PERI-MIND for Menopause and Dementia Risk
(PERI-MIND Trial)
Trial Summary
What is the purpose of this trial?
By age 45, women's lifetime risk of dementia is estimated to be 1 in 5. Two-thirds of people currently living with a dementia diagnosis are women, and-women make up the majority of carers for people with dementia. Because women bear a larger burden of the dementia epidemic, they tend to be more fearful about dementia compared to men. Women may be especially fearful during the menopause transition, which can impact cognition. These fears can cause significant psychological distress, functional impairment, and avoidance of help seeking. Interventions that acknowledge women's fears and promote adaptive coping during the menopause transition are needed to combat dementia-related fear and its negative impacts.This project aims to develop, and pilot test a brief personalized, psychosocial intervention for middle-aged perimenopausal individuals with elevated dementia risk. The investigators will assess the intervention's acceptability and feasibility for use in this population. The project will be completed in three stages. First, the investigators will conduct focus groups to better understand individual fears about dementia, informational and decisional needs, and strategies to promote adaptive coping as they transition through menopause (case-only, single time point). Second, the investigators will develop an intervention to meet the specific needs identified by the focus groups. Intervention components will address multiple areas of women's health in midlife, including aspects of physical and psychological health, as well as functional health outcomes that have important and long-lasting life implications. Finally, the investigators will conduct pilot testing to assess the acceptability and feasibility of the intervention (cohort, 3-week testing period).This project will deliver a novel psychosocial intervention that can provide middle-aged perimenopausal women with the information and practical skills that can help them manage their dementia-related fears and encourage adaptive coping behaviors. Outputs from the project will serve as preliminary data for a fully powered randomized controlled trial.
Research Team
Francesca Farina, PhD
Principal Investigator
University of Chicago
Eligibility Criteria
This trial is for middle-aged perimenopausal individuals who are at an increased risk of developing dementia. It aims to help them manage fears related to dementia and improve their coping during the menopause transition. The eligibility criteria details were not provided, so specific inclusions or exclusions cannot be listed.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Focus Groups
Participants take part in a single 1-hour remote focus group session to discuss fears about dementia and strategies for adaptive coping
Intervention Development
Development of a personalized intervention based on focus group findings
Pilot Testing
Participants evaluate the online intervention materials over a 3-week period focusing on feasibility and acceptability
Follow-up
Participants are monitored for feedback on the intervention's effectiveness and any long-term impacts
Treatment Details
Interventions
- PERI-MIND
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor