Group Compassionate Mind Training for Adults Experiencing the Menopause Transition

Menopause Clinical Trial

Official title:

The Feasibility and Effects of Group Compassionate Mind Training for Adults Experiencing the Menopause Transition: a Preliminary Investigation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06462157
• Other study ID #: 26701/001
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 10, 2024
• Est. completion date: October 23, 2026

Study information

• Verified date: June 2024
• Source: University College, London
• Contact: Aimee Spector
• Phone: 020 7679 1844
• Email: a.spector[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 23, 2026
• Est. primary completion date: October 23, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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 question 1 and cannot answer No on question 3 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)

Related Conditions & MeSH terms

• Menopause

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	University College London	London	County

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Revised Women's Health Questionnaire	Measures health-related quality of life by measuring perceptions of physical and emotional experiences of middle-aged women.	To be completed within one week before and within one week after the intervention
Primary	36-Item Short Form Survey	Measures quality of life	To be completed within one week before and within one week after the intervention
Primary	The Menopause Representations Questionnaire	Measure to assess beliefs about menopause.	To be completed within one week before and within one week after the intervention
Primary	Self-Compassion Scale - Short Form	Measures Self compassion	To be completed within one week before and within one week after the intervention
Primary	Patient Health Questionnaire-9 (PHQ-9)	Measures severity of depression	To be completed within one week before and within one week after the intervention
Primary	General Anxiety Disorder-7 (GAD-7)	Measures severity of anxiety	To be completed within one week before and within one week after the intervention
Secondary	Post intervention interviews	Qualitative data on experiences from the group	Within 5 weeks post intervention