Clinical trial NCT06076954: Development, Feasibility and Acceptability of an iCBT Intervention for Adolescents With Anxiety
Official title: Development, Feasibility and Acceptability of an Internet-based Cognitive Behavioral (iCBT) Intervention for Adolescents With Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2023-10-11
Enrollment: 16
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: The Youth Online Diagnostic Assessment (YODA)
timeFrame: Pre-intervention, post-intervention (12 weeks after commencing treatment)
measure: Spence Children's Anxiety Scale (SCAS-C/P)
timeFrame: Pre-intervention, post-intervention (12 weeks after commencing treatment)
Secondary outcomes:
measure: Child Anxiety Life Interference Scale (CALIS)
timeFrame: Pre-intervention, post-intervention (12 weeks after commencing treatment)
measure: The Patient Health Questionnaire (PHQ-9)
timeFrame: Pre-intervention, post-intervention (12 weeks after commencing treatment)
Other outcomes:
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: Post-intervention (12 weeks after commencing treatment)
measure: EuroQol-5 Dimension Youth (EQ-5D-5L)
timeFrame: Pre-intervention, post-intervention (12 weeks after commencing treatment)
measure: Negative Effects Questionnaire (NEQ)
timeFrame: Post-intervention (12 weeks after commencing treatment)
measure: Systems Usability Scale (SUS)
timeFrame: Post-intervention (12 weeks after commencing treatment)
measure: Engagement with the program: Wordcount
timeFrame: Post-intervention (12 weeks after commencing treatment)
measure: Engagement with the program: number of logins
timeFrame: Post-intervention (12 weeks after commencing treatment)
measure: Engagement with the program: Time spent on feedback
timeFrame: Post-intervention (12 weeks after commencing treatment)
measure: Demography
timeFrame: Pre-intervention
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
state: Region Of Southern Denmark
Study officials:
affiliation: University of Southern Denmark
name: Kim Mathiasen, PhD
role: PRINCIPAL_INVESTIGATOR
References: