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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05116553
Other study ID # COADAPT 2021 T-6.4
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 11, 2021
Est. completion date January 20, 2022

Study information

Verified date January 2022
Source Idego srl
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to identify effective methodologies to help people to improve their awareness of change, motivation, self-confidence and self-efficacy, compliance in behavioral change and psychological well-being.


Description:

Subjects involved will have the opportunity to partecipate in a two-weeks course: two SDT (Self Determination Theory) psychological interviews are scheduled (1 per week) to help the participant increase his motivation and awareness about the problem reported during the counseling session. For this purpose, the use of an APP with a CA (Conversational Agent) will be implemented as a support to help people to identify one's thoughts and emotional states as well as increase their awareness about themselves. Test will be administered at the beginning (T1) and at the end of the meetings (T2). Participants will be randomly divided into one of two groups to understand whether APP and CA has a significant impact in increasing motivation and awareness of the need for a pathway with a professional.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date January 20, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 67 Years
Eligibility Inclusion Criteria: - whitecollar - a sufficient level of education to understand study procedures and be able to communicate with site personnel - 50 to 70 years old Exclusion Criteria: - current use of narcotics or other substances

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SDT
Standard 2 SDT (Self Determination Theory) psychological interviews.
Device:
APP + CA
An APP with a CA (Conversational Agent).

Locations

Country Name City State
Italy Idego srl Rome

Sponsors (1)

Lead Sponsor Collaborator
Idego srl

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in levels of General Self-Efficacy Scale-10 (GSE-10) GSE-10 test is a validated test for the detection of general self efficacy. The total score ranges from 10 to 40. Higher scores mean better outcomes. Up to day 14
Primary Change in levels of Basic Psychological Need Satisfaction and Frustration Scale (BPNSFS) The BPNSFP-24 test is a validated test for the detection of the satisfaction and frustration of the primary needs: autonomy, relatedness and competence (according to SDT Theory). The total score ranges from 24 to 120. Higher scores mean better outcomes. Up to day 14
Secondary Change of the scales contained in the Depression Anxiety Stress Scales-21 (DASS-21) The DASS-21 test is a validated test for the detection of depression, anxiety and stress. The total score of each subscale ranges from 0 to 42. Higher scores mean worse outcomes. Up to day 14
Secondary Change in World Health Organisation-Five Well-Being Index (WHO-5) The WHO-5 test is a validated test for the detection of psychological wellbeing. The total score ranges from 0 to 100. Higher scores mean better outcomes. Up to day 14
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