Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-26 @ 5:41 AM
Study NCT ID:
NCT06462157
Status:
RECRUITING
Last Update Posted:
2024-07-29
First Post:
2024-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Group Compassionate Mind Training for Adults Experiencing the Menopause Transition
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': 'RECRUITING', 'startDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-10-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-26', 'studyFirstSubmitDate': '2024-06-11', 'studyFirstSubmitQcDate': '2024-06-11', 'lastUpdatePostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The Revised Women's Health Questionnaire", 'timeFrame': 'To be completed within one week before and within one week after the intervention', 'description': 'Measures health-related quality of life by measuring perceptions of physical and emotional experiences of middle-aged women. All subscales are scored from yes, definitely (1) to no, not at all (4) with subscales scored with a scoring algorithm transforming each score to a 0-100 scale.'}, {'measure': '36-Item Short Form Survey', 'timeFrame': 'To be completed within one week before and within one week after the intervention', 'description': 'Measures quality of life. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.'}, {'measure': 'The Menopause Representations Questionnaire (MRQ)', 'timeFrame': 'To be completed within one week before and within one week after the intervention', 'description': 'Measure to assess beliefs about menopause. It consists of 20 items, scored either no (0), uncertain (1) or yes (2). Higher scores indicate more beliefs about the menopause.'}, {'measure': 'Fears of Compassion Scale', 'timeFrame': 'To be completed within one week before and within one week after the intervention', 'description': 'Measures fears of compassion. It has 38 items, scored either dont agree at all (0) to completely agree (4) on a Likert scale. There are three subscales, subscale items are summed, with higher scores indicating higher fears of compassion.'}, {'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'To be completed within one week before and within one week after the intervention', 'description': 'Measures severity of depression. Score from 0-27, higher scores represent higher severity of symptoms of depression.'}, {'measure': 'General Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'To be completed within one week before and within one week after the intervention', 'description': 'Measures severity of anxiety. Score from 0-21, higher scores represent higher severity of symptoms of anxiety.'}, {'measure': 'The forms of Self Criticising/Attaching & Self-reassuring scale (FSCRS) SELF-REASSURING SCALE (FSCR', 'timeFrame': 'To be completed within one week before and within one week after the intervention', 'description': 'Measures self criticism and the ability to self-reassure. It is a 22-item scale with the items making up three components; inadequate self, hatred self and self-reassure. Responses are given on a 5-point likert scale (0 = not at all lime me, to 4 = extremely like me). Higher scores indicate a greater sense of inadequacy (score 0-20), self-hate (score 0-16), and self-reassurance (score 0-20).'}], 'secondaryOutcomes': [{'measure': 'Post intervention interviews', 'timeFrame': 'Within 5 weeks post intervention', 'description': 'Qualitative data on experiences from the group'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Menopause']}, 'descriptionModule': {'briefSummary': "Menopause transition occurs naturally for women aged 45-55. In addition to the hormone changes, there are often changes in other areas of life including low mood, anxiety, 'brain fog' and embarrassment. Some people may not be eligible for or want to receive hormone replacement therapy, therefore psychological treatments for menopause have been investigated. There is growing evidence for the use of Compassionate Mind Training (CMT). CMT aims to reduce feelings of self-criticism and shame which are commonly reported by adults experiencing the menopause, by helping individuals to take better care of themselves, known as self-compassion. Findings show menopausal individuals who are more self-critical may be more vulnerable to difficulties during menopause. Therefore, CMT could help manage this. CMT improves self-compassion and reduces depressive symptoms, with group formats found to be more effective than individual or self-help. A previous study of online self-help CMT for the menopause received positive feedback for the therapy and people improved in several areas including self-compassion. Clearly, there could be benefits to offering CMT as a treatment for menopause. Given that group CMT is effective in other populations and groups are more economical and practical for the NHS, this study is interested in looking at the impact of group CMT on menopause.\n\nThis study aims to find out how practical and suitable group CMT is for improving the wellbeing of adults experiencing the menopause, and what their views are on the therapy and taking part in the study. To measure the aims, we will look at the ease of recruiting people to the study, whether they are happy to be randomly allocated to receive the therapy or not, whether they stay in the study, the number of completed questionnaires and feedback from participants. It will also look at whether there have been any changes in different domains e.g. anxiety and self-compassion. This will be done through a variety of quantitative and qualitative outcomes."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (aged 40-60) who are biologically female\n* Women who are experiencing symptoms of the menopause or peri-menopause; which is naturally occurring. This is identified through the STRAW criteria. Individuals have to answer Yes on at least one of the STRAW screening questions to ensure women are in the perimenopause or menopausal period.\n* Substantial English verbal communication and comprehension skills\n* Capacity to consent\n* Confident in using video conferencing applications (MsTeams)\n* Willingness to take part in a post-intervention interview about their experience.\n* PHQ-9 score 5-19 (mild to moderate clinical cut offs)\n* GAD-7 score 5-15 (mild to moderate clinical cut offs)\n\nExclusion Criteria:\n\n* People under the age of 40\n* People currently receiving any form of psychology intervention.\n* Transgender females who are biologically male\n* More than 5 years post menopause.\n* PHQ-9 score greater or equal to 20 (severe clinical cut off)\n* GAD-7 score greater or equal to 15 (severe clinical cut off)'}, 'identificationModule': {'nctId': 'NCT06462157', 'briefTitle': 'Group Compassionate Mind Training for Adults Experiencing the Menopause Transition', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'The Feasibility and Effects of Group Compassionate Mind Training for Adults Experiencing the Menopause Transition: a Preliminary Investigation', 'orgStudyIdInfo': {'id': '26701/001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Online CMT groups', 'description': 'Online Compassionate Mind Training', 'interventionNames': ['Other: Compassionate Mind Training']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Treatment as usual'}], 'interventions': [{'name': 'Compassionate Mind Training', 'type': 'OTHER', 'otherNames': ['CMT'], 'description': 'Participants will attend 6 x 90-minute online CMT sessions. CMT is delivered by combining taught information, exercises, and practices. It is effective, so the aim is to explore its use with menopausal women.', 'armGroupLabels': ['Online CMT groups']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WC1E 6BT', 'city': 'London', 'state': 'County', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Aimee Spector', 'role': 'CONTACT', 'email': 'a.spector@ucl.ac.uk', 'phone': '020 7679 1844', 'phoneExt': '41844'}, {'name': 'Kate Robinson', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Simone Saidel', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Helen Donovan', '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': 'Kate Robinson', 'role': 'CONTACT', 'email': 'kate.robinson.22@ucl.ac.uk', 'phone': '07545561796'}], 'overallOfficials': [{'name': 'Aimee Spector', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}