Development of a Personalized, Psychosocial Intervention for Menopausal Individuals With Elevated Dementia Risk
Who can join
Ages 40 to 58 · Women
Full eligibility criteria
Inclusion Criteria: * Female sex at birth * Aged between 40-58 years * Late perimenopause or early post-menopause * Elevated dementia risk characterized by first degree relative with diagnosis of Alzheimer's disease or another dementia Exclusion Criteria: * Diagnosis of Mild Cognitive Impairment, Alzheimer's or another dementia * Diagnosis of other chronic illness or condition that affects cognition (e.g., Axis I psychiatric disorders such as schizophrenia or mood disorders, neurological disorders such as stroke, cancer, traumatic brain injury) * Inadequate vision or hearing to engage with intervention materials * Unable or unwilling to provide informed consent * Iatrogenic menopause (i.e., due to surgery)
About the study
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.
What is being tested
- PERI-MIND (behavioral)
Sponsor: University of Chicago · Participants: 60 · Started: Jan 31, 2025
Contact the study team
- Grace Bardwick, MPH · Phone: 773-702-1972
Official record on ClinicalTrials.gov — NCT06965686
Locations in the U.S.
| Illinois | University of Chicago Medicine, Chicago |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.