MenopauseNCT06462157
Group Compassionate Mind Training for Adults Experiencing the Menopause Transition
A study testing Compassionate Mind Training in people with Menopause, run by University College, London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Compassionate Mind Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jun 2024to 23 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London
London, County, WC1E 6BT
About this study
Official title: The Feasibility and Effects of Group Compassionate Mind Training for Adults Experiencing the Menopause Transition: a Preliminary Investigation
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
- Being tested
- Compassionate Mind Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassionate Mind TrainingOther
Also called CMT
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.
| Study group | Role | What they receive |
|---|---|---|
| Online CMT groups | Experimental | Online Compassionate Mind Training Receives: Other: Compassionate Mind Training |
| Control Group | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: To be completed within one week before and within one week after the intervention
Secondary outcomes (1)
Post intervention interviews
Qualitative data on experiences from the group
Measured: Within 5 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start20 Jun 2024
- Primary completion23 Oct 2025
- Study completion23 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aimee Spector, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462157
- Sponsor's protocol ID
- 26701/001
- Status last verified
- May 2026
- First submitted
- 11 Jun 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Effects of Group Compassionate Mind Training for Adults Experiencing the Menopause Transition: a Preliminary Investigation
- ClinicalTrials.gov ID
- NCT06462157
- Acronym / sponsor ID
- 26701/001
- Conditions
- Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 23 Oct 2025 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online CMT groups | Experimental | Other: Compassionate Mind TrainingOnline Compassionate Mind Training |
| Control Group | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compassionate Mind TrainingAlso: CMTParticipants 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. | Other | Online CMT groups |
Primary outcome
The Revised Women's Health Questionnaire
Time frame: To be completed within one week before and within one week after the intervention
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.
36-Item Short Form Survey
Time frame: To be completed within one week before and within one week after the intervention
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.
The Menopause Representations Questionnaire (MRQ)
Time frame: To be completed within one week before and within one week after the intervention
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.
Fears of Compassion Scale
Time frame: To be completed within one week before and within one week after the intervention
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.
Patient Health Questionnaire-9 (PHQ-9)
Time frame: To be completed within one week before and within one week after the intervention
Measures severity of depression. Score from 0-27, higher scores represent higher severity of symptoms of depression.
General Anxiety Disorder-7 (GAD-7)
Time frame: To be completed within one week before and within one week after the intervention
Measures severity of anxiety. Score from 0-21, higher scores represent higher severity of symptoms of anxiety.
The forms of Self Criticising/Attaching & Self-reassuring scale (FSCRS) SELF-REASSURING SCALE (FSCR
Time frame: To be completed within one week before and within one week after the intervention
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).
1 secondary outcome
Post intervention interviews
Time frame: Within 5 weeks post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aimee Spector principal investigator
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassionate Mind Training in people with Menopause, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Revised Women's Health Questionnaire (time frame: To be completed within one week before and within one week after the intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.