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

NCT06940466 | Completed

• 1 other identifier: 167427
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Outcome Measures

Primary Outcomes (10)

• Patient Health Questionnaire-9 (PHQ-9)

  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.

  Pre-intervention and within 6 weeks post intervention

• Generalised Anxiety Disorder (GAD-7)

  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.

  Pre-intervention and within 6 weeks post intervention

• Menopause-Specific Quality of Life (MENQoL)

  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.

  Pre-intervention and within 6 weeks post intervention

• Hot Flush Rating Scale (HFRS)

  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.

  Pre-intervention and within 6 weeks post intervention

• The Multifactoral Memory Questionnaire (MMQ)

  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.

  Pre-intervention and within 6 weeks post intervention

• Menopause-specific Cognitive Scale (MENO-Cog)

  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.

  Pre-intervention and within 6 weeks post intervention

• Rey Auditory Verbal Learning Test (RAVLT)

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

  Pre-intervention and within 6 weeks post intervention

• Trail Making Test (TMT)

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

  Pre-intervention and within 6 weeks post intervention

• Digit Span subtest (WISC-V)

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

  Pre-intervention and within 6 weeks post intervention

• Controlled Word Association Test

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

  Pre-intervention and within 6 weeks post intervention

Secondary Outcomes (1)

• Post intervention interviews

  Pre-intervention and within 6 weeks post intervention

Study Arms (2)

Treatment group

EXPERIMENTAL

Treatment group participants will complete a 4 x 2-hour intervention. Key components will include education about menopause and cognition, cognitive strategies (memory, attention and executive functioning), CBT techniques and emotional support

Other: Online cognitive intervention

Control group

NO INTERVENTION

Treatment as usual

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.

Treatment group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• diagnosis of dementia
• new regimen (under 6 months) of medication likely to impact on cognition (i.e. hormonal or anti-depressant)

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London

London, WC1E 6BT, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 23, 2025
• Study Start: June 27, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)