Anxiety DisordersNOVA-IVNCT01402258
Internet-administrated Treatment of Anxiety Symptoms for Young Adults
A study testing Tailored Internet-administrated CBT-Treatment in people with Anxiety Disorders and Depression, run by Linkoeping University at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether tailored internet-administrated CBT is a feasible approach in the treatment of anxiety symptoms and comorbid anxiety and depressive symptoms in a clinical setting. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Anxiety Disorders, Depression
- What is being tested?
- Tailored Internet-administrated CBT-Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2011to Jun 2015
- 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 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Be between the ages of 16-25 years old
- Have anxiety symptoms and/or anxiety syndrome
Who cannot join
- Suicide prone
- Alcohol addiction
- Ongoing psychological treatment
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Behavioral Sciences and Learning, Linköping University
Linköping, Östergötland County, 58183
About this study
Official title: Tailored Internet-administrated Treatment of Anxiety Symptoms for Young Adults
The purpose of this study is to determine whether tailored internet-administrated CBT is a feasible approach in the treatment of anxiety symptoms and comorbid anxiety and depressive symptoms in a clinical setting.
- Conditions
- Anxiety Disorders, Depression
- Being tested
- Tailored Internet-administrated CBT-Treatment
- 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 6-8 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.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Internet-delivered CBT | Experimental | Behavioral: Tailored Internet-delivered CBT Receives: Behavioral: Tailored Internet-administrated CBT-Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Inventory (BAI)- Change from baseline
Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Measured: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Secondary outcomes (3)
Quality of Life Inventory (QOLI)- Change from baseline
Change from baseline in quality of life statements two weeks post treatment, at six months and at 12 months post treatment.
Measured: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)- Change from baseline
Change from baseline in depressive symptoms two weeks post treatment, at six months and at 12 months post treatment.
Measured: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)- Change from baseline
Change from baseline in anxiety and depressive symptoms two weeks post treatment, at six months and at 12 months post treatment.
Measured: Two weeks pre treatment, two weeks post treatment, six months 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 posted26 Jul 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Linkoeping 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
- Investigators
- Gerhard Andersson, PhD, Principal investigator, Department of Behavioral Sciences and Learning, Linköping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402258
- Sponsor's protocol ID
- GA-FORSS-2011-150291
- Acronym
- NOVA-IV
- Status last verified
- Dec 2023
- First submitted
- 1 Jul 2011
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Internet-administrated Treatment of Anxiety Symptoms for Young Adults
- ClinicalTrials.gov ID
- NCT01402258
- Acronym / sponsor ID
- NOVA-IV / GA-FORSS-2011-150291
- Conditions
- Anxiety Disorders, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Apr 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 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-administrated CBT is a feasible approach in the treatment of anxiety symptoms and comorbid anxiety and depressive symptoms in a clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tailored Internet-delivered CBT | Experimental | Behavioral: Tailored Internet-administrated CBT-TreatmentBehavioral: Tailored Internet-delivered CBT |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Be between the ages of 16-25 years old
- Have anxiety symptoms and/or anxiety syndrome
Key exclusion criteria (3 listed)
- Suicide prone
- Alcohol addiction
- Ongoing psychological treatment
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 6-8 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-delivered CBT |
Primary outcome
Beck Anxiety Inventory (BAI)- Change from baseline
Time frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
3 secondary outcomes
Quality of Life Inventory (QOLI)- Change from baseline
Time frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)- Change from baseline
Time frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)- Change from baseline
Time frame: Two weeks pre treatment, two weeks post treatment, six months 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 14 Dec 2023.
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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.
Gerhard Andersson, PhD principal investigator
Department of Behavioral Sciences and Learning, Linköping 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 in people with Anxiety Disorders and Depression, run by Linkoeping 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 14 Dec 2023. 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?
Beck Anxiety Inventory (BAI)- Change from baseline (time frame: Two weeks pre treatment, two weeks post treatment, six months 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?
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 14 Dec 2023.