Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04809090
Other study ID # COADAPT 2019-2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT05472935 - Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT05946018 - Physiatrist Ergonomic Intervention on Work Related Musculoskeletal Pain in Surgeons N/A
Completed NCT04805294 - Pediatrician Wellbeing Program
Recruiting NCT05100108 - A Dog-assisted Therapy to Reduce Burnout Among Professionals Working in a School for Special Education N/A
Completed NCT05766852 - Potential Benefits of the Somatic Psychoeducational Intervention N/A
Not yet recruiting NCT04752683 - Validation of an Employee Remote Workplace Stress Measure Embedded Within a Novel Employee Wellbeing App
Recruiting NCT06302764 - Emergency Medical Staff Workload Analysis
Completed NCT05150574 - HRV and Coaching Preparation Phase Study Phase 1
Recruiting NCT06035705 - Patient Acuity in Somatic In-patient Care
Active, not recruiting NCT04398407 - Testing the Effectiveness of Mainstream Management Tools to Increase Organizational Commitment and Job Satisfaction and Decrease Turnover Among Peer Providers N/A
Completed NCT06228495 - mHealth Intervention for Work-Related Stress N/A
Recruiting NCT05791825 - Evaluation of the CHIME Intervention for Improving Early Head Start/Head Start Educator Well-being N/A
Enrolling by invitation NCT05757050 - Mental Balance Study N/A
Active, not recruiting NCT06354335 - Impact of a Major Organizational Change on Employee Productivity and Mental Health
Active, not recruiting NCT04247880 - The Use of Mentoring to Promote Well-being for Female SMART Members N/A
Enrolling by invitation NCT04775524 - AWARENESS Trial (AWARENESS) of Storytelling Through Music in Healthcare Workers N/A
Completed NCT04050241 - Workload in Anesthesiological Practice N/A
Recruiting NCT06111001 - NHS Staff Digital Wellbeing Via AirEmail N/A
Recruiting NCT06158204 - Improving Metabolic & Mental Health in Female Healthcare Shift Workers N/A