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

NCT ID: NCT06076954

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2023-07-30

Brief Summary

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.

Conditions

Anxiety Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Planned therapist feedback iCBT

Participants in the planned therapist feedback iCBT condition will receive the iCBT intervention with planned feedback after each completed module. The therapist may spend a max. of 15 minutes giving feedback per module.

Group Type: EXPERIMENTAL

CoolMinds

Intervention Type: BEHAVIORAL

CoolMinds consists of 11 adolescent sessions and 9 parent sessions to be completed simultaneously during a 14-week treatment period. The main components comprise psychoeducation, cognitive restructuring, exposure therapy, and relapse prevention. The parent program also comprises information on how to handle school absenteeism for parents and teachers or pedagogues. The intervention is mainly transdiagnostic within the anxiety disorders but also includes diagnosis specific modules and content allowing for more personalized treatment. The treatment is delivered via a telephone app but can also be accessed via computer.

On-demand therapist feedback iCBT

Participants in the on-demand therapist feedback iCBT condition will receive the intervention with on-demand feedback that is participant-initiated. The therapist may spend a max. of 15 minutes giving feedback per module.

Group Type: EXPERIMENTAL

CoolMinds

Intervention Type: BEHAVIORAL

CoolMinds consists of 11 adolescent sessions and 9 parent sessions to be completed simultaneously during a 14-week treatment period. The main components comprise psychoeducation, cognitive restructuring, exposure therapy, and relapse prevention. The parent program also comprises information on how to handle school absenteeism for parents and teachers or pedagogues. The intervention is mainly transdiagnostic within the anxiety disorders but also includes diagnosis specific modules and content allowing for more personalized treatment. The treatment is delivered via a telephone app but can also be accessed via computer.

Interventions

CoolMinds

CoolMinds consists of 11 adolescent sessions and 9 parent sessions to be completed simultaneously during a 14-week treatment period. The main components comprise psychoeducation, cognitive restructuring, exposure therapy, and relapse prevention. The parent program also comprises information on how to handle school absenteeism for parents and teachers or pedagogues. The intervention is mainly transdiagnostic within the anxiety disorders but also includes diagnosis specific modules and content allowing for more personalized treatment. The treatment is delivered via a telephone app but can also be accessed via computer.

Intervention Type: BEHAVIORAL

Other Intervention Names

Internet-based cognitive behavioral therapy; Technology-delivered cognitive behavioral therapy; iCBT

Eligibility Criteria

Inclusion Criteria

• Between 12 and 17 years of age
• Primary anxiety diagnosis
• Must have the ability to read and write Danish
• Must have Internet access
• Must have a parent able to participate in the treatment alongside the adolescent

Exclusion Criteria

• Specific phobia of blood-injection-injury type
• An autism spectrum disorder
• Psychotic symptoms
• Bipolar disorder
• Current suicidal ideation or self-mutilating behavior
• Current alcohol or substance abuse
• Moderate to severe depression
• Current eating disorder

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Southern Denmark

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kim Mathiasen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Locations

University of Southern Denmark

Odense, Region Syddanmark, Denmark

Countries

Denmark

References

Sorensen NM, Skaarnes H, Mathiasen K, McLellan LF, Thastum M, Lomholt JJ. Internet-based cognitive behavioral therapy (ICBT) for adolescents with anxiety disorders delivered with different types of therapist support: a randomized feasibility trial. Cogn Behav Ther. 2025 Jul 3:1-24. doi: 10.1080/16506073.2025.2522995. Online ahead of print.

Reference Type: DERIVED

PMID: 40607688 (View on PubMed)

Other Identifiers

CM1

Identifier Type: -

Identifier Source: org_study_id