Evaluation of a Brief, Online Intervention for Military Personnel

Experimental Clinical Trial

Official title:

Evaluation of a Brief, Online Intervention for Military Personnel

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03579706
• Other study ID #: Norr02
• Status: Completed
• Phase: N/A
• Start date: June 25, 2018
• Est. completion date: October 1, 2018

Study information

• Verified date: February 2020
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• none

Related Conditions & MeSH terms

• Experimental
• Placebo Contol

Intervention

Behavioral:
• Cognitive Anxiety Sensitivity Treatment
The Cognitive Anxiety Sensitivity Treatment is a computerized treatment that is a combination of psychoeducation plus interoceptive exposure 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.
• Physical Health Education Training
The Physical Health Education Training is a computerized active placebo matched in time and structure to CAST that includes information about general health and wellness (e.g. diet, exercise etc.).

Locations

Country	Name	City	State
United States	Florida State University	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	Change in Anxiety Sensitivity	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).	Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU
Secondary	Change in Anxiety Symptoms	The Generalized Anxiety Disorder 7-item scale (GAD-7; Spitzer et al., 2006) is a 7- item self-report measure of generalized anxiety. Participants rate the frequency with which they experience anxiety-related symptoms on a scale of 0 (Not at all) to 3 (Nearly every day). The GAD-7 exhibited excellent internal consistency and good test-retest reliability (Spitzer et al., 2006). Total scores range from 0-21 with higher scores indicating greater anxiety symptoms.	Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU
Secondary	Change in Depressive Symptoms Module (PHQ-9).	The Patient Health Questionnaire - Depression (PHQ-9) is the 9-item depression module of the larger Patient Health Questionnaire (PHQ;Spitzer et al., 1999) which was designed to assess eight DSM-IV diagnoses, including major depressive disorder. The PHQ-9 exhibited excellent internal reliability and excellent test-retest reliability (Kroenke et al., 2001). Total scores range from 0-27 with higher scores indicating greater depressive symptoms.	Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU
Secondary	Change in Post-Traumatic Stress Disorder Symptoms	The Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a brief, 20-item self-report instrument that assesses the 20 DSM-5 symptoms of posttraumatic stress disorder. We will use the PCL-5 to obtain total symptom severity scores and DSM-5 symptom cluster severity scores for each participant.	Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU
Secondary	Usability of the computerized intervention	The System Usability Scale (SUS) is a 10 item self-report questionnaire assessing general usability of a given program (Brooke, 1996). The SUS total score ranges from 5 to 50 with higher scores indicating better usability.	Immediately post intervention
Secondary	Client Satisfaction	The Client Satisfaction Questionnaire (CSQ) is an 8 item self-report questionnaire assessing general satisfaction with services of treatment received by the individual (Attkisson and Zwick, 1982). The CSQ has shown high reliability and internal consistency (Attkisson and Zwick, 1982). Total score ranges from 8 to 32 with higher scores indicating greater satisfaction.	Immediately post intervention