Cognitive Behavioral Therapy for Menopause

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Haley Miles-McLean, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Haley Miles-McLean, PhD

Principal Investigator

Rehabilitation R&D Service, Baltimore, MD

Eligibility Criteria

This trial is for aging women veterans dealing with menopause. Participants should be seeking care through the VA and are experiencing negative impacts on their mental or physical health due to menopause.

Inclusion Criteria

I am female.

I experience moderate to severe menopause symptoms.

I can attend appointments via video or phone.

Exclusion Criteria

I have participated in cognitive behavioral therapy for menopause.

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)

Participated in Aim 1 as a Veteran stakeholder

Treatment Details

Interventions

• Tailored Cognitive Behavioral Therapy for Menopause (Behavioral Intervention)

Trial Overview The study tests a specialized Cognitive Behavioral Therapy tailored for menopausal symptoms (CBT-Meno) in women veterans, aiming to improve their functioning and quality of life by addressing both mental and physical health concerns.

Participant Groups

Group I: Tailored CBT-Meno Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine