BIP in Jämtland Härjedalen: Increased Access to CBT Within Regular Health Care in Northern Sweden (BIPBJÖRN)
Primary Purpose
Anxiety Disorder, Obsessive-Compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
ICBT
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorder
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)
Sites / Locations
- BUP Jämtland Härjedalen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ICBT
Arm Description
Therapist-supported internet-delivered CBT
Outcomes
Primary Outcome Measures
CGI-S
Clinical Global Impression - Severity
Secondary Outcome Measures
CGI-S
Clinical Global Impression - Severity
CGI-I
Clinical Global Impression - Improvement
CGAS
Children's Global Assessment Scale
CY-BOCS
Children's Yale Brown Obsessive Compulsive Scale
RCADS
Revised Children's Anxiety and Depression Scale
EWSAS
Education, Work and Social Adjustment Scale - Child and parent versions
Patient satisfaction
Questionnaire on child- and parent rated treatment satisfaction
Adverse events
Unintended treatment effects - child and parent version
Full Information
NCT ID
NCT02926365
First Posted
September 20, 2016
Last Updated
October 3, 2023
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT02926365
Brief Title
BIP in Jämtland Härjedalen: Increased Access to CBT Within Regular Health Care in Northern Sweden
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
December 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder, Obsessive-Compulsive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ICBT
Arm Type
Experimental
Arm Description
Therapist-supported internet-delivered CBT
Intervention Type
Behavioral
Intervention Name(s)
ICBT
Primary Outcome Measure Information:
Title
CGI-S
Description
Clinical Global Impression - Severity
Time Frame
24 weeks from baseline
Secondary Outcome Measure Information:
Title
CGI-S
Description
Clinical Global Impression - Severity
Time Frame
12 weeks from baseline
Title
CGI-I
Description
Clinical Global Impression - Improvement
Time Frame
12 and 24 weeks from baseline
Title
CGAS
Description
Children's Global Assessment Scale
Time Frame
12 and 24 weeks from baseline
Title
CY-BOCS
Description
Children's Yale Brown Obsessive Compulsive Scale
Time Frame
12 and 24 weeks from baseline
Title
RCADS
Description
Revised Children's Anxiety and Depression Scale
Time Frame
12 and 24 weeks from baseline
Title
EWSAS
Description
Education, Work and Social Adjustment Scale - Child and parent versions
Time Frame
Week 1 through 12 + 24 weeks from baseline
Title
Patient satisfaction
Description
Questionnaire on child- and parent rated treatment satisfaction
Time Frame
12 weeks from baseline
Title
Adverse events
Description
Unintended treatment effects - child and parent version
Time Frame
12 weeks from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Serlachius, Med Dr
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
BUP Jämtland Härjedalen
City
Östersund
State/Province
Region Jämtland Härjedalen
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No such plan exists at the moment
Learn more about this trial
BIP in Jämtland Härjedalen: Increased Access to CBT Within Regular Health Care in Northern Sweden
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