Improving Functioning Among Aging Women Veterans

NCT06580470 | Not Yet Recruiting

• 2 other identifiers: D4792-WRX004792
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Menopause

Keywords

Menopause; Cognitive Behavioral Therapy; Veterans; Women's Health; Aging

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Tailored CBT-Meno

EXPERIMENTAL

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.

Behavioral: Tailored Cognitive Behavioral Therapy for Menopause

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.

Also known as: Tailored CBT-Meno

Tailored CBT-Meno

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female sex
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD

Perry Point, Maryland, 21201-1524, United States

Location

MeSH Terms

Interventions

Menopause

Intervention Hierarchy (Ancestors)

Climacteric; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Sexual Development

Study Officials

• Haley Miles-McLean, PhD

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haley Miles-McLean, PhD

CONTACT

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

Amy L Drapalski, PhD

CONTACT

(410) 637-1855; amy.drapalski@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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 tested in this clinical trial.

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: August 30, 2024
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)