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Computerized Anxiety Treatment for Suicide (CATS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01990131
First Posted: November 21, 2013
Last Update Posted: August 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Norman Schmidt, Florida State University
  Purpose
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.

Condition Intervention
Anxiety Suicide Other: Cognitive Anxiety Sensitivity Treatment Other: Physical Health Education Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Suicide Risk Prevention Among Patients With Anxiety Psychopathology

Resource links provided by NLM:


Further study details as provided by Norman Schmidt, Florida State University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 74
Study Start Date: October 2013
Study Completion Date: July 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990131


Locations
United States, Florida
Anxiety and Behavioral Health Clinic
Tallahassee, Florida, United States, 32304
Sponsors and Collaborators
Florida State University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Norman Schmidt, Distinguished Professor, Florida State University
ClinicalTrials.gov Identifier: NCT01990131     History of Changes
Other Study ID Numbers: RF02397
First Submitted: November 15, 2013
First Posted: November 21, 2013
Last Update Posted: August 9, 2016
Last Verified: August 2016

Keywords provided by Norman Schmidt, Florida State University:
computerized intervention
cognitive bias modification
anxiety
suicide

Additional relevant MeSH terms:
Anxiety Disorders
Suicide
Mental Disorders
Self-Injurious Behavior
Behavioral Symptoms