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Completed

NCT Number: NCT02306356

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

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.

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Key information

Conditions

Specific Phobia Anxiety Disorders Anxiety, Separation Generalized Anxiety Disorder Mental Disorders Neurodevelopmental Disorders Phobia, Specific Separation Anxiety

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Child and Adolescent Mental Health Services Östersund

Östersund, Jämtland County, 83183, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Internet-delivered Cognitive Behavior Therapy

Behavioral

Primary outcomes

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

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

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

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)

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • BUP Östersund

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 3, 2014
Registry last updated
Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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