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

NCT06076954 | Completed DMC

• 1 other identifier: CM1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• The Youth Online Diagnostic Assessment (YODA)

  An online diagnostic assessment tool that assesses DSM-5 anxiety disorders and specific phobias. Each present diagnosis is assigned a clinician-rated severity score ranging from 0 (minimal/absent) to 4 (pervasive). Typically subclinical disorders would receive a rating of 0 or 1, and clinical disorders a rating of 1 to 4.

  Pre-intervention, post-intervention (12 weeks after commencing treatment)

• Spence Children's Anxiety Scale (SCAS-C/P)

  A 44-item self-report questionnaire assessing anxiety symptoms of six different anxiety disorders in DSM-IV: generalized anxiety, panic/agoraphobia, social phobia, separation anxiety, obsessive compulsive disorder and physical injury fears. Symptoms are rated on a 4-point frequency scale ranging from 0 (never) to 3 (always) (min. = 0; max. = 114). A higher score indicates increased symptom severity. The Danish version has demonstrated good psychometric properties

  Pre-intervention, post-intervention (12 weeks after commencing treatment)

Secondary Outcomes (2)

• Child Anxiety Life Interference Scale (CALIS)

  Pre-intervention, post-intervention (12 weeks after commencing treatment)

• The Patient Health Questionnaire (PHQ-9)

  Pre-intervention, post-intervention (12 weeks after commencing treatment)

Other Outcomes (8)

• Client Satisfaction Questionnaire-8 (CSQ-8)

  Post-intervention (12 weeks after commencing treatment)

• EuroQol-5 Dimension Youth (EQ-5D-5L)

  Pre-intervention, post-intervention (12 weeks after commencing treatment)

• Negative Effects Questionnaire (NEQ)

  Post-intervention (12 weeks after commencing treatment)

Study Arms (2)

Planned therapist feedback iCBT

EXPERIMENTAL

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.

Behavioral: CoolMinds

On-demand therapist feedback iCBT

EXPERIMENTAL

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.

Behavioral: CoolMinds

Interventions

CoolMinds 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.

Also known as: Internet-based cognitive behavioral therapy, Technology-delivered cognitive behavioral therapy, iCBT

On-demand therapist feedback iCBT; Planned therapist feedback iCBT

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• University of Southern Denmark: collaborator

Study Sites (1)

University of Southern Denmark

Odense, Region Syddanmark, 5000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 40607688 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Kim Mathiasen, PhD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 11, 2023
• Study Start: December 15, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)