- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06842628
Savor-Aging: the Art of Savoring Positive Emotions
Promoting Positive Emotions and Savoring in the Elderly Through an Online Self-help Intervention: a Controlled Study.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Milan, Italy
- Universita Cattolica del Sacro Cuore
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age over 60
- Adequate understanding of the Italian language
- Possession of a technological tool to be able to access the Internet
Exclusion Criteria:
- Having a score below 26 on the MMSE that will be administered by telephone (Itel-MMSE) before division into the two groups. The Itel-MMSE scores will be converted into MMSE scores.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: E-Savoring Group
Participants will complete the online savoring training for 3 weeks, by doing 2 activities per week.
The exercises will be focused on savoring past, present and future time.
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Participants will follow an e-savoring training for 3 weeks. The first week will be focused on savoring past positive experiences (positive reminiscence and life lessons); the second week will be focused on savoring the present (absorption during an activity and writing a letter of gratitude to a significant person); and the third week will be focused on savoring the future (anticipating positive future events and making kind gestures to a significant person). After each activity, they will be guided to reflect and savor the positive emotions that emerge from the activity. The participants will complete some questionnaires at baseline, post-intervention, and in the one-month follow-up. |
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Active Comparator: Emotional Induction group
Participants will complete six emotional induction exercises.
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Participants will follow a positive emotional induction training for 3 weeks, with 2 exercises per week. The first week, they will listen to a piece of music and watch a video that elicits positive emotions; the second week, they will do an activity that they particularly enjoy in solitude and listen to a narrative about gratitude; the third week, they will listen to a narrative about hope and carry out an activity they like with a loved one. The participants will complete some questionnaires at baseline, post-intervention, and in the one-month follow-up. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction With Life Scale (SWLS)
Time Frame: This questionnaire will be administered in T0 (baseline), T1 (post intervention - after 3 weeks) and T2 (one-month follow up).
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This scale was designed by Diener and colleagues (1985; Italian version: Di Fabio & Busoni, 2009) to investigate life satisfaction and consists of 5 items that can be answered through a 7-step Likert scale ranging from 1 "strongly disagree" to 7 "strongly agree."
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This questionnaire will be administered in T0 (baseline), T1 (post intervention - after 3 weeks) and T2 (one-month follow up).
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Scale of Positive and Negative Experiences (SPANE)
Time Frame: This questionnaire will be administered in T0 (baseline), T1 (post-intervention - after 3 weeks) and T2 (one-month follow-up).
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This self-report scale consists of 12 items and was developed by Diener and colleagues (2010; Italian version: Corno, Molinari, & Baños, 2016) to measure positive and negative affect.
It is composed of two sub-scales: the first refers to positive emotions (6 items: positive, good, pleasant, happy, joyful, satisfied) and the second to negative emotions (6 items: negative, bad, unpleasant, sad, fearful, angry).
It can be answered through a 5-step Likert scale where 1 means "very rarely or never" and 5 means "very often or always."
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This questionnaire will be administered in T0 (baseline), T1 (post-intervention - after 3 weeks) and T2 (one-month follow-up).
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Flourishing Scale (FS)
Time Frame: his questionnaire will be administered in stages T0 (baseline), T1 (post-intervention - after 3 weeks) and T2 (one-month follow-up)
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This scale, developed by Ryan and Deci (2001; Italian version Di Fabio, 2010), aims to investigate the elements that make up psychological well-being, including relationships, self-esteem, life purpose and optimism.
It consists of 8 items and each is positively worded and responses are measured on a 7-step Likert scale, where 1 means "strongly disagree" and 7 means "strongly agree."
The score range is from 8 to 56.
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his questionnaire will be administered in stages T0 (baseline), T1 (post-intervention - after 3 weeks) and T2 (one-month follow-up)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DeJong Gierveld Loneliness Scale
Time Frame: This instrument will be administered in T0 (baseline), T1 (post-intervention - after 3 weeks) and T2 (one-month follow-up).
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This self-report scale, developed by Jong-Gierveld and van Tilburg (2006), assesses through 6 items social loneliness, which occurs when an individual lacks a larger social network, and emotional loneliness, caused by the lack of more intimate relationships.
For each statement, the participant must express his or her degree of agreement on a 5-point Likert scale, where 0 means "Absolutely true" and 4 means "Absolutely not true" A higher score corresponds to a lower perception of social and emotional loneliness.
For the purpose of this study, the items were translated into Italian from the original 6-item English version.
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This instrument will be administered in T0 (baseline), T1 (post-intervention - after 3 weeks) and T2 (one-month follow-up).
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Center for Epidemiologic Studies- Depression Scale (CES-D)
Time Frame: This scale will be administered in T0 (baseline), T1 (post-intervention - after 3 weeks) and T2 (one-month follow up).
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Developed by Radloff (1977), it is a 20-item self-report scale used as a screening tool for depression in the elderly.
For the purpose of this study, the 10-item short version, validated by Andersen and colleagues in 1994, will be used.
Participants will be asked to indicate on a 5-step Likert scale, where 0 corresponds to "never or almost never" (less than 1 day), 1 corresponds to "sometimes or infrequently" (1-2 days), 2 corresponds to "occasionally or for a moderate amount of time" (3-4 days), and 4 corresponds to "most of the time or all of the time" (5-7 days), how they have been feeling in recent weeks.
For the purpose of this study, the items have been translated into Italian.
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This scale will be administered in T0 (baseline), T1 (post-intervention - after 3 weeks) and T2 (one-month follow up).
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Perceived Usefulness and Pleasantness of the Exercises
Time Frame: Immediately after each of the 6 activities of the training
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- Item ad hoc to investigate perceived usefulness and pleasantness of the exercise just done.
After each activity of the training, participants will be asked to rate perceived usefulness and pleasantness through a 7-step Likert scale where 1 corresponds to "very little" and 7 to "very much."
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Immediately after each of the 6 activities of the training
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User Experience
Time Frame: This questionnaire will be administered at T1 (post-intervention - after 3 weeks from baseline).
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A 5-item questionnaire, scored on a 7-step Likert scale, where 1 corresponds to "not at all" and 7 to "very much," will be proposed, aimed at investigating the subject's experience of using the website.
In particular, the degree of aesthetic pleasantness of the website, its functionality, and the ability to engage the user will be investigated.
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This questionnaire will be administered at T1 (post-intervention - after 3 weeks from baseline).
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Perceived Usefulness of the Training
Time Frame: This questionnaire will be administered at T1 (post-intervention - after 3 weeks from baseline).
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The perceived usefulness of the training will be measured through a single item ("Referring to the entire training, how useful do you think it was for you?") that can be answered through a 7-step Likert scale where 1 corresponds to "very little" and 7 to "very much."
In addition, there will be a section where it will be possible to express a reflection regarding the evaluation provided.
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This questionnaire will be administered at T1 (post-intervention - after 3 weeks from baseline).
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Usefulness and Pleasantness of the exercises when the training is completed
Time Frame: These items will be administered at T2 (one-month follow-up).
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Two items ad hoc will be administered to investigate which exercise they found most useful and which was the most enjoyable, specifying their reasons.
In addition, they will be optionally asked to express a general reflection on the exercise they did.
These ad hoc items will be differentiated according to their group.
In fact, for the experimental group, reference will be made to the exercises proposed in the e-savoring training, while for the control group, positive emotion induction activities will be reported.
The aim of these final items is to understand which exercises were found most useful and enjoyable overall by the participants, both in the control and experimental groups, so as to take them into account for future studies.
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These items will be administered at T2 (one-month follow-up).
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Frequency of Use of the exercises learned during the training
Time Frame: This item will be administred in T2 (one-month follow - up).
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Participants will be asked about the frequency with which they have put into practice in the last month the exercises experienced during the training for both the experimental and control groups.
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This item will be administred in T2 (one-month follow - up).
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Collaborators and Investigators
Publications and helpful links
General Publications
- Villani D, Pancini E, Pesce F, Scuzzarella L. Savoring life during pandemic: an online intervention to promote well-being in emerging adults. BMC Psychol. 2023 Jul 4;11(1):196. doi: 10.1186/s40359-023-01225-z.
- Salces-Cubero IM, Ramirez-Fernandez E, Ortega-Martinez AR. Strengths in older adults: differential effect of savoring, gratitude and optimism on well-being. Aging Ment Health. 2019 Aug;23(8):1017-1024. doi: 10.1080/13607863.2018.1471585. Epub 2018 May 21.
- Gaggioli A, Villani D, Serino S, Banos R, Botella C. Editorial: Positive Technology: Designing E-experiences for Positive Change. Front Psychol. 2019 Jul 9;10:1571. doi: 10.3389/fpsyg.2019.01571. eCollection 2019. No abstract available.
- Bryant FB, Osowski KA, Smith JL. Gratitude as a Mediator of the Effects of Savoring on Positive Adjustment to Aging. Int J Aging Hum Dev. 2021 Apr;92(3):275-300. doi: 10.1177/0091415020919999. Epub 2020 May 5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 128/24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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