NCT05460663

Brief Summary

The study purpose 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 COVID-19. 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. Regression models will be conducted 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

October 8, 2024

Completed
Last Updated

October 8, 2024

Status Verified

September 1, 2024

Enrollment Period

1.2 years

First QC Date

July 7, 2022

Results QC Date

December 19, 2023

Last Update Submit

September 27, 2024

Conditions

Keywords

Air ForceMilitaryStressResilience

Outcome Measures

Primary Outcomes (1)

  • Changes in Connor-Davidson 10-Item Scale (CD-10)

    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. The scale was administered to each participants at 4 times: baseline, and 12/18/24 weeks after SMART completion.

    Changes in self-reported CD-10 from Baseline at 12, 18, and 24 weeks post-SMART completion

Secondary Outcomes (3)

  • Changes in Perceived Stress Scale (PSS)

    Changes in self-reported PSS from Baseline at 12, 18, and 24 weeks post-SMART completion

  • Changes in Generalized Anxiety Disorder Scale (GAD-7)

    Changes in self-reported GAD-7 scores from Baseline at 12, 18, and 24 weeks post-SMART completion

  • Changes in Quality of Life (QOL)

    Changes in self-reported QOL scores from Baseline at 12, 18, and 24 weeks post-SMART completion

Study Arms (2)

In-person SMART training

EXPERIMENTAL

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. VTC and in-person sessions were provided using the same materials and methods, with the same instructors. Therefore, these are considered to be 'In-Person".

Behavioral: Stress Management and Resilience Training (SMART)

CBT SMART training

EXPERIMENTAL

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)

Interventions

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) and in-person training or by completion of a self-paced, on-line version completed over a period of four to eight weeks.

CBT SMART trainingIn-person SMART training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wright-Patterson Air Force Base

Dayton, Ohio, 45433, United States

Location

Related Publications (32)

  • Meredith LS, Sherbourne CD, Gaillot SJ, Hansell L, Ritschard HV, Parker AM, Wrenn G. Promoting Psychological Resilience in the U.S. Military. Rand Health Q. 2011 Jun 1;1(2):2. eCollection 2011 Summer.

    PMID: 28083176BACKGROUND
  • Thompson SR, Dobbins S. The Applicability of Resilience Training to the Mitigation of Trauma-Related Mental Illness in Military Personnel [Formula: see text]. J Am Psychiatr Nurses Assoc. 2018 Jan/Feb;24(1):23-34. doi: 10.1177/1078390317739957. Epub 2017 Nov 15.

    PMID: 29139325BACKGROUND
  • Rocklein Kemplin K, Paun O, Godbee DC, Brandon JW. Resilience and Suicide in Special Operations Forces: State of the Science via Integrative Review. J Spec Oper Med. 2019 Summer;19(2):57-66. doi: 10.55460/BQES-AM8H.

    PMID: 31201752BACKGROUND
  • Committee on the Assessment of Resiliency and Prevention Programs for Mental and Behavioral Health in Service Members and Their Families; Board on the Health of Select Populations; Institute of Medicine; Denning LA, Meisnere M, Warner KE, editors. Preventing Psychological Disorders in Service Members and Their Families: An Assessment of Programs. Washington (DC): National Academies Press (US); 2014 Feb 11. Available from http://www.ncbi.nlm.nih.gov/books/NBK222170/

    PMID: 25057692BACKGROUND
  • 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

    BACKGROUND
  • Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.

    PMID: 12964174BACKGROUND
  • Windle G. The contribution of resilience to healthy ageing. Perspect Public Health. 2012 Jul;132(4):159-60. doi: 10.1177/1757913912449572. No abstract available.

    PMID: 22729003BACKGROUND
  • Resilient Option. (n.d.). Resilient option on-line program. Retrieved June 30, 2020 from https://www.resilientoption.com/online-program

    BACKGROUND
  • Loprinzi CE, Prasad K, Schroeder DR, Sood A. Stress Management and Resilience Training (SMART) program to decrease stress and enhance resilience among breast cancer survivors: a pilot randomized clinical trial. Clin Breast Cancer. 2011 Dec;11(6):364-8. doi: 10.1016/j.clbc.2011.06.008. Epub 2011 Aug 10.

    PMID: 21831722BACKGROUND
  • Sood A, Prasad K, Schroeder D, Varkey P. Stress management and resilience training among Department of Medicine faculty: a pilot randomized clinical trial. J Gen Intern Med. 2011 Aug;26(8):858-61. doi: 10.1007/s11606-011-1640-x. Epub 2011 Jan 29.

    PMID: 21279454BACKGROUND
  • Sood A, Sharma V, Schroeder DR, Gorman B. Stress Management and Resiliency Training (SMART) program among Department of Radiology faculty: a pilot randomized clinical trial. Explore (NY). 2014 Nov-Dec;10(6):358-63. doi: 10.1016/j.explore.2014.08.002. Epub 2014 Aug 21.

    PMID: 25443423BACKGROUND
  • Chesak SS, Bhagra A, Schroeder DR, Foy DA, Cutshall SM, Sood A. Enhancing resilience among new nurses: feasibility and efficacy of a pilot intervention. Ochsner J. 2015 Spring;15(1):38-44.

    PMID: 25829879BACKGROUND
  • Magtibay DL, Chesak SS, Coughlin K, Sood A. Decreasing Stress and Burnout in Nurses: Efficacy of Blended Learning With Stress Management and Resilience Training Program. J Nurs Adm. 2017 Jul/Aug;47(7-8):391-395. doi: 10.1097/NNA.0000000000000501.

    PMID: 28727625BACKGROUND
  • Kashani K, Carrera P, De Moraes AG, Sood A, Onigkeit JA, Ramar K. Stress and burnout among critical care fellows: preliminary evaluation of an educational intervention. Med Educ Online. 2015 Jul 23;20:27840. doi: 10.3402/meo.v20.27840. eCollection 2015.

    PMID: 26208706BACKGROUND
  • Stonnington CM, Darby B, Santucci A, Mulligan P, Pathuis P, Cuc A, Hentz JG, Zhang N, Mulligan D, Sood A. A resilience intervention involving mindfulness training for transplant patients and their caregivers. Clin Transplant. 2016 Nov;30(11):1466-1472. doi: 10.1111/ctr.12841. Epub 2016 Oct 14.

    PMID: 27618687BACKGROUND
  • Werneburg BL, Jenkins SM, Friend JL, Berkland BE, Clark MM, Rosedahl JK, Preston HR, Daniels DC, Riley BA, Olsen KD, Sood A. Improving Resiliency in Healthcare Employees. Am J Health Behav. 2018 Jan 1;42(1):39-50. doi: 10.5993/AJHB.42.1.4.

    PMID: 29320337BACKGROUND
  • Dyrbye LN, Shanafelt TD, Werner L, Sood A, Satele D, Wolanskyj AP. The Impact of a Required Longitudinal Stress Management and Resilience Training Course for First-Year Medical Students. J Gen Intern Med. 2017 Dec;32(12):1309-1314. doi: 10.1007/s11606-017-4171-2. Epub 2017 Aug 31.

    PMID: 28861707BACKGROUND
  • Sharma V, Sood A, Prasad K, Loehrer L, Schroeder D, Brent B. Bibliotherapy to decrease stress and anxiety and increase resilience and mindfulness: a pilot trial. Explore (NY). 2014 Jul-Aug;10(4):248-52. doi: 10.1016/j.explore.2014.04.002. Epub 2014 Apr 19.

    PMID: 25037668BACKGROUND
  • Bezdjian S, Schneider KG, Burchett D, Baker MT, Garb HN. Resilience in the United States Air Force: Psychometric properties of the Connor-Davidson Resilience Scale (CD-RISC). Psychol Assess. 2017 May;29(5):479-485. doi: 10.1037/pas0000370. Epub 2016 Aug 8.

    PMID: 27504904BACKGROUND
  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PMID: 6668417BACKGROUND
  • 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.

    BACKGROUND
  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PMID: 16717171BACKGROUND
  • Locke DE, Decker PA, Sloan JA, Brown PD, Malec JF, Clark MM, Rummans TA, Ballman KV, Schaefer PL, Buckner JC. Validation of single-item linear analog scale assessment of quality of life in neuro-oncology patients. J Pain Symptom Manage. 2007 Dec;34(6):628-38. doi: 10.1016/j.jpainsymman.2007.01.016. Epub 2007 Aug 20.

    PMID: 17703910BACKGROUND
  • Hernandez SHA, Morgan BJ, Parshall MB. Treatment-Seeking Beliefs and Behaviors in Air Force Nursing Personnel. Mil Med. 2017 Jul;182(7):e1687-e1692. doi: 10.7205/MILMED-D-16-00397.

    PMID: 28810957BACKGROUND
  • Pietrzak RH, Goldstein MB, Malley JC, Rivers AJ, Johnson DC, Southwick SM. Risk and protective factors associated with suicidal ideation in veterans of Operations Enduring Freedom and Iraqi Freedom. J Affect Disord. 2010 Jun;123(1-3):102-7. doi: 10.1016/j.jad.2009.08.001. Epub 2009 Oct 12.

    PMID: 19819559BACKGROUND
  • Hernandez SH, Morgan BJ, Parshall MB. Resilience, Stress, Stigma, and Barriers to Mental Healthcare in U.S. Air Force Nursing Personnel. Nurs Res. 2016 Nov/Dec;65(6):481-486. doi: 10.1097/NNR.0000000000000182.

    PMID: 27529539BACKGROUND
  • Maguen S, Turcotte DM, Peterson AL, Dremsa TL, Garb HN, McNally RJ, Litz BT. Description of risk and resilience factors among military medical personnel before deployment to Iraq. Mil Med. 2008 Jan;173(1):1-9. doi: 10.7205/milmed.173.1.1.

    PMID: 18251325BACKGROUND
  • Sood, A. (n.d.). Transform course. Retrieved June 30, 2020 from https://www.resiliencetrainer.com/transform-course

    BACKGROUND
  • Pietrzak RH, Southwick SM. Psychological resilience in OEF-OIF Veterans: application of a novel classification approach and examination of demographic and psychosocial correlates. J Affect Disord. 2011 Oct;133(3):560-8. doi: 10.1016/j.jad.2011.04.028. Epub 2011 May 31.

    PMID: 21624683BACKGROUND
  • Singh JA, Satele D, Pattabasavaiah S, Buckner JC, Sloan JA. Normative data and clinically significant effect sizes for single-item numerical linear analogue self-assessment (LASA) scales. Health Qual Life Outcomes. 2014 Dec 18;12:187. doi: 10.1186/s12955-014-0187-z.

    PMID: 25519478BACKGROUND
  • Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

    PMID: 18929686BACKGROUND
  • Campbell-Sills L, Stein MB. Psychometric analysis and refinement of the Connor-davidson Resilience Scale (CD-RISC): Validation of a 10-item measure of resilience. J Trauma Stress. 2007 Dec;20(6):1019-28. doi: 10.1002/jts.20271.

    PMID: 18157881BACKGROUND

Limitations and Caveats

We cannot preclude self-selection bias. Although invitations to participate and reminder e-mails were sent to participants, there was variable completion rates of follow-up surveys. In-person SMART was conducted via VTC and small face-to-face classes. Although the content of face-to-face delivery of SMART was identical to VTC, we do not know if a difference in teaching effectiveness due to the difference in delivery method was present. We were unable to recruit 90 participants, as planned.

Results Point of Contact

Title
Stephen H. A. Hernandez, PhD, RN, FAAN
Organization
University of New Mexico, College of Nursing

Study Officials

  • Stephen Hernandez, PhD, RN

    University of New Mexico College of Nursing

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 7, 2022

First Posted

July 15, 2022

Study Start

December 4, 2020

Primary Completion

February 1, 2022

Study Completion

May 31, 2022

Last Updated

October 8, 2024

Results First Posted

October 8, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations