Computerized Anxiety Treatment for Suicide (CATS)

August 8, 2016 updated by: Norman Schmidt, Florida State University

Suicide Risk Prevention Among Patients With Anxiety Psychopathology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

74

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

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32304
        • Anxiety and Behavioral Health Clinic

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
The anxiety risk reduction condition will be a combination of psychoeducation plus Cognitive Bias Modification (CBM-I) for anxiety sensitivity (AS). The psychoeducational component will focus on the nature of stress and its effect on the body. Interoceptive exposure (IE) exercises, designed to correct the conditioned fear to these bodily sensations, will be explained and practiced.
Other: Cognitive Anxiety Sensitivity Treatment
Other Names:
  • Computerized Anxiety Treatment for Suicide (CATS)
PLACEBO_COMPARATOR: Control
The control condition will be a combination of information about general health and wellness (e.g. diet, exercise etc.) plus an inert Cognitive Bias Modification (CBM-I) task.
Other: Physical Health Education Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Sensitivity Index-3 (ASI-3)
Time Frame: Month 4 follow-up
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Suicide Scale (BSS)
Time Frame: Month 4 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 4 follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2013

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

November 15, 2013

First Submitted That Met QC Criteria

November 20, 2013

First Posted (ESTIMATE)

November 21, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RF02397

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.

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