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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Anxiety Disorder, Obsessive-Compulsive Disorder

Intervention / Treatment
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* Behavioral: ICBT


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICBT<br>Therapist-supported internet-delivered CBT | Behavioral: ICBT<br> <br> |

What is the study measuring?
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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 |