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Clinical Trials/NCT03579706
NCT03579706
Completed
N/A

Evaluation of a Brief, Online Intervention for Military Personnel

Florida State University1 site in 1 country180 target enrollmentJune 25, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Experimental
Sponsor
Florida State University
Enrollment
180
Locations
1
Primary Endpoint
Change in Anxiety Sensitivity
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This randomized controlled trial will compare the effectiveness and acceptability of a computerized treatment targeting anxiety sensitivity compared to an active control: Physical Health Education Treatment (PHET) to determine efficacy among military personnel when delivered over the Internet.

Purpose: To investigate the efficacy and acceptability of a computerized stress sensitivity treatment delivered online among a population of U.S. military personnel.

Detailed Description

The objective of the current proposal is to evaluate the efficacy of the Cognitive Anxiety Sensitivity Treatment (CAST) program in an online RCT through Amazon's Mechanical Turk with Veterans and military personnel. The primary outcome variables will be traumatic stress, anxiety, and depressive symptoms. The study is being conducted at Florida State University. Specific Aims: (1) Evaluate the efficacy of the CAST program delivered over the Internet among Veterans and military personnel; (2) Assess acceptability and usability of the CAST program delivered over the Internet without in person appointments; (3) Determine the feasibility of using Amazon's Mechanical Turk to recruit and conduct a fully online randomized controlled trial of a computerized treatment. Veterans or active duty personnel (N = 100) who are at increased risk for mental health problems, as indicated by elevated anxiety sensitivity, will be recruited through Amazon's Mechanical Turk. Mechanical Turk is an online marketplace for individuals interested in completing computerized tasks, such as research surveys, for compensation. Participants will complete self-report symptom measures before and after the intervention as well as at a 4-month follow-up appointment. The intervention is a single session and lasts approximately 45 minutes. The intervention contains educational material to dispel commonly held false beliefs about the dangerousness of experiencing anxiety symptoms, for example elevated heart rate or a difficulty concentrating. Then participants are guided through an exercise designed to bring on these uncomfortable bodily sensations to help participants reduce the amount of distress these symptoms cause. Participants will also be asked to provide feedback related to acceptability and usability of the intervention.

Registry
clinicaltrials.gov
Start Date
June 25, 2018
End Date
October 1, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Norman Schmidt

Professor

Florida State University

Eligibility Criteria

Inclusion Criteria

  • at least 18 years of age
  • current or past member of the U.S. military
  • elevated anxiety sensitivity as indexed by ASI-3 cognitive concerns subscale

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Anxiety Sensitivity

Time Frame: Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU

The Anxiety Sensitivity Index - 3 (ASI-3; Taylor et al., 2007) is an 18-item self-report measure of 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. The measure has shown good psychometric properties (Taylor et al., 2007).

Secondary Outcomes

  • Usability of the computerized intervention(Immediately post intervention)
  • Change in Depressive Symptoms Module (PHQ-9).(Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU)
  • Change in Post-Traumatic Stress Disorder Symptoms(Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU)
  • Change in Anxiety Symptoms(Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU)
  • Client Satisfaction(Immediately post intervention)

Study Sites (1)

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