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Cognitive Anxiety Sensitivity Treatment for Suicide (CAST)

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anxiety Risk Reduction
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Florida State University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Physical Health Training

Anxiety Risk Reduction

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 12, 2013
Last Updated
September 25, 2013
Sponsor
Florida State University
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT01947179
Brief Title
Cognitive Anxiety Sensitivity Treatment for Suicide
Acronym
CAST
Official Title
Development and Evaluation of a Brief, Suicide Prevention Intervention Reducing Anxiety Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Health Training
Arm Type
No Intervention
Arm Description
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.
Arm Title
Anxiety Risk Reduction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Anxiety Risk Reduction
Intervention Description
Involves psychoeducation and interoceptive exposure exercises
Primary Outcome Measure Information:
Title
Anxiety Sensitivity Index (ASI)
Description
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.
Time Frame
Month one follow-up
Secondary Outcome Measure Information:
Title
Beck Suicide Scale (BSS)
Description
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.
Time Frame
Month one follow-up
Other Pre-specified Outcome Measures:
Title
Posttraumatic Diagnostic Scale (PDS)
Description
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.
Time Frame
Month one follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32304
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Cognitive Anxiety Sensitivity Treatment for Suicide

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