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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders
• Intervention / Treatment: Behavioral: ICBT

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICBT; 14 weeks of internet-based cognitive behavioral therapy with therapist support	Behavioral: ICBT
No Intervention: Wait-list; 14 weeks wait-list control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in Self-Efficacy Questionnaire for Children (SEQ-c)	Measures youth self-efficacy	Pre- (baseline) and post- (14 weeks) treatment
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
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
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
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
Experience of Service Questionnaire (ESQ)	Measures youths' and parents' satisfaction with the treatment	Post- (14 weeks) treatment
Adherence to the program I	Degree of program completion (number of completed modules)	Post- (14 weeks) treatment
Adherence to the program II	Total amount of log ins to the program	Post- (14 weeks) treatment
Adherence to the program III	Average time spent per week on program relevant activities (online)	Post- (14 weeks) treatment
Adherence to the program IV	Average time spent per week on program relevant activities (offline)	Post- (14 weeks) treatment
Parent support	Parents' average time spent per week helping their child with program relevant activities (on- and offline)	Post- (14 weeks) treatment

Collaborators and Investigators

• Sponsor: University of Aarhus

Publications and helpful links

General Publications

• Stjerneklar S, Hougaard E, McLellan LF, Thastum M. A randomized controlled trial examining the efficacy of an internet-based cognitive behavioral therapy program for adolescents with anxiety disorders. PLoS One. 2019 Sep 18;14(9):e0222485. doi: 10.1371/journal.pone.0222485. eCollection 2019.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: August 21, 2015
• First Submitted That Met QC Criteria: August 25, 2015
• First Posted (Estimate): August 28, 2015

Study Record Updates

• Last Update Posted (Estimate): January 27, 2017
• Last Update Submitted That Met QC Criteria: January 26, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Chilled Out DK