Development of a Personalized, Psychosocial Intervention for Menopausal Individuals With Elevated Dementia Risk
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PERI-MIND.
- Who it may be relevant to
- Registry conditions: Menopausal, Dementia. Basic parameters: 40 years — 58 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 ac
Primary outcome measures
- Number of participants who are enrolled and complete the study [Time frame: From enrollment until pilot testing is completed]
- Acceptability of intervention content [Time frame: From enrollment until pilot testing is completed]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Chicago Medicine — Chicago
Identifiers
NCT: NCT06965686 · IRB24-1148