Internet-based Cognitive Behavioral Therapy (CBT) for Adolescents With Anxiety Disorders
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|ClinicalTrials.gov Identifier: NCT02535403|
Recruitment Status : Completed
First Posted : August 28, 2015
Last Update Posted : January 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Disorders||Behavioral: ICBT||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
14 weeks of internet-based cognitive behavioral therapy with therapist support
No Intervention: Wait-list
14 weeks wait-list control
- Change in The Anxiety Disorder Interview Schedule for DSM-IV, Parent and Child Versions (ADIS-IV c/p) [ Time Frame: Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up ]Measures clinician rated anxiety symptoms through Clinician Severity Rating (CSR)
- Change in Spence Child Anxiety Scale (SCAS-C/P) [ Time Frame: Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up ]Measures self-rated youth anxiety symptoms
- Change in Children's Anxiety Life Inference Scale (CALIS) [ 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
- Change in Self-Efficacy Questionnaire for Children (SEQ-c) [ Time Frame: Pre- (baseline) and post- (14 weeks) treatment ]Measures youth self-efficacy
- Change in the Short version of the Mood and Feelings Questionnaire (S-MFQ-c/p) [ Time Frame: Pre- (baseline) and post- (14 weeks) treatment ]Measures youth depressive symptoms as assessed by parents and youths
- Change in WHO Quality of Life (5 items) [ 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
- Change in Strength and Difficulties Questionnaire for Youth (SDQ) [ Time Frame: Pre- (baseline) and post- (14 weeks) treatment ]Measures youth strengths and difficulties as assessed by youths and parents
- Change in Working Alliance Inventory - Short form (WAI-S) [ Time Frame: Mid- (4 and 8 weeks) and post- (14 weeks) treatment ]Measures the therapeutic alliance between youth and therapist
- Experience of Service Questionnaire (ESQ) [ Time Frame: Post- (14 weeks) treatment ]Measures youths' and parents' satisfaction with the treatment
- Adherence to the program I [ Time Frame: Post- (14 weeks) treatment ]Degree of program completion (number of completed modules)
- Adherence to the program II [ Time Frame: Post- (14 weeks) treatment ]Total amount of log ins to the program
- Adherence to the program III [ Time Frame: Post- (14 weeks) treatment ]Average time spent per week on program relevant activities (online)
- Adherence to the program IV [ Time Frame: Post- (14 weeks) treatment ]Average time spent per week on program relevant activities (offline)
- Parent support [ Time Frame: Post- (14 weeks) treatment ]Parents' average time spent per week helping their child with program relevant activities (on- and offline)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02535403
|Aarhus, Denmark, 8000|