NCT06340841

Brief Summary

The goal of this substudy is to determine if a brief single-session-intervention (SSI) coupled with different incentive strategies to support engaging in wellness-related activities.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
25mo left

Started Feb 2024

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Feb 2024May 2028

Study Start

First participant enrolled

February 12, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 22, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Expected
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

March 22, 2024

Last Update Submit

March 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Activity Completion

    Number of wellness activities completed

    up to 6 months

Secondary Outcomes (5)

  • Depression, Anxiety, Stress Scale - 21

    up to 6 months

  • Depression, Anxiety, Stress Scale - 21

    up to 6 months

  • Depression, Anxiety, Stress Scale - 21

    up to 6 months

  • Warwick-Edinburgh Mental Well-being Scale

    up to 6 months

  • Oura Ring Sleep Index

    up to 6 months

Study Arms (4)

Individual Receives Incentive - No Restorative Incentive

EXPERIMENTAL

Participant receives incentives directly

Behavioral: Personal Incentives

Individual Receives Incentive -Restorative Incentive

EXPERIMENTAL

The participant receives incentives directly. There is a restorative incentive if they miss an activity.

Behavioral: Personal Restorative Incentives

Charity Receives Incentive - No Restorative Incentive

EXPERIMENTAL

Participant earns money for charity

Behavioral: Charity Incentives

Charity Receives Incentive -Restorative Incentive

EXPERIMENTAL

Participant earns money for charity. There is a restorative incentive if they miss an activity.

Behavioral: Charity Restorative Incentives

Interventions

The participant receives incentives directly if they complete an activity on a given day.

Individual Receives Incentive - No Restorative Incentive

The participant receives incentives directly if they complete an activity on a given day. They are given an additional incentive to return to completing activities if they did not complete an activity on a prior day.

Individual Receives Incentive -Restorative Incentive

The participant earns compensation for charity if they complete an activity on a given day.

Charity Receives Incentive - No Restorative Incentive

The participant earns compensation for charity if they complete an activity on a given day. They are given an additional incentive for charity to return to completing activities if they did not complete an activity on a prior day.

Charity Receives Incentive -Restorative Incentive

Eligibility Criteria

Age18 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Current undergraduate student in their first year of school own a mobile device

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, United States

RECRUITING

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: Participants will be randomized to one of four incentive conditions and receive rewards based on their completion of such activities. There are two main factors (Recipient x Restoration) that will create four distinct groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 22, 2024

First Posted

April 2, 2024

Study Start

February 12, 2024

Primary Completion

May 31, 2024

Study Completion (Estimated)

May 31, 2028

Last Updated

April 2, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations