QT-Digital Mental Health Engagement Study

NCT07278765 | Recruiting DMC

• 2 other identifiers: STUDY00017726K01MH131795-01A1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Digital Mental Health

Outcome Measures

Primary Outcomes (2)

• Proximal engagement

  Initial engagement, i.e., click-through to the targeted Next Steps resource, capped at 30 minutes of inactivity.

  30 minutes

• Proximal engagement

  Sustained engagement, i.e., total time on the targeted Next Steps resource, capped at 30 minutes of inactivity.

  30 minutes

Secondary Outcomes (2)

• Proximal engagement

  30 minutes

• Proximal engagement

  30 minutes

Study Arms (3)

HAPA Engagement Strategies

EXPERIMENTAL

At each decision point in the MHA Screening Program flow, each eligible participant will be randomized to either receive a HAPA-based engagement strategy or not. Participants will be randomized with equal probability (0.2) to either receive: 1) no engagement strategy (i.e., the standard Next Steps resource page as usual; control), or; 2) one of four types of HAPA-based engagement strategies. Participants randomized to receive an engagement strategy will be randomized with equal probability to an engagement strategy targeting a HAPA construct: 1) outcome expectancy; 2) self-efficacy; 3) perceived risk, and; 4) barriers and resources. The first decision point will be the screening Results page which is displayed immediately after completing the PHQ-9 and optional demographic questions. The second decision point will be the targeted Next Steps resource page that participants click on from the Results page.

Behavioral: HAPA Engagement Strategies

Results Page Comparator

NO INTERVENTION

Users see the usual MHA Results Page without engagement strategies.

Resource Page Comparator

NO INTERVENTION

Users see the usual MHA Next Steps resource pages without engagement strategies.

Interventions

HAPA Engagement Strategies BEHAVIORAL

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.

HAPA Engagement Strategies

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Users of the Mental Health America (MHA) website engaging from Internet Protocol (IP) addresses in the United States
• Completed the PHQ-9 depression screener in English
• Answered MHA's standard demographic questions that identify users as age 14 and older
• Answered MHA's standard demographic questions that identify users as LGBTQ+.

You may not qualify if:

• IP addresses outside of the United States
• Do not answer MHA's standard demographic questions
• Answered MHA's standard demographic questions that identify users as age 13 and younger
• Answered MHA's standard demographic questions that identify users as not LGBTQ+.

Sponsors & Collaborators

• University of Washington: lead
• Mental Health America: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Mental Health America

Alexandria, Virginia, 22314, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Meghan Romanelli, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meghan Romanelli, PhD

CONTACT

206-685-6948; mbromane@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor: School of Social Work

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 12, 2025
• Study Start: March 12, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)