Work Related StressNCT04809090
CO-ADAPT: Adaptive Environments and Conversational Agent Based Approaches for Healthy Ageing and Work Ability
A study testing SMT and App CA in people with Work Related Stress and Psychologic Adaptation, run by Tommaso Ciulli at 1 site in Italy.
Trial summary
The purpose of this study is to identify effective methodologies to help people improve their ability to adapt to psychological stress. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Work Related Stress, Psychologic Adaptation
- What is being tested?
- SMT and App CA
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 9 Mar 2021to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- High levels of depression combined with other psychological risk indices (such as suicidal thoughts)
- Current use of narcotics or other substances
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to identify effective methodologies to help people improve their ability to adapt to psychological stress.
Read the 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.
- Conditions
- Work Related Stress, Psychologic Adaptation
- Being tested
- SMT, App CA
- Keywords
- work related stress, Psychological Adaptation
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMTBehavioural
Standard 8 SMT (Stress Management Training) psychological interviews.
App CADevice
An APP together a CA (Conversational Agent).
| Study group | Role | What they receive |
|---|---|---|
| SMT Group | Active comparator | This group will receive a standard 8 SMT (Stress Management Training) psychological interviews Receives: Behavioral: SMT |
| 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. Receives: Behavioral: SMT; Device: App CA |
| Only CA | Experimental | This group will receive only an APP together a CA (Conversational Agent) an Artificial Intelligence. Receives: Device: App CA |
| Waiting-List | No intervention | This group will not receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to day 60
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.
Measured: Up to day 60
Secondary outcomes (3)
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.
Measured: Up to day 60
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.
Measured: Up to day 60
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.
Measured: Up to day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start9 Mar 2021
- Primary completion30 Jul 2021
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Work Related StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tommaso Ciulli
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Università degli Studi di Trento
- Responsible party
- Sponsor-investigator, Tommaso Ciulli, Idego srl
- Investigators
- Tommaso Ciulli, Principal investigator, Idego srl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809090
- Sponsor's protocol ID
- COADAPT 2019-2021
- Status last verified
- Jul 2022
- First submitted
- 18 Mar 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical data obtained from psychological testing and socio-demographic data and any feedback collected during the trial will be shared.
Publications
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.
PubMed 36149730
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CO-ADAPT: Adaptive Environments and Conversational Agent Based Approaches for Healthy Ageing and Work Ability
- ClinicalTrials.gov ID
- NCT04809090
- Acronym / sponsor ID
- COADAPT 2019-2021
- Conditions
- Work Related Stress, Psychologic Adaptation
- Keywords
- work related stress, Psychological Adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tommaso CiulliIndustry (pharma, biotech, devices)
- Collaborators
- Università degli Studi di Trento
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- 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).
| Arm | Type | Receives |
|---|---|---|
| SMT Group | Active comparator | Behavioral: SMTThis group will receive a standard 8 SMT (Stress Management Training) psychological interviews |
| SMT+CA | Experimental | Behavioral: SMT, Device: App CAThis 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. |
| Only CA | Experimental | Device: App CAThis group will receive only an APP together a CA (Conversational Agent) an Artificial Intelligence. |
| Waiting-List | No intervention | –This group will not receive any intervention |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- High levels of depression combined with other psychological risk indices (such as suicidal thoughts)
- Current use of narcotics or other substances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMTStandard 8 SMT (Stress Management Training) psychological interviews. | Behavioural | SMT Group, SMT+CA |
| App CAAn APP together a CA (Conversational Agent). | Device | Only CA, SMT+CA |
Primary outcome
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.
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.
3 secondary outcomes
An improvement in levels of general psychological well-being Symptom Check List-90-Revised (SCL-90-R)
Time frame: Up to day 60
An improvement in levels of GAD-7 test scores
Time frame: Up to day 60
An improvement in levels of PHQ-8 test scores
Time frame: Up to day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Derived from this study: PubMed 36149730Danieli 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.
- Individual participant dataSharing planned: Yes. Clinical data obtained from psychological testing and socio-demographic data and any feedback collected during the trial will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tommaso Ciulli principal investigator
Idego srl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMT and App CA in people with Work Related Stress and Psychologic Adaptation, run by Tommaso Ciulli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
An improvement of the scales contained in the OSI questionnaire (time frame: Up to day 60). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04809090, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.