Actively Recruiting

Phase Not Applicable
Age: 40Years - 58Years
FEMALE
NCT06965686

Development of a Personalized, Psychosocial Intervention for Menopausal Individuals With Elevated Dementia Risk

Led by University of Chicago · Updated on 2026-02-05

60

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Development of a Personalized, Psychosocial Intervention for Menopausal Individuals With Elevated Dementia Risk

Who Can Participate

Age: 40Years - 58Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female sex at birth
  • Aged between 40-58 years
  • Late perimenopause or early post-menopause
  • Elevated dementia risk defined by a first degree relative with Alzheimer's disease or another dementia diagnosis
Not Eligible

You will not qualify if you...

  • Diagnosis of mild cognitive impairment, Alzheimer's disease, or another dementia
  • Diagnosis of other chronic illness or condition affecting cognition (e.g., schizophrenia, mood disorders, stroke, cancer, traumatic brain injury)
  • Inadequate vision or hearing to engage with intervention materials
  • Unable or unwilling to provide informed consent
  • Menopause caused by surgery (iatrogenic menopause)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Chicago Medicine

Chicago, Illinois, United States, 60637

Actively Recruiting

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Research Team

G

Grace Bardwick, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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Development of a Personalized, Psychosocial Intervention for Menopausal Individuals With Elevated Dementia Risk | DecenTrialz