Clinical trial NCT06462157: Group Compassionate Mind Training for Adults Experiencing the Menopause Transition
Official title: The Feasibility and Effects of Group Compassionate Mind Training for Adults Experiencing the Menopause Transition: a Preliminary Investigation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Menopause
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: The Revised Women's Health Questionnaire
timeFrame: To be completed within one week before and within one week after the intervention
measure: 36-Item Short Form Survey
timeFrame: To be completed within one week before and within one week after the intervention
measure: The Menopause Representations Questionnaire (MRQ)
timeFrame: To be completed within one week before and within one week after the intervention
measure: Fears of Compassion Scale
timeFrame: To be completed within one week before and within one week after the intervention
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: To be completed within one week before and within one week after the intervention
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: To be completed within one week before and within one week after the intervention
measure: The forms of Self Criticising/Attaching & Self-reassuring scale (FSCRS) SELF-REASSURING SCALE (FSCR
timeFrame: To be completed within one week before and within one week after the intervention
Secondary outcomes:
measure: Post intervention interviews
timeFrame: Within 5 weeks post intervention
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London
state: County
Study officials:
affiliation: UCL
name: Aimee Spector
role: PRINCIPAL_INVESTIGATOR
References: