NCT07331922

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

December 18, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

December 18, 2025

Last Update Submit

May 4, 2026

Conditions

Keywords

Digital Mental HealthCollege StudentsWell-being

Outcome Measures

Primary Outcomes (4)

  • Well-being related to Attention and Cognitive Functioning

    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

    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

    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

    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 Outcomes (3)

  • Usability

    From enrollment to the end of treatment at 5 weeks

  • Usage

    From enrollment to the end of the intervention at 5 weeks

  • Engagement

    From enrollment to the end of the intervention at 5 weeks

Study Arms (2)

Control Group

NO INTERVENTION

Group 1 will not use the app at all.

App-intervention group

EXPERIMENTAL

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: * Cognitive exercise (2 per week) * Mindfulness (2 per week) * Mood tracker (4 per week) * Chat feature (2 per week) * Articles (3 across the 4 weeks) * Journal (3 across the 4 weeks) * To-do (related to the goal, once a week) * Goals (1 goal at the beginning)

Behavioral: mental health app

Interventions

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.

App-intervention group

Eligibility Criteria

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

You may qualify if:

  • Penn State Behrend students
  • Over the age of 18
  • Must have an iPhone

You may not qualify if:

  • People outside of Penn State
  • Minors
  • People currently in therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PennState the Beherend College/VAR Lab

Erie, Pennsylvania, 16563, United States

Location

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Central Study Contacts

Christopher R Shelton, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 18, 2025

First Posted

January 12, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Beginning 3 months and ending 3 years after the publication of results
Access Criteria
IPD will be shared with qualified researchers upon submission of a scientifically sound research proposal. Requests must include a description of the research objectives and planned analyses and must be consistent with the original informed consent and applicable ethical approvals. Access to the data will be granted following review of the proposal for scientific and methodological appropriateness. Approved requestors will be required to sign a data sharing agreement that outlines the conditions for data use, data security, confidentiality, and publication. De-identified data will be made available in a secure manner and will be used solely for the purposes approved.

Locations