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Completed

NCT Number: NCT06940466

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

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.

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Key information

Conditions

Menopause

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University College London

London, WC1E 6BT, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 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.

  2. Generalised Anxiety Disorder (GAD-7)

    Time frame: 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 15 or above was severe anxiety.

  3. Menopause-Specific Quality of Life (MENQoL)

    Time frame: 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.

  4. Hot Flush Rating Scale (HFRS)

    Time frame: 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.

  5. The Multifactoral Memory Questionnaire (MMQ)

    Time frame: 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.

  6. Menopause-specific Cognitive Scale (MENO-Cog)

    Time frame: Pre-intervention and within 6 weeks post intervention

    The measure is in development with a PhD student in the same research team. It measures self-reported cognition functioning with a 5-point Likert scale; higher scores indicate worse perceived cognitive function.

  7. Rey Auditory Verbal Learning Test (RAVLT)

    Time frame: Pre-intervention and within 6 weeks post intervention

    The RAVLT is a neuropsychological test measuring verbal learning and (immediate and delayed) verbal memory.

  8. Trail Making Test (TMT)

    Time frame: Pre-intervention and within 6 weeks post intervention

    The TMT (Part A and B) is a neuropsychological test assessing executive function; shorter reaction times indicate better performance.

  9. Digit Span subtest (WISC-V)

    Time frame: Pre-intervention and within 6 weeks post intervention

    The Digit Span test (backward and forward) is a neuropsychological test assessing attention and working memory.

  10. Controlled Word Association Test

    Time frame: Pre-intervention and within 6 weeks post intervention

    The Controlled Word Association Test is a neuropsychological test assessing verbal fluency.

Secondary outcomes

  1. Post intervention interviews

    Time frame: Pre-intervention and within 6 weeks post intervention

    Around 15 participants will be invited to qualitative semi-structured audio-recorded interviews to explore their feedback of the intervention.

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 23, 2025
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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