Anxiety DisordersNOVA IIINCT01296321
Tailored Internet-administrated Treatment of Panic Symptoms - A Randomised Controlled Trial
A study testing Tailored Internet-administrated CBT-Treatment and Waitlist in people with Anxiety Disorders and Depression, run by Linkoeping University.
Trial summary
The purpose of this study is to determine whether tailored internet-administrated CBT is a feasible approach in the treatment of panic symptoms and comorbid anxiety and depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- 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
- 57 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Apr 2011
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be between the ages of 18-30 years old or 31-46 years old
- Have reoccurring panic attacks
Who cannot join
- Suicide prone
- Alcohol addiction
- PTSD
- OCD
- Ongoing psychological treatment
About this study
The purpose of this study is to determine whether tailored internet-administrated CBT is a feasible approach in the treatment of panic symptoms and comorbid anxiety and depressive symptoms.
- 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 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.
WaitlistBehavioural
Passive waitlist during 8-10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Internet-delivered CBT | Experimental | Behavioral: Tailored Internet-delivered 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.
Panic Disorder Severity Scale (PDSS)
Change from baseline in panic 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 (4)
Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)
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
Beck Anxiety Inventory (BAI)
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
Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)
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
Quality of Life Inventory (QOLI)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startFeb 2010
- Primary completionApr 2011 (estimated)
- Study completionApr 2011 (estimated)
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Investigators
- Gerhard Andersson, PhD, Principal investigator, Department of Behavioral Sciences and Learning, Linköping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296321
- Sponsor's protocol ID
- GA-FAS-2008-1145
- Acronym
- NOVA III
- Status last verified
- Feb 2011
- First submitted
- 14 Feb 2011
- Last updated
- 16 Feb 2011
- Results posted
- No
Publications
Silfvernagel K, Carlbring P, Kabo J, Edstrom S, Eriksson J, Manson L, Andersson G. Individually tailored internet-based treatment for young adults and adults with panic attacks: randomized controlled trial. J Med Internet Res. 2012 Jun 26;14(3):e65. doi: 10.2196/jmir.1853.
PubMed 22732098
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Internet-administrated Treatment of Panic Symptoms - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01296321
- Acronym / sponsor ID
- NOVA III / GA-FAS-2008-1145
- Conditions
- Anxiety Disorders, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Feb 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 15 Feb 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 panic symptoms and comorbid anxiety and depressive symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored Internet-delivered CBT | Experimental | Behavioral: Tailored Internet-administrated CBT-TreatmentBehavioral: Tailored Internet-delivered CBT |
| Waitlist | Active comparator | Behavioral: WaitlistWaitlist. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Be between the ages of 18-30 years old or 31-46 years old
- Have reoccurring panic attacks
Key exclusion criteria (5 listed)
- Suicide prone
- Alcohol addiction
- PTSD
- OCD
- 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 |
| WaitlistPassive waitlist during 8-10 weeks. | Behavioural | Waitlist |
Primary outcome
Panic Disorder Severity Scale (PDSS)
Time frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Change from baseline in panic symptoms two weeks post treatment, at six months and at 12 months post treatment.
4 secondary outcomes
Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)
Time frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Beck Anxiety Inventory (BAI)
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)
Time frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Quality of Life Inventory (QOLI)
Time frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2011.
- Derived from this study: PubMed 22732098Silfvernagel K, Carlbring P, Kabo J, Edstrom S, Eriksson J, Manson L, Andersson G. Individually tailored internet-based treatment for young adults and adults with panic attacks: randomized controlled trial. J Med Internet Res. 2012 Jun 26;14(3):e65. doi: 10.2196/jmir.1853.
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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
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 Linkoeping University.
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 5 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: status not confirmed, as of the sponsor's last update on 16 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Panic Disorder Severity Scale (PDSS) (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?
On the ClinicalTrials.gov record for NCT01296321, 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 16 Feb 2011.