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OpenTrials
Completed

NCT Number: NCT05116553

Motivational Evaluation and Intervention With Co-Adapt Application for Healthy Ageing

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.

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Key information

Age range

50 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Idego srl

Rome, 00197, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SDT

Behavioral

Standard 2 SDT (Self Determination Theory) psychological interviews.

APP + CA

Device

An APP with a CA (Conversational Agent).

Primary outcomes

  1. Change in levels of General Self-Efficacy Scale-10 (GSE-10)

    Time frame: Up to day 14

    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.

  2. Change in levels of Basic Psychological Need Satisfaction and Frustration Scale (BPNSFS)

    Time frame: Up to day 14

    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.

Secondary outcomes

  1. Change of the scales contained in the Depression Anxiety Stress Scales-21 (DASS-21)

    Time frame: Up to day 14

    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.

  2. Change in World Health Organisation-Five Well-Being Index (WHO-5)

    Time frame: Up to day 14

    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.

Sponsors and collaborators

Lead sponsor

Idego srl

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Nov 11, 2021
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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