Clinical trial NCT05460663: Improving Resiliency in Air Force Personnel
Official title: Improving Resiliency in U.S. Air Force Healthcare Personnel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Military Personnel
Health Promotion
Keywords: Air Force
Military
Stress
Resilience
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: A pre/post-training randomized control trial is proposed to examine the effectiveness of the Stress Management and Resilience Training in increasing the levels of resiliency in healthcare personnel serving in the U.S. Air Force.

Intervention Group Assignment. Simple randomization will be utilized for participant assignment into the intervention delivery type (i.e. VTC/in-person group sessions or on-line SMART program). However, participants will be allowed to switch to their desired delivery type. The investigators will track those individuals who chose to switch their randomized assignment. If in-person training becomes feasible and safe during the planned study period, in-person training will be used to supplement or replace VTC. VTC and in-person sessions are provided using the same materials and methods, with the same instructors. Therefore, these are considered to be 'In-Person". Based on our estimation of the sample size needed and potential attrition, the investigators will seek to enroll at least 60 participants into both the VTC and on-line training groups.

The investigators will assess the participants' level of resilience at baseline (enrollment) and at 12, 18, and 24 weeks post SMART training. A second post-test will be attempted for participants who completed the SMART training no later than the end of February 2021 to test for longer-term changes in resilience.

Sample Size. The investigators have conducted a thorough analysis to determine a sample size for this proposed study using information derived from the available literature. The investigators considered changes in CD-RISC scores, the primary outcome, from baseline to 12 weeks post-intervention after receiving SMART training (efficacy). Assuming a pre-post intervention change in CD-RISC scores of 7.7 (SD = 8.7) to be achievable and meaningful. This corresponds to a standardized mean difference between 0.8 and 0.9 SD. Sample size estimates specified a two-tailed alpha error of .05 for either paired or two-sample t-tests or corresponding nonparametric tests (i.e. Wilcoxon signed ranks or rank sum tests) using a range of effect size and power specifications for mean difference.

Based on this analysis, the investigators propose to recruit 120 active duty service members in total. Assuming up to 25% attrition between enrollment and 12 weeks post-intervention follow-up (i.e. a final sample of 90 or 45 per group), this would be sufficient to achieve 90% power to detect a standardized mean difference of 0.5 SD in either a paired t-test or Wilcoxon signed ranks test.

Intervention. SMART is focused on improving the practices of gratitude, mindful presence, kindness, and developing a resilient mindset. In this study, SMART will be offered via a two-hour VTC training provided by the PI or a qualified AI or via a self-paced on-line course. The two-hour VTC will be provided 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 participant 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.

In order to provide the in-person or VTC SMART training, instructors must complete the Transform course in Rochester, MN or at another designated location. The Transform course consists of two days of initial classroom training, at least three months of distance-learning with the developer of the SMART training, and a one-day, end-of-course classroom training.

At the end of the course, participants will be offered a copy of SMART with Dr. Sood: The Four-Module Stress Management and Resilience Training Program at no charge to the participants. This book will serve as a review of the practices and course content for improving gratitude, mindful presence, kindness, and developing a resilient mindset. Additionally, in previous studies, individual participants were contacted by phone four weeks after attending the SMART course. These phone calls were offered to provide participants the opportunity to ask questions and to provide reinforcement of the principles presented during the SMART training. Therefore, study participants will be contacted by the PI two weeks after completing the SMART training by e-mail or phone and asked if participants would like to schedule a follow-up phone meeting. If so, the PI will work to schedule a 30-minute follow-up phone call with participants. At the end of this follow-up session, participants will be provided the option to schedule a final 30-minute follow-up phone call. All phone consultations will be completed before the 12-week follow-up survey. These consultations will be a budget item for the proposed study and provided at no cost to participants.

Procedures. Letters of support have been received from the 88th MDG and USAFA Commanders. These letters of support includes permission to recruit potential participants with posted flyers, newspapers, social media, and informational e-mail announcements. Recruitment materials will be distributed in accordance with any limitations set by the governing IRBs and any future Commander instructions. Study information will be distributed as broadly as possible.

Initial recruitment and randomization will be completed during months 3 through 10 of the study. However, if the study team determines the need to recruit additional participants to ensure adequate statistical power, additional participants will be recruited in month 11 and 12. The study team will work with identified local points of contact to develop a schedule to assure the maximum number of participants can receive information about SMART during a variety of times. If approved by the chain of command, SMART could be completed during the participants' scheduled period of work.

After informed consent is obtained and prior to the delivery of the intervention, a survey will be administered to collect demographic information and baseline measurements with the CD-RISC, PSS, GAD-7, and QoL measures. Participant demographic data, e-mail and phone contact information, and responses to survey items will be initially completed using a paper survey prior to the delivery of SMART and manually entered into the Research Electronic Data Capture System (REDCap; DHHS/NIH/NCRR #8UL1TR000041) by a study team member. If a participant prefers, participants will be provided a web-link to enter the initial information directly into REDCap. REDCap is a secure and encrypted, web-based platform licensed to and managed by the University of New Mexico Health Sciences Center Clinical and Translational Science Center (UNM HSC CTSC). REDCap includes a suite of research tools for project management, survey administration, encrypted database storage and retrieval, and reporting. REDCap will be utilized to administer follow-up surveys at week 12, 18 and 24 (if applicable) after participants complete SMART. The investigators propose to collect the 24-week follow-up survey responses in order to conduct an exploratory analysis to assess the longevity of the effect of SMART on resilience and stress.

Study team members will verify participant data has been entered correctly. Participant e-mail and phone contact information will be used to schedule a follow-up phone call two weeks after completing the SMART training (see intervention). Participants' e-mail contact information will be used be utilized to send follow-up surveys through REDCap. Each survey will take approximately 10 to 15 minutes for participants to complete. If the participant does not respond to the initial REDCap invitation, a maximum of three e-mail reminders (one reminder per week after the initial e-mail is sent) will be sent to complete the survey. If a participant does not complete the survey after all e-mail requests have been sent, a study team member may call the participant to verify their e-mail information and offer to assist the participant with accessing the survey. Because participants' demographic information will be associated with an individual's contact information in REDCap, demographic information will not be requested as part of the surveys at weeks 12, 18 or 24. All data will be de-identified prior to exporting the data for analysis.

Data Analysis. IBM® SPSS® Statistics and R will be used for the statistical analysis. Initial analysis will include descriptive statistics, including means or medians, frequencies and percentages, as appropriate, to characterize demographic status, military grade, duty location, military occupation, and previous deployment status. Cronbach's α will be calculated for each multi-item scale.

The objectives of our analysis include testing and estimating the efficacy of the intervention by comparing pre-post intervention changes (improvements) in the outcome measurements of interest. Analyses will be reported as point estimates with 95% confidence intervals and appropriate estimates of effect size. In this analysis, both the VTC and on-line groups will be analyzed separately and scores will also be pooled together to test for overall intervention effects.

To better understand factors that can impact the intervention effects, the investigators will conduct regression models on the pre-post intervention difference while controlling for demographic characteristics, AFSC, and previous deployment. The investigators will also take into consideration potential clustering effects among the participants from the same organizational unit using random effects (e.g. in regression models).

Changes in resilience, stress, anxiety, and QoL over time will be assessed by separately analyzing changes from baseline to week 12 and to week 24. A joint analysis of the longitudinal trend over the three time points at baseline, 12-week, and 24-week will be completed. The investigators will also consider a joint analysis of resilience, stress, anxiety, or QOL, as well as, analysis for subscales of any specific domain of interest.

Recruitment Plan. Study team members will work to recruit a sample of active component Air Force healthcare personnel. For in-person recruitment sessions, all infection control practices and guidelines required by the installation will be enforced. Informational sessions will be coordinated at the 88th MDG and USAFA to occur at unit or staff meetings and open sessions in prearranged locations. The location, number, and timing of these sessions will be designed to make information about the study accessible to service members on all shifts. Team members will be attired in civilian clothing during these meetings. Informed consent will be completed by a study team member after the completion of the described information sessions with individuals or groups.

Eligibility 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.

Primary outcomes:
measure: Changes in Connor-Davidson 10-Item Scale (CD-10)
timeFrame: Changes in self-reported CD-10 from Baseline at 12, 18, and 24 weeks post-SMART completion
Secondary outcomes:
measure: Changes in Perceived Stress Scale (PSS)
timeFrame: Changes in self-reported PSS from Baseline at 12, 18, and 24 weeks post-SMART completion
measure: Changes in Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: Changes in self-reported GAD-7 scores from Baseline at 12, 18, and 24 weeks post-SMART completion
measure: Changes in Quality of Life (QOL)
timeFrame: Changes in self-reported QOL scores from Baseline at 12, 18, and 24 weeks post-SMART completion
Other outcomes:
Locations:
city: Dayton
country: United States
facility: Wright-Patterson Air Force Base
state: Ohio
Study officials:
affiliation: University of New Mexico College of Nursing
name: Stephen Hernandez, PhD, RN
role: PRINCIPAL_INVESTIGATOR
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