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CompletedNCT02306356Updated Jan 20, 2016

Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting

An interventional study of Internet-delivered Cognitive Behavior Therapy in Specific Phobia, Separation Anxiety and Generalized Anxiety Disorder, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2016-01-20.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
8 Years to 12 Years
Sex
All
01

Study summary

An open trial will be conducted at the Child and Mental Health Service (CAMHS) unit in the rural county Jämtland in Sweden to test the feasibility and efficacy of Internet-delivered Cognitive Behavior Therapy (ICBT) for children with anxiety disorders in a clinical setting. 20 children with a principal diagnosis of Generalized Anxiety Disorder (GAD), separation anxiety, specific phobia and their parents will be recruited from the CAMHS-center in Östersund. They will receive 12 weeks of therapist-supported ICBT and will be assessed by clinician ratings and child- and parent-reports at baseline, post-treatment and 3 month follow-up. The primary outcome measures the Clinical Global Impressions - Severity scale (CGI-S). Secondary outcome measures include clinician rated global functioning, and child and parent-rated anxiety and functioning.

02

Conditions studied

  • Specific Phobia
  • Separation Anxiety
  • Generalized Anxiety Disorder
03

In context

Phobia, Specific

85 studies on the registry are indexed under Phobia, Specific; 13 are open to participants now.

This study's planned enrollment of 20 is below the median of 74 across 81 interventional studies indexed under Phobia, Specific.

Browse Phobia, Specific studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 8-12 years of age
  • Fulfilling diagnostic criteria for Generalized Anxiety Disorder (GAD), Separation anxiety, Specific phobia
  • Ability to read and write Swedish
  • Daily access to the internet
  • A parent that is able to co-participate in the treatment
  • Participants on psychotropic medication must have been on a stable dose for the last 3 months prior to baseline assessment

Exclusion criteria

Exclusion Criteria:

  • Diagnosed autism spectrum disorder or Attention-deficit/hyperactivity disorder (ADHD), or principal primary disorder other than GAD, Separation anxiety, Specific phobia
  • Acute/severe psychiatric problems such as suicidal risk or severe depression
  • Ongoing psychological treatment for anxiety disorders
  • Ongoing child custody dispute or abuse in the family
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Interventional

    Behavioral: Internet-delivered Cognitive Behavior Therapy

    Behavioral: Internet-delivered Cognitive Behavior Therapy

Interventions

  • BehavioralInternet-delivered Cognitive Behavior Therapy
06

What researchers measure

Primary outcomes

  1. Change in Clinical Global Impressions - severity (CGI-S)

    Change in CGI-s from baseline to post-treatment and follow-up

    Time frame: baseline, post-treatment (12 weeks), follow-up (3 months)

Secondary outcomes

  1. Children´s Global Assessment Scale (CGAS

    Time frame: Baseline, post-treatment (12 weeks), follow-up (3 months)

  2. Spence Child Anxiety Scale C/P (SCAS-C/P)

    Time frame: Baseline, post-treatment (12 weeks), follow-up (3 months)

  3. Penn State Worry Questionnaire (PSWQ)

    Time frame: Baseline, post-treatment (12 weeks), follow-up (3 months)

  4. Separation Anxiety Index (SAI)

    Time frame: Baseline, post-treatment (12 weeks), follow-up (3 months)

  5. Fear Survey Schedule for Children - Revised (FSSC-R)

    Time frame: Baseline, post-treatment (12 weeks), follow-up (3 months)

  6. Child Sheehan Disability Scale (CSDS)

    Time frame: Baseline, post-treatment (12 weeks), follow-up (3 months)

  7. Child Depression Inventory (CDI)

    Time frame: Baseline, post-treatment (12 weeks), follow-up (3 months)

  8. Hospital Anxiety Depression Scale (HAD)

    Time frame: Baseline, post-treatment (12 weeks), follow-up (3 months)

  9. Client Satisfaction Scale (CSS)

    Time frame: post-treatment (12 weeks)

  10. Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)

    Time frame: Baseline, post-treatment (12 weeks), follow-up (3 months)

07

Study locations

1 site
  • Child and Adolescent Mental Health Services Östersund
    Östersund, Jämtland 83183, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02306356
Collaborators
BUP Östersund
Responsible party
Eva Serlachius (associate professor, Karolinska Institutet) — Principal investigator
First posted
Dec 3, 2014
Start date
Sep 2014
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Jan 20, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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