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

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02306356
• Other study ID #: 2014/1225-31/4
• Status: Completed
• Phase: N/A
• First received: September 27, 2014
• Last updated: January 18, 2016
• Start date: September 2014
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety, Separation
• Generalized Anxiety Disorder
• Separation Anxiety
• Specific Phobia

Intervention

Behavioral:
• Internet-delivered Cognitive Behavior Therapy

Locations

Country	Name	City	State
Sweden	Child and Adolescent Mental Health Services Östersund	Östersund	Jämtland

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	BUP Östersund

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinical Global Impressions - severity (CGI-S)	Change in CGI-s from baseline to post-treatment and follow-up	baseline, post-treatment (12 weeks), follow-up (3 months)	No
Secondary	Children´s Global Assessment Scale (CGAS		Baseline, post-treatment (12 weeks), follow-up (3 months)	No
Secondary	Spence Child Anxiety Scale C/P (SCAS-C/P)		Baseline, post-treatment (12 weeks), follow-up (3 months)	No
Secondary	Penn State Worry Questionnaire (PSWQ)		Baseline, post-treatment (12 weeks), follow-up (3 months)	No
Secondary	Separation Anxiety Index (SAI)		Baseline, post-treatment (12 weeks), follow-up (3 months)	No
Secondary	Fear Survey Schedule for Children - Revised (FSSC-R)		Baseline, post-treatment (12 weeks), follow-up (3 months)	No
Secondary	Child Sheehan Disability Scale (CSDS)		Baseline, post-treatment (12 weeks), follow-up (3 months)	No
Secondary	Child Depression Inventory (CDI)		Baseline, post-treatment (12 weeks), follow-up (3 months)	No
Secondary	Hospital Anxiety Depression Scale (HAD)		Baseline, post-treatment (12 weeks), follow-up (3 months)	No
Secondary	Client Satisfaction Scale (CSS)		post-treatment (12 weeks)	No
Secondary	Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)		Baseline, post-treatment (12 weeks), follow-up (3 months)	No