Clinical trial NCT06965686: Development of a Personalized, Psychosocial Intervention for Menopausal Individuals With Elevated Dementia Risk
Official title: Development of a Personalized, Psychosocial Intervention for Menopausal Individuals With Elevated Dementia Risk
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Menopausal
Dementia
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


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)

Primary outcomes:
measure: Feasibility
timeFrame: From enrollment until pilot testing is completed
measure: Acceptability
timeFrame: From enrollment until pilot testing is completed
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
Study officials:
affiliation: University of Chicago
name: Francesca Farina, PhD
role: PRINCIPAL_INVESTIGATOR
References: