Clinical trial NCT04809090: 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
Overall status: COMPLETED
Phase: NA
Conditions: Work Related Stress
Psychologic Adaptation
Keywords: work related stress
Psychological Adaptation
Lead sponsor: Idego srl
Sponsor class: INDUSTRY
Collaborators: name: Università degli Studi di Trento
First posted: 2021-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: An improvement of the scales contained in the OSI questionnaire
timeFrame: Up to day 60
measure: An average improvement in Perceived Stress Scale (PSS) test scores
timeFrame: Up to day 60
Secondary outcomes:
measure: An improvement in levels of general psychological well-being Symptom Check List-90-Revised (SCL-90-R)
timeFrame: Up to day 60
measure: An improvement in levels of GAD-7 test scores
timeFrame: Up to day 60
measure: An improvement in levels of PHQ-8 test scores
timeFrame: Up to day 60
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Idego srl
Study officials:
affiliation: Idego srl
name: Tommaso Ciulli
role: PRINCIPAL_INVESTIGATOR
References:
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.