Group Compassionate Mind Training for Adults Experiencing the Menopause Transition

NCT ID: NCT06462157

Last Updated: 2024-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-20

Study Completion Date

2026-10-23

Brief Summary

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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.

This 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.

Detailed Description

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Conditions

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Menopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Online CMT groups

Online Compassionate Mind Training

Group Type EXPERIMENTAL

Compassionate Mind Training

Intervention Type OTHER

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.

Control Group

Treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Compassionate Mind Training

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.

Intervention Type OTHER

Other Intervention Names

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CMT

Eligibility Criteria

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Inclusion Criteria

* Adults (aged 40-60) who are biologically female
* 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.
* Substantial English verbal communication and comprehension skills
* Capacity to consent
* Confident in using video conferencing applications (MsTeams)
* Willingness to take part in a post-intervention interview about their experience.
* PHQ-9 score 5-19 (mild to moderate clinical cut offs)
* GAD-7 score 5-15 (mild to moderate clinical cut offs)

Exclusion Criteria

* People under the age of 40
* People currently receiving any form of psychology intervention.
* Transgender females who are biologically male
* More than 5 years post menopause.
* PHQ-9 score greater or equal to 20 (severe clinical cut off)
* GAD-7 score greater or equal to 15 (severe clinical cut off)
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aimee Spector

Role: PRINCIPAL_INVESTIGATOR

UCL

Locations

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University College London

London, County, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Aimee Spector

Role: CONTACT

020 7679 1844 ext. 41844

Kate Robinson

Role: CONTACT

07545561796

Facility Contacts

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Aimee Spector

Role: primary

020 7679 1844 ext. 41844

Other Identifiers

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26701/001

Identifier Type: -

Identifier Source: org_study_id

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