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OpenTrials
Completed

NCT Number: NCT04809090

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

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

Completed

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Idego srl

Rome, 00197, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

SMT

Behavioral

Standard 8 SMT (Stress Management Training) psychological interviews.

App CA

Device

An APP together a CA (Conversational Agent).

Primary outcomes

  1. An improvement of the scales contained in the OSI questionnaire

    Time frame: 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.

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

    Time frame: Up to day 60

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

Secondary outcomes

  1. An improvement in levels of general psychological well-being Symptom Check List-90-Revised (SCL-90-R)

    Time frame: Up to day 60

    The Symptom Check List-90-Revised (SCL-90-R) test is a validated test for the detection of some psychological scales such as anxiety, depression and the level of general psychological well-being.

  2. An improvement in levels of GAD-7 test scores

    Time frame: Up to day 60

    The GAD-7 test is a validated test for the detection of generalized anxiety disorder. GAD-7 total score for the seven items ranges from 0 to 21. Higher scores mean worse outcome.

  3. An improvement in levels of PHQ-8 test scores

    Time frame: Up to day 60

    The PHQ-8 test is a validated test for the detection of depression. The PHQ-8 is scored just like the PHQ-9 and its total score ranges from 0 to 24. Higher scores mean worse outcome.

Sponsors and collaborators

Lead sponsor

Tommaso Ciulli

Industry

Collaborators

  • Università degli Studi di Trento

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 22, 2021
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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