Anxiety DisorderBIPBJÖRNNCT02926365
BIP in Jämtland Härjedalen: Increased Access to CBT Within Regular Health Care in Northern Sweden
A study testing ICBT in people with Anxiety Disorder and Obsessive-Compulsive Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Anxiety Disorder, Obsessive-Compulsive Disorder
- What is being tested?
- ICBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2016to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Fulfills diagnostic criteria for an anxiety disorder or OCD
- Access to a computer and internet connection
- Read and speak Swedish
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Anxiety Disorder, Obsessive-Compulsive Disorder
- Being tested
- ICBT
- Medical subject headings
- Anxiety Disorders, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICBTBehavioural
| Study group | Role | What they receive |
|---|---|---|
| ICBT | Experimental | Therapist-supported internet-delivered CBT Receives: Behavioral: ICBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
CGI-S
Clinical Global Impression - Severity
Measured: 24 weeks from baseline
Secondary outcomes (8)
CGI-S
Clinical Global Impression - Severity
Measured: 12 weeks from baseline
CGI-I
Clinical Global Impression - Improvement
Measured: 12 and 24 weeks from baseline
CGAS
Children's Global Assessment Scale
Measured: 12 and 24 weeks from baseline
CY-BOCS
Children's Yale Brown Obsessive Compulsive Scale
Measured: 12 and 24 weeks from baseline
RCADS
Revised Children's Anxiety and Depression Scale
Measured: 12 and 24 weeks from baseline
EWSAS
Education, Work and Social Adjustment Scale - Child and parent versions
Measured: Week 1 through 12 + 24 weeks from baseline
Patient satisfaction
Questionnaire on child- and parent rated treatment satisfaction
Measured: 12 weeks from baseline
Adverse events
Unintended treatment effects - child and parent version
Measured: 12 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start1 Oct 2016
- Primary completionApr 2019
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Vigerland, Karolinska Institutet
- Investigators
- Eva Serlachius, Med Dr, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926365
- Sponsor's protocol ID
- EPN DNR 2016/1355-31/5
- Acronym
- BIPBJÖRN
- Status last verified
- Jul 2024
- First submitted
- 20 Sep 2016
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No such plan exists at the moment
Publications
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.
PubMed 38617387
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02926365
- Acronym / sponsor ID
- BIPBJÖRN / EPN DNR 2016/1355-31/5
- Conditions
- Anxiety Disorder, Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICBT | Experimental | Behavioral: ICBTTherapist-supported internet-delivered CBT |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Fulfills diagnostic criteria for an anxiety disorder or OCD
- Access to a computer and internet connection
- Read and speak Swedish
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICBT | Behavioural | ICBT |
Primary outcome
CGI-S
Time frame: 24 weeks from baseline
Clinical Global Impression - Severity
8 secondary outcomes
CGI-S
Time frame: 12 weeks from baseline
CGI-I
Time frame: 12 and 24 weeks from baseline
CGAS
Time frame: 12 and 24 weeks from baseline
CY-BOCS
Time frame: 12 and 24 weeks from baseline
RCADS
Time frame: 12 and 24 weeks from baseline
EWSAS
Time frame: Week 1 through 12 + 24 weeks from baseline
Patient satisfaction
Time frame: 12 weeks from baseline
Adverse events
Time frame: 12 weeks from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Background: PubMed 38617387Vigerland 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.
- Individual participant dataSharing planned: No. No such plan exists at the moment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Serlachius, Med Dr principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICBT in people with Anxiety Disorder and Obsessive-Compulsive Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CGI-S (time frame: 24 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02926365, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.