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NCT Number: NCT06965686

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

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.

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Key information

Age range

40 year–58 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location status: Recruiting

Location contact

Francesca Farina, PhD

CONTACT

[email protected]

773-702-1972

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PERI-MIND

Behavioral

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).

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Grace Bardwick, MPH

CONTACT

[email protected]

773-702-1972

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Acronym: PERI-MIND

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 11, 2025
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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