Anxiety DisordersNOVA IINCT01390168
Internet-administrated Treatment of Anxiety Disorders
A study testing Tailored Internet-administrated CBT-Treatment and Waitlist in people with Anxiety Disorders and Depression, run by Umeå University at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether tailored internet-administered cbt is a feasible treatment for anxiety disorders in clinical settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Depression
- What is being tested?
- Tailored Internet-administrated CBT-Treatment and Waitlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2010to Dec 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years
- fulfill the criteria for at least one anxiety syndrome
Who cannot join
- ongoing psychological treatment
- suicidal prone
- ongoing alcohol addiction
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Behavioural Sciences and Learning, Linköping University
Linköping, Östergötland County, 581 83
About this study
Official title: Tailored Internet-administrated Treatment of Anxiety Disorders - A Randomised Controlled Trial (NOVA II)
The purpose of this study is to determine whether tailored internet-administered cbt is a feasible treatment for anxiety disorders in clinical settings.
- Conditions
- Anxiety Disorders, Depression
- Being tested
- Tailored Internet-administrated CBT-Treatment, Waitlist
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Internet-administrated CBT-TreatmentBehavioural
This intervention contains up to 6-10 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are "prescribed following the diagnostic telephone interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things.
WaitlistBehavioural
active waitlist
| Study group | Role | What they receive |
|---|---|---|
| tailored internet-administrated CBT | Experimental | Behavioral: tailored internet-administrated CBT Receives: Behavioral: Tailored Internet-administrated CBT-Treatment |
| waitlist | Active comparator | waitlist Receives: Behavioral: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)
Measures anxiety and depressive symptoms.
Change from baseline in anxiety and depressive symptoms expected between time frames.
Measured: Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment
Secondary outcomes (3)
Change from baseline in Beck Anxiety Inventory (BAI)
Measures anxiety symtoms.
Change from baseline in anxiety symptoms expected between time frames.
Measured: Two weeks pre treatment (baseline), two weeks post treatment, 12 months post treatment
Change from baseline in Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)
Measures depressive symptoms.
Change from baseline in depressive symptoms expected between time frames.
Measured: Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment
Change from baseline in Quality of Life Inventory (QOLI)
Measures quality of life.
Change from baseline in quality of life expected between time frames.
Measured: Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Carlbring, PhD, Umeå University
- Investigators
- Per Carlbring, Professor, Study director, Umeå UniversityGerhard Andersson, Professor, Study chair, Linkoeping UniversityLise Bergman Nordgren, Ph D Student, Study chair, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390168
- Sponsor's protocol ID
- PC-FAS-2008-1145
- Acronym
- NOVA II
- Status last verified
- Mar 2013
- First submitted
- 1 Jul 2011
- Last updated
- 5 Mar 2013
- Results posted
- No
Publications
Nordgren LB, Hedman E, Etienne J, Bodin J, Kadowaki A, Eriksson S, Lindkvist E, Andersson G, Carlbring P. Effectiveness and cost-effectiveness of individually tailored Internet-delivered cognitive behavior therapy for anxiety disorders in a primary care population: a randomized controlled trial. Behav Res Ther. 2014 Aug;59:1-11. doi: 10.1016/j.brat.2014.05.007. Epub 2014 Jun 2.
PubMed 24933451Nordgren LB, Andersson G, Kadowaki A, Carlbring P. Tailored internet-administered treatment of anxiety disorders for primary care patients: study protocol for a randomised controlled trial. Trials. 2012 Feb 9;13:16. doi: 10.1186/1745-6215-13-16.
PubMed 22321916
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Internet-administrated Treatment of Anxiety Disorders - A Randomised Controlled Trial (NOVA II)
- ClinicalTrials.gov ID
- NCT01390168
- Acronym / sponsor ID
- NOVA II / PC-FAS-2008-1145
- Conditions
- Anxiety Disorders, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Jul 2011 (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 determine whether tailored internet-administered cbt is a feasible treatment for anxiety disorders in clinical settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tailored internet-administrated CBT | Experimental | Behavioral: Tailored Internet-administrated CBT-TreatmentBehavioral: tailored internet-administrated CBT |
| waitlist | Active comparator | Behavioral: Waitlistwaitlist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over 18 years
- fulfill the criteria for at least one anxiety syndrome
Key exclusion criteria (3 listed)
- ongoing psychological treatment
- suicidal prone
- ongoing alcohol addiction
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 |
|---|---|---|
| Tailored Internet-administrated CBT-TreatmentThis intervention contains up to 6-10 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are "prescribed following the diagnostic telephone interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things. | Behavioural | tailored internet-administrated CBT |
| Waitlistactive waitlist | Behavioural | waitlist |
Primary outcome
Change from baseline in Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)
Time frame: Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment
Measures anxiety and depressive symptoms. Change from baseline in anxiety and depressive symptoms expected between time frames.
3 secondary outcomes
Change from baseline in Beck Anxiety Inventory (BAI)
Time frame: Two weeks pre treatment (baseline), two weeks post treatment, 12 months post treatment
Change from baseline in Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)
Time frame: Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment
Change from baseline in Quality of Life Inventory (QOLI)
Time frame: Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment
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 5 Mar 2013.
- Derived from this study: PubMed 24933451Nordgren LB, Hedman E, Etienne J, Bodin J, Kadowaki A, Eriksson S, Lindkvist E, Andersson G, Carlbring P. Effectiveness and cost-effectiveness of individually tailored Internet-delivered cognitive behavior therapy for anxiety disorders in a primary care population: a randomized controlled trial. Behav Res Ther. 2014 Aug;59:1-11. doi: 10.1016/j.brat.2014.05.007. Epub 2014 Jun 2.
- Derived from this study: PubMed 22321916Nordgren LB, Andersson G, Kadowaki A, Carlbring P. Tailored internet-administered treatment of anxiety disorders for primary care patients: study protocol for a randomised controlled trial. Trials. 2012 Feb 9;13:16. doi: 10.1186/1745-6215-13-16.
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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.
Per Carlbring, Professor study director
Umeå University
Gerhard Andersson, Professor study chair
Linkoeping University
Lise Bergman Nordgren, Ph D Student study chair
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Internet-administrated CBT-Treatment and Waitlist in people with Anxiety Disorders and Depression, run by Umeå University 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 2 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 5 Mar 2013. 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?
Change from baseline in Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM) (time frame: Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment). 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 NCT01390168, which also lists 2 linked publications.
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 5 Mar 2013.