NCT02535403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

August 21, 2015

Last Update Submit

January 26, 2017

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

  • Change in Children's Anxiety Life Inference Scale (CALIS)

    Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up

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

    Pre- (baseline) and post- (14 weeks) treatment

  • Change in the Short version of the Mood and Feelings Questionnaire (S-MFQ-c/p)

    Pre- (baseline) and post- (14 weeks) treatment

  • Change in WHO Quality of Life (5 items)

    Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up

  • Change in Strength and Difficulties Questionnaire for Youth (SDQ)

    Pre- (baseline) and post- (14 weeks) treatment

  • +7 more secondary outcomes

Study Arms (2)

ICBT

EXPERIMENTAL

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

Behavioral: ICBT

Wait-list

NO INTERVENTION

14 weeks wait-list control

Interventions

ICBTBEHAVIORAL
ICBT

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 31532802DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2015

First Posted

August 28, 2015

Study Start

August 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

January 27, 2017

Record last verified: 2017-01

Locations

DK(1)