Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580470
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Improving Functioning Among Aging Women Veterans
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Improving Functioning Among Aging Women Veterans With Major Mental Illness
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Women are the fastest-growing group of US 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 Veterans Healthcare The VAs 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 eg 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 ie 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 N6 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 N48 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
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 eg 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 ie 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 N6 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 N48 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None