NCT05700435

Brief Summary

The goal of this clinical trial is to examine the effectiveness of the Stress Management and Resilience Training (SMART) in increasing resilience in a population of U.S. Air Force personnel at Joint Base Andrews, Joint Base San Antonio-Lackland, Nellis Air Force Base, and Wright-Patterson Air Force Base. The main questions it aims to answer are:

  1. 1.When delivered in real-world conditions, to what extent does SMART increase levels of resiliency and decrease levels of stress in a sample of active component U.S. Air Force personnel?
  2. 2.Does SMART have a sustained effectiveness from baseline to 12, 24 and 36-weeks after training completion in a sample of active component U.S. Air Force personnel?
  3. 3.Does SMART provided via an in-person/video-teleconference (VTC) or Computer-Based Training (CBT) modality demonstrate equivalent effectiveness in increasing resilience and decreasing stress in active component Air Force personnel?

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

January 12, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

1.8 years

First QC Date

January 12, 2023

Last Update Submit

August 20, 2025

Conditions

Keywords

militaryAir Forceresiliencestress

Outcome Measures

Primary Outcomes (1)

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

    Resilience will be 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.

    Changes in self-reported CD-10 from Baseline at 12, 24, and 36 weeks post-SMART completion

Secondary Outcomes (3)

  • Changes in Perceived Stress Scale (PSS)

    Changes in self-reported PSS from Baseline at 12, 24, and 36 weeks post-SMART completion

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

    Changes in self-reported GAD-7 from Baseline at 12, 24, and 36 weeks post-SMART completion

  • Changes in Quality of Life (QOL)

    Changes in self-reported QOL scores from Baseline at 12, 24, and 36 weeks post-SMART completion

Study Arms (2)

Randomization

EXPERIMENTAL

At two study sites, we will randomly assign participants to the VTC/in-person group or CBT group using a ratio of 2:1 to assign participants to the VTC/in-person or CBT training modalities. We anticipate 84 participants (42 per site) will be assigned to the CBT modality and 168 (84 per site) will be assigned to the VTC/in-person modality.

Behavioral: Stress Management and Resilience Training

Self-selection

ACTIVE COMPARATOR

At two study sites, participants will be able to self-select which SMART training modality they will complete (VTC/in-person or CBT).We aim to recruit 250 participants in the self-selection arm.

Behavioral: Stress Management and Resilience Training

Interventions

The Stress Management and Resilience Training (SMART) program focuses on improving the practices of gratitude, mindful presence, kindness, and developing a resilient mindset. 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. The modalities VTC and in-person are the two intervention conditions.

RandomizationSelf-selection

Eligibility Criteria

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

You may qualify if:

  • Active Component Air Force personnel assigned or attached to the:
  • th Medical Wing, including the 59th Medical Operations Group, 59th Medical Support Group, 559th MDG, 959th MDG, 59th Training Group, and 59th Dental Group (Joint Base San Antonio-Lackland, TX \[JBSA-L\])
  • th Medical Group (Joint Base Andrews, MD \[JBA\])
  • th Medical Group (Nellis AFB, NV)
  • th Human Performance Wing (HPW), including the U.S. Air Force School of Aerospace Medicine (USAFSAM), and the 88th Medical Group (MDG) at Wright-Patterson Air Force Base, OH (WPAFB)
  • Able to provide informed consent
  • ≥ 18 years of age

You may not qualify if:

  • Personnel at the above locations who are not Active Component Air Force personnel (e.g. individuals on temporary duty \[TDY\] at the location or civilian personnel):
  • Unable to provide informed consent
  • Basic Military Trainees (BMTs)
  • \< 18 years of age
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Mountain Home Air Force Base

Mountain Home, Idaho, 83648, United States

Location

Johns Hopkins University, School of Nursing (Joint Base Andrews)

Baltimore, Maryland, 21205, United States

Location

University of Nevada Las Vegas, School of Nursing (Nellis Air Force Base)

Las Vegas, Nevada, 89154, United States

Location

Wright-Patterson Air Force Base

Dayton, Ohio, 45433, United States

Location

Joint Base San Antonio-Lackland

San Antonio, Texas, 78236, United States

Location

Related Publications (15)

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Campbell-Sills L, Flynn PJ, Choi KW, Ng THH, Aliaga PA, Broshek C, Jain S, Kessler RC, Stein MB, Ursano RJ, Bliese PD. Unit cohesion during deployment and post-deployment mental health: is cohesion an individual- or unit-level buffer for combat-exposed soldiers? Psychol Med. 2022 Jan;52(1):121-131. doi: 10.1017/S0033291720001786. Epub 2020 Jun 10.

    PMID: 32517825BACKGROUND
  • Rubin, D.B., Causal inference using potential outcomes. Journal of the American Statistical Association, 2005. 100(469): p. 322-331.

    BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Stephen Hernandez, PhD

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Cluster randomized, pragmatic-explorative two-arm multi-site study. Arm 1: Randomization Arm 2: Self-selection
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 26, 2023

Study Start

October 1, 2023

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations