Improving Functioning Among Aging Women Veterans
NCT Number: NCT06580470
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Menopause
Interventions: BEHAVIORAL: Tailored Cognitive Behavioral Therapy for Menopause
Sponsor: VA Office of Research and Development
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2026-12-01
Completion Date: 2028-12-01
Locations: Rehabilitation R&D Service, Baltimore, MD, Baltimore, Maryland, 21202, United States|Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD, Perry Point, Maryland, 21201-1524, United States

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.

Primary Outcome Measures: Client Satisfaction Questionnaire (CSQ-8), To examine acceptability, the investigators will collect satisfaction ratings via the Client Satisfaction Questionnaire (CSQ-8) at post-treatment assessment. The CSQ-8 contains eight Likert scale items that ask about quality of service received and if services have been helpful and provides an overall score. Reliability/validity for the measure is good. The minimum score is 8 and the maximum score is 32, with greater scores indicating more client satisfaction., Post-treatment, approximately 12 weeks|Recruitment, As a measure of feasibility, the investigators will evaluate recruitment by calculating the number of eligible participants (e.g., those that passed screening) divided by the number of potential participants that were approached for recruitment (# eligible ÷ # approached)., At completion of study recruitment, approximately 1.5 years|Retention Rate, As a measure of feasibility, investigators will calculate retention rates defined as the percentage of enrolled participants who attend first 2 sessions ("engaged")., Following completion of all intervention groups, approximately 2 years|Outreach Efforts, As a measure of feasibility, investigators will examine our study outreach efforts by calculating the mean number of reminders and outreach contacts made for each participant during the course of treatment., Throughout intervention delivery, approximately 2 years|Suitability of Eligibility, As a measure of feasibility, the investigators will evaluate suitability of eligibility criteria by calculating the number of participants enrolled in the study divided by the number eligible (e.g., those that passed screening;# enrolled ÷ # eligible)., At completion of study recruitment, approximately 1.5 years|Adherence rate, As a measure of feasibility, investigators will calculate the adherence rate measured by treatment dropout percentages. This will be calculated as the number of participants who dropped out prior to completing treatment divided by the number who engaged (i.e., "engaged" = enrolled participants who attend first 2 sessions; #who dropped out prior to completing treatment ÷ # who engaged)., Following completion of all intervention groups, approximately 2 years