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

What this trial studies

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.

Conditions in scope

• Menopause

Interventions

• Online cognitive intervention (Other) — A 4 x 2-hour intervention with the following key components: education about menopause and cognition, cognitive strategies (memory, attention and executive functioning), CBT techniques and emotional support.

Who can join

Women only · Ages 40 Years to 60 Years · Accepts healthy volunteers.

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)

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2025-06-27
• Primary completion: 2025-10-01
• Last update posted: 2026-02-06
• First posted: 2025-04-23

Sponsor & contact

Lead sponsor: University College, London (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Patient Health Questionnaire-9 (PHQ-9) (Pre-intervention and within 6 weeks post intervention)
  The PHQ9 is a self-administered questionnaire measuring levels of depression over the past 2 weeks. The questionnaire uses a 4-point Likert rating scale, ranging from 0 (not at all) to 3 (nearly every day). The total score can range from 0 to 27, with high scores meaning high depression.
• Generalised Anxiety Disorder (GAD-7) (Pre-intervention and within 6 weeks post intervention)
  The GAD 7 is a self-administered questionnaire measuring levels of anxiety over the past 2 weeks. The questionnaire uses a 4 Likert rating scale, ranging from 0 (not at all) to 3 (nearly every day). Total score can range from 0 to 21 and is categorised by 0-4 was no anxiety, 5-9 was mild anxiety, 10-14 was moderate anxiety, and…
• Menopause-Specific Quality of Life (MENQoL) (Pre-intervention and within 6 weeks post intervention)
  The MENQoL measures the quality of life over 4 domains of menopausal symptoms: Vasomotor, Psychosocial, Physical and Sexual, asking if a symptom is present or not and if it is to score how bothersome it is on a 7-point Likert scale, ranging from 0 'not bothered at all' to 6 'extremely bothered.
• Hot Flush Rating Scale (HFRS) (Pre-intervention and within 6 weeks post intervention)
  The HFRS is a self-report measure of the frequency and problem rating of hot flashes and night sweats (also known as vasomotor symptoms \[VMS\]) over the past week.
• The Multifactoral Memory Questionnaire (MMQ) (Pre-intervention and within 6 weeks post intervention)
  The MMQ measures self-reported cognitive functions with three subscales: abilities, contentment, strategies. Items are rated on a 5-point scale (0-4), lower scores indicate worse perceived memory.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.