Clinical trial NCT06940466: A Cognitive Intervention to Manage 'Brain Fog' in Menopause Transition: Feasibility Study
Official title: A Cognitive Intervention to Manage 'Brain Fog' in Menopause Transition: Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Menopause
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Pre-intervention and within 6 weeks post intervention
measure: Generalised Anxiety Disorder (GAD-7)
timeFrame: Pre-intervention and within 6 weeks post intervention
measure: Menopause-Specific Quality of Life (MENQoL)
timeFrame: Pre-intervention and within 6 weeks post intervention
measure: Hot Flush Rating Scale (HFRS)
timeFrame: Pre-intervention and within 6 weeks post intervention
measure: The Multifactoral Memory Questionnaire (MMQ)
timeFrame: Pre-intervention and within 6 weeks post intervention
measure: Menopause-specific Cognitive Scale (MENO-Cog)
timeFrame: Pre-intervention and within 6 weeks post intervention
measure: Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: Pre-intervention and within 6 weeks post intervention
measure: Trail Making Test (TMT)
timeFrame: Pre-intervention and within 6 weeks post intervention
measure: Digit Span subtest (WISC-V)
timeFrame: Pre-intervention and within 6 weeks post intervention
measure: Controlled Word Association Test
timeFrame: Pre-intervention and within 6 weeks post intervention
Secondary outcomes:
measure: Post intervention interviews
timeFrame: Pre-intervention and within 6 weeks post intervention
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London
Study officials:
References: