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

University of Aarhus

Status: Completed

Conditions: Anxiety Disorders

Treatments: Behavioral: CoolMinds

Study type: Interventional

Funder types: Other

Identifiers

NCT06076954

CM1

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Planned therapist feedback iCBT

Experimental group

Description:

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.

Treatment:

Behavioral: CoolMinds

On-demand therapist feedback iCBT

Experimental group

Description:

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.

Treatment:

Behavioral: CoolMinds