Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-28 @ 4:47 AM
Study NCT ID:
NCT06940466
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-23
First Post:
2025-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Cognitive Intervention to Manage 'Brain Fog' in Menopause Transition: Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2025-04-03', 'studyFirstSubmitQcDate': '2025-04-15', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'Pre-intervention and within 6 weeks post intervention', 'description': '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.'}, {'measure': 'Generalised Anxiety Disorder (GAD-7)', 'timeFrame': 'Pre-intervention and within 6 weeks post intervention', 'description': '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.'}, {'measure': 'Menopause-Specific Quality of Life (MENQoL)', 'timeFrame': 'Pre-intervention and within 6 weeks post intervention', 'description': "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."}, {'measure': 'Hot Flush Rating Scale (HFRS)', 'timeFrame': 'Pre-intervention and within 6 weeks post intervention', 'description': '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.'}, {'measure': 'The Multifactoral Memory Questionnaire (MMQ)', 'timeFrame': 'Pre-intervention and within 6 weeks post intervention', 'description': '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.'}, {'measure': 'Menopause-specific Cognitive Scale (MENO-Cog)', 'timeFrame': 'Pre-intervention and within 6 weeks post intervention', 'description': '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.'}, {'measure': 'Rey Auditory Verbal Learning Test (RAVLT)', 'timeFrame': 'Pre-intervention and within 6 weeks post intervention', 'description': 'The RAVLT is a neuropsychological test measuring verbal learning and (immediate and delayed) verbal memory.'}, {'measure': 'Trail Making Test (TMT)', 'timeFrame': 'Pre-intervention and within 6 weeks post intervention', 'description': 'The TMT (Part A and B) is a neuropsychological test assessing executive function; shorter reaction times indicate better performance.'}, {'measure': 'Digit Span subtest (WISC-V)', 'timeFrame': 'Pre-intervention and within 6 weeks post intervention', 'description': 'The Digit Span test (backward and forward) is a neuropsychological test assessing attention and working memory.'}, {'measure': 'Controlled Word Association Test', 'timeFrame': 'Pre-intervention and within 6 weeks post intervention', 'description': 'The Controlled Word Association Test is a neuropsychological test assessing verbal fluency.'}], 'secondaryOutcomes': [{'measure': 'Post intervention interviews', 'timeFrame': 'Pre-intervention and within 6 weeks post intervention', 'description': 'Around 15 participants will be invited to qualitative semi-structured audio-recorded interviews to explore their feedback of the intervention.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Menopause']}, 'descriptionModule': {'briefSummary': "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.\n\nStudy 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\n\nRelevance: 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* people with ovaries (women, trans-men and non-binary people) aged 40-60\n* late-reproductive, early-late perimenopause or early post-menopause stages according to the Stages of Reproductive Aging Workshop (STRAW+10Íž Harlow et al., 2012)\n* stable dose of hormonal (oestrogen, progesterone, testosterone) or antidepressant (SSRI, SSNI) medication for 6 months or more\n* self-reported cognitive difficulties impacting on quality of life\n* ability to communicate in English\n\nExclusion Criteria:\n\n* diagnosis of dementia\n* new regimen (under 6 months) of medication likely to impact on cognition (i.e. hormonal or anti-depressant)'}, 'identificationModule': {'nctId': 'NCT06940466', 'briefTitle': "A Cognitive Intervention to Manage 'Brain Fog' in Menopause Transition: Feasibility Study", 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': "A Cognitive Intervention to Manage 'Brain Fog' in Menopause Transition: Feasibility Study", 'orgStudyIdInfo': {'id': '167427'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment 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', 'interventionNames': ['Other: Online cognitive intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Treatment as usual'}], 'interventions': [{'name': 'Online cognitive intervention', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WC1E 6BT', 'city': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'Aimee Spector', 'role': 'CONTACT', 'email': 'a.spector@ucl.ac.uk', 'phone': '020 7679 1844', 'phoneExt': '41844'}, {'name': 'Alex Faulkner', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Helena Gilchrist', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sunaina Sethi', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lexi He', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Aimee Spector', 'role': 'CONTACT', 'email': 'a.spector@ucl.ac.uk', 'phone': '020 7679 1844', 'phoneExt': '41844'}, {'name': 'Alex Faulkner', 'role': 'CONTACT', 'email': 'alexandra.faulkner.19@ucl.ac.uk', 'phone': '020 7679 1844', 'phoneExt': '41844'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}