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.

Study Overview

• Status: Completed
• Conditions: Menopause
• Intervention / Treatment: Other: Online cognitive intervention

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1E 6BT
    • University College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Treatment as usual
Experimental: Treatment group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post intervention interviews	Around 15 participants will be invited to qualitative semi-structured audio-recorded interviews to explore their feedback of the intervention.	Pre-intervention and within 6 weeks post intervention

Collaborators and Investigators

• Sponsor: University College, London

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2025
• Primary Completion (Actual): October 1, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Fatigue; Mental Fatigue
• Other Study ID Numbers: 167427

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No