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Behavioral Intervention
Cognitive Behavioral Therapy for Menopause
N/A
Waitlist Available
Led By Haley Miles-McLean, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female sex
Presence of at least one symptom rated 'moderate' or above or two symptoms rated 'mild' or above on the Menopause Rating Scale (MRS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at completion of study recruitment, approximately 1.5 years
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to create a tailored Cognitive Behavioral Therapy for Menopause (CBT-Meno) for women Veterans with menopause concerns. It seeks to address the age-related health issues and gender-specific stress
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since CBT-Meno is a form of therapy rather than medication, it typically doesn't have side effects like drugs do. However, discussing sensitive topics may cause temporary emotional discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am female.
Select...
I experience moderate to severe menopause symptoms.
Select...
I am 45 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at completion of study recruitment, approximately 1.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at completion of study recruitment, approximately 1.5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adherence rate
Client Satisfaction Questionnaire (CSQ-8)
Outreach Efforts
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Tailored CBT-MenoExperimental Treatment1 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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,765 Total Patients Enrolled
2 Trials studying Menopause
202 Patients Enrolled for Menopause
Haley Miles-McLean, PhDPrincipal InvestigatorRehabilitation R&D Service, Baltimore, MD
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