Evaluation of a Brief, Online Intervention for Military Personnel

NCT ID: NCT03579706

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-25

Study Completion Date

2018-10-01

Brief Summary

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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

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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.

Conditions

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Experimental Placebo Contol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Cognitive Anxiety Sensitivity Treatment

Intervention Type 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.

Control

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

Group Type PLACEBO_COMPARATOR

Physical Health Education Training

Intervention Type 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.).

Interventions

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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.

Intervention Type BEHAVIORAL

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.).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Florida State University

OTHER

Sponsor Role lead

Responsible Party

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Norman Schmidt

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Norman B Schmidt, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

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Florida State University

Tallahassee, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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Norr02

Identifier Type: -

Identifier Source: org_study_id

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