NCT05121675

Brief Summary

The purpose of the study is to understand how incentives (either points alone or points that can be exchanged for gift certificates) encourage engagement with an online mental health app (Neuroflow) for University students. Overall, the hope of this study is to help the investigators understand how best to support mental health and wellness in university students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 2, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

August 12, 2024

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

November 2, 2021

Results QC Date

June 30, 2022

Last Update Submit

August 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Engagement (Percentage of Daily check-in Activities)

    User engagement will be measured as the percentage of daily check-in activities (number completed out of the total number of activities assigned)

    Throughout 28-day trial (averaged)

Secondary Outcomes (4)

  • Generalized Anxiety Disorder (GAD-7)

    Baseline and post-trial, up to 28 days

  • Patient Health Questionnaire (PHQ-8)

    Baseline and post-trial, up to 28 days

  • World Health Organization (WHO-5)

    Baseline and post-trial, up to 28 days

  • Difficulties Emotion Regulation Scale (DERS)

    Baseline and post-trial, up to 28 days

Study Arms (2)

App with behavioral economics + financial incentives

EXPERIMENTAL

NeuroFlow uses behavioral economics reminders, gamification, and fun, motivating messages to encourage use. It also includes financial incentives so users can earn redeemable points accrued for activity completion for gift cards at popular outlets (e.g., 1000 points which is the maximum per month = $10 gift card).

Behavioral: Neuroflow app: Mental health and wellbeing resources for adults

App with behavioral economics incentives only

ACTIVE COMPARATOR

NeuroFlow uses behavioral economics reminders, gamification, and fun, motivating messages to encourage use. including points accrued for activity completion. This version of the app does not have financial incentives.

Behavioral: Neuroflow app: Mental health and wellbeing resources for adults

Interventions

The NeuroFlow app delivers resources on resilience training, mindfulness-based strategies and cognitive behavioral therapy to adults looking to support their mental health and wellbeing. The specific "journey" (i.e., content such as activities, videos, trackers, and journaling) is tailored to individuals based on depression and anxiety screeners administered upon signing up to the app.

App with behavioral economics + financial incentivesApp with behavioral economics incentives only

Eligibility Criteria

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

You may qualify if:

  • The target population for this study are college students either at the University of Pennsylvania or other US universities. Participants will be included if they have a smartphone and are willing to download and use the Neuroflow app throughout the duration of the study

You may not qualify if:

  • Does not own a smartphone capable of downloading the NeuroFlow application or is unwilling to download and use the Neuroflow app throughout the duration of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

  • Huang HY, Bashir M. Users' Adoption of Mental Health Apps: Examining the Impact of Information Cues. JMIR Mhealth Uhealth. 2017 Jun 28;5(6):e83. doi: 10.2196/mhealth.6827.

    PMID: 28659256BACKGROUND
  • Huckvale K, Nicholas J, Torous J, Larsen ME. Smartphone apps for the treatment of mental health conditions: status and considerations. Curr Opin Psychol. 2020 Dec;36:65-70. doi: 10.1016/j.copsyc.2020.04.008. Epub 2020 May 4.

    PMID: 32553848BACKGROUND
  • Lecomte T, Potvin S, Corbiere M, Guay S, Samson C, Cloutier B, Francoeur A, Pennou A, Khazaal Y. Mobile Apps for Mental Health Issues: Meta-Review of Meta-Analyses. JMIR Mhealth Uhealth. 2020 May 29;8(5):e17458. doi: 10.2196/17458.

    PMID: 32348289BACKGROUND

MeSH Terms

Conditions

Gift Giving

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Results Point of Contact

Title
Dr. Heather Nuske
Organization
Perelman School of Medicine

Study Officials

  • Heather Nuske

    Penn Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be randomized to one of the two groups and will not be informed of which one. If they directly ask the investigators will tell them at the end of the trial.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomized to one of the two arms. The participants getting the app with behavioral economics incentives only will be enrolled at the same time as the participants getting the app with behavioral economics + financial incentives.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2021

First Posted

November 16, 2021

Study Start

November 15, 2021

Primary Completion

April 15, 2022

Study Completion

May 15, 2022

Last Updated

August 12, 2024

Results First Posted

August 12, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations