Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02926365
Recruitment Status : Active, not recruiting
First Posted : October 6, 2016
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Sarah Vigerland, 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.

Condition or disease Intervention/treatment Phase
Anxiety Disorder Obsessive-Compulsive Disorder Behavioral: ICBT Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ICBT
Therapist-supported internet-delivered CBT
Behavioral: ICBT



Primary Outcome Measures :
  1. CGI-S [ Time Frame: 24 weeks from baseline ]
    Clinical Global Impression - Severity


Secondary Outcome Measures :
  1. CGI-S [ Time Frame: 12 weeks from baseline ]
    Clinical Global Impression - Severity

  2. CGI-I [ Time Frame: 12 and 24 weeks from baseline ]
    Clinical Global Impression - Improvement

  3. CGAS [ Time Frame: 12 and 24 weeks from baseline ]
    Children's Global Assessment Scale

  4. CY-BOCS [ Time Frame: 12 and 24 weeks from baseline ]
    Children's Yale Brown Obsessive Compulsive Scale

  5. RCADS [ Time Frame: 12 and 24 weeks from baseline ]
    Revised Children's Anxiety and Depression Scale

  6. EWSAS [ Time Frame: Week 1 through 12 + 24 weeks from baseline ]
    Education, Work and Social Adjustment Scale - Child and parent versions

  7. Patient satisfaction [ Time Frame: 12 weeks from baseline ]
    Questionnaire on child- and parent rated treatment satisfaction

  8. Adverse events [ Time Frame: 12 weeks from baseline ]
    Unintended treatment effects - child and parent version



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Locations
Layout table for location information
Sweden
BUP Jämtland Härjedalen
Östersund, Region Jämtland Härjedalen, Sweden
Sponsors and Collaborators
Karolinska Institutet
Investigators
Layout table for investigator information
Principal Investigator: Eva Serlachius, Med Dr Karolinska Institutet

Layout table for additonal information
Responsible Party: Sarah Vigerland, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02926365     History of Changes
Other Study ID Numbers: EPN DNR 2016/1355-31/5
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No such plan exists at the moment
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Anxiety Disorders
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Mental Disorders
Personality Disorders