NCT07013357

Brief Summary

This study evaluates a virtual program designed to boost the physical well-being goals, civic engagement, social connection, and anxiety of U.S. adults.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Dec 2025Jul 2026

First Submitted

Initial submission to the registry

June 2, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

December 4, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

June 2, 2025

Last Update Submit

March 24, 2026

Conditions

Keywords

Virtual InterventionSetting GoalsCivic ParticipationSocial ConnectionPhysical Well-beingAnxiety and Distress

Outcome Measures

Primary Outcomes (4)

  • Physical Wellbeing Goal Progress

    How much progress have you made towards this goal? (1, No progress \| 2, Little progress \| 3, Some progress \| 4, Substantial progress \| 5, Goal achieved)

    Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up

  • Civic Participation

    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)

    Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up

  • Social Connection

    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)

    Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up

  • Anxiety

    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 ... * In the past month (Baseline)/Since joining the study, about how often did you feel anxious? * In the past month (Baseline)/Since joining the study, about how often did you feel restless or fidgety? * In the past month (Baseline)/Since joining the study, about how often did you feel that everything took effort? * In the past month (Baseline)/Since joining the study, about how often did you feel so sad that nothing could cheer you up? Mean of 4 item raw score.

    Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up

Secondary Outcomes (6)

  • Attitude toward Health

    Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up

  • Attitude toward Social Connections

    Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up

  • Political Trust

    Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up

  • Attitude toward Problem Solving

    Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up

  • Political Participation

    Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up

  • +1 more secondary outcomes

Other Outcomes (6)

  • Exploratory Outcome: Primary Outcomes Supplement

    Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up

  • Exploratory Outcome: Wellbeing

    Measured at Baseline, Immediate Follow-Up (1 week after the last session), and Three-Month Follow-Up

  • Exploratory outcome: Goal progress

    Three-Month Follow-Up only

  • +3 more other outcomes

Study Arms (2)

Intervention sessions along with GROV engagement

EXPERIMENTAL

Participants in the experimental group will attend three highly structured Virtual intervention sessions, hosted on Zoom and facilitated by trained research team members. They will also be encouraged to sign up for GROV after completing the baseline and are expected to engage with the GROV platform throughout the study period. The GROV platform will serve as a digital community space for ongoing interaction and discussion.

Behavioral: Virtual Community Intervention

Self-help sessions without GROV engagement

ACTIVE COMPARATOR

Participants will attend loosely structured, self-run, virtual group self-help sessions at the same time and duration as intervention sessions. No discussion on the GROV platform for the control group.

Behavioral: Control

Interventions

ControlBEHAVIORAL

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.

Self-help sessions without GROV engagement

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.

Intervention sessions along with GROV engagement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18 years or older
  • Residency: Must live in a U.S. state (including D.C. and U.S. territories)
  • Technology access: Reliable internet, a webcam, and Zoom capability in a private space
  • Language: Able to read and speak English (all materials and sessions are in English)

You may not qualify if:

  • Inability to provide informed consent
  • Under 18 years of age
  • Not living in the U.S.
  • Lack of reliable access to the required technology (e.g., internet-connected device)
  • Unable to read and understand English at the level required for full participation in the study activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Dolores Albarracin, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Cohorts will be randomized to the experimental or control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2025

First Posted

June 10, 2025

Study Start

December 4, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations