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临床试验/NCT05133063
NCT05133063Unknown不适用

The Impact of a Gratitude Intervention on Stress Reactivity: A Randomised Control Trial

National University of Ireland, Maynooth1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2021年10月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
130
试验地点
1
主要终点
Systolic Blood pressure reactivity

研究概览

简要总结

This study will employ a randomized mixed between-within experimental stress-testing protocol design. Physiological responses (blood pressure and pulse) will be recorded throughout a baseline, gratitude induction, standard stress-task and recovery period. Participants will be randomly allocated to the experimental (grateful induction) or control condition (neutral induction). Gratitude will be induced by completing a gratitude letter. Demographics will be measured. Psychosocial and health variables will be measured psychometrically at baseline to assess pre-existing levels and after both manipulations (allocated induction and stress task) to monitor expected change over time between conditions. Stress task is an adapted version of the Trier Stress Testing protocol.

详细描述

This study will employ an experimental within-subjects design, in which all participants are exposed to the same task and measures. The study will take place in Cubicle 1 of the Psychology Department, 2nd floor John Hume Building. On entry into the lab, participants will first be required to read the study information sheet and provide informed consent before the formal testing session begins. This standard protocol will comprise of the collection of demographic information, the administration of questionnaires (See supporting documentation) and the monitoring of physiological responses. The monitoring phase involves the following periods, a 20 minute acclimatisation, 10 minute baseline, 8 minute intervention, a 12-stress task and a 10 minute recovery period. During baseline general socio-demographic and lifestyle information will be collected through standard questionnaires (e.g. age, gender, height smoking status, health status and family history pertaining to the cardiovascular system; see supporting documentation). If predictive of blood pressure in the current study all potential confounds will be controlled for statistically in relevant analyses to isolate the contribution of the predictor variables, in this case state and trait gratitude, to the cardiovascular changes. Physiological responses -systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR)- will be measured noninvasively using a GE Dinamap Pro 400 and will be recorded throughout with a standard blood pressure cuff placed over the brachial artery on the participant's non-dominant arm. During the baseline phase psychological variables will be measured psychometrically.

Following this baseline phase, participants will randomly be allocated to either the control or experimental condition. The experimental condition will involve writing a letter thanking someone the participant had not thanked before. The control group will complete a writing exercise wherein they describe the laboratory room. They will have 8 minutes to complete this.

Following this intervention phase, participants will then complete an adapted form of the widely used Trier Social Stress Test, which involves participants subtracting numbers out loud and giving a short speech wherein they describe three of their best and worst characteristics . After the stress task, in the recovery phase participants will answer a series of questions pertaining to how they found the stress task. They will then sit for 8 minutes while recovery measures are taken.

Following this, all participants will be fully debriefed (supporting documentation) and thanked for their participation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years and older
  • Able to consent

排除标准

  • Participants with a diagnosis of cardiovascular disease, hypertension, oran immune disorder
  • Participants who are pregnant.
  • Participants taking medication influencing cardiovascular measures.
  • Participants who consumed alcohol 12 hours before study.
  • Participants who exercised 12 hours before study.
  • Participants who consumed nicotine 2 hours before study.
  • Participants who consumed caffeine 2 hours before study.
  • Participants who ate 1 hour before study.

结局指标

主要结局

Systolic Blood pressure reactivity

时间窗: Measured over the course of the study (1 hour)

This will be done by taking the mean of the baseline measures and subtracting it from the mean of the stress task measures.

Diastolic Recovery

时间窗: Measured over the course of the study (1 hour)

This will be done by taking the mean of the baseline measures and subtracting it from the mean of the recovery measures taken after the stress task.

Heart rate reactivity

时间窗: Measured over the course of the study (1 hour)

This will be done by taking the mean of the baseline measures and subtracting it from the mean of the stress task measures.

Heart Rate Recovery

时间窗: Measured over the course of the study (1 hour)

This will be done by taking the mean of the baseline measures and subtracting it from the mean of the recovery measures taken after the stress task.

Diastolic Blood pressure reactivity

时间窗: Measured over the course of the study (1 hour)

This will be done by taking the mean of the baseline measures and subtracting it from the mean of the stress task measures.

Systolic Recovery

时间窗: Measured over the course of the study (1 hour)

This will be done by taking the mean of the baseline measures and subtracting it from the mean of the recovery measures taken after the stress task.

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

Brian Leavy

Principle Investigator

National University of Ireland, Maynooth

研究点 (1)

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