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临床试验/NCT05700435
NCT05700435终止不适用

Increasing Resiliency in U.S. Air Force Personnel: A Multi-Site Trial

University of New Mexico10 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
46
试验地点
10
主要终点
Changes in Connor-Davidson 10-Item Scale (CD-10)

研究概览

简要总结

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. 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. 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. 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?

Participants will be asked to complete a pre-intervention survey, complete the assigned modality of SMART ( in-person/VTC or CBT), and complete follow-up measurements at 12-, 24-, and 36-weeks post-intervention completion.

Researchers will compare in-person/VTC and CBT groups' measurements to see if a difference in self-reported resilience, stress, anxiety, or quality of life is present pre-intervention. Researchers will compare in-person/VTC and CBT groups' measurements to see if a difference in self-reported resilience, stress, anxiety, or quality of life is present post-intervention.

详细描述

A cluster randomized, pragmatic-explorative two-arm multi-site study is proposed to examine the effectiveness of the Stress Management and Resilience Training (SMART) in increasing the levels of resiliency in active component personnel serving in the U.S. Air Force. The SMART training will be provided through either video-teleconference (VTC), in-person or computer-based training (CBT).The VTC/in-person trainings will be provided to a maximum of 10 individuals per session. Participants in the CBT group will be provided a code to access the training website. A cluster randomization of sites will take place first to place two sites into the self-selection arm, a pragmatic trial where study participants will choose intervention arm and place the other two sites into a randomization-arm in which participants will be randomized into either the VTC or CBT arms. SMART is focused on improving the practices of gratitude, mindful presence, kindness, and developing a resilient mindset.

Four study sites have been identified for the study (Joint Base Andrews, Joint Base San Antonio-Lackland, Nellis Air Force Base, and Wright-Patterson Air Force Base). Simple randomization will be used to assign 2 sites to the randomization arm (Arm 1) and 2 sites to the self-selection arm (Arm 2). Arm randomization will be accomplished in Year1, Month 1. Initial recruitment and randomization will be completed during Month 2 of Year 1 through Month 5 of year 2 of the study.

Arm 1: Randomization: At two study site locations, the investigators will use a ratio of 2:1 to randomly assign participants to the VTC/in-person or CBT training modalities. Therefore, the investigators 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. Randomization will be stratified with respect to military grade and sex to reduce potential confounding due to baseline differences. There may be important differences based upon military grade between the 5 categories of military grade or two categories of participants may select. Under stratification, 1 in every 3 participants will be assigned to complete CBT and the other two participants will be assigned to VTC/in-person training to maintain a balanced distribution between groups.

Arm 2: Self-selection: At two study site locations, the investigators aim to recruit 250 participants in the self-selection arm. Participants will be able to self-select their preferred method of SMART completion (VTC/in-person or CBT training modality).

In order to assure consistent delivery of the intervention, the study PI and the Site AIs will meet to discuss course delivery, make notations, and jointly agree to incorporate recommendations for improving training delivery. At the end of the course, participants will be offered a copy of a Resilience Journal. This book will serve as a review of the resiliency practices and allow participants to track their use of these practices for improving gratitude, mindful presence, kindness, and developing a resilient mindset.

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

入选标准

  • Active Component Air Force personnel assigned or attached to the:
  • 59th 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])
  • 316th Medical Group (Joint Base Andrews, MD [JBA])
  • 99th Medical Group (Nellis AFB, NV)
  • 711th 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

排除标准

  • 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

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, 24, and 36 weeks post-SMART completion

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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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