Improving Functioning Among Aging Women Veterans

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
VA Office of Research and Development
Study ID
NCT06580470
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tailored Cognitive Behavioral Therapy for Menopause — BEHAVIORAL
    Cognitive Behavioral Therapy for Menopause (CBT-Meno) is an evidenced-based intervention that includes psychoeducation, cognitive, and behavioral strategies for coping with common menopause symptoms and experiences. In Aims 1 and 2, CBT-Meno materials and procedures will be tailored for women Veterans through an iterative process involving: a) data from preliminary studies and a pre-pilot trial; b) input from content area experts; and c) stakeholder advisory panels. This tailored version of CBT-Meno will then be test in this clinical trial.

Study Details

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.

Key Dates

Start date
Dec 1, 2026
Status verified
Sep 2025
Primary completion
Dec 1, 2027
Completion
Dec 1, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tailored CBT-Meno
    Cognitive Behavioral Therapy for Menopause (CBT-Meno) is an evidenced-based intervention that includes psychoeducation, cognitive, and behavioral strategies for coping with common menopause symptoms and experiences. In Aims 1 and 2, CBT-Meno materials and procedures will be tailored for women Veterans through an iterative process involving: a) data from preliminary studies and a pre-pilot trial; b) input from content area experts; and c) stakeholder advisory panels. This tailored version of CBT-Meno will then be test in this clinical trial.

Primary Outcome Measure

Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: Post-treatment, approximately 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MDBaltimoreMaryland21201
Haley Miles-McLean, PhD
443-610-9194
Amy L Drapalski, PhD
(410) 637-1855
Haley Miles-McLean, PhD (PRINCIPAL_INVESTIGATOR)
Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MDPerry PointMaryland21201-1524
Haley Miles-McLean, PhD
443-610-9194
Amy L Drapalski
4434216273

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