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

• Sponsor: Idego srl (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05116553
• Collaborator: (none)
• Enrollment: 74
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.3
• Patients Per Site Per Month: 32.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Motivation; Self Efficacy	Behavioral: SDT; Device: APP + CA	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Pre-intervention test will be administered to the participants (T1) to assess their psychological well-being, motivation, awareness of change, self-confidence and self-efficacy. Participants will be randomly divided into two group: the experimental group will receive the standard 2 Self Determination Theory (SDT) psychological interviews with the support of the APP with the Conversational Agent (CA), while the control group will receive the 2 SDT (Self Determination Theory) psychological interviews. At the end of the pathway post-intervention test (T2) will be administered to the participants with the same questionnaire of the beginning.Pre-intervention test will be administered to the participants (T1) to assess their psychological well-being, motivation, awareness of change, self-confidence and self-efficacy. Participants will be randomly divided into two group: the experimental group will receive the standard 2 Self Determination Theory (SDT) psychological interviews with the support of the APP with the Conversational Agent (CA), while the control group will receive the 2 SDT (Self Determination Theory) psychological interviews. At the end of the pathway post-intervention test (T2) will be administered to the participants with the same questionnaire of the beginning.
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Motivational Evaluation and Intervention With Co-Adapt Application for Healthy Ageing
• Actual Study Start Date: Nov 11, 2021
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Jan 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: SDT (MI) This group will receive standard 2 SDT (Self Determination Theory) psychological interviews.	Behavioral: SDT; Standard 2 SDT (Self Determination Theory) psychological interviews.
Experimental: SDT (MI) + CA This group will receive standard 2 SDT (Self Determination Theory) psychological interviews; moreover they will use an APP with a CA (Conversational Agent), an Artificial Intelligence.	Behavioral: SDT; Standard 2 SDT (Self Determination Theory) psychological interviews.; Device: APP + CA; An APP with a CA (Conversational Agent).

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 67 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Idego srl	Rome		Italy	00197

Sponsors and Collaborators

• Idego srl

Investigators

• Principal Investigator: Tommaso Ciulli, Idego srl

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Idego srl
• ClinicalTrials.gov Identifier: NCT05116553
• Other Study ID Numbers: COADAPT 2021 T-6.4
• First Posted: Nov 11, 2021
• Last Update Posted: Jan 21, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Idego srl: Motivation; Self efficacy

Study Results

No Results Posted as of Jan 21, 2022