: NCT06368557, orgStudyIdInfo id: 22/59602, briefTitle: Internet-based Cognitive Behavioral Intervention for Adolescents With Anxiety Disorders, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-10, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Region of Southern Denmark, class: OTHER, collaborators name: University of Aarhus, descriptionModule briefSummary: 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 theDiagnostic 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., conditionsModule conditions: Anxiety Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: The RCT is designed as a superiority RCT 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 upon completing session 8 in the program, participants will be randomized to receive or not receive a booster session 12 weeks after finishing the intervention with an allocation ratio of 1:1. The design of the randomized trial is thus factorial including two factors: type of therapist feedback (factor 1) and booster or no booster (factor 2). Data will be collected with parent and adolescent questionnaires at five time points: pre-treatment, post-treatment and at follow-ups after 3, 6 and 12 months., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: As the study concerns itself with psychotherapy and examines the difference in therapist support, it is practically impossible to blind participants and clinicians, and thus they are not blinded. The research team is involved in the day-to-day operation of the project, including the screening for suicidality, why blinding of the research team is also practically impossible with the current setup. However the analyzes of the trial results will be pseudo-anonymized, so that only the ID number appears on the data sheet in order to get as close to blinding as possible in relation to the research design., enrollmentInfo count: 168, type: ESTIMATED, armsInterventionsModule interventions name: CoolMinds: Internet-based cognitive behavioral therapy (iCBT), outcomesModule primaryOutcomes measure: The Youth Online Diagnostic Assessment - Child and Parent Versions, primaryOutcomes measure: Spence Children's Anxiety Scale- Child and Parent Versions, secondaryOutcomes measure: Child Anxiety Life Interference Scale- Child and Parent Version, secondaryOutcomes measure: The Mood and Feelings Questionnaire- Child and Parent Version, secondaryOutcomes measure: Working Alliance Inventory - Short Form, secondaryOutcomes measure: Working Alliance Inventory for Online Interventions, otherOutcomes measure: Children´s Anxiety Scale, otherOutcomes measure: The Short Mood and Feelings questionnaire, otherOutcomes measure: EuroQol-5 Dimension Youth, otherOutcomes measure: Client Satisfaction Questionnaire-8, otherOutcomes measure: Systems Usability Scale, otherOutcomes measure: Negative Effects Questionnaire, otherOutcomes measure: Sociodemographic measures, otherOutcomes measure: Engagement, otherOutcomes measure: Cost-effectiveness, otherOutcomes measure: Cost-effectiveness, otherOutcomes measure: The Anxiety Disorders Interview Schedule for Children, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Centre for Digital Psychiatry, status: RECRUITING, city: Odense, state: Region Of Southern Denmark, zip: 5000, country: Denmark, contacts name: Helene Skaarnes, MSc (psych)), role: CONTACT, phone: +4529649702, email: helene.skaarnes@rsyd.dk, contacts name: Kim Mathiasen, Ph.d., role: CONTACT, phone: +4561677747, email: kmathiasen@health.sdu.dk, geoPoint lat: 55.39594, lon: 10.38831, hasResults: False