Anxiety SensitivityNCT02874417
Computerized Psychoeducation for Anxiety Sensitivity
A study testing CAST psychoeducation and PHET in people with Anxiety Sensitivity, run by Florida State University.
Trial summary
This investigation examines the efficacy of a 35 minute computerized psychoeducation protocol in the reduction of elevated anxiety sensitivity cognitive concerns, a risk factor for the development and maintenance of various forms of psychopathology. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Anxiety Sensitivity
- What is being tested?
- CAST psychoeducation and PHET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Nov 2014
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elevated Anxiety Sensitivity Cognitive Concerns and indicated by the anxiety sensitivity index-3
Who cannot join
- History of epilepsy or seizures
About this study
This investigation examines the efficacy of a 35 minute computerized psychoeducation protocol in the reduction of elevated anxiety sensitivity cognitive concerns, a risk factor for the development and maintenance of various forms of psychopathology.
- Conditions
- Anxiety Sensitivity
- Being tested
- CAST psychoeducation, PHET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAST psychoeducationBehavioural
PHETBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation | Experimental | The program was designed to dispel exaggerated thoughts surrounding the danger of the experience of anxiety symptoms, specifically focusing on fears regarding feelings of cognitive dyscontrol. The psychoeducation portion contains video animation and audio narration throughout, as well as some interactive features . Participants are provided with corrective information about the experience of anxiety-related sensations, with a particular focus on dispelling myths commonly held by individuals with high anxiety sensitivity cognitive concerns . Participants are taught that anxiety-related sensations are not dangerous and that they may have developed a conditioned fear to these symptoms of arousal. Receives: Behavioral: CAST psychoeducation |
| Health and Wellness | Placebo comparator | The controlled condition consisted Physical Health Education Training (PHET), a computerized presentation which focuses on information on general healthy living. The PHET program contains information on nutrition, alcohol, water consumption, exercise, sexual health, hygiene, stress management, life organization, social support, positive outlook, and sleep. Receives: Behavioral: PHET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Sensitivity Index-3
Measure of anxiety sensitivity
Measured: 10 minutes post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startSep 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety SensitivityStudies of the same condition, open and under way.
- More trials run by Florida State 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norman Schmidt, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874417
- Sponsor's protocol ID
- Norr01
- Status last verified
- Aug 2016
- First submitted
- 8 Aug 2016
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Psychoeducation for Anxiety Sensitivity
- ClinicalTrials.gov ID
- NCT02874417
- Acronym / sponsor ID
- Norr01
- Conditions
- Anxiety Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 22 Aug 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.
This investigation examines the efficacy of a 35 minute computerized psychoeducation protocol in the reduction of elevated anxiety sensitivity cognitive concerns, a risk factor for the development and maintenance of various forms of psychopathology.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation | Experimental | Behavioral: CAST psychoeducationThe program was designed to dispel exaggerated thoughts surrounding the danger of the experience of anxiety symptoms, specifically focusing on fears regarding feelings of cognitive dyscontrol. The psychoeducation portion contains video animation and audio narration throughout, as well as some interactive features . Participants are provided with corrective information about the experience of anxiety-related sensations, with a particular focus on dispelling myths commonly held by individuals with high anxiety sensitivity cognitive concerns . Participants are taught that anxiety-related sensations are not dangerous and that they may have developed a conditioned fear to these symptoms of arousal. |
| Health and Wellness | Placebo comparator | Behavioral: PHETThe controlled condition consisted Physical Health Education Training (PHET), a computerized presentation which focuses on information on general healthy living. The PHET program contains information on nutrition, alcohol, water consumption, exercise, sexual health, hygiene, stress management, life organization, social support, positive outlook, and sleep. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elevated Anxiety Sensitivity Cognitive Concerns and indicated by the anxiety sensitivity index-3
Key exclusion criteria (1 listed)
- History of epilepsy or seizures
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 |
|---|---|---|
| CAST psychoeducation | Behavioural | Psychoeducation |
| PHET | Behavioural | Health and Wellness |
Primary outcome
Anxiety Sensitivity Index-3
Time frame: 10 minutes post intervention
Measure of anxiety sensitivity
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 22 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CAST psychoeducation and PHET in people with Anxiety Sensitivity, run by Florida State 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 1 inclusion and 1 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 22 Aug 2016. 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. Some participants in this study may receive a placebo. 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?
Anxiety Sensitivity Index-3 (time frame: 10 minutes post intervention). 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 22 Aug 2016.