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NCT06940466 | NOT YET RECRUITING | Menopause

A Cognitive Intervention to Manage 'Brain Fog' in Menopause Transition: Feasibility Study
Sponsor:

University College, London

Brief Summary:

Cognitive complaints at menopause transition (MT), often described as 'brain fog'; can include difficulty recalling words and numbers, misplacing items, trouble concentrating and forgetfulness. Whilst these difficulties resolve for most people, several years of reduced cognitive functioning can be highly damaging and result in problems including leaving work, depression and relationship breakdown. Study Aims: This project aims 1) to develop and finalise a cognitive intervention for the menopause, 2) To evaluate the feasibility, acceptability and preliminary effects of the intervention. 3) To evaluate the interventions preliminary effects on subjective and objective cognition Relevance: Traditionally Menopause Hormone Therapy (MHT) is offered to women with cognitive complaints due to its beneficial effect. However, many women are unable to take it due to medical reasons or choose not to. If this intervention is concluded as feasible and acceptable it may then be appropriate to conduct a full RCT of this intervention. It could reduce excess disability, potentially enabling people to remain at work and function better in daily life. Costs to the NHS might be reduced through decreased service and medication use.

Condition or disease

Menopause

Intervention/treatment

Online cognitive intervention

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Cognitive Intervention to Manage 'Brain Fog' in Menopause Transition: Feasibility Study
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2026-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 60 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * people with ovaries (women, trans-men and non-binary people) aged 40-60
  • * late-reproductive, early-late perimenopause or early post-menopause stages according to the Stages of Reproductive Aging Workshop (STRAW+10; Harlow et al., 2012)
  • * stable dose of hormonal (oestrogen, progesterone, testosterone) or antidepressant (SSRI, SSNI) medication for 6 months or more
  • * self-reported cognitive difficulties impacting on quality of life
  • * ability to communicate in English
Exclusion Criteria
  • * diagnosis of dementia
  • * new regimen (under 6 months) of medication likely to impact on cognition (i.e. hormonal or anti-depressant)
A Cognitive Intervention to Manage 'Brain Fog' in Menopause Transition: Feasibility Study

Location Details

NCT06940466

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Locations

Not yet recruiting

United Kingdom,

University College London

London, United Kingdom, WC1E 6BT