AnxietyCASTNCT01947179
Cognitive Anxiety Sensitivity Treatment for Suicide
A study testing Anxiety Risk Reduction in people with Anxiety, run by Florida State University at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness and usability of a computer-based treatment for mood and anxiety relevant risk factors. The target of the treatment is related to cognitive stress, which has been shown to be associated with several negative mental health outcomes such as suicidal ideation… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Anxiety Risk Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Feb 2013
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At or above the community sample mean on the ASI
- English speakers
- 18 years of age or older
Who cannot join
- Significant medical illness
- Current substance dependence
- Current or past psychotic-spectrum disorders
- Uncontrolled bipolar disorder
- Serious suicidal intent that warranted immediate medical treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32304
About this study
Official title: Development and Evaluation of a Brief, Suicide Prevention Intervention Reducing Anxiety Sensitivity
The purpose of this study is to test the effectiveness and usability of a computer-based treatment for mood and anxiety relevant risk factors. The target of the treatment is related to cognitive stress, which has been shown to be associated with several negative mental health outcomes such as suicidal ideation, substance use disorders, and Post-Traumatic Stress Disorder.
Read the detailed description
CAST is a newly developed computerized treatment targeting specific risk factors associated with PTSD, substance use, anxiety, and suicide. Eligible individuals will be randomized to one of two conditions. In both conditions, participants will complete various self-report questionnaires and a computerized presentation. Additionally, all participants will be asked to complete a one month follow-up appointment.
- Conditions
- Anxiety
- Being tested
- Anxiety Risk Reduction
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anxiety Risk ReductionBehavioural
Involves psychoeducation and interoceptive exposure exercises
| Study group | Role | What they receive |
|---|---|---|
| Physical Health Training | No intervention | The Physical Health Training condition will include information on the importance and benefits of a healthy lifestyle. Additionally, the program will discuss guidelines for a healthy lifestyle including information on diet, water consumption, exercise, and sleep. |
| Anxiety Risk Reduction | Experimental | The anxiety risk reduction intervention will include psychoeducation focused on the nature of stress and its effect on the body. Interoceptive exposure exercises that were designed to correct the conditioned fear of bodily sensations will be explained and practiced. Receives: Behavioral: Anxiety Risk Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Sensitivity Index (ASI)
The ASI is a 16-item self-report measure of anxiety sensitivity. Each item consists of a possible negative consequence of anxiety symptoms. The scale assesses three AS subfactors including cognitive, physical, and social concerns. The measure has shown good psychometric properties.
Measured: Month one follow-up
Secondary outcomes (1)
Beck Suicide Scale (BSS)
The BSS is a 21-item widely used self-report measure assessing a broad spectrum of behaviors and attitudes related to suicide risk, including suicidal ideation and past suicide attempts. It has demonstrated strong reliability and validity.
Measured: Month one follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startSep 2011
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Norman Schmidt, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947179
- Sponsor's protocol ID
- 03969
- Acronym
- CAST
- Status last verified
- Sep 2013
- First submitted
- 12 Sep 2013
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Brief, Suicide Prevention Intervention Reducing Anxiety Sensitivity
- ClinicalTrials.gov ID
- NCT01947179
- Acronym / sponsor ID
- CAST / 03969
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Sep 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 20 Sep 2013 (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 the effectiveness and usability of a computer-based treatment for mood and anxiety relevant risk factors. The target of the treatment is related to cognitive stress, which has been shown to be associated with several negative mental health outcomes such as suicidal ideation, substance use disorders, and Post-Traumatic Stress Disorder.
Detailed description
CAST is a newly developed computerized treatment targeting specific risk factors associated with PTSD, substance use, anxiety, and suicide. Eligible individuals will be randomized to one of two conditions. In both conditions, participants will complete various self-report questionnaires and a computerized presentation. Additionally, all participants will be asked to complete a one month follow-up appointment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Health Training | No intervention | –The Physical Health Training condition will include information on the importance and benefits of a healthy lifestyle. Additionally, the program will discuss guidelines for a healthy lifestyle including information on diet, water consumption, exercise, and sleep. |
| Anxiety Risk Reduction | Experimental | Behavioral: Anxiety Risk ReductionThe anxiety risk reduction intervention will include psychoeducation focused on the nature of stress and its effect on the body. Interoceptive exposure exercises that were designed to correct the conditioned fear of bodily sensations will be explained and practiced. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At or above the community sample mean on the ASI
- English speakers
- 18 years of age or older
Key exclusion criteria (5 listed)
- Significant medical illness
- Current substance dependence
- Current or past psychotic-spectrum disorders
- Uncontrolled bipolar disorder
- Serious suicidal intent that warranted immediate medical 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 |
|---|---|---|
| Anxiety Risk ReductionInvolves psychoeducation and interoceptive exposure exercises | Behavioural | Anxiety Risk Reduction |
Primary outcome
Anxiety Sensitivity Index (ASI)
Time frame: Month one follow-up
The ASI is a 16-item self-report measure of anxiety sensitivity. Each item consists of a possible negative consequence of anxiety symptoms. The scale assesses three AS subfactors including cognitive, physical, and social concerns. The measure has shown good psychometric properties.
1 secondary outcome
Beck Suicide Scale (BSS)
Time frame: Month one follow-up
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 26 Sep 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anxiety Risk Reduction in people with Anxiety, run by Florida State University at 1 site in United States.
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 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: finished, as of the sponsor's last update on 26 Sep 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 United States. 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?
Anxiety Sensitivity Index (ASI) (time frame: Month one follow-up). 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 26 Sep 2013.