- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05121675
Investigating How Incentives Impact Engagement With an Online Mental Health Application (Neuroflow)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
As mental health awareness and intervention has gained more traction throughout the years, applications - such as NeuroFlow - have emerged in an effort to facilitate aid to those who are unable to afford or access alternative mental health care methods. However, over 95% of mental health and wellness applications have not actually been studied. Additionally, a large portion examines user adoption of various mental health applications based on different factors, leaving a gap in research regarding client engagement and interest post-installation. Thus, despite promises, applications for promoting mental health often do not achieve their intended goals due to lack of sufficient client engagement/interest. In order to address this discrepancy, the use of financial incentives and other incentives from the field of behavioral economics may help. As an application, NeuroFlow embeds behavioral economic principles to increase motivation and engagement with the application (such as personalized pop-up notification reminders and app gamification including points accrual for activity completion and celebratory messages for meeting points thresholds) and also provides financial incentives whereby points accrued can be redeemed into gift cards for popular outlets such as Amazon. However, it is not clear if this financial incentive increases engagement or has knock-on effects for mental health and wellbeing over and above the behavioral economics incentives per se. In this study, the investigators will conduct a pilot two-arm randomized controlled trial where the investigators will examine the effect of a treatment group (NeuroFlow app with behavioral economics and financial incentives vs. NeuroFlow app with behavioral economics incentives only) on application engagement and mental health and wellbeing (anxiety and depression symptoms, sleep, self-regulation and wellbeing). The purpose of this study is to gain an understanding of how incentives encourage participation and engagement with an online mental health platform, NeuroFlow.
This study is a two-arm pilot randomized controlled trial to assess differences in user retention and usage rates associated with two incentive structures within the NeuroFlow app (I.e., general structure versus financial compensation). The investigators will assess user engagement with utilization data (ie., daily, weekly, and monthly active users) and measures of the total number of activity counts completed by a user. After consenting to participate in the study, participants will be randomly assigned to use Neuroflow either with points only or with points and the opportunity to exchange those points for gift cards. In both conditions, participants will begin by completing a consent form and a brief questionnaire with their contact information, which will be used to grant them access to the Neuroflow platform.
In both recruitment methods, participants will be required to sign up for a 15 minute check in and check out meeting before and after the trial to answer participant questions regarding the app/app set up or concerns about the consent form. Furthermore, a Qualtrics survey will also be dispersed to participants to be taken during this time along with an initial baseline assessment (to be administered in the NeuroFlow app).
Baseline and post-app usage Qualtrics survey links will also be sent with measures (Generalized anxiety disorder (GAD), Patient Health Questionnaire (PHQ), World Health Organization- Five Well-Being Index (WHO-5), and Difficulties in Emotion Regulation Scale (DERS)) to participants in order to assess differences in user retention.
In both conditions, participants will use the Neuroflow app throughout the duration of the 4-week study (28 days). Participants will be sent a push notification each day through the app to complete their daily activities, which could include surveys, videos, or skill-based practice materials.
With the collaboration of the Neuroflow team, the usage metrics of the app will be pulled after the end of the study. The user metrics of interest are identifying factors that include first name, last name, gender, age, date of birth, and the applicable assignments to each participant - care team manager and behavioral health specialist. Additionally, the first and last score, first and last date, and time between the first and last assessment dates for the measures of interest (PHQ-9, GAD-7, WHO-5, DERS). Furthermore, the total activity number and the total activity rate across all measures will be collected. No additional data from or about participant phone usage or activities will be pulled as part of the study other than the usage metrics specified above, specific to Neuroflow.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: App with behavioral economics + financial incentives
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).
|
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.
|
|
Active Comparator: App with behavioral economics incentives only
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Engagement (Percentage of Daily check-in Activities)
Time Frame: Throughout 28-day trial (averaged)
|
User engagement will be measured as the percentage of daily check-in activities (number completed out of the total number of activities assigned)
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Throughout 28-day trial (averaged)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Generalized Anxiety Disorder (GAD-7)
Time Frame: Baseline and post-trial, up to 28 days
|
Change from pre-trial to post-trial score in anxiety.
Scores range from 0 to 21.
Higher scores = higher symptoms of anxiety.
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Baseline and post-trial, up to 28 days
|
|
Patient Health Questionnaire (PHQ-8)
Time Frame: Baseline and post-trial, up to 28 days
|
Change from pre-trial to post-trial score in depression.
Scores range from 0-24.
Higher scores = higher symptoms of depression.
|
Baseline and post-trial, up to 28 days
|
|
World Health Organization (WHO-5)
Time Frame: Baseline and post-trial, up to 28 days
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Change from pre-trial to post-trial score in wellbeing.
Scores range from 0-100 (raw score is multiplied by 4).
Higher scores = higher wellbeing.
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Baseline and post-trial, up to 28 days
|
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Difficulties Emotion Regulation Scale (DERS)
Time Frame: Baseline and post-trial, up to 28 days
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Change from pre-trial to post-trial score in emotion regulation difficulties.
Scores range from 36-180.
Higher scores = greater problems with emotion regulation.
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Baseline and post-trial, up to 28 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Heather Nuske, Penn Medicine
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 849894
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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