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

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
ICBT
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ICBT

Wait-list

Arm Description

14 weeks of internet-based cognitive behavioral therapy with therapist support

14 weeks wait-list control

Outcomes

Primary Outcome Measures

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)
Change in Spence Child Anxiety Scale (SCAS-C/P)
Measures self-rated youth anxiety symptoms

Secondary Outcome Measures

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
Change in Self-Efficacy Questionnaire for Children (SEQ-c)
Measures youth self-efficacy
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
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
Change in Strength and Difficulties Questionnaire for Youth (SDQ)
Measures youth strengths and difficulties as assessed by youths and parents
Change in Working Alliance Inventory - Short form (WAI-S)
Measures the therapeutic alliance between youth and therapist
Experience of Service Questionnaire (ESQ)
Measures youths' and parents' satisfaction with the treatment
Adherence to the program I
Degree of program completion (number of completed modules)
Adherence to the program II
Total amount of log ins to the program
Adherence to the program III
Average time spent per week on program relevant activities (online)
Adherence to the program IV
Average time spent per week on program relevant activities (offline)
Parent support
Parents' average time spent per week helping their child with program relevant activities (on- and offline)

Full Information

First Posted
August 21, 2015
Last Updated
January 26, 2017
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT02535403
Brief Title
Internet-based Cognitive Behavioral Therapy (CBT) for Adolescents With Anxiety Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICBT
Arm Type
Experimental
Arm Description
14 weeks of internet-based cognitive behavioral therapy with therapist support
Arm Title
Wait-list
Arm Type
No Intervention
Arm Description
14 weeks wait-list control
Intervention Type
Behavioral
Intervention Name(s)
ICBT
Primary Outcome Measure Information:
Title
Change in The Anxiety Disorder Interview Schedule for DSM-IV, Parent and Child Versions (ADIS-IV c/p)
Description
Measures clinician rated anxiety symptoms through Clinician Severity Rating (CSR)
Time Frame
Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up
Title
Change in Spence Child Anxiety Scale (SCAS-C/P)
Description
Measures self-rated youth anxiety symptoms
Time Frame
Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up
Secondary Outcome Measure Information:
Title
Change in Children's Anxiety Life Inference Scale (CALIS)
Description
Measures life interference and impairment associated with the anxiety disorder(s) as assessed by parents and youths
Time Frame
Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up
Title
Change in Self-Efficacy Questionnaire for Children (SEQ-c)
Description
Measures youth self-efficacy
Time Frame
Pre- (baseline) and post- (14 weeks) treatment
Title
Change in the Short version of the Mood and Feelings Questionnaire (S-MFQ-c/p)
Description
Measures youth depressive symptoms as assessed by parents and youths
Time Frame
Pre- (baseline) and post- (14 weeks) treatment
Title
Change in WHO Quality of Life (5 items)
Description
A short version of The World Health Organization Quality of Life questionnaire (WHOQOL) measuring youth quality of life
Time Frame
Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up
Title
Change in Strength and Difficulties Questionnaire for Youth (SDQ)
Description
Measures youth strengths and difficulties as assessed by youths and parents
Time Frame
Pre- (baseline) and post- (14 weeks) treatment
Title
Change in Working Alliance Inventory - Short form (WAI-S)
Description
Measures the therapeutic alliance between youth and therapist
Time Frame
Mid- (4 and 8 weeks) and post- (14 weeks) treatment
Title
Experience of Service Questionnaire (ESQ)
Description
Measures youths' and parents' satisfaction with the treatment
Time Frame
Post- (14 weeks) treatment
Title
Adherence to the program I
Description
Degree of program completion (number of completed modules)
Time Frame
Post- (14 weeks) treatment
Title
Adherence to the program II
Description
Total amount of log ins to the program
Time Frame
Post- (14 weeks) treatment
Title
Adherence to the program III
Description
Average time spent per week on program relevant activities (online)
Time Frame
Post- (14 weeks) treatment
Title
Adherence to the program IV
Description
Average time spent per week on program relevant activities (offline)
Time Frame
Post- (14 weeks) treatment
Title
Parent support
Description
Parents' average time spent per week helping their child with program relevant activities (on- and offline)
Time Frame
Post- (14 weeks) treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Aarhus University
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
31532802
Citation
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.
Results Reference
derived

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

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