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临床试验/NCT03308344
NCT03308344已完成不适用

Promoting Wellbeing in Military Spouses With Training

University of Miami2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2017年10月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
2
主要终点
Change in Sustained Attention to Response Task (SART)

研究概览

简要总结

This project aims to contextualize the delivery of mindfulness training for military spouses and evaluate its effectiveness on measures of executive functions and psychological well-being.

详细描述

In addition to psychological and physical health challenges that military service members face, military deployment is known to have deleterious effects on the entire family unit. The January 2010 issue of the New England Journal of Medicine reported medical data from over 250,000 wives of deployed soldiers. These women suffered from clinically significant levels of anxiety, depression, sleep disturbances, and adjustment disorders. Thus, the psychological profile of military spouses sadly parallels that of the military servicemembers. Unfortunately, the effect of deployment on the psychological health in military spouses is largely unstudied, and very few resilience-building programs are available for military families.

Prior research showed that mindfulness training (MT), as a resilience-building program in civilian and military servicemembers, can effectively protect against degradation in of executive functions (i.e., attention, working memory) and benefit psychological well-being over high-demand intervals. While research evidence mounts that MT is beneficial for service members, there is almost no research examining the impact of MT on military spouses' cognitive functioning and psychological well-being.

The present study aims to investigate if MT may successfully benefit cognitive functioning and psychological well-being in military spouses.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English-speaking
  • Being in a relationship or married to U.S. Army active-duty member or veteran.

排除标准

  • A non-controlled severe medical disease that might interfere with the performance in the study.
  • Any other condition that the investigator might deem problematic for the inclusion of the volunteer in a training study of this nature.

研究组 & 干预措施

Spouse Trainers (MT-ST)

Experimental

Participants will engage in a short-form mindfulness training delivered by their peers who underwent an extensive training practicum.

干预措施: Mindfulness training (Behavioral)

Wait-list control

No Intervention

Participants will be tested before and after a no-training interval and may receive training at a later time.

Mindfulness Expert (MT-ME)

Experimental

Participants will engage in a short-form mindfulness training delivered by an expert mindfulness trainer.

干预措施: Mindfulness training (Behavioral)

结局指标

主要结局

Change in Sustained Attention to Response Task (SART)

时间窗: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.

SART is used to assess attentional performance and mind wandering. The task uses a continuous performance paradigm involving button presses to frequently presented non-targets (numbers 1, 2, 4, 5, 6, 7, 8, and 9) but requires the participants to withhold their motor response to the infrequent target (number 3). The subjective experience of mind wandering during SART is assessed through experience sampling probes randomly presented throughout the task.

Change in Working Memory task (WM)

时间窗: Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.

WMMW is used to assess working memory performance

次要结局

  • Change in Self-Compassion Scale (SCQ)(Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.)
  • Change in Anxiety Sensitivity Index (ASI)(Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.)
  • Change in Perseverative Thoughts Questionnaire (PTQ)(Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.)
  • Practice Logs(Participants will complete paper practice logs tracking their daily practice (i.e., minutes) from the beginning through the study completion, which is an average of 5 weeks after the beginning of the intervention.)
  • Change in Center for Epidemiological Studies Depression Scale (CES-D)(Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.)
  • Demographic Questions(Demographic questions will only be asked at the pre-intervention baseline (testing 1).)
  • Change in Cognitive Failures Questionnaire (CFQ)(Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.)
  • General questions regarding life tendencies(Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.)
  • Change in Positive and Negative Affect Scale (PANAS)(Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.)
  • Change in Perceived Stress Scale (PSS)(Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.)
  • Change in Marital Satisfaction(Change from the pre-intervention baseline (testing 1) to post-intervention (testing 2), which is an average of 5 weeks from the baseline.)
  • Feedback regarding the training(Feedback questions will be asked only at the second testing session (testing 2), which is an average of 5 weeks from the baseline.)
  • Feedback regarding the testing(Feedback questions will be asked only at the second testing session (testing 2), which is an average of 5 weeks from the baseline.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amishi Jha

Associate Professor

University of Miami

研究点 (2)

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