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

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02926365
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 74
• Patients Per Site Per Month: 2.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorder; Obsessive-Compulsive Disorder	Behavioral: ICBT	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: N/A
• 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: Oct 1, 2016
• Actual Primary Completion Date: Apr 1, 2019
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. CGI-S [24 weeks from baseline]

   Clinical Global Impression - Severity

Secondary Outcome Measures

1. CGI-S [12 weeks from baseline]

   Clinical Global Impression - Severity

2. CGI-I [12 and 24 weeks from baseline]

   Clinical Global Impression - Improvement

3. CGAS [12 and 24 weeks from baseline]

   Children's Global Assessment Scale

4. CY-BOCS [12 and 24 weeks from baseline]

   Children's Yale Brown Obsessive Compulsive Scale

5. RCADS [12 and 24 weeks from baseline]

   Revised Children's Anxiety and Depression Scale

6. EWSAS [Week 1 through 12 + 24 weeks from baseline]

   Education, Work and Social Adjustment Scale - Child and parent versions

7. Patient satisfaction [12 weeks from baseline]

   Questionnaire on child- and parent rated treatment satisfaction

8. Adverse events [12 weeks from baseline]

   Unintended treatment effects - child and parent version

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BUP Jämtland Härjedalen	Östersund	Region Jämtland Härjedalen	Sweden

Sponsors and Collaborators

• Karolinska Institutet

Investigators

• Principal Investigator: Eva Serlachius, Med Dr, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sarah Vigerland, PhD, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT02926365
• Other Study ID Numbers: EPN DNR 2016/1355-31/5
• First Posted: Oct 6, 2016
• Last Update Posted: Aug 17, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Disease; Anxiety Disorders; Obsessive-Compulsive Disorder

Study Results

No Results Posted as of Aug 17, 2022