Short summary

CoolMinds is an iCBT intervention, based on cognitive behavioral therapy for adolescents. The program consists of eleven sessions for the adolescent and nine sessions for the parents to be completed simultaneously over a twelve-week period. This study examine the effectivness of CoolMinds, on adolescents with a principal anxiety diagnosis.

Rationale

Anxiety disorders are the most prevalent mental health conditions among children and adolescents. However, it is estimated that less than 25% of all children and adolescents with an anxiety disorder receive professional help. Thus, it is of utmost importance to develop novel interventions that aim to increase treatment accessibility.

The aim of this study is threefold, to determine the effectiveness of CoolMinds, an iCBT intervention for adolescents with anxiety disorders. In addition to investigate predictive factors and the networks between symptoms, severity and change from pre- to post- treatment.

The study is designed as a three-armed randomized controlled trial comparing iCBT with planned feedback, iCBT with on-demand help and a waitlist control, with 56 patients in each group. The participants in the two treatment conditions will receive 12 weeks of iCBT, while participants in the waitlist control wait for 12 weeks, before receiving iCBT with planned feedback. The participants in the two iCBT conditions will be randomized to get a booster session or not, 12 weeks after finishing treatment. The participants are adolescents between the age of 12 and 17 years and their parents. The families must live in the Region of Southern Denmark, and the adolescents must have a principal anxiety diagnosis according to DSM-5 criteria. The primary outcome measure are the Youth Online Diagnostic Assessment - child and parent versions. Outcomes will be evaluated at baseline, post-treatment and at the 3-, 6- and 12-month follow-ups. Symptoms of anxiety and depression are also measured between each session with PHQ-9 and CAS-8.

Description of the cohort

Participants are adolescents between the age of 12 and 17 years with a principal anxiety diagnosis according to DSM-5 criteria. Participants are recruited through self-referral and referral from health specialists within the Region of Southern Denmark.

Data and biological material

Questionnaire data.

Primary outcome measures:

The Youth Online Diagnostic Assessment (YODA) - Child and Parent Versions (McLellan et al., 2021).

Secondary outcome measures:

Spence Children's Anxiety Scale (SCAS-C/P) (Spence, 1998).

Child Anxiety Life Interference Scale (CALIS) (Lyneham et al., 2013).

The Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2001).

4.2.2.3. Weekly outcome measures:

The short version of Spence Children's Anxiety Scale (S-SCAS-C/P) (Ahlen, Vigerland, & Ghaderi, 2018).

The Patient Health Questionnaire (PHQ-9) (Kroenke et al., 2001).

Other measures:

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

Client Satisfaction Questionnaire-8 (CSQ-8) (Larsen, Attkisson, Hargreaves, & Nguyen, 1979).

Systems Usability Scale (SUS) (Brooke, 1996).

Negative Effects Questionnaire (NEQ) (Rozental et al., 2019).

Collaborating researchers and departments

Center for Psychological Treatment of Children and Adolescents, Aarhus university

• Associate Professor, PhD, MSc (Psych) Johanne Jeppesen Lomholt
• Professor Mikael Thastum
• MSc (Psych) Nikita Marie Sørensen

Research Unit for Digital Psychiatry, Department of Clinical Research, University of Southern Denmark, Odense, Denmark

• Associate Professor, PhD, MSc (Psych) Kim Mathiasen