Aarhus University
Aarhus, 8000, Denmark
NCT Number: NCT02535403
Cognitive behavioral therapy (CBT) is a well-documented and effective method for the treatment of children and adolescents with anxiety disorders. Lately there has been an increase in the development and use of internet-based CBT programs (ICBT), as a means to reduce costs and enhance accessibility of psychological interventions. ICBT has proven efficacious towards adults with anxiety disorders. Research in the field of ICBT with children and adolescents is still in its infancy though and to date, no program targeting anxiety disorders has been developed nor evaluated in Denmark. The primary objective of this study is to investigate the efficacy of a newly developed internet-based treatment program for adolescents with anxiety disorders. The effect will be examined in a randomized controlled trial comparing ICBT to a wait-list control condition.
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Notify Me13 year–17 year
All sexes
Interventional
Not applicable
Aarhus, 8000, Denmark
Within the context of a research and teaching clinic at the Department of Psychology and Behavioral Sciences, Aarhus University, Denmark, 70 adolescents aged 13-17 with a primary anxiety disorder as assessed by the ADIS C/P will be randomly allocated to either a 3 month wait-list control condition or a treatment condition.
The treatment consists of an internet-based self-help program for adolescents with anxiety disorders called 'Chilled Out', based on material from the well-established manualised group-treatment Cool Kids Program: Adolescent version. It consists of 8 CBT-inspired modules of approximately 30 minutes each distributed over a 14-week period. The program is interactive using a combination of different media (text, audio, illustrations, cartoons, and videos) to deliver psychoeducation and CBT-inspired techniques, activities and exercises for adolescents to manage their anxiety. In addition, the adolescent will receive a limited amount of therapist support calls.
Participants (youth and parents) are assessed with semi-structured diagnostic interviews and self-report measures before treatment, after 14 weeks (post treatment) and 3 months after treatment (follow-up).
Participants are assessed at pre, post and 3-month follow up.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All participants are asked not to make changes to their medication status during the course of the trial
Time frame: Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up
Measures clinician rated anxiety symptoms through Clinician Severity Rating (CSR)
Time frame: Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up
Measures self-rated youth anxiety symptoms
Time frame: Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up
Measures life interference and impairment associated with the anxiety disorder(s) as assessed by parents and youths
Time frame: Pre- (baseline) and post- (14 weeks) treatment
Measures youth self-efficacy
Time frame: Pre- (baseline) and post- (14 weeks) treatment
Measures youth depressive symptoms as assessed by parents and youths
Time frame: Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up
A short version of The World Health Organization Quality of Life questionnaire (WHOQOL) measuring youth quality of life
Time frame: Pre- (baseline) and post- (14 weeks) treatment
Measures youth strengths and difficulties as assessed by youths and parents
Time frame: Mid- (4 and 8 weeks) and post- (14 weeks) treatment
Measures the therapeutic alliance between youth and therapist
Time frame: Post- (14 weeks) treatment
Measures youths' and parents' satisfaction with the treatment
Time frame: Post- (14 weeks) treatment
Degree of program completion (number of completed modules)
Time frame: Post- (14 weeks) treatment
Total amount of log ins to the program
Time frame: Post- (14 weeks) treatment
Average time spent per week on program relevant activities (online)
Time frame: Post- (14 weeks) treatment
Average time spent per week on program relevant activities (offline)
Time frame: Post- (14 weeks) treatment
Parents' average time spent per week helping their child with program relevant activities (on- and offline)
University of Aarhus
Other
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