- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01947179
Cognitive Anxiety Sensitivity Treatment for Suicide (CAST)
September 25, 2013 updated by: Norman Schmidt, Florida State University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Tallahassee, Florida, United States, 32304
- Florida State University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- At or above the community sample mean on the ASI
- English speakers
- 18 years of age or older
Exclusion Criteria:
- Significant medical illness
- Current substance dependence
- Current or past psychotic-spectrum disorders
- Uncontrolled bipolar disorder
- Serious suicidal intent that warranted immediate medical treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Physical Health Training
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.
|
|
|
Experimental: Anxiety Risk Reduction
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.
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Involves psychoeducation and interoceptive exposure exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Month one follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Suicide Scale (BSS)
Time Frame: Month one follow-up
|
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.
|
Month one follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Posttraumatic Diagnostic Scale (PDS)
Time Frame: Month one follow-up
|
The PDS is a self-report measure used to assess the severity of posttraumatic stress symptoms during the past month.
The measure was designed based on Diagnostic and Statistical Manual-IV criteria.
Respondents report if they have experienced any of 12 traumatic events, including an "other" category, and then indicate which event was the most disturbing.
Additionally, respondents rate the frequency of 17 PTSD symptoms experienced in the past month in relation to the most disturbing event they endorsed.
The PDS has excellent psychometric properties and can be used as a continuous measure of PTSD symptom severity.
|
Month one follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
September 12, 2013
First Submitted That Met QC Criteria
September 17, 2013
First Posted (Estimate)
September 20, 2013
Study Record Updates
Last Update Posted (Estimate)
September 26, 2013
Last Update Submitted That Met QC Criteria
September 25, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03969
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.