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

Work Related Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04809090
• Other study ID #: COADAPT 2019-2021
• Status: Completed
• Phase: N/A
• Start date: March 9, 2021
• Est. completion date: January 30, 2022

Study information

• Verified date: July 2022
• Source: Idego srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 30, 2022
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Occupational Stress
• Psychologic Adaptation
• Work Related Stress

Intervention

Behavioral:
• SMT
Standard 8 SMT (Stress Management Training) psychological interviews.

Device:
• App CA
An APP together a CA (Conversational Agent).

Locations

Country	Name	City	State
Italy	Idego srl	Rome

Sponsors (2)

Lead Sponsor	Collaborator
Tommaso Ciulli	Università degli Studi di Trento

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	An improvement of the scales contained in the OSI questionnaire	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.	Up to day 60
Primary	An average improvement in Perceived Stress Scale (PSS) test scores	The Perceived Stress Scale (PSS) test is a validated test for detecting general stress levels.	Up to day 60
Secondary	An improvement in levels of general psychological well-being Symptom Check List-90-Revised (SCL-90-R)	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.	Up to day 60
Secondary	An improvement in levels of GAD-7 test scores	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.	Up to day 60
Secondary	An improvement in levels of PHQ-8 test scores	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.	Up to day 60