Refinement and Validation of an Awareness Training Program

Sponsor

William D. Killgore (Other)

Overall Status

Recruiting

CT.gov ID

NCT02721680

Collaborator

United States Department of Defense (U.S. Fed)

1,082

Enrollment

Locations

Arms

Anticipated Duration (Months)

541

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of the proposed project is to provide the Army with a brief, well-validated, internet-based training program for enhancing Awareness Training and resilience skills. This project will address the needs outlined for the Military Operational Medicine Research Program, particularly with regard to enhancing Psychological Health and Resilience. The fundamental approach of the project directly addresses the need to "develop psychological resilience among Service members and families to promote well-being and prevent behavioral health outcomes." Addressing this need is crucial, as military personnel are often required to serve under dangerous and emotionally stressful conditions. Prolonged stress or exposure to very intense life threatening experiences, such as those encountered in combat or other hazardous duty deployments can increase the risk of developing mental health problems including depression, anxiety, or post-traumatic stress disorder (PTSD). One possible way to minimize the effects of these stressful experiences on Service members is to strengthen their emotional flexibility, adaptability, and capacity to cope with adversity before they find themselves faced with such situations. To fill this need, the investigators propose to provide the military with a web-based program that focuses on enhancing Awareness Training, a core set of trainable awareness skills that collectively include the capacity to understand, perceive, control, and use emotions effectively.

While the previous pilot program was successful in some ways, it needs further research before it is ready for widespread use. The investigators therefore propose to build upon the existing strengths already in the program and redesign the weaker modules to be more effective. Over the course of a four-year study, the investigators propose to develop this program. The proposed Awareness Training program is brief, web-based, easily accessible, and sufficiently focused such that it could be completed by large numbers of military personnel with minimal time burden, leading to rapid enhancement of awareness skills. Such a program could have a significant effect in promoting resilience, interpersonal functioning, and brain health among Service members and their families, while reducing the likelihood of mental health problems among those returning from exposure to potentially traumatic experiences.

The central hypothesis is that a set of well designed and targeted training modules addressing core awareness ability domains will significantly enhance measured awareness skills, will translate into improved performance on militarily relevant metrics, and will lead to better mental and emotional health, as well as well being during stressful situations and subsequent cognitive processing.

Condition or Disease	Intervention/Treatment	Phase
Awareness Training	Other: Internal Awareness Training Program Other: External Awareness Training Program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1082 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Refinement and Validation of a Military Emotional Intelligence Training Program

Actual Study Start Date :

Dec 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy Subjects- Awareness Training Group 1 Subjects in this arm will undergo an internal awareness training program.	Other: Internal Awareness Training Program
Experimental: Healthy Subjects - Awareness Training Group 2 Subjects in this arm will undergo an external awareness training program.	Other: External Awareness Training Program

Arm

Intervention/Treatment

Experimental: Healthy Subjects- Awareness Training Group 1

Subjects in this arm will undergo an internal awareness training program.

Other: Internal Awareness Training Program

Experimental: Healthy Subjects - Awareness Training Group 2

Subjects in this arm will undergo an external awareness training program.

Other: External Awareness Training Program

Outcome Measures

Primary Outcome Measures

Change in Mayer-Salovey Caruso Emotional Intelligence Test (MSCEIT) [Measured before and after the Awareness Training Program is given on Day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

English as a primary language

Exclusion Criteria:

History of neurological illness, current DSM-5 Axis I disorder
Traumatic brain injury with loss of consciousness greater than 30 minutes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona Psychiatry Department	Tucson	Arizona	United States	85724
2	University of Arizona	Tucson	Arizona	United States	85724

Sponsors and Collaborators

William D. Killgore
United States Department of Defense

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

William D. Killgore, Principal Investigator, University of Arizona

ClinicalTrials.gov Identifier:

NCT02721680

Other Study ID Numbers:

1607696724

First Posted:

Mar 29, 2016

Last Update Posted:

Apr 1, 2021

Last Verified:

Mar 1, 2021

Study Results

No Results Posted as of Apr 1, 2021