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

NCT ID: NCT02306356

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-10-31

Brief 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.

Conditions

Specific Phobia; Separation Anxiety; Generalized Anxiety Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional

Behavioral: Internet-delivered Cognitive Behavior Therapy

Group Type: EXPERIMENTAL

Internet-delivered Cognitive Behavior Therapy

Intervention Type: BEHAVIORAL

Interventions

Internet-delivered Cognitive Behavior Therapy

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BUP Östersund

UNKNOWN

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Eva Serlachius

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Child and Adolescent Mental Health Services Östersund

Östersund, Jämtland County, Sweden

Countries

Sweden

Other Identifiers

2014/1225-31/4

Identifier Type: -

Identifier Source: org_study_id