60 Participants Needed

PERI-MIND for Menopause and Dementia Risk

(PERI-MIND Trial)

GB
Overseen ByGrace Bardwick, MPH
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

FF

Francesca Farina, PhD

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for middle-aged perimenopausal individuals who are at an increased risk of developing dementia. It aims to help them manage fears related to dementia and improve their coping during the menopause transition. The eligibility criteria details were not provided, so specific inclusions or exclusions cannot be listed.

Inclusion Criteria

I am between 40 and 58 years old.
I have a high risk of dementia due to a family history.
I was born female.
See 1 more

Exclusion Criteria

Inadequate vision or hearing to engage with intervention materials
I have been diagnosed with Mild Cognitive Impairment, Alzheimer's, or another form of dementia.
Unable or unwilling to provide informed consent
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Focus Groups

Participants take part in a single 1-hour remote focus group session to discuss fears about dementia and strategies for adaptive coping

1 session
1 visit (virtual)

Intervention Development

Development of a personalized intervention based on focus group findings

Not specified

Pilot Testing

Participants evaluate the online intervention materials over a 3-week period focusing on feasibility and acceptability

3 weeks

Follow-up

Participants are monitored for feedback on the intervention's effectiveness and any long-term impacts

4 weeks

Treatment Details

Interventions

  • PERI-MIND
Trial Overview The PERI-MIND intervention is being tested, which is a personalized psychosocial program designed to address women's health issues during midlife. This includes physical, psychological, and functional health aspects with the goal of reducing fear and promoting adaptive coping strategies.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Perimenopausal individuals with a family history of dementiaExperimental Treatment1 Intervention
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.

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Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

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Recruited
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