Group Compassionate Mind Training for Adults Experiencing the Menopause Transition
NCT Number: NCT06462157
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Menopause
Interventions: OTHER: Compassionate Mind Training
Sponsor: University College, London
Sex: FEMALE
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-20
Completion Date: 2026-10-23
Locations: University College London, London, County, WC1E 6BT, United Kingdom

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.

Primary Outcome Measures: 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 Outcome Measures: Post intervention interviews, Qualitative data on experiences from the group, Within 5 weeks post intervention