BIP in Jämtland Härjedalen: Increased Access to CBT Within Regular Health Care in Northern Sweden (BIPBJÖRN)

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

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.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder; Anxiety Disorder
• Intervention / Treatment: Behavioral: ICBT

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Region Jämtland Härjedalen
    • Östersund, Region Jämtland Härjedalen, Sweden
      • BUP Jämtland Härjedalen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICBT; Therapist-supported internet-delivered CBT	Behavioral: ICBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGI-S	Clinical Global Impression - Severity	24 weeks from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGI-S	Clinical Global Impression - Severity	12 weeks from baseline
CGI-I	Clinical Global Impression - Improvement	12 and 24 weeks from baseline
CGAS	Children's Global Assessment Scale	12 and 24 weeks from baseline
CY-BOCS	Children's Yale Brown Obsessive Compulsive Scale	12 and 24 weeks from baseline
RCADS	Revised Children's Anxiety and Depression Scale	12 and 24 weeks from baseline
EWSAS	Education, Work and Social Adjustment Scale - Child and parent versions	Week 1 through 12 + 24 weeks from baseline
Patient satisfaction	Questionnaire on child- and parent rated treatment satisfaction	12 weeks from baseline
Adverse events	Unintended treatment effects - child and parent version	12 weeks from baseline

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Eva Serlachius, Med Dr, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: September 20, 2016
• First Submitted That Met QC Criteria: October 5, 2016
• First Posted (Estimated): October 6, 2016

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Obsessive-Compulsive Disorder; Anxiety Disorders
• Other Study ID Numbers: EPN DNR 2016/1355-31/5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No such plan exists at the moment