Recruiting

Digital Mental Health

Sponsor:

University of Washington

Code:

NCT07278765

Conditions

Engagement, Patient

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Accepted

Interventions

HAPA Engagement Strategies

Study Details

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

Study ID

NCT07278765

Start date

Mar 12, 2026

Status verified date

May, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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+.

Exclusion Criteria:

  • 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+.

Study Design

Enrollment

2300 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: HAPA Engagement Strategies

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.

no intervention: Results Page Comparator

Users see the usual MHA Results Page without engagement strategies.

no intervention: Resource Page Comparator

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

Interventions

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.

Primary outcome measure

  • Proximal engagement [ Time Frame: Single web session capped at 30 minutes of inactivity ]
  • Proximal engagement [ Time Frame: Single web session capped at 30 minutes of inactivity ]

Central Contacts and Locations

Central contacts

Meghan Romanelli, PhD

206-685-6948mbromane@uw.edu

Locations

Mental Health America

Recruiting

Alexandria, Virginia, United States, 22314

University of Washington

Recruiting

Seattle, Washington, United States, 98195

More Information

Sponsor

University of Washington

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • Digital Mental Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2026-05-08.