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.
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
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.
- Conditions
- Awareness Training
- 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 group | Role | What they receive |
|---|---|---|
| Healthy Subjects- Awareness Training Group 1 | Experimental | Subjects in this arm will undergo an internal awareness training program. Receives: Other: Internal Awareness Training Program |
| Healthy Subjects - Awareness Training Group 2 | Experimental | Subjects 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.
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.
- First posted29 Mar 2016 (estimated)
- Study startDec 2016
- Primary completionNov 2021
- Study completionNov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Awareness TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- William D. Killgore
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, William D. Killgore, University of Arizona
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refinement and Validation of a Military Emotional Intelligence Training Program
- ClinicalTrials.gov ID
- NCT02721680
- Acronym / sponsor ID
- 1607696724
- Conditions
- Awareness Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,266 participants (actual)
- Lead sponsor
- William D. KillgoreUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Dec 2016 (actual)
- Primary completion
- Nov 2021 (actual)
- Study completion
- Nov 2021 (actual)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects- Awareness Training Group 1 | Experimental | Other: Internal Awareness Training ProgramSubjects in this arm will undergo an internal awareness training program. |
| Healthy Subjects - Awareness Training Group 2 | Experimental | Other: External Awareness Training ProgramSubjects in this arm will undergo an external awareness training program. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- English as a primary language
Key exclusion criteria (2 listed)
- History of neurological illness, current DSM-5 Axis I disorder
- Traumatic brain injury with loss of consciousness greater than 30 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internal Awareness Training Program | Other | Healthy Subjects- Awareness Training Group 1 |
| External Awareness Training Program | Other | Healthy Subjects - Awareness Training Group 2 |
Primary outcome
Change in Mayer-Salovey Caruso Emotional Intelligence Test (MSCEIT)
Time frame: Measured before and after the Awareness Training Program is given on Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
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.