NCT01533402

Brief Summary

The purpose of this study is to investigate whether a 10 week Internet-delivered CBT is a feasible approach to treat children (age 8-12 years) with anxiety disorder (social phobia, panic disorder, specific phobia, generalized anxiety disorder or separation anxiety disorder). The program is directed toward both the parents and children. The patients work with the treatment is supported through on-line contact with a therapist. Approximately 128 patients will be included in the study and randomized to either condition. All included patients are assessed before the treatment starts and after 10 weeks (post treatment). Follow-up assessments are conducted at 3 and 12 months after treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

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

February 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

1.8 years

First QC Date

February 6, 2012

Last Update Submit

September 8, 2014

Conditions

Anxiety Disorders

Keywords

Cognitive behavior therapyInternetAnxiety disordersChildren

Outcome Measures

Primary Outcomes (1)

  • Anxiety symptoms

    Change from baseline in anxiety symptoms. Clinician Severity Rating (CSR) assessed by a clinician with Anxiety Diagnostic Interview Schedule (ADIS C/P).

    two - three weeks pre treatment and 10 weeks, 3 months and 12 months post treatment

Secondary Outcomes (11)

  • Anxiety symptoms

    two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment

  • Quality of Life

    two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment

  • comorbidity

    two - four weeks before treatment starts

  • Depressive symptoms

    two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment

  • Funtional impairment

    two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment

  • +6 more secondary outcomes

Study Arms (2)

Attention control

PLACEBO COMPARATOR

Weekly support from therapist without CBT-interventions

Behavioral: therapist support

Internet CBT

EXPERIMENTAL

Internet-delivered cognitive behavioural therapy with therapy support

Behavioral: Internet-delivered CBT

Interventions

therapist supportBEHAVIORAL

Weekly therapist support without CBT-interventions

Attention control
Internet-delivered CBTBEHAVIORAL

Internet-delivered cognitive behavioural therapy with therapist support

Internet CBT

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • primary diagnosis of social phobia, panic disorder, specific phobia, generalized anxiety disorder or separation anxiety disorder,
  • age between 8 and 12 years,
  • ability to read and write Swedish and
  • with access to a computer and use of internet.

You may not qualify if:

  • Presence of neuropsychiatric diagnosis or a primary psychiatric disorder other than those that the treatment aims at.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barn-och ungdomspsykiatrin, Stockholm

Stockholm, 118 91, Sweden

Location

Related Publications (2)

  • Vigerland S, Serlachius E, Thulin U, Andersson G, Larsson JO, Ljotsson B. Long-term outcomes and predictors of internet-delivered cognitive behavioral therapy for childhood anxiety disorders. Behav Res Ther. 2017 Mar;90:67-75. doi: 10.1016/j.brat.2016.12.008. Epub 2016 Dec 14.

    PMID: 28012300DERIVED

  • Vigerland S, Ljotsson B, Thulin U, Ost LG, Andersson G, Serlachius E. Internet-delivered cognitive behavioural therapy for children with anxiety disorders: A randomised controlled trial. Behav Res Ther. 2016 Jan;76:47-56. doi: 10.1016/j.brat.2015.11.006. Epub 2015 Nov 19.

    PMID: 26649465DERIVED

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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD, PhD

Study Record Dates

First Submitted

February 6, 2012

First Posted

February 15, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2013

Study Completion

April 1, 2014

Last Updated

September 9, 2014

Record last verified: 2014-09

Locations

SE(1)