Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05121675
Other study ID # 849894
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 15, 2021
Est. completion date June 2022

Study information

Verified date December 2021
Source University of Pennsylvania
Contact Cheryl Chang
Phone 5169968699
Email cherylcc@sas.upenn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 2022
Est. primary completion date April 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania NeuroFlow

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. Review. — View Citation

Lecomte T, Potvin S, Corbière 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 28 days (specific end date of study varies depending on participant start date)
Secondary Anxiety symptoms Change from pre-trial to post-trial score in anxiety (measured with the Generalized Anxiety Disorder) 28 days (specific end date of study varies depending on participant start date)
Secondary Depression symptoms Change from pre-trial to post-trial score in depression (measured with the Patient Health Questionnaire) 28 days (specific end date of study varies depending on participant start date)
Secondary Mental Wellbeing measurement Change from pre-trial to post-trial score in mental wellbeing (measured with the World Health Organization) 28 days (specific end date of study varies depending on participant start date)
Secondary Emotion regulation ability Change from pre-trial to post-trial score in emotion regulation (measured with the Difficulties Emotion Regulation Scale) 28 days (specific end date of study varies depending on participant start date)
See also
  Status Clinical Trial Phase
Recruiting NCT06155292 - Report Cards and Feedback for PCCE N/A
Not yet recruiting NCT06298253 - Behavioral Economics to Implement a Traffic Light Nutrition Ranking System: Study 2 N/A
Not yet recruiting NCT05854212 - Behavioral Economics to Implement Nutrition Ranking in Food Pantries N/A
Active, not recruiting NCT05226260 - Decreasing Antibiotic Duration for Skin and Soft Tissue Infection Using Behavioral Economics in Primary Care N/A
Completed NCT04237883 - Primary Care Clinical Excellence Incentive Study N/A
Completed NCT03464279 - Use of a Behavioral Economic Intervention to Reduce Antibiotic Prescription for Upper Respiratory Infections N/A
Completed NCT04263779 - Repisodic & Skilled Nursing Facility Preferred Provider Networks N/A
Not yet recruiting NCT06446076 - Feedback Using behaviOral econOmic Theories on STEP countS in Cardiovascular Disease Patients N/A
Recruiting NCT06101251 - A Randomized Field Trial of Smartphone-based Feedback to Encourage Safe Driving N/A
Enrolling by invitation NCT06454019 - Phone Outreach Nudges Among Individuals Losing Medicaid Coverage N/A