MotivationNCT05116553
Motivational Evaluation and Intervention With Co-Adapt Application for Healthy Ageing
A study testing SDT and APP + CA in people with Motivation and Self Efficacy, run by Idego srl at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 50 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Motivation, Self Efficacy
- What is being tested?
- SDT and APP + CA
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteItaly
- Study dates
- 11 Nov 2021to 20 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- whitecollar
- a sufficient level of education to understand study procedures and be able to communicate with site personnel
- 50 to 70 years old
Who cannot join
- current use of narcotics or other substances
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Motivation, Self Efficacy
- Being tested
- SDT, APP + CA
- Keywords
- Motivation, Self efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDTBehavioural
Standard 2 SDT (Self Determination Theory) psychological interviews.
APP + CADevice
An APP with a CA (Conversational Agent).
| Study group | Role | What they receive |
|---|---|---|
| SDT (MI) | Active comparator | This group will receive standard 2 SDT (Self Determination Theory) psychological interviews. Receives: Behavioral: SDT |
| SDT (MI) + CA | Experimental | 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. Receives: Behavioral: SDT; Device: APP + CA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to day 14
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.
Measured: Up to day 14
Secondary outcomes (2)
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.
Measured: Up to day 14
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.
Measured: Up to day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start11 Nov 2021
- Primary completion31 Dec 2021
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MotivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idego srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tommaso Ciulli, Principal investigator, Idego srl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116553
- Sponsor's protocol ID
- COADAPT 2021 T-6.4
- Status last verified
- Jan 2022
- First submitted
- 26 Oct 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical data obtained from psychological testing and socio-demographic data and any feedback collected during the trial will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Evaluation and Intervention With Co-Adapt Application for Healthy Ageing
- ClinicalTrials.gov ID
- NCT05116553
- Acronym / sponsor ID
- COADAPT 2021 T-6.4
- Conditions
- Motivation, Self Efficacy
- Keywords
- Motivation, Self efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Idego srlIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SDT (MI) | Active comparator | Behavioral: SDTThis group will receive standard 2 SDT (Self Determination Theory) psychological interviews. |
| SDT (MI) + CA | Experimental | Behavioral: SDT, Device: APP + CAThis 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. |
Who may qualify
- Ages
- 50 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- whitecollar
- a sufficient level of education to understand study procedures and be able to communicate with site personnel
- 50 to 70 years old
Key exclusion criteria (1 listed)
- current use of narcotics or other substances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SDTStandard 2 SDT (Self Determination Theory) psychological interviews. | Behavioural | SDT (MI), SDT (MI) + CA |
| APP + CAAn APP with a CA (Conversational Agent). | Device | SDT (MI) + CA |
Primary outcome
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.
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.
2 secondary outcomes
Change of the scales contained in the Depression Anxiety Stress Scales-21 (DASS-21)
Time frame: Up to day 14
Change in World Health Organisation-Five Well-Being Index (WHO-5)
Time frame: Up to day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Individual participant dataSharing planned: Yes. Clinical data obtained from psychological testing and socio-demographic data and any feedback collected during the trial will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tommaso Ciulli principal investigator
Idego srl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SDT and APP + CA in people with Motivation and Self Efficacy, run by Idego srl at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in levels of General Self-Efficacy Scale-10 (GSE-10) (time frame: Up to day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.