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Internet-based Cognitive Behavioral Intervention for Adolescents With Anxiety Disorders

NCT06368557 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2024-04-16

No results posted yet for this study

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.

Conditions

  • Anxiety Disorders

Interventions

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.

Sponsors & Collaborators

  • University of Aarhus

    collaborator OTHER

  • Region of Southern Denmark

    lead OTHER

Principal Investigators

  • Kim Mathiasen, P.hd · Region of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-10
Primary Completion
2025-03-31
Completion
2025-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06368557 on ClinicalTrials.gov