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临床试验/NCT05818488
NCT05818488尚未招募不适用

The Effect of a Mind-body Exercise Program on Aspects of Attention in Individuals With Anxiety: Protocol for a Randomized Controlled Trial

Universidade Federal do Rio de Janeiro0 个研究点目标入组 16 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
16
主要终点
Anxiety symptoms

研究概览

简要总结

Mind-body exercises is a non-pharmacological intervention to mental health and can improve interoceptive capacity. Interoceptive is linked to the process of sensory information within the body playing an important role in behavior. Consequently, interoceptive can be modulated by mind-body training through sustained attention to breathing signals, certainty of movements, and also related to activation of brain processes. The present study aimed to evaluation the effect of mind-body in interoceptive capacity in individuals with anxiety. An anamnesis will be performed with demographic data, as well as questions about medications and physical and mental health history. After that, subjects will be randomized into an intervention (one session of mind-body exercises) where they will be asked to sit in a comfortable armchair and remain in a comfortable posture with their eyes closed. A meditation will be guided by an audio through headphones. The audio will last 15 minutes with an initial invitation to centering (full attention to the state of the body and the breath, bringing the attention to the present moment), followed by a body scan considering the seven dimensions of interoceptive capacity (noticing, not being distracted, not worrying, attentional regulation, emotional awareness, self-regulation, and trust) and the passive control group (waiting room), after the intervention the same cognitive tests will be reapplied. Then, the groups will be switched for a crossover analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • clinical diagnosis of anxiety
  • must be able to understand procedures

排除标准

  • Clinical diagnosis of Alzheimer's Disease

结局指标

主要结局

Anxiety symptoms

时间窗: 15 minutes after the intervention

A 14-item Hamilton anxiety scale will be applied, each item is scored from 0 (absent symptoms) to 4 (disabling symptoms)

interoceptive capacity.

时间窗: 15 minutes after the intervention

Evaluated by the interoceptive awareness multidimensional assessment scale, the average of each of the seven dimensions is calculated, the higher the value, the higher the interoceptive capacity

Concentrated attention test

时间窗: 15 minutes after the intervention

The D2-R Concentrated Attention Assessment Test evaluates the ability to concentrate attention, realized by the speed and accuracy with which the individual can discriminate symbols. The test is composed of the letters d or p, and 1 to 4 strokes. In total, get 13 different signs, of which three (d with 2 dashes) represent the target objects, the task is to cancel all the target objects of the test (d with 2 dashes)

Digit Span test

时间窗: 15 minutes after the intervention

Assists in measuring the Distraction Resistance Index. The direct order is applied first applied first, followed by the reverse order, which is administered The direct order is applied first, followed by the reverse order, which is administered regardless if the examinee fails the direct order entirely. Each item is made up of two sets of digits constituting two trials, both of which are applied. attempts, both of which are applied. The maximum score on the subtest is 30 points, where the maximum raw score in direct order is 16 points while in reverse order it is 14 points.

次要结局

未报告次要终点

研究者

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

Erica Simone Rodrigues Moraes

Master Student Mental Health

Universidade Federal do Rio de Janeiro

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