Group Compassionate Mind Training for Adults Experiencing the Menopause Transition

NCT06462157 | Completed DMC

• 1 other identifier: 26701/001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopause

Outcome Measures

Primary Outcomes (7)

• The Revised Women's Health Questionnaire

  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.

  To be completed within one week before and within one week after the intervention

• 36-Item Short Form Survey

  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.

  To be completed within one week before and within one week after the intervention

• The Menopause Representations Questionnaire (MRQ)

  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.

  To be completed within one week before and within one week after the intervention

• Fears of Compassion Scale

  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.

  To be completed within one week before and within one week after the intervention

• Patient Health Questionnaire-9 (PHQ-9)

  Measures severity of depression. Score from 0-27, higher scores represent higher severity of symptoms of depression.

  To be completed within one week before and within one week after the intervention

• General Anxiety Disorder-7 (GAD-7)

  Measures severity of anxiety. Score from 0-21, higher scores represent higher severity of symptoms of anxiety.

  To be completed within one week before and within one week after the intervention

• The forms of Self Criticising/Attaching & Self-reassuring scale (FSCRS) SELF-REASSURING SCALE (FSCR

  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).

  To be completed within one week before and within one week after the intervention

Secondary Outcomes (1)

• Post intervention interviews

  Within 5 weeks post intervention

Study Arms (2)

Online CMT groups

EXPERIMENTAL

Online Compassionate Mind Training

Other: Compassionate Mind Training

Control Group

NO INTERVENTION

Treatment as usual

Interventions

Compassionate Mind Training 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.

Also known as: CMT

Online CMT groups

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London

London, County, WC1E 6BT, United Kingdom

Location

Study Officials

• Aimee Spector

  UCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 17, 2024
• Study Start: June 20, 2024
• Primary Completion: October 23, 2025
• Study Completion: October 23, 2025
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)