Development of a Personalized, Psychosocial Intervention for Menopausal Individuals With Elevated Dementia Risk (PERI-MIND)

February 4, 2026 updated by: University of Chicago

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perimenopausal individuals with a family history of dementia

For the focus groups, the investigators will recruit a minimum of 20 participants. Participants will take part in a single 1-hour remote focus group session, where they will be asked about their fears about dementia, informational and decisional needs, and strategies to promote adaptive coping as they transition through menopause.

For pilot testing, we will recruit a minimum of 30 participants. Participants will be asked to evaluate the online intervention materials across 3-weeks. The evaluation will focus on feasibility and acceptability of the intervention.
Behavioral: PERI-MIND
PERI-MIND will be informed by the focus group findings from phase one. However, the investigators anticipate including core components related to psychoeducation, psychological grounding, & behavioral activation, which will be specifically adapted to the perimenopausal and menopausal population. Psychoeducation in this context will focus on menopausal symptoms like brain fog (e.g., how common they are, how long they typically last), information about dementia and its risk factors (e.g., most actionable risk factors in mid-life), and links between menopause and dementia (e.g., hormonal replacement therapy). Psychological grounding content will focus on practical training exercises in mindful monitoring of concerns about brain fog and other menopausal symptoms (e.g., meditation, deep breathing). Behavioral activation will focus on exercises to recognize and disrupt avoidant coping behaviors, and increase engagement in valued activities (e.g., social engagement, exercise, healthy eating).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who are enrolled and complete the study
Time Frame: From enrollment until pilot testing is completed
Feasibility outcomes will relate to the successful implementation and completion of the intervention, including the ease of recruitment and ability of participants to enroll and complete the study. Metrics will include the total number of participants identified and enrolled in the study and completion rate.
From enrollment until pilot testing is completed
Acceptability of intervention content
Time Frame: From enrollment until pilot testing is completed
Acceptability will be assessed using standard Likert-type scales, informed by the Theoretical Framework of Acceptability for healthcare interventions. Questions will focus on the content, presentation format and length.
From enrollment until pilot testing is completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Francesca Farina, PhD, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

May 1, 2025

First Posted (Actual)

May 11, 2025

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB24-1148

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified datasets generated and analyzed during the study will be made available in the Open Science Framework (OSF) repository on completion of the study: https://osf.io/cwn79/.

IPD Sharing Time Frame

IPD and supporting information will be made permanently available online on completion of the study.

IPD Sharing Access Criteria

De-identified data will be made available to researchers, the public and funders.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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