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Completed

NCT Number: NCT02535403

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.

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Key information

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICBT

Behavioral

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. 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

  2. Change in Self-Efficacy Questionnaire for Children (SEQ-c)

    Time frame: Pre- (baseline) and post- (14 weeks) treatment

    Measures youth self-efficacy

  3. 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

  4. 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

  5. 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

  6. 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

  7. Experience of Service Questionnaire (ESQ)

    Time frame: Post- (14 weeks) treatment

    Measures youths' and parents' satisfaction with the treatment

  8. Adherence to the program I

    Time frame: Post- (14 weeks) treatment

    Degree of program completion (number of completed modules)

  9. Adherence to the program II

    Time frame: Post- (14 weeks) treatment

    Total amount of log ins to the program

  10. Adherence to the program III

    Time frame: Post- (14 weeks) treatment

    Average time spent per week on program relevant activities (online)

  11. Adherence to the program IV

    Time frame: Post- (14 weeks) treatment

    Average time spent per week on program relevant activities (offline)

  12. Parent support

    Time frame: Post- (14 weeks) treatment

    Parents' average time spent per week helping their child with program relevant activities (on- and offline)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 28, 2015
Registry last updated
Jan 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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