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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01990131
Other study ID # RF02397
Secondary ID
Status Completed
Phase N/A
First received November 15, 2013
Last updated August 8, 2016
Start date October 2013
Est. completion date July 2016

Study information

Verified date August 2016
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 multiple computer-based treatments 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 a variety of negative mental health outcomes such as Post-Traumatic Stress Disorder, suicidal ideation, and substance use disorders.


Description:

CATS is a newly developed computerized treatment targeting specific risk factors associated with anxiety symptoms and suicidal thoughts. Individuals will be asked to complete four appointments, where they will complete various self-report questionnaires as well as a newly developed computerized treatment targeting risk factors associated with anxiety.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date July 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Meet diagnostic criteria for a primary Axis 1 anxiety disorder or meet diagnostic criteria for a unipolar mood disorder along with an Axis 1 anxiety disorder.

- Show evidence of current suicidal ideation (BSS above 6.

- Show elevated AS indicated by scoring at or above the community sample mean on the ASI-Cog (above 9.

Exclusion Criteria:

- No significant medical illness (e.g. sig cardiovascular disease, epilepsy, stroke).

- Current or past psychotic-spectrum disorders or uncontrolled bipolar disorder

- No current substance dependence

- Must be an English speaker.

- Must be 18 years or older.

- Must have normal or corrected vision

- Cannot begin treatment/therapy within 1 month of baseline.

- Cannot begin a new medication within 3 months of baseline.

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
Cognitive Anxiety Sensitivity Treatment

Physical Health Education Training


Locations

Country Name City State
United States Anxiety and Behavioral Health Clinic Tallahassee Florida

Sponsors (1)

Lead Sponsor Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anxiety Sensitivity Index-3 (ASI-3) The ASI-3 is an 18-item self-report measure of anxiety sensitivity (AS). This scale was developed to provide a more stable measure of the three most widely recognized AS subfactors (cognitive, social and physical concerns) than the original ASI provides. Each subfactor is represented by six items. The measure has shown good psychometric properties. Month 4 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 4 follow-up Yes
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