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

July 18, 2022 updated by: Tommaso Ciulli
The purpose of this study is to identify effective methodologies to help people improve their ability to adapt to psychological stress.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00197
        • Idego srl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SMT Group
This group will receive a standard 8 SMT (Stress Management Training) psychological interviews
Behavioral: SMT
Standard 8 SMT (Stress Management Training) psychological interviews.
Experimental: SMT+CA
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.
Behavioral: SMT
Standard 8 SMT (Stress Management Training) psychological interviews.
Device: App CA
An APP together a CA (Conversational Agent).
Experimental: Only CA
This group will receive only an APP together a CA (Conversational Agent) an Artificial Intelligence.
Device: App CA
An APP together a CA (Conversational Agent).
No Intervention: Waiting-List
This group will not receive any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to day 60
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.
Up to day 60

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to day 60
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.
Up to day 60
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.
Up to day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tommaso Ciulli

Collaborators

Università degli Studi di Trento

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2021

Primary Completion (Actual)

July 30, 2021

Study Completion (Actual)

January 30, 2022

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

March 18, 2021

First Posted (Actual)

March 22, 2021

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COADAPT 2019-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Clinical data obtained from psychological testing and socio-demographic data and any feedback collected during the trial will be shared.

IPD Sharing Time Frame

Data will be available starting from March 2022 for five years.

IPD Sharing Access Criteria

The data available on the research website (www.co-adapt.it). A specific page will be create where researchers can download the raw data to perform any analysis.

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Work Related Stress

Clinical Trials on SMT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe