Computerized Anxiety Treatment for Suicide (CATS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Florida State University
Sponsor:
Information provided by (Responsible Party):
Norman Schmidt, Florida State University
ClinicalTrials.gov Identifier:
NCT01990131
First received: November 15, 2013
Last updated: July 15, 2014
Last verified: July 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Florida State University:

Primary Outcome Measures:
  • Anxiety Sensitivity Index-3 (ASI-3) [ Time Frame: Month 4 follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 74
Study Start Date: October 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01990131

Contacts
Contact: Norman B Schmidt, Ph.D. (850) 645-1766 abhcfsu@psy.fsu.edu

Locations
United States, Florida
Anxiety and Behavioral Health Clinic Recruiting
Tallahassee, Florida, United States, 32304
Contact: Norman B Schmidt, Ph.D.    850-645-1766    abhcfsu@psy.fsu.edu   
Sponsors and Collaborators
Florida State University
  More Information

No publications provided

Responsible Party: Norman Schmidt, Distinguished Professor, Florida State University
ClinicalTrials.gov Identifier: NCT01990131     History of Changes
Other Study ID Numbers: RF02397
Study First Received: November 15, 2013
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 01, 2014