Clinical trial NCT06580470: Improving Functioning Among Aging Women Veterans
Official title: Improving Functioning Among Aging Women Veterans With Major Mental Illness
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Menopause
Keywords: Menopause
Cognitive Behavioral Therapy
Veterans
Women's Health
Aging
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-08-30
Enrollment: 48
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

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.

Detailed description: Anticipated Impact on Veteran's Healthcare: The VA's commitment to serving all Veterans must include effective, gender-informed services that address the needs of women Veterans. This application will address this need by exploring one method of offering gender-informed care by tailoring an existing intervention to optimize functioning among mid-life and older women Veterans.

Background: Women are the fastest-growing cohort of Veterans. They have higher rates of age-related health concerns than non-Veteran women, experiences that are further complicated by intersecting mental, physical, and gender-linked stressors. One prominent example of this intersection is menopause, a health transition period that can be associated with negative health impacts and functional challenges. These difficulties can be further complicated for women Veterans given high rates of physical and mental health conditions as well as exposure to challenging experiences associated with military service (e.g., military sexual trauma, service connected conditions, combat exposure). The VA urgently needs interventions that integrate such knowledge to help VA healthcare providers effectively, respectfully, and efficiently address the needs of aging women Veterans via gender-informed, tailored approaches. Cognitive behavioral therapies for menopause (CBT-Meno) are promising treatments for disruptive menopause concerns, showing effectiveness among non-Veteran women for many menopause symptoms (i.e., sleep, hot flashes, anxiety, depression), and quality of life. However, CBT-Meno research has not addressed the needs and risk factors specific to women Veterans and is limited in assessing functional outcomes. Research and VA policy also highlight the need for gender-informed interventions to address women Veterans' health concerns, including menopause care.

Project Objectives: This proposed CDA-2 research study will address these clinical and research gaps by testing one approach for delivering gender-informed services to aging women Veterans by: (1) integrating stakeholder feedback to tailor Cognitive Behavioral Therapy for Menopause (CBT-Meno) for women Veterans with menopause concerns; and (2) refining and evaluating tailored CBT-Meno as a treatment to address the intersecting needs of women Veterans with menopause concerns. This application will first, develop a tailored version of CBT-Meno, to be delivered via telehealth, utilizing feedback from stakeholder panels to address the intersecting care needs of women Veterans with menopause concerns. Second, it will examine the initial acceptability of tailored CBT-Meno through a pre-pilot group with women Veterans with menopause concerns - seeking feedback from the women Veteran participants and the stakeholder panels to inform refinement of tailored CBT-Meno for testing in Aim 3. \[Third, a single-arm pilot trial of tailored CBT-Meno will be conducted to examine the feasibility, acceptability and fidelity of tailored CBT-Meno, and its impact on women Veterans' functioning, quality of life, and menopause symptom severity among women Veterans 45 years with menopause concerns.

Project Methods: The tailoring of CBT-Meno will start with existing knowledge and incorporate input from stakeholder panels of women Veterans, VA providers, and women Veterans' healthcare leaders to create a first draft of tailored CBT-Meno, which will be used to examine its acceptability in a pre-pilot group with women Veterans aged 45 with menopause concerns (N=6). Next, findings will be integrated with additional stakeholder feedback to generate a finalized version of tailored CBT-Meno for testing in Aim 3. Then, tailored CBT-Meno will be tested in a single-arm pilot trial (N=48) enrolling the same population. Feasibility, acceptability, fidelity, and preliminary efficacy will be assessed via quantitative and qualitative methods. The trial will assess health, quality of life, and community functioning at Baseline, Post, and Follow-up timepoints.

Eligibility criteria: 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

Primary outcomes:
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Post-treatment, approximately 12 weeks
measure: Recruitment
timeFrame: At completion of study recruitment, approximately 1.5 years
measure: Retention Rate
timeFrame: Following completion of all intervention groups, approximately 2 years
measure: Outreach Efforts
timeFrame: Throughout intervention delivery, approximately 2 years
measure: Suitability of Eligibility
timeFrame: At completion of study recruitment, approximately 1.5 years
measure: Adherence rate
timeFrame: Following completion of all intervention groups, approximately 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Rehabilitation R&D Service, Baltimore, MD
state: Maryland
city: Perry Point
country: United States
facility: Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD
state: Maryland
Study officials:
affiliation: Rehabilitation R&D Service, Baltimore, MD
name: Haley Miles-McLean, PhD
role: PRINCIPAL_INVESTIGATOR
References: