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临床试验/NCT04809090
NCT04809090已完成不适用

CO-ADAPT: Adaptive Environments and Conversational Agent Based Approaches for Healthy Ageing and Work Ability

Tommaso Ciulli1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月9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
发起方
入组人数
60
试验地点
1
主要终点
An improvement of the scales contained in the OSI questionnaire

研究概览

简要总结

The purpose of this study is to identify effective methodologies to help people improve their ability to adapt to psychological stress.

详细描述

The subjects involved will follow a Stress Management Training (SMT) to learn some techniques to manage stress in the workplace and to increase the effectiveness of the intervention will use an APP and a Conversational Agent (CA) an Artificial Intelligence (AI).

The purpose of the smartphone Application (APP) and CA will be to help people identify their thoughts, help them understand their emotions and the events that generated them.

The data collected and analyzed will be integrated into artificial intelligence to improve understanding of what people are writing.

Based on these analyses, it will be possible to identify the many different variables that interact in cases where a subject shows signs of stress related to adapting to change in the work environment and possible resilience factors that contribute to decreasing the state of stress.

Tests will be administered at the beginning, at the end of the meetings, and 3 months after the end of the sessions. Subjects will be divided into various groups to understand whether APP and CA have a significant impact in increasing psychological well-being and stress coping strategies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •whitecollar
  • •Normal or moderate levels of anxiety and stress
  • •A sufficient level of education to understand study procedures and be able to communicate with site personnel
  • •at least 40 to 70 years old

排除标准

  • •High levels of depression combined with other psychological risk indices (such as suicidal thoughts)
  • •Current use of narcotics or other substances

研究组 & 干预措施

SMT+CA

Experimental

This group will receive a standard 8 SMT (Stress Management Training) psychological interviews and subjects will use an APP together a CA (Conversational Agent) an Artificial Intelligence.

干预措施: SMT (Behavioral)

SMT+CA

Experimental

This group will receive a standard 8 SMT (Stress Management Training) psychological interviews and subjects will use an APP together a CA (Conversational Agent) an Artificial Intelligence.

干预措施: App CA (Device)

SMT Group

Active Comparator

This group will receive a standard 8 SMT (Stress Management Training) psychological interviews

干预措施: SMT (Behavioral)

Only CA

Experimental

This group will receive only an APP together a CA (Conversational Agent) an Artificial Intelligence.

干预措施: App CA (Device)

Waiting-List

No Intervention

This group will not receive any intervention

结局指标

主要结局

An improvement of the scales contained in the OSI questionnaire

时间窗: Up to day 60

The Occupational Stress Indicator (OSI) test is a validated tool to detect sources of stress, coping styles, and the effects of stress on the job.

An average improvement in Perceived Stress Scale (PSS) test scores

时间窗: Up to day 60

The Perceived Stress Scale (PSS) test is a validated test for detecting general stress levels.

次要结局

  • An improvement in levels of general psychological well-being Symptom Check List-90-Revised (SCL-90-R)(Up to day 60)
  • An improvement in levels of GAD-7 test scores(Up to day 60)
  • An improvement in levels of PHQ-8 test scores(Up to day 60)

研究者

发起方
Tommaso Ciulli
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Tommaso Ciulli

Chief Research Officer

Idego srl

研究点 (1)

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