Cognitive Anxiety Sensitivity Treatment for Suicide

Anxiety Clinical Trial

— CAST  

Official title:

Development and Evaluation of a Brief, Suicide Prevention Intervention Reducing Anxiety Sensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947179
• Other study ID #: 03969
• Status: Completed
• Phase: N/A
• First received: September 12, 2013
• Last updated: September 25, 2013
• Start date: September 2011
• Est. completion date: February 2013

Study information

• Verified date: September 2013
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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, substance use disorders, and Post-Traumatic Stress Disorder.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• Anxiety Risk Reduction
Involves psychoeducation and interoceptive exposure exercises

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida State University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Posttraumatic Diagnostic Scale (PDS)	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	No
Primary	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.	Month one follow-up	No
Secondary	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.	Month one follow-up	Yes