Improving Resiliency in U.S. Air Force Healthcare Personnel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Changes in Connor-Davidson 10-Item Scale (CD-10)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Changes in Connor-Davidson 10-Item Scale (CD-10)
时间窗: 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. The scale was administered to each participants at 4 times: baseline, and 12/18/24 weeks after SMART completion.
次要结局
- 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)
研究者
Stephen H. Hernandez
Associate Professor
University of New Mexico