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

Obsessive-Compulsive Disorder Clinical Trial

— BIPBJÖRN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02926365
• Other study ID #: EPN DNR 2016/1355-31/5
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: December 2022

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 2022
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• ICBT

Locations

Country	Name	City	State
Sweden	BUP Jämtland Härjedalen	Östersund	Region Jämtland Härjedalen

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

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