Clinical trial NCT02926365: BIP in Jämtland Härjedalen: Increased Access to CBT Within Regular Health Care in Northern Sweden
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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorder
Obsessive-Compulsive Disorder
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 83
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: CGI-S
timeFrame: 24 weeks from baseline
Secondary outcomes:
measure: CGI-S
timeFrame: 12 weeks from baseline
measure: CGI-I
timeFrame: 12 and 24 weeks from baseline
measure: CGAS
timeFrame: 12 and 24 weeks from baseline
measure: CY-BOCS
timeFrame: 12 and 24 weeks from baseline
measure: RCADS
timeFrame: 12 and 24 weeks from baseline
measure: EWSAS
timeFrame: Week 1 through 12 + 24 weeks from baseline
measure: Patient satisfaction
timeFrame: 12 weeks from baseline
measure: Adverse events
timeFrame: 12 weeks from baseline
Other outcomes:
Locations:
city: Östersund
country: Sweden
facility: BUP Jämtland Härjedalen
state: Region Jämtland Härjedalen
Study officials:
affiliation: Karolinska Institutet
name: Eva Serlachius, Med Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vigerland S, Fredlander S, Aspvall K, Jolstedt M, Lenhard F, Mataix-Cols D, Ljotsson B, Serlachius E. Effectiveness of internet-delivered cognitive behavioural therapy for anxiety and obsessive-compulsive disorders within routine clinical care in rural Sweden. Internet Interv. 2024 Apr 6;36:100738. doi: 10.1016/j.invent.2024.100738. eCollection 2024 Jun.