Improving Functioning Among Aging Women Veterans
ConditionMenopause
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45+
SponsorVA Office of Research and Development
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Tailored Cognitive Behavioral Therapy for Menopause
BehavioralCognitive 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.
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: Tailored CBT-MenoExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Post-treatment, approximately 12 weeks2
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).
Time frame
At completion of study recruitment, approximately 1.5 years3
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").
Time frame
Following completion of all intervention groups, approximately 2 years4
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.
Time frame
Throughout intervention delivery, approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: