- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07331922
Mental Health App and Impact on Wellbeing
Landing Place: Impact of the Landing Place Mental Health App on Mental Health and Well-being
The goal of this clinical trial is to learn if intervention with Landing Place mental health app can support wellness in college students. The main questions it aims to answer are:
Can the app increased well-being in college students? Will the app have increased use and usability by the college students? Researchers will compare two groups of participants to see if the app intervention will increase wellbeing and app usability rates.
Participants will randomly assigned into group 1 and 2. Group 1 will not use the app at all. Group 2 will use the app almost every day for 4 weeks.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Mental health concerns across the United States have increased substantially, affecting individuals across age groups, geographic regions, and socioeconomic backgrounds. Emerging adults demonstrate the highest prevalence of mental health conditions among adult populations, while simultaneously exhibiting the lowest rates of treatment utilization. Barriers to treatment for this population include limited affordability, accessibility, availability, and acceptability of mental health services.
Digital mental health interventions have demonstrated effectiveness across a range of outcomes, including symptom reduction, self-management, and well-being enhancement. Smartphone-based applications, in particular, have been evaluated as tools to integrate mental health support through scalable and accessible technologies. Such applications may offer features including guided self-help activities, mindfulness practices, journaling, mood tracking, psychoeducational content, and location-based resources for mental health services.
Following the COVID-19 pandemic, mental health challenges among U.S. college students have intensified, with documented impacts on academic performance and overall functioning. These challenges are further exacerbated by stigma, financial constraints, and limited access to campus-based or community mental health services, particularly for students from historically marginalized backgrounds.
In response to these needs, Penn State Behrend's Virtual/Augmented Reality (VAR) Lab developed the Landing Place mental health app, a free digital intervention designed to support mental wellness among college students in the Erie region. The application was developed with an emphasis on usability, privacy, and accessibility, and is tailored to the developmental and contextual needs of young adults. Planned future iterations of the application aim to extend its use to additional populations, such as survivors of domestic violence.
The Landing Place app incorporates artificial intelligence, supported features and evidence-based therapeutic components, including mindfulness exercises, goal-setting activities, journaling, mood tracking, and educational content related to mental health and coping strategies. This clinical trial evaluates the effectiveness, usability, and acceptability of the application when used as a self-guided mental wellness intervention among college students.
The study examines multiple forms of data, including behavioral change measures, user engagement metrics, usability assessments, and participant feedback, to assess the app's utility in supporting well-being. It is hypothesized that participants who use the application will demonstrate increased well-being compared to a control group, along with higher engagement and acceptability of the app-based intervention modality.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christopher R Shelton, PhD
- Phone Number: 814-898-6082
- Email: cshelton@psu.edu
Study Locations
-
-
Pennsylvania
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Erie, Pennsylvania, United States, 16563
- PennState the Beherend College/VAR Lab
-
Contact:
- Christopher R Shelton, PhD
- Phone Number: : 814-898-6082
- Email: cshelton@psu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Penn State Behrend students
- Over the age of 18
- Must have an iPhone
Exclusion Criteria:
- People outside of Penn State
- Minors
- People currently in therapy
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 |
|---|---|
|
No Intervention: Control Group
Group 1 will not use the app at all.
|
|
|
Experimental: App-intervention group
Group 2 will use the mental health app almost every day for 4 weeks. The following activities must be completed in-app by participants in this arm:
|
The intervention will be the use of an AI-powered mental health app that includes activities based on evidence-based therapeutic techniques, mindfulness, goal setting, journaling, mood tracking, and educational material.
The app is secure, easy-to-use, and customized for the needs of the college students.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Well-being related to Attention and Cognitive Functioning
Time Frame: From enrollment to the end of intervention at 5 weeks
|
Attention-related symptoms will be assessed using the DSM-5-TR Attention-Deficit/Hyperactivity Disorder and Sluggish Cognitive Tempo Measure, a self-report scale evaluating attentional functioning.
Scores vary by subscale, with higher scores indicating greater symptom severity.
|
From enrollment to the end of intervention at 5 weeks
|
|
Well-being related to Health-related quality of life
Time Frame: From enrollment to the end of the intervention at 5 weeks
|
Health-related quality of life will be measured using the Medical Outcomes Study Short Form-36 Health Survey (SF-36).
The instrument generates domain scores ranging from 0 to 100, with higher scores indicating better perceived health and well-being.
|
From enrollment to the end of the intervention at 5 weeks
|
|
Well-being related to Mental Health Symptom Severity
Time Frame: From enrollment to the end of the intervention at 5 weeks
|
Mental health symptom severity will be assessed using the Depression Anxiety Stress Scales - 21 Items (DASS-21), a self-report instrument measuring symptoms of depression, anxiety, and stress.
Scores range from 0 to 63, with higher scores indicating greater symptom severity.
|
From enrollment to the end of the intervention at 5 weeks
|
|
Well-being related to Functional Impairment
Time Frame: From enrollment to the end of the intervention at 5 weeks
|
Functional impairment will be evaluated using the Brief Functional Impairment Scale - Long Form (BFIS-LF), which assesses impairment across daily functioning domains.
Scores range from 0 to 100, with higher scores indicating greater functional impairment.
|
From enrollment to the end of the intervention at 5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Usability
Time Frame: From enrollment to the end of treatment at 5 weeks
|
App usability will be assessed using the mHealth App Usability Questionnaire - Standalone Patient App Version (MAUQ-SPA), a self-report instrument designed to evaluate the usability of standalone mHealth applications.
Items are rated on a 7-point Likert scale, and total scores range from 1 to 7, with higher scores indicating better perceived usability.
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From enrollment to the end of treatment at 5 weeks
|
|
Usage
Time Frame: From enrollment to the end of the intervention at 5 weeks
|
Patterns of mobile health application use will be assessed using the mHealth Usage Questionnaire, a self-report measure evaluating frequency and duration of app use.
Scores are reported in units on a scale, with higher scores indicating greater application use.
|
From enrollment to the end of the intervention at 5 weeks
|
|
Engagement
Time Frame: From enrollment to the end of the intervention at 5 weeks
|
Engagement with mobile health technology will be measured using the mHealth Technology Use Questionnaire, which assesses overall use and engagement with mHealth technologies.
Scores are reported in units on a scale, with higher scores indicating greater technology engagement.
|
From enrollment to the end of the intervention at 5 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Andersson, G., & Titov, N. (2014). Advantages and limitations of Internet-based interventions for common mental disorders. World Psychiatry; Official Journal of the World Psychiatric Association (WPA), 13(1), 4-11. doi:10.1002/wps.20083 PMID:24497236 Barak, A., Hen, L., Boniel-Nissim, M., & Shapira, N. (2008). A comprehensive review and a meta-analysis of the effectiveness of internet-based psychotherapeutic interventions. Journal of Technology in Human Services, 26(2-4), 109-160. doi:10.1080/15228830802094429 Boggs, J. M., Beck, A., Felder, J. N., Dimidjian, S., Metcalf, C. A., & Segal, Z. V. (2014). Web-Based Intervention in Mindfulness Meditation for Reducing Residual Depressive Symptoms and Relapse Prophylaxis: A Qualitative Study. Journal of Medical Internet Research, 16(3), e87. doi:10.2196/jmir.3129 PMID:24662625 Hedman, E., El Alaoui, S., Lindefors, N., Andersson, E., Rück, C., Ghaderi, A., Kaldo, V., Lekander, M., Andersson, G., & Ljótsson, B. (2014). Clinical effectiveness and cost-effectiveness of Internet- vs. group-based cognitive behavior therapy for social anxiety disorder: 4-year follow-up of a randomized trial. Behaviour Research and Therapy, 59, 20-29. doi:10.1016/j.brat.2014.05.010 PMID:24949908 Luxton, D. D., McCann, R. A., Bush, N. E., Mishkind, M. C., & Reger, G. M. (2011). mHealth for mental health: Integrating smartphone technology in behavioral healthcare. Professional Psychology, Research and Practice, 42(6), 505-512. doi:10.1037/a0024485 Proudfoot, J. G. (2004). Computer-based treatment for anxiety and depression: Is it feasible? Is it effective? Neuroscience and Biobehavioral Reviews, 28(3), 353-363. doi:10.1016/j.neubiorev.2004.03.008 PMID:15225977 Substance Abuse and Mental Health Services Administration. (2017). Key substance use and mental health indicators in the United States: Results from the 2016 National Survey on Drug Use and Health (HHS Publication No. SMA 17-5044, NSDUH Series H-52). Rockville, MD: Center for Behavioral
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00024830
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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