NCT02926365

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

2.5 years

First QC Date

September 20, 2016

Last Update Submit

July 5, 2024

Conditions

Anxiety DisorderObsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

  • CGI-S

    Clinical Global Impression - Severity

    24 weeks from baseline

Secondary Outcomes (8)

  • CGI-S

    12 weeks from baseline

  • CGI-I

    12 and 24 weeks from baseline

  • CGAS

    12 and 24 weeks from baseline

  • CY-BOCS

    12 and 24 weeks from baseline

  • RCADS

    12 and 24 weeks from baseline

  • +3 more secondary outcomes

Study Arms (1)

ICBT

EXPERIMENTAL

Therapist-supported internet-delivered CBT

Behavioral: ICBT

Interventions

ICBTBEHAVIORAL
ICBT

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Fulfills diagnostic criteria for an anxiety disorder or OCD
  • Access to a computer and internet connection
  • Read and speak Swedish

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BUP Jämtland Härjedalen

Östersund, Region Jämtland Härjedalen, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 38617387BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersObsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Eva Serlachius, Med Dr

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 20, 2016

First Posted

October 6, 2016

Study Start

October 1, 2016

Primary Completion

April 1, 2019

Study Completion

December 1, 2022

Last Updated

July 8, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

No such plan exists at the moment

Locations

SE(1)