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

Not Applicable

Completed

• Conditions: Anxiety Disorder; Obsessive-Compulsive Disorder
• Interventions: Behavioral: ICBT

• Registration Number: NCT02926365
• Lead Sponsor: Karolinska Institutet

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2016-09-20
• Study Start: 2016-10-01
• Study First Submitted QC: 2016-10-05
• Study First Posted: 2016-10-06
• Primary Completion: 2019-04
• Study Completion: 2022-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-05
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICBT	ICBT	Therapist-supported internet-delivered CBT

Primary Outcome Measures

Name	Time	Method
CGI-S	24 weeks from baseline	Clinical Global Impression - Severity

Secondary Outcome Measures

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

Trial Locations

Locations (1)

BUP Jämtland Härjedalen; 🇸🇪 Östersund, Region Jämtland Härjedalen, Sweden