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Clinical Trials/NCT02926365
NCT02926365
Completed
N/A

Increased Access to Psychological Treatment for Children and Adolescents Through Internet-delivered CBT - a Pragmatic Evaluation Within Regular Health Care in a Rural Area of Sweden

Karolinska Institutet1 site in 1 country83 target enrollmentOctober 1, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety Disorder
Sponsor
Karolinska Institutet
Enrollment
83
Locations
1
Primary Endpoint
CGI-S
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to test internet-delivered cognitive behavior therapy for children and adolescents with anxiety disorders and obsessive-compulsive disorder in a routine clinical setting in a rural part of Sweden.

Detailed Description

Aim The aim of this study is to conduct a pragmatic evaluation of ICBT for children and adolescents with anxiety disorders and OCD within routine health care in a rural area. Research questions * Is ICBT an acceptable method for the patient group? * Is ICBT effective in a clinical setting? * Is further treatment needed after ICBT? * What are the long-term effects of ICBT? * What predicts treatment outcome? * How does ICBT work in a clincal setting? (time spent, negative effects etc)? Design This is a uncontrolled intervention study where included families and children will be recruited consecutively during two years from a routine care CAMHS unit. All participants will be offered ICBT and assessed pre- and post-treatment, and at three-month follow-up through clinician ratings and self-report measures. The primary outcome measure is clinician rated severity of principal disorder at three-month follow-up. Long-term results will be assessed through study of medical records two years after completed ICBT.

Registry
clinicaltrials.gov
Start Date
October 1, 2016
End Date
December 2022
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sarah Vigerland

PhD

Karolinska Institutet

Eligibility Criteria

Inclusion Criteria

  • Fulfills diagnostic criteria for an anxiety disorder or OCD
  • Access to a computer and internet connection
  • Read and speak Swedish

Exclusion Criteria

  • ICBT is currently not assessed to be a suitable treatment
  • Acute psychiatric problem (eg. severe depression or suicidality)
  • Current psychosocial problems in the family (i.e substance abuse, abuse, neglect)

Outcomes

Primary Outcomes

CGI-S

Time Frame: 24 weeks from baseline

Clinical Global Impression - Severity

Secondary Outcomes

  • Patient satisfaction(12 weeks from baseline)
  • CGI-S(12 weeks from baseline)
  • CGI-I(12 and 24 weeks from baseline)
  • RCADS(12 and 24 weeks from baseline)
  • CY-BOCS(12 and 24 weeks from baseline)
  • CGAS(12 and 24 weeks from baseline)
  • EWSAS(Week 1 through 12 + 24 weeks from baseline)
  • Adverse events(12 weeks from baseline)

Study Sites (1)

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