MenopauseNCT06580470
Improving Functioning Among Aging Women Veterans
A study testing Tailored Cognitive Behavioral Therapy for Menopause in people with Menopause, run by VA Office of Research and Development at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Tailored Cognitive Behavioral Therapy for Menopause
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
Haley Miles-McLean, PhD, (443) 610-9194, Haley.Miles-Mclean@va.gov
Amy L Drapalski, PhD, (410) 637-1855, amy.drapalski@va.gov
Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD
Perry Point, Maryland, 21201-1524
Haley Miles-McLean, PhD, 443-610-9194, haley.miles-mclean@va.gov
Amy L Drapalski, 4434216273, Amy.Drapalski@va.gov
About this study
Official title: Improving Functioning Among Aging Women Veterans With Major Mental Illness
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.
Read the 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.
- Conditions
- Menopause
- Being tested
- Tailored Cognitive Behavioral Therapy for Menopause
- Keywords
- Menopause, Cognitive Behavioral Therapy, Veterans, Women's Health, Aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Cognitive Behavioral Therapy for MenopauseBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Tailored Cognitive Behavioral Therapy for Menopause |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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").
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Following completion of all intervention groups, approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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 tested in this clinical trial.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Haley Miles-McLean, PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580470
- Sponsor's protocol ID
- D4792-W
- Other IDs
- RX004792
- Status last verified
- Sep 2026
- First submitted
- 29 Aug 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Functioning Among Aging Women Veterans With Major Mental Illness
- ClinicalTrials.gov ID
- NCT06580470
- Acronym / sponsor ID
- D4792-W
- Conditions
- Menopause
- Keywords
- Menopause, Cognitive Behavioral Therapy, Veterans, Women's Health, Aging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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 tested in this clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Tailored CBT-Meno | Experimental | Behavioral: Tailored Cognitive Behavioral Therapy for MenopauseCognitive 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored Cognitive Behavioral Therapy for MenopauseAlso: Tailored CBT-MenoCognitive 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. | Behavioural | Tailored CBT-Meno |
Primary outcome
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Post-treatment, approximately 12 weeks
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.
Recruitment
Time frame: At completion of study recruitment, approximately 1.5 years
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).
Retention Rate
Time frame: Following completion of all intervention groups, approximately 2 years
As a measure of feasibility, investigators will calculate retention rates defined as the percentage of enrolled participants who attend first 2 sessions ("engaged").
Outreach Efforts
Time frame: Throughout intervention delivery, approximately 2 years
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.
Suitability of Eligibility
Time frame: At completion of study recruitment, approximately 1.5 years
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).
Adherence rate
Time frame: Following completion of all intervention groups, approximately 2 years
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haley Miles-McLean, PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Cognitive Behavioral Therapy for Menopause in people with Menopause, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haley Miles-McLean, PhD ((443) 610-9194, Haley.Miles-Mclean@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Satisfaction Questionnaire (CSQ-8) (time frame: Post-treatment, approximately 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.