University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT07013357
This study evaluates a virtual program designed to boost the physical well-being goals, civic engagement, social connection, and anxiety of U.S. adults.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
This single-blind, cluster randomized controlled trial aims to develop a virtual intervention designed to support US adults who wish to work with others to achieve physical wellbeing goals, improve social connectedness, promote community engagement, and reduce anxiety. Research coordinators randomize 10 participants to facilitator-led intervention sessions, and 10 to self-run discussion sessions by assigning random computer generated codes, sorting in ascending order, and alternating "control" and "experimental" assignments. This project is funded by the Annenberg Endowment of the Division of Communication Science.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will attend three Virtual intervention sessions, hosted on Zoom and facilitated by trained research team members. Co-facilitators (comprised of lab staff) will also be there to ensure no technical difficulties and record the meeting. Sessions will be held at the same time each week for three weeks. After each session, facilitators will be assessed for fidelity based on feedback from the session quality assessment survey.
Every session will have its primary focus, respectively:
Session 1 will focus on fostering social connections. Session 2 will focus on setting mental/physical wellbeing goals. Session 3 will focus on pursuing similar goals for their community.
During the sessions, participants will work together and offer mutual support under the direction of the facilitator. Furthermore, facilitators will communicate with participants between sessions to check in on their progress toward their goals.
Participants will attend three 90-minute Virtual self-help sessions, hosted on Zoom. Sessions will be held at the same time each week for three weeks, in parallel to the experimental condition. First, the co-facilitator will let participants into the Zoom room and begin the recording. After they introduce themselves, they will remain on mute/camera off for the entire meeting to handle technical difficulties or intervene when violations occur, for example, using inappropriate language. Co-facilitators may also interact with participants through the chat to provide referrals. Then, the discussion leader will explain their role and ask everyone to introduce themselves. As a group, they will set some ground rules. Then, the discussion leaders will guide the discussion, using the Self-Help Session Manual as a reference, which provides structure and reference questions to facilitate discussion. Beyond this guideline, participants can discuss anything they decide as a group.
Time frame: Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up
How much progress have you made towards this goal? (1, No progress | 2, Little progress | 3, Some progress | 4, Substantial progress | 5, Goal achieved)
Time frame: Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up
In the past month (baseline)/since the beginning of this study (follow-up) have you participated in or taken action through a group or organization to improve yourself, your community, or help others? (0, No | 1, Yes)
Time frame: Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up
In the past month (baseline)/Since joining the study (follow-up), have you started a new social connection or re-established an old one? (0, No | 1, Yes)
Time frame: Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up
On a scale from 1, None of the time | 2, A little of the time | 3, Some of the time | 4, Most of the time | 5, All of the time ...
Mean of 4 item raw score.
Time frame: Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up
I feel confident in my ability to seek help for my health problems. I feel confident in my ability to solve my health problems. I feel comfortable with challenges related to solving my health problems.
Response Scale: 1, Not confident at all | 2, Slightly | 3, Somewhat | 4, Confident | 5, Very confident Score: Mean of 1-5 Scores
Time frame: Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up
How easy is it to get help from members of your community if you need it? 1, Impossible | 2, Difficult | 3, Possible | 4, Easy | 5, Very easy How often do you feel that there are people you can turn to? 1, Never | 2, Sometimes | 3, Often | 4, Most of the time | 5, Always To what extent were you hesitant to tell others what you want or need from them? 1, Very much | 2, Quite a bit | 3, Somewhat | 4, A little | 5, Not at all To what extent are you willing to seek support from others if you need it? 1, Not at all | 2, A little | 3, Somewhat | 4, Quite a bit | 5, Very much When you feel afraid, anxious, or uncertain, how often do you seek help or support from others in your life (e.g., reaching out to neighbors, joining support groups, attending social events?) 1, Never | 2, Sometimes | 3, Often | 4, Most of the time | 5, Always
Score: Mean of 1-5 Scores
Time frame: Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up
How much can you trust the federal government to do what is right regarding the social changes you want to make? (1, No trust | 2, Little | 3, Some | 4, Quite a lot | 5, A great deal ) How often can you trust your state government to do what is right when it comes to handling the social changes you want to make? (1, Never | 2, Rarely | 3, Sometimes | 4, Often | 5, Always ) How often can you trust your local government to do what is right when it comes to handling the social changes you want to make? (1, Never | 2, Rarely | 3, Sometimes | 4, Often | 5, Always )
Score: Mean of 1-5 scores
Time frame: Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up
When I face problems, I am confident that I can solve them. How confident do you feel in your ability to achieve your goals? How comfortable are you with taking on new challenges? Response Scale: 1, Almost never | 2, Rarely | 3, Sometimes | 4, Often | 5, Almost always Score: Mean of 1-5 Scores
Time frame: Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up
How likely or unlikely are you to vote in the next local, state, or national elections? (1, Extremely unlikely | 2, Unlikely | 3, Neutral | 4, Likely | 5, Extremely likely)
Time frame: Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up
I feel responsible for the well-being of others in groups I belong to I am committed to help others in groups I belong to I believe that all citizens have a responsibility to their fellow citizens I believe that it is important to be informed of societal issues Response Scale: 1, Strongly disagree | 2, Disagree | 3, Neither | 4, Agree | 5, Strongly agree In the past month (Baseline)/Since the beginning of the study (follow-up), how concerned, if at all, were you about others with whom you are connected? Response Scale: 1, Not at all | 2, Slightly | 3, Moderately | 4, Very | 5, Extremely Score: Mean of 1-5 Scores
Time frame: Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up
Physical well-being goal: In the past month, what is a physical well-being goal (e.g., going to the gym, doctor's visit, sports, etc.) you've set for yourself? (Open text).
Civic participation supplement: If Yes to civic action - Were your interactions primarily in person, primarily online/phone, or both? (1, In person | 2, Online/phone | 3, Both).
In the past month (Baseline) / since the beginning of this study (follow-up) / In the last three months (3MFU), how often did you participate in group/organization activities? (0-7 days per week).
Do you currently belong to any of these groups? (Select all that apply: Professional/work-related organizations; Religious/spiritual groups; Parenting/educational/learning groups; Neighborhood/local associations; Political/advocacy organizations; Charitable organizations; Support/self-help groups; Other).
Social connection supplement: If Yes to new social connection - How many connections have you made? (Numeric)
Time frame: Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up
Subjective well-being: In the past month (Baseline) / Since joining the study (IMFU) / In the last three months (3MFU): I have felt cheerful and in good spirits; I have felt calm and relaxed; I have felt active and vigorous; I woke up feeling fresh and rested; My daily life has been filled with things that interest me.
Response Scale: 1, None of the time | 2, A little of the time | 3, Some of the time | 4, Most of the time | 5, All of the time.
Score: Mean of 5-item raw scores.
Subjective health [3MFU only]: In general, how would you rate your health today? (1, Very good | 2, Good | 3, Moderate | 4, Bad | 5, Very bad).
Self-care behaviors [3MFU only]: In the last three months, how many hours of sleep did you typically get each night? (Numeric). How frequently did you shower/take a bath? Cook for yourself? Clean your space? (1, More than once a day | 2, Every day | 3, Every other day | 4, Once a week | 5, Less than once a week).
Time frame: Three-Month Follow-Up only
In the last three months, how much progress have you made towards this goal? (1, No progress | 2, Little progress | 3, Some progress | 4, Substantial progress | 5, Goal achieved). Assessed for: (a) the goal set at Baseline; (b) the goal set at Immediate Follow-Up; (c) a goal mentioned during the discussion sessions; and (d) any other goal the participant identifies. Score: Individual item rating (1-5) per goal.
Time frame: Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up
Social support received:
On a scale from 1, None of the time | 2, A little of the time | 3, Some of the time | 4, Most of the time | 5, All of the time ...
Social support offered (Three Month Follow Up only):
In the last three months, have you supported (emotionally or with concrete actions) somebody who has a health issue? (Yes|No)
Time frame: Three-Month Follow-Up only
In the last three months, have you visited any of the following for yourself? (Select all that apply): Primary care / general practitioner; Mental health professional (e.g., therapist, psychologist, psychiatrist); Specialist (e.g., cardiologist, dermatologist); Emergency room or urgent care; Dentist or orthodontist; Other healthcare provider; I have not visited any healthcare provider in the last three months. In the last three months, have you received or are you currently receiving mental health treatment or therapy? (0, No | 1, Yes)
Time frame: Three-Month Follow-Up only
In the last three months, how often did you refrain from using hurtful language toward or about: people with substance use disorder; people with mental health conditions; people of a different race or ethnicity; people of a different political affiliation; people of a different religion; other groups? Response Scale: 1, Never | 2, Rarely | 3, Sometimes | 4, Often | 5, Always. Score: Mean of item raw scores.
University of Pennsylvania
Other
Digital, Community-Advised, Social Action Cluster-Randomized Trial to Increase Civic Participation and Social Connection in the US
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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