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

University College London (UCL)

Status: Completed

Conditions: Menopause

Treatments: Other: Online cognitive intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06940466

167427

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Treatment group

Experimental group

Description:

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

Treatment:

Other: Online cognitive intervention

Control group

No Intervention group

Description:

Treatment as usual