NCT07831759

Brief Summary

There are over one million Veterans who identify as lesbian, gay, bisexual, (LGB) or a related identity. Older LGB Veterans face unique hurdles as they age, including stress, anxiety, heart disease, cancer, decreased ability to perform activities of daily living, delayed care, and increased likelihood of entering a nursing home. Sparse social networks and limited access to aging resources are common for LGB Veterans and contribute to adverse outcomes. The proposed study will partner with older Veterans to adapt and test a virtual structured group that promotes healthy aging, self-acceptance, and connection to health-related resources. This study aims to improve Veterans' health and well-being through increased resilience, positive healthcare engagement, and access to resources that support older Veterans' needs. There are currently no other VA programs designed to address the unmet needs of older LGB Veterans. By learning more about how to serve subgroups of Veterans more effectively, this study will also improve outcomes for all older Veterans and their care partners.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
38mo left

Started Jul 2027

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

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

September 1, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2027

Expected
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2030

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2030

Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

2.8 years

First QC Date

September 1, 2026

Last Update Submit

September 17, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Participant Retention in the Intervention (Feasibility Indicator)

    The primary indicator of intervention feasibility will be retention rate, operationalized as the % of enrolled participants who complete the intervention as tracked on attendance logs (observational data). Feasible retention in this multi-session psychosocial intervention is set at \>60% given anticipated intervention duration, prior trials with the parent intervention, and population comorbidities.

    Active intervention-delivery period

  • Generalized Anxiety Disorder Score (GAD-7)

    Symptoms of anxiety will be assessed using a 7-item self-report measure used frequently in clinical care settings within VHA. It will be completed by Veterans before and after the group.

    Pre/Post Measures will be collected within approximately 1 month before the first session, and within 1 month of the last session. Time between pre and post measures will be approximately 4-6 months apart.

Secondary Outcomes (1)

  • Patient Health Questionnaire (PHQ-9)

    Pre/Post Measures will be collected within approximately 1 month before the first session, and within 1 month of the last session. Time between pre and post measures will be approximately 4-6 months apart.

Study Arms (1)

Intervention Group

EXPERIMENTAL

Manualized, structured, health promotion group delivered over tele-health or in a hybrid format.

Behavioral: Geri Pride Health Promotion Group

Interventions

A structured, health promotion intervention adapted from the VA Pride in All Who Served program that covers a different topic each week related to healthy aging, internalized stress, what matters most/goals of care, social connections and care networks, VA and community resources, and other topics that promote well-being.

Intervention Group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets Pride in All Who Served (PAWS) clinical care service delivery screening criteria (e.g., identify as lesbian, gay, bisexual (LGB) or related identity, not experiencing acute symptoms that prevent meaningful participation in group-delivered care, able to access clinical care at a partnering site)
  • Cognitively able to provide consent to participate in research
  • years or older at the time of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Tuscaloosa, Alabama, 35404-5015, United States

Location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

Location

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, 75216-7167, United States

Location

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148-0001, United States

Location

Study Officials

  • Michelle Marie Hilgeman, PhD

    Tuscaloosa VA Medical Center, Tuscaloosa, AL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle M Hilgeman, PhD

CONTACT

Teddy K Bishop, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Not applicable for this single group feasibility pilot study.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a behavioral health intervention development and adaptation study that will adapt an existing VA intervention called Pride in All Who Served (PAWS) for older Veterans in Year 1. The resulting structured group intervention will then be tested beginning in Year 2 of the study for feasibility, acceptability, and preliminary indicators of impact on clinical and social outcomes.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2026

First Posted

September 21, 2026

Study Start (Estimated)

July 1, 2027

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

July 31, 2030

Last Updated

September 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations