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Group Compassionate Mind Training for Adults Experiencing the Menopause Transition

University College London (UCL) logo

University College London (UCL)

Status

Enrolling

Conditions

Menopause

Treatments

Other: Compassionate Mind Training

Study type

Interventional

Funder types

Other

Identifiers

NCT06462157
26701/001

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

Female

Ages

40 to 60 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Online CMT groups
Experimental group
Description:
Online Compassionate Mind Training
Treatment:
Other: Compassionate Mind Training
Control Group
No Intervention group
Description:
Treatment as usual

Trial contacts and locations

1

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Central trial contact

Aimee Spector; Kate Robinson

Data sourced from clinicaltrials.gov

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