CO-ADAPT: Adaptive Environments and Conversational Agent Based Approaches for Healthy Ageing and Work Ability
Primary Purpose
Work Related Stress, Psychologic Adaptation
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
SMT
App CA
Sponsored by
About this trial
This is an interventional treatment trial for Work Related Stress focused on measuring work related stress, Psychological Adaptation
Eligibility Criteria
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
Sites / Locations
- Idego srl
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
No Intervention
Arm Label
SMT Group
SMT+CA
Only CA
Waiting-List
Arm Description
This group will receive a standard 8 SMT (Stress Management Training) psychological interviews
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.
This group will receive only an APP together a CA (Conversational Agent) an Artificial Intelligence.
This group will not receive any intervention
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04809090
First Posted
March 18, 2021
Last Updated
July 18, 2022
Sponsor
Tommaso Ciulli
Collaborators
Università degli Studi di Trento
1. Study Identification
Unique Protocol Identification Number
NCT04809090
Brief Title
CO-ADAPT: Adaptive Environments and Conversational Agent Based Approaches for Healthy Ageing and Work Ability
Official Title
CO-ADAPT: Adaptive Environments and Conversational Agent Based Approaches for Healthy Ageing and Work Ability
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 9, 2021 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
January 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tommaso Ciulli
Collaborators
Università degli Studi di Trento
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to identify effective methodologies to help people improve their ability to adapt to psychological stress.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Work Related Stress, Psychologic Adaptation
Keywords
work related stress, Psychological Adaptation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Subjects who will participate in the study voluntarily will be given some pre-intervention tests (T1) to assess their psychological well-being, to understand the main coping strategies they employ to manage stress, general stress, and the presence of cognitive impairment. Questionnaires will be used to collect data and exclude those subjects who do not meet the inclusion criteria.
Subjects included in the research will be randomly divided into 4 groups, one group will receive a standard 8 SMT (Stress Management Training) psychological interviews, one group will receive 8 (SMT) psychological interviews and subjects will use an APP together with a CA (Conversational Agent), one group will receive only the APP and the CA, one group will be placed in waiting-list.
After the closing of the pathway (T2) the subjects will receive the same questionnaires they received at the beginning and again after 3 months (T3).
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SMT Group
Arm Type
Active Comparator
Arm Description
This group will receive a standard 8 SMT (Stress Management Training) psychological interviews
Arm Title
SMT+CA
Arm Type
Experimental
Arm Description
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.
Arm Title
Only CA
Arm Type
Experimental
Arm Description
This group will receive only an APP together a CA (Conversational Agent) an Artificial Intelligence.
Arm Title
Waiting-List
Arm Type
No Intervention
Arm Description
This group will not receive any intervention
Intervention Type
Behavioral
Intervention Name(s)
SMT
Intervention Description
Standard 8 SMT (Stress Management Training) psychological interviews.
Intervention Type
Device
Intervention Name(s)
App CA
Intervention Description
An APP together a CA (Conversational Agent).
Primary Outcome Measure Information:
Title
An improvement of the scales contained in the OSI questionnaire
Description
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.
Time Frame
Up to day 60
Title
An average improvement in Perceived Stress Scale (PSS) test scores
Description
The Perceived Stress Scale (PSS) test is a validated test for detecting general stress levels.
Time Frame
Up to day 60
Secondary Outcome Measure Information:
Title
An improvement in levels of general psychological well-being Symptom Check List-90-Revised (SCL-90-R)
Description
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.
Time Frame
Up to day 60
Title
An improvement in levels of GAD-7 test scores
Description
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.
Time Frame
Up to day 60
Title
An improvement in levels of PHQ-8 test scores
Description
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.
Time Frame
Up to day 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tommaso Ciulli
Organizational Affiliation
Idego srl
Official's Role
Principal Investigator
Facility Information:
Facility Name
Idego srl
City
Rome
ZIP/Postal Code
00197
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.co-adapt.it/research/
Citations:
PubMed Identifier
36149730
Citation
Danieli M, Ciulli T, Mousavi SM, Silvestri G, Barbato S, Di Natale L, Riccardi G. Assessing the Impact of Conversational Artificial Intelligence in the Treatment of Stress and Anxiety in Aging Adults: Randomized Controlled Trial. JMIR Ment Health. 2022 Sep 23;9(9):e38067. doi: 10.2196/38067.
Results Reference
derived
Learn more about this trial
CO-ADAPT: Adaptive Environments and Conversational Agent Based Approaches for Healthy Ageing and Work Ability
We'll reach out to this number within 24 hrs