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

NCT04809090 | Completed

• 1 other identifier: COADAPT 2019-2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to identify effective methodologies to help people improve their ability to adapt to psychological stress.

Conditions

Work Related Stress; Psychologic Adaptation

Keywords

work related stress; Psychological Adaptation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• An improvement in levels of general psychological well-being Symptom Check List-90-Revised (SCL-90-R)

  Up to day 60

• An improvement in levels of GAD-7 test scores

  Up to day 60

• An improvement in levels of PHQ-8 test scores

  Up to day 60

Study Arms (4)

SMT Group

ACTIVE COMPARATOR

This group will receive a standard 8 SMT (Stress Management Training) psychological interviews

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.

Behavioral: SMT; Device: App CA

Only CA

EXPERIMENTAL

This group will receive only an APP together a CA (Conversational Agent) an Artificial Intelligence.

Device: App CA

Waiting-List

NO INTERVENTION

This group will not receive any intervention

Interventions

SMT BEHAVIORAL

Standard 8 SMT (Stress Management Training) psychological interviews.

SMT Group; SMT+CA

App CA DEVICE

An APP together a CA (Conversational Agent).

Only CA; SMT+CA

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• High levels of depression combined with other psychological risk indices (such as suicidal thoughts)
• Current use of narcotics or other substances

Sponsors & Collaborators

• Tommaso Ciulli: lead
• Università degli Studi di Trento: collaborator

Study Sites (1)

Idego srl

Rome, 00197, Italy

Location

Related Publications (1)

• 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.

  PMID: 36149730 DERIVED

MeSH Terms

Conditions

Occupational Stress

Condition Hierarchy (Ancestors)

Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Tommaso Ciulli

  Idego srl

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Research Officer

Model Details: 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).

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 22, 2021
• Study Start: March 9, 2021
• Primary Completion: July 30, 2021
• Study Completion: January 30, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available starting from March 2022 for five years.
• 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.

Locations

IT (1)