Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 21, 2015
First Posted Date  ICMJE August 28, 2015
Last Update Posted Date January 27, 2017
Study Start Date  ICMJE August 2015
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2015)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2015)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Internet-based Cognitive Behavioral Therapy (CBT) for Adolescents With Anxiety Disorders
Official Title  ICMJE Not Provided
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anxiety Disorders
Intervention  ICMJE Behavioral: ICBT
Study Arms  ICMJE
  • Experimental: ICBT
    14 weeks of internet-based cognitive behavioral therapy with therapist support
    Intervention: Behavioral: ICBT
  • No Intervention: Wait-list
    14 weeks wait-list control
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2015)
70
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02535403
Other Study ID Numbers  ICMJE Chilled Out DK
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Aarhus
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP