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Improving Air Force Resilience

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05460663
Recruitment Status : Completed
First Posted : July 15, 2022
Last Update Posted : July 21, 2022
Sponsor:
Information provided by (Responsible Party):
Stephen H. Hernandez, University of New Mexico

Brief Summary:

The purpose of this study is to examine the effectiveness of the Stress Management and Resilience Training (SMART) in increasing resilience in Air Force (AF) healthcare personnel. SMART includes practices that focus on six factors that promote individual-level resilience. A pretest-posttest, randomized control trial will be used to examine the effectiveness of SMART and is guided by the Defense Centers of Excellence Resilience Continuum. After institutional review board approval, the principal investigator (PI) will recruit a sample of AF healthcare personnel assigned to the 88th Medical Group or USAF School of Aerospace Medicine at Wright Patterson AF Base.

SMART will be provided via either a two-hour, video teleconference (VTC) or in-person training or a self-paced, on-line version completed over four to eight weeks. VTC or on-line versions will be utilized to prevent transmission of severe acute respiratory syndrome coronavirus-2. If in-person training is feasible and safe at a future point in time, in-person training will replace VTC training.

A baseline survey will include questions regarding age, gender, marital status, race, ethnicity, previous deployment, military rank, and military job duty. The Connor Davidson 10-Item Resilience Scale has demonstrated reliability and validity, and has been used in studies to measure service member resilience. Additional measures include the Perceived Stress Scale, Generalized Anxiety Disorder Scale, and a Quality of Life measure. The CD-10, PSS, GAD-7, and QoL measure will be readministered 12, 18, and 24-weeks after SMART completion.

Initial analysis will include descriptive statistics to characterize demographics, military grade, duty location, and previous deployment status. Cronbach's α will be calculated for each scale. Analyses will be reported as point estimates with 95% confidence intervals and estimates of effect size. Both VTC and on-line groups will be analyzed separately and scores will be pooled to test for overall intervention effects.

The investigators will conduct regression models on the pre-post intervention difference while controlling for demographic characteristics and previous deployment. The investigators will consider clustering effects among participants from the same organizational unit using random effects. Changes in resilience, stress, anxiety, and QoL over time will be assessed by analyzing changes from baseline to weeks 12, 18, and 24. The investigators will consider a joint analysis of resilience, stress, anxiety, or QOL.


Condition or disease Intervention/treatment Phase
Military Personnel Health Promotion Behavioral: Stress Management and Resilience Training (SMART) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Control Trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improving Resiliency in U.S. Air Force Healthcare Personnel
Actual Study Start Date : December 4, 2020
Actual Primary Completion Date : February 1, 2022
Actual Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VTC/In-person SMART training
The two-hour VTC or in-person will be provided SMART synchronously to a maximum of 10 individuals. A study team member will contact participants in the VTC group to provide available dates and times of scheduled classes, and these participants will be scheduled for a class they would like to attend. Participants in the VTC group will be provided a web-link prior to the session, and each session will have a unique password to access the training. Participants in the on-line training group will be provided a code to access the training website. If local conditions permit in-person group meetings (i.e. Health Protection Condition [HPCON] Alpha or Bravo), in-person group SMART training in a classroom will be offered as an alternative to VTC sessions.
Behavioral: Stress Management and Resilience Training (SMART)
The Stress Management and Resilience Training (SMART) program was developed by Dr. Amit Sood. SMART focuses on improving the practices of gratitude, mindful presence, kindness, and developing a resilient mindset. The SMART program incorporates practices that focus on six individual factors that have been found to promote individual-level resilience: positive coping, positive affect, positive thinking, realism, behavioral control, and altruism. In this proposed study, SMART will be provided via either a two-hour, video teleconference (VTC) or in-person training or by completion of a self-paced, on-line version completed over a period of four to eight weeks.

Experimental: CBT SMART training
SMART will be provided via completion of a self-paced, on-line version completed over a period of four to eight weeks.
Behavioral: Stress Management and Resilience Training (SMART)
The Stress Management and Resilience Training (SMART) program was developed by Dr. Amit Sood. SMART focuses on improving the practices of gratitude, mindful presence, kindness, and developing a resilient mindset. The SMART program incorporates practices that focus on six individual factors that have been found to promote individual-level resilience: positive coping, positive affect, positive thinking, realism, behavioral control, and altruism. In this proposed study, SMART will be provided via either a two-hour, video teleconference (VTC) or in-person training or by completion of a self-paced, on-line version completed over a period of four to eight weeks.




Primary Outcome Measures :
  1. Changes in Connor-Davidson 10-Item Scale (CD-10) [ Time Frame: Changes in self-reported CD-10 from Baseline at 12, 18, and 24 weeks post-SMART completion ]
    Resilience was measured using the CD-10, a 10-item scale derived from the original, 25-item Connor Davidson Resilience Scale. Respondents can answer each item using a five-point rating ranging from not true at all (0) to true nearly all the time (4). A total CD-RISC score is calculated by summing the score of all 10 items for a total possible score of 40, with a higher score reflecting a greater level of resilience. The CD-10 has a reported Cronbach's alpha of .85 and has demonstrated construct validity.


Secondary Outcome Measures :
  1. Changes in Perceived Stress Scale (PSS) [ Time Frame: Changes in self-reported PSS from Baseline at 12, 18, and 24 weeks post-SMART completion ]
    The PSS was developed to provide both a global measure and a measure for current levels of perceived stress. The PSS is a 14-item instrument, and respondents answer each item on a four-point scale ranging from never (0) to very often (4). An individual's score is calculated by reverse scoring seven items and then summing all item scores, resulting in a score range of 0-56.

  2. Changes in Generalized Anxiety Disorder Scale (GAD-7) [ Time Frame: Changes in self-reported GAD-7 scores from Baseline at 12, 18, and 24 weeks post-SMART completion ]
    Anxiety was measured with the GAD-7. Respondents can answer each item using a four-point scale ranging from not at all (0) nearly every day (3). A total score is calculated by summing the scores of the seven items with possible scores ranging from 0-21. Scores between 5-9 are indicative of mild anxiety, and score between 15-21 are indicative of severe anxiety.

  3. Changes in Quality of Life (QOL) [ Time Frame: Changes in self-reported QOL scores from Baseline at 12, 18, and 24 weeks post-SMART completion ]
    A Linear Analogue Self-Assessment (LASA) QoL measure was used to measure overall quality of life for this study. Participants responded to each item using an 11-pointLikert scale ranging from as bad as it can be (0) to as good as it can be (10).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants must be active component healthcare personnel (any 4XXX Officer or Enlisted AFSC) serving in the U.S. Air Force, assigned to 88th MDG and USAFA at WPAFB, OH.
  • Participants must be ≥ 18 years of age to participate.

Exclusion Criteria:

  • Adults unable or unwilling to provide consent and individuals who are not yet adults will be excluded from this study.
  • Active component Air Force service members without a healthcare AFSC will be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05460663


Locations
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United States, Ohio
Wright-Patterson Air Force Base
Dayton, Ohio, United States, 45433
Sponsors and Collaborators
University of New Mexico
Publications:
5 Department of Defense. (2015, July). Report to Congressional Armed Services Committees: Implementation of recommendations of Institute of Medicine on improvements on certain resilience and prevention programs of the Department of Defense. Retrieved from https://www.pdhealth.mil/report-implementation-recommendations-institute-medicine-improvements-certain-resilience-and
Resilient Option. (n.d.). Resilient option on-line program. Retrieved June 30, 2020 from https://www.resilientoption.com/online-program
Cohen, S., & Williamson, G. (1988). Perecived stress in a probablility sample of the United States. In S. Spacapan & S. Oskamp (Eds.), The social psychology of health (pp. 31-67). Newbury Park, CA: Sage.
Sood, A. (n.d.). Transform course. Retrieved June 30, 2020 from https://www.resiliencetrainer.com/transform-course

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Responsible Party: Stephen H. Hernandez, Associate Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT05460663    
Other Study ID Numbers: FWR20200166E
N20A19IR ( Other Grant/Funding Number: TriService Nursing Research Program )
HRRC 20-522 ( Other Identifier: University of New Mexico Health Science Center HRRC )
First Posted: July 15, 2022    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephen H. Hernandez, University of New Mexico:
Air Force
Military
Stress
Resilience