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Awareness TrainingNCT02721680

Refinement and Validation of an Awareness Training Program

A study testing Internal Awareness Training Program and External Awareness Training Program in people with Awareness Training, run by William D. Killgore at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Awareness Training
What is being tested?
Internal Awareness Training Program and External Awareness Training Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,266 participants
Where
2 sitesUnited States
Study dates
Dec 2016to Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • English as a primary language

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Arizona Psychiatry Department

    Tucson, Arizona, 85724

  • University of Arizona

    Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: Refinement and Validation of a Military Emotional Intelligence Training Program

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.

Being tested
Internal Awareness Training Program, External Awareness Training Program

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internal Awareness Training ProgramOther

  • External Awareness Training ProgramOther

Study groups in NCT02721680
Study groupRoleWhat they receive
Healthy Subjects- Awareness Training Group 1ExperimentalSubjects in this arm will undergo an internal awareness training program.
Receives: Other: Internal Awareness Training Program
Healthy Subjects - Awareness Training Group 2ExperimentalSubjects in this arm will undergo an external awareness training program.
Receives: Other: External Awareness Training Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Mayer-Salovey Caruso Emotional Intelligence Test (MSCEIT)

    Measured: Measured before and after the Awareness Training Program is given on Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionNov 2021
  4. Study completionNov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
1,266 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02721680
Sponsor's protocol ID
1607696724
Status last verified
Sep 2022
First submitted
1 Mar 2016
Last updated
14 Sep 2022
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Internal Awareness Training Program and External Awareness Training Program in people with Awareness Training, run by William D. Killgore at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mayer-Salovey Caruso Emotional Intelligence Test (MSCEIT) (time frame: Measured before and after the Awareness Training Program is given on Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.

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