NCT07130734

Brief Summary

The present study will assess the effects of a four-week digitally delivered intervention on physical activity and depressive symptoms among adults experiencing at least moderate depressive symptoms. The main questions this research aims to answer are:

  • Does a digitally-delivered intervention increase physical activity levels?
  • Does a digitally-delivered intervention reduce symptoms of depression? Researchers will compare an intervention promoting physical activity to a passive control (does not receive the intervention) group to see if the intervention reduces depressive symptoms and increases physical activity levels. Participants will:
  • Visit the laboratory at two separate time points before group assignment, separated by one week of physical activity monitoring
  • Be randomly assigned to complete four weeks of a digital intervention prompting engagement in physical activity or have their mental health symptoms monitored over four weeks (i.e., passive control group)
  • Visit the laboratory at two separate time points after the intervention, separated by one week of physical activity monitoring

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

August 11, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 22, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

August 11, 2025

Last Update Submit

September 12, 2025

Conditions

Keywords

Physical ActivityDigital InterventionDepressionMobile Application

Outcome Measures

Primary Outcomes (2)

  • Depressive Symptoms

    Depression, Anxiety, and Stress Scale (DASS-21) will be used to assess changes in symptoms of depression. The DASS-21 includes 7 items that assess for depression. Total scores for depression range from 0-42, with higher scores indicating greater depression severity.

    pre-intervention, at the two-week time point during the intervention, and immediately after the intervention

  • Moderate-to-vigorous physical activity

    Physical activity will be assessed using a wrist-worn accelerometer before and after the intervention. Physical activity outcomes will be calculated as amount of time spent in a specific intensity.

    pre-intervention and immediately after the intervention

Study Arms (2)

Digital Intervention Group

EXPERIMENTAL

Participants allocated to this group will be instructed to download a Pathverse mobile application on their Apple or Android smartphone device. The Pathverse mobile application will be used to send participants daily push notifications to engage in physical activity of their choice. During on-boarding at pre-intervention, each participant will choose approximately five types of physical activity they find enjoyable that they would like to engage in throughout the four-week intervention. They will report on the physical activity they completed, along with the duration and intensity of each activity. Participants will have the choice of when they would like to receive their daily notifications on their smartphone device.

Behavioral: Digital Physical Activity

Passive Control Group

NO INTERVENTION

Participants will be informed that their mental health will be monitored over four weeks as a control condition. After the study, they will be offered the digital PA intervention, if desired.

Interventions

The Pathverse mobile application platform will be downloaded on each participant's smartphone. Participants will be guided on how to download and use the application, as well as how to interact with the application during the intervention period. Participants will choose approximately five types of physical activity they enjoy before the intervention and will be prompted to complete these physical activities throughout the intervention. Participants will also self-report the duration and type of physical activity performed each day of the intervention.

Digital Intervention Group

Eligibility Criteria

Age19 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 19 and 40 years
  • Verbally fluent in English (i.e., must be able to speak or understand English)
  • No uncorrected visual or hearing impairment
  • Moderate depressive symptoms or greater of at least 10 or higher on the Patient Health Questionnaire-8 screening instrument
  • Eligible to participate in physical activity
  • Physically inactive (i.e., engaging in less than 150 min of weekly moderate-to-vigorous physical activity)
  • Owns an Apple or Android mobile device, willing to download the Pathverse app , and willing to keep the device on during the study period
  • Not currently pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kinesiology Building

Auburn, Alabama, 36849, United States

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersMotor ActivityDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehaviorBehavioral Symptoms

Central Study Contacts

Christopher J Brush, Ph.D.

CONTACT

Karly A Knudson, B.S.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The investigator and outcomes assessor will be unaware of group assignment; research staff working for the investigator will perform randomization. Participants will know whether they are assigned to the digital physical activity or passive control arm.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Between-subjects randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 19, 2025

Study Start

September 22, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations