Evaluation of a Brief, Online Intervention for Military Personnel

NCT03579706 | Completed DMC

• 1 other identifier: Norr02
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Experimental; Placebo Contol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Anxiety Symptoms

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

• 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

• Usability of the computerized intervention

  Immediately post intervention

• Client Satisfaction

  Immediately post intervention

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention condition will involve participants completing baseline measures, the Cognitive Anxiety Sensitivity Treatment, post measures, and a 4 month follow up assessment.

Behavioral: Cognitive Anxiety Sensitivity Treatment

Control

PLACEBO COMPARATOR

The control condition will involve participants completing baseline measures, the Physical Health Education Training, post measures, and a 4 month follow up assessment.

Behavioral: Physical Health Education Training

Interventions

Cognitive Anxiety Sensitivity Treatment BEHAVIORAL

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.

Intervention

Physical Health Education Training BEHAVIORAL

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.).

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32304, United States

Location

Study Officials

• Norman B Schmidt, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants anonymously complete all online measures and the intervention without contact with study personnel. Participants are randomized to the active or control condition without being told which condition they are participating in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: July 6, 2018
• Study Start: June 25, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)