NCT06076954

Development, Feasibility and Acceptability of an iCBT Intervention for Adolescents With Anxiety

Completed NA Last updated 11 October 2023

What this trial tests

NA trial testing CoolMinds in Anxiety Disorders in 16 participants. Completed in 30 July 2023.

Timeline

15 December 2022

Primary endpoint
30 June 2023

30 July 2023

Quick facts

Lead sponsor	University of Aarhus
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	16
Start date	15 December 2022
Primary completion	30 June 2023
Estimated completion	30 July 2023
Sites	1 location across Denmark

Drugs / interventions tested

• CoolMinds

Conditions studied

• Anxiety Disorders — all drugs for Anxiety Disorders →

Sponsor

University of Aarhus

Who can join

Adults 12 to 17, any sex, with Anxiety Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of the feasibility study is twofold: 1) to test the feasibility of the study design, and 2) to test the preliminary efficacy and the acceptability of a new iCBT intervention when delivered with different levels of therapist support. The feasibility trial will provide important information on the initial participant responses, and on how to properly collect data in the subsequent RCT.

The feasibility trial is conducted as a randomized study with 16 participants consisting of two conditions: 1) guided iCBT, and 2) on-demand iCBT, both to be completed over a 14-week period. Participants in the guided iCBT condition will receive the new iCBT intervention with planned feedback after each completed module. Participants in the on-demand iCBT condition will receive the intervention with on-demand feedback that is participant-initiated. In both conditions, the therapist may spend a max. of 15 minutes giving feedback per module. As there is no evidence on what amount of therapist support is sufficient for adolescents, the allowed time spent giving feedback will not differ between the two conditions in the feasibility trial. Thus, data on engagement will be collected to inform how the two treatment conditions differ. The trial includes data points at pre-treatment (T1) and post-treatment (T2) where the same measures will be administered as are planned in the RCT.

Acceptability of the intervention will be investigated by conducting semi-structured interviews with the participants. The interview will include an evaluation of the intervention, client satisfaction and potential reasons for drop out.

The results from the feasibility trial will be used to inform the subsequent RCT and to revise the intervention, procedures, and conditions if needed.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Internet-based cognitive behavioral therapy (ICBT) for adolescents with anxiety disorders delivered with different types of therapist support: a randomized feasibility trial.
   Sørensen NM, Skaarnes H, Mathiasen K, McLellan LF, et al · · 2025 · PMID 40607688 · DOI 10.1080/16506073.2025.2522995