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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
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief 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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Behavioral: ICBT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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



Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

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


Locations
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Denmark
Aarhus University
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02535403    
Other Study ID Numbers: Chilled Out DK
First Posted: August 28, 2015    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders