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QT-Digital Mental Health Engagement Study

NCT07278765 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2300

Last updated 2026-05-08

No results posted yet for this study

Summary

Sexual and gender minority (SGM) populations are disproportionately impacted by mental health concerns relative to their heterosexual and cisgender peers. Despite high need, SGM populations continue to report unmet mental health needs because they cannot or do not access mental health services. Digital Mental Health (DMH) services have been recognized as feasible, economical, and effective options to broaden the availability of mental health care to consumers who face barriers to mental health help-seeking. SGM consumers cite a preference for DMH care and this delivery format holds promise to attend to major mental health care access barriers experienced by this consumer group. Yet, the availability of DMH services tailored to the needs of SGM consumers is limited, and a dearth of research examines SGM populations' actual engagement with DMH services. A potential solution to fully understand how SGM populations utilize DMH services would be to characterize their engagement within a natural setting. Leveraging an established partnership with Mental Health America (MHA), a non-profit mental health advocacy group offering free, evidence-based screenings and self-guided DMH resources, this study will follow a large, naturalistic sample of SGM DMH consumers with the aim to test tailored engagement strategies with SGM DMH consumers using a micro-randomized trial (MRT) design. Results of this study will inform if delivering engagement strategies can meaningfully increase initial and sustained engagement with MHA resources and which types of strategies, specifically, work best for which users.

Conditions

  • Engagement, Patient

Interventions

BEHAVIORAL

HAPA Engagement Strategies

Participants will be delivered HAPA-based engagement strategies directly on the MHA website, including on the Results page and targeted Next Steps resource page. The engagement strategies target HAPA behavioral determinants: outcome expectancy, self-efficacy, perceived risk, and barriers and resources. On the Results page, these engagement strategies will be displayed as inline messages designed to quickly reinforce a HAPA behavioral determinant before users choose their Next Steps. On the Next Steps resource page, these HAPA-based engagement strategies will be displayed as inline cards embedded directly within the page layout.

Sponsors & Collaborators

  • Mental Health America

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

  • Meghan Romanelli, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-12
Primary Completion
2026-07-31
Completion
2027-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07278765 on ClinicalTrials.gov