Internet-based Cognitive Behavioral Therapy (CBT) for Adolescents With Anxiety Disorders

Anxiety Disorders Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535403
• Other study ID #: Chilled Out DK
• Status: Completed
• Phase: N/A
• First received: August 21, 2015
• Last updated: January 26, 2017
• Start date: August 2015
• Est. completion date: July 2016

Study information

• Verified date: January 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• a primary diagnosis of separation anxiety disorder, generalized anxiety disorder, social phobia, specific phobia, obsessive compulsive disorder or panic disorder

• age between 13 and 17 years

• ability to read and write in Danish

• direct access to a home computer and internet

Exclusion Criteria:

• high degree of comorbid depression (CSR above 5 as measured with ADIS-IV)

• substance abuse

• current self-harm or suicidal ideation

• pervasive developmental disorder

• learning disorder

• intellectual disability

• psychotic symptoms

All participants are asked not to make changes to their medication status during the course of the trial

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• ICBT

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in The Anxiety Disorder Interview Schedule for DSM-IV, Parent and Child Versions (ADIS-IV c/p)	Measures clinician rated anxiety symptoms through Clinician Severity Rating (CSR)	Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up
Primary	Change in Spence Child Anxiety Scale (SCAS-C/P)	Measures self-rated youth anxiety symptoms	Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up
Secondary	Change in Children's Anxiety Life Inference Scale (CALIS)	Measures life interference and impairment associated with the anxiety disorder(s) as assessed by parents and youths	Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up
Secondary	Change in Self-Efficacy Questionnaire for Children (SEQ-c)	Measures youth self-efficacy	Pre- (baseline) and post- (14 weeks) treatment
Secondary	Change in the Short version of the Mood and Feelings Questionnaire (S-MFQ-c/p)	Measures youth depressive symptoms as assessed by parents and youths	Pre- (baseline) and post- (14 weeks) treatment
Secondary	Change in WHO Quality of Life (5 items)	A short version of The World Health Organization Quality of Life questionnaire (WHOQOL) measuring youth quality of life	Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up
Secondary	Change in Strength and Difficulties Questionnaire for Youth (SDQ)	Measures youth strengths and difficulties as assessed by youths and parents	Pre- (baseline) and post- (14 weeks) treatment
Secondary	Change in Working Alliance Inventory - Short form (WAI-S)	Measures the therapeutic alliance between youth and therapist	Mid- (4 and 8 weeks) and post- (14 weeks) treatment
Secondary	Experience of Service Questionnaire (ESQ)	Measures youths' and parents' satisfaction with the treatment	Post- (14 weeks) treatment
Secondary	Adherence to the program I	Degree of program completion (number of completed modules)	Post- (14 weeks) treatment
Secondary	Adherence to the program II	Total amount of log ins to the program	Post- (14 weeks) treatment
Secondary	Adherence to the program III	Average time spent per week on program relevant activities (online)	Post- (14 weeks) treatment
Secondary	Adherence to the program IV	Average time spent per week on program relevant activities (offline)	Post- (14 weeks) treatment
Secondary	Parent support	Parents' average time spent per week helping their child with program relevant activities (on- and offline)	Post- (14 weeks) treatment