Clinical trial NCT03579706: Evaluation of a Brief, Online Intervention for Military Personnel
Official title: Evaluation of a Brief, Online Intervention for Military Personnel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Experimental
Placebo Contol
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

* none

Primary outcomes:
measure: Change in Anxiety Sensitivity
timeFrame: Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU
Secondary outcomes:
measure: Change in Anxiety Symptoms
timeFrame: Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU
measure: Change in Depressive Symptoms Module (PHQ-9).
timeFrame: Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU
measure: Change in Post-Traumatic Stress Disorder Symptoms
timeFrame: Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU
measure: Usability of the computerized intervention
timeFrame: Immediately post intervention
measure: Client Satisfaction
timeFrame: Immediately post intervention
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: Florida State University
name: Norman B Schmidt, PhD
role: PRINCIPAL_INVESTIGATOR
References: