BIP in Jämtland Härjedalen: Increased Access to CBT Within Regular Health Care in Northern Sweden (BIPBJÖRN)
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|ClinicalTrials.gov Identifier: NCT02926365|
Recruitment Status : Active, not recruiting
First Posted : October 6, 2016
Last Update Posted : October 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Disorder Obsessive-Compulsive Disorder||Behavioral: ICBT||Not Applicable|
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.
- 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 (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 1, 2016|
|Actual Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||December 2021|
Therapist-supported internet-delivered CBT
- CGI-S [ Time Frame: 24 weeks from baseline ]Clinical Global Impression - Severity
- CGI-S [ Time Frame: 12 weeks from baseline ]Clinical Global Impression - Severity
- CGI-I [ Time Frame: 12 and 24 weeks from baseline ]Clinical Global Impression - Improvement
- CGAS [ Time Frame: 12 and 24 weeks from baseline ]Children's Global Assessment Scale
- CY-BOCS [ Time Frame: 12 and 24 weeks from baseline ]Children's Yale Brown Obsessive Compulsive Scale
- RCADS [ Time Frame: 12 and 24 weeks from baseline ]Revised Children's Anxiety and Depression Scale
- EWSAS [ Time Frame: Week 1 through 12 + 24 weeks from baseline ]Education, Work and Social Adjustment Scale - Child and parent versions
- Patient satisfaction [ Time Frame: 12 weeks from baseline ]Questionnaire on child- and parent rated treatment satisfaction
- Adverse events [ Time Frame: 12 weeks from baseline ]Unintended treatment effects - child and parent version
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926365
|BUP Jämtland Härjedalen|
|Östersund, Region Jämtland Härjedalen, Sweden|
|Principal Investigator:||Eva Serlachius, Med Dr||Karolinska Institutet|