MenopauseNCT06940466
A Cognitive Intervention to Manage 'Brain Fog' in Menopause Transition: Feasibility Study
A study testing Online cognitive intervention in people with Menopause, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Online cognitive intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jun 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- diagnosis of dementia
- new regimen (under 6 months) of medication likely to impact on cognition (i.e. hormonal or anti-depressant)
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Menopause
- Being tested
- Online cognitive intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online cognitive interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Online cognitive intervention |
| Control group | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-intervention and within 6 weeks post intervention
Controlled Word Association Test
The Controlled Word Association Test is a neuropsychological test assessing verbal fluency.
Measured: Pre-intervention and within 6 weeks post intervention
Secondary outcomes (1)
Post intervention interviews
Around 15 participants will be invited to qualitative semi-structured audio-recorded interviews to explore their feedback of the intervention.
Measured: Pre-intervention and within 6 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start27 Jun 2025
- Primary completion1 Oct 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940466
- Sponsor's protocol ID
- 167427
- Status last verified
- Feb 2026
- First submitted
- 3 Apr 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cognitive Intervention to Manage 'Brain Fog' in Menopause Transition: Feasibility Study
- ClinicalTrials.gov ID
- NCT06940466
- Acronym / sponsor ID
- 167427
- Conditions
- Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Online cognitive interventionTreatment 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 |
| Control group | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- diagnosis of dementia
- new regimen (under 6 months) of medication likely to impact on cognition (i.e. hormonal or anti-depressant)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online cognitive interventionA 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. | Other | Treatment group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
1 secondary outcome
Post intervention interviews
Time frame: Pre-intervention and within 6 weeks post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online cognitive intervention in people with Menopause, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PHQ-9) (time frame: Pre-intervention and within 6 weeks post intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.