Not Yet RecruitingNot Applicable

Improving Functioning Among Aging Women Veterans

United States48 participantsStarted 2026-12-01

Plain-language summary

Women are the fastest-growing group of U.S. Veterans. Over half of those using VA care are 45 or older, with more age-related health concerns than civilian women. The VA urgently needs gender-informed strategies to ensure women Veterans receive tailored care that addresses their intersecting mental, physical, and age related health concerns, as well as gender-linked stressors. One prominent example is menopause, a health transition period that, for many women, can be associated with negative physical and mental health concerns that can worsen their functioning and quality of life. This project will: (1) integrate stakeholder feedback to tailor Cognitive Behavioral Therapy for Menopause (CBT-Meno) for women Veterans with menopause concerns; and (2) refine and evaluate tailored CBT-Meno as a treatment to address these intersecting needs in a clinical trial.

Who can participate

Age range

45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * female sex * 45 years of age or older * currently receiving services at the VA Maryland Healthcare System * presence of at least one symptom rated "moderate" or above or two symptoms rated "mild" or above the Menopause Rating Scale (MRS) * ability to participate in telehealth appointments Exclusion Criteria: * are engaging in moderate-to-severe substance use that would impact their ability to participate and/or would require a higher level of care (as determined by chart review) * engagement in CBT-Meno, whether currently or in the past * participated in Aim 1 as a Veteran stakeholder

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Client Satisfaction Questionnaire (CSQ-8)

Timeframe: Post-treatment, approximately 12 weeks

Recruitment

Timeframe: At completion of study recruitment, approximately 1.5 years

Retention Rate

Timeframe: Following completion of all intervention groups, approximately 2 years

Outreach Efforts

Timeframe: Throughout intervention delivery, approximately 2 years

Suitability of Eligibility

Timeframe: At completion of study recruitment, approximately 1.5 years

Adherence rate

Timeframe: Following completion of all intervention groups, approximately 2 years

Trial details

NCT IDNCT06580470

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2027-12-01

Contact for this trial

Haley Miles-McLean, PhD

(443) 610-9194 Haley.Miles-Mclean@va.gov

View on ClinicalTrials.gov More Menopause trials

Plain-language summary

Who can participate

Age range

45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Client Satisfaction Questionnaire (CSQ-8)

Timeframe: Post-treatment, approximately 12 weeks

Recruitment

Timeframe: At completion of study recruitment, approximately 1.5 years

Retention Rate

Timeframe: Following completion of all intervention groups, approximately 2 years

Outreach Efforts

Timeframe: Throughout intervention delivery, approximately 2 years

Suitability of Eligibility

Timeframe: At completion of study recruitment, approximately 1.5 years

Adherence rate

Timeframe: Following completion of all intervention groups, approximately 2 years