A Feasibility Study of a Group Talking Therapy Programme for NHS Staff With Menopausal Hot Flushes and Night Sweats.

Overview

The goal of this feasibility study/clinical trial is to evaluate the feasibility and acceptability of a CBT group programme (MENOS protocol) for hot flushes and night sweats for National Health Service (in The United Kingdom) healthcare workers experiencing difficult menopause symptoms to inform how to run a larger definitive randomised controlled trial in the future. The main questions it aims to answer is: \[Primary Outcomes\] (1) Is the approach of the study feasible (possible to do) and acceptable (Do participants think it is a good approach) in terms of recruitment, completion of measures and the use of a control arm? (2) Is the CBT group (MENOS protocol) intervention feasible and acceptable for the participants based on retention, satisfaction, acceptability and feasibility ratings of the intervention and participant feedback? \[Secondary Outcomes\] (3) Are the menopause and work-related outcome questionnaires able to capturing change to inform the selection of measures for a future definitive Randomised Controlled Trial? (4) Did the participants find completing self-reported memory measures acceptable? Participants will be allocated to an intervention and control arm but the arms will not be compared as this is a feasibility study not designed to test the effectiveness of the intervention. Rather it is to evaluate the acceptability of a control arm and the approach of the study for a future larger trial. Intervention Participants will be: asked to attend a 6 x 2hours weekly CBT group therapy sessions for menopause related Hot flushes and Night Sweats. Intervention Participants will be invited to take part in a focus group post intervention. All participants (Control and Intervention arm) will be asked to complete online survey at pre-intervention, post-intervention and at 3-months after the end of the intervention. At the end of the study, the control arm will be offered a guided self-help CBT book of the programme.

Challenging menopause symptoms can affect healthcare workers' well-being and work life, potentially contributing to career changes and thus impacting workforce retention and health service delivery. Increasing numbers of UK National Health Service (NHS) workers are working through menopause transition and reporting problematic menopausal symptoms in the workplace. Although psychosocial interventions have been developed for menopause, the evaluation of their effectiveness within the healthcare workforce remains scarce . This study assesses the feasibility and acceptability of a Cognitive Behavioural Therapy (CBT) group intervention for UK NHS workers experiencing problematic hot flushes/night sweats (HF/NS). A mixed-methods design employing a randomised two-arm parallel design with intervention and control conditions was used to assess feasibility and acceptability. Measures of menopause symptoms, beliefs and behaviour, midlife female health, memory and of the menopause-related impact on work were collected through online surveys from both study arms at baseline (6 days before the start of the intervention), post-intervention (to be sent within 1 week of the last intervention session) and three months post-intervention. Focus groups were conducted around 4 months after completion of the intervention with participants in the intervention group to gather their perspectives on the acceptability of the study and intervention. The extension of the CONSORT 2010 checklist for feasibility trials was used for reporting this study. Participants and Recruitment Procedure. Participants were recruited from NHS workers in a single Health Service Trust in Northern Ireland (UK) between March and June 2025. The project was advertised through a direct email to a Trust-wide staff mailing list, Trust social media, the Trust-based menopause café and posters in the workplace. Recruitment material directed staff to register interest with a designated member of the research team based in the Trust via telephone or email. Trust Occupational Health also provided staff who were referred to their service with menopausal complaints with recruitment information on the study. An eligibility screening tool was developed and completed with all participants by phone or via email. Those deemed eligible were sent a participant information sheet and an informed consent form. Once, the participants consented by completing a consent form, they were randomly allocated to either the intervention or control arm until a sufficient sample size was generated. Further Information on inclusion and exclusion criteria is included later in the application. Measure Collection and Anonymity. Once consent was given and participants were allocated to either the intervention or control arm, they were sent an email by a designated member of the research team with a link to online questionnaires. Participants were issued with a computer-generated code to complete the first survey. This code was known only to them. They were asked to make note of this code and re-use it for completing further questionnaires at Time Point 2 (Post-Intervention) \& Time Point 3 (3-month-follow up). Therefore, there was no link between the participants' identifiable information and the coded data that they provided throughout the study. Intervention The intervention arm received the CBT group programme for menopausal symptoms - Hot Flushes/Night Sweats (using the MENOS protocol) for 6 weeks in weekly two-hour sessions. The intervention includes psychoeducation about menopause, the hot flushes cognitive behavioural model, plus the identification of triggers, stress management, sleep hygiene, cognitive techniques and paced breathing techniques. The CBT intervention was held during working hours in a healthcare setting and was delivered by two facilitators, a trainee clinical psychologist/CBT therapist and a senior nurse. The control arm continued to receive usual care. At the end of the study, participants in the control arm were offered a self-help book of the CBT programme for hot flushes and night sweats. Primary Outcome Measures 1. The acceptability and feasibility of the study methodology Recruitment rates were a primary feasibility outcome measure. Data was collected on the number of staff who expressed an interest in the study and progressed to screening. This enabled the calculation of an estimate of reach in terms of the potential target participants and the proportion who contacted the study. Completion rates of self-report measures of menopause symptoms, work and memory measures at three time points were a primary outcome to examine the acceptability and feasibility of the measures and the collection method for a future definitive Randomised Controlled Trial. At the post-intervention survey, participants were asked whether they found the randomisation process acceptable, while the control arm participants were also asked if they found their allocation to the control group acceptable. 2. The Feasibility and Acceptability of the Intervention Retention and attendance across the 6-week intervention were primary acceptability and feasibility measures of the intervention. Specific measures of acceptability and feasibility were collected post-intervention from participants in the intervention arm, including the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Feasibility of Intervention Measure (FIM) and the Client Satisfaction Questionnaire (CSQ-8). Qualitative data on the acceptability of the intervention was collected post-intervention through two focus groups drawn from the intervention arm. The focus groups explored the acceptability of the intervention, the setting and barriers and facilitators to recruitment and engagement, participants' experiences, perceived benefits or drawbacks, and recommendations for the future trial design. Secondary Outcomes (3) Responsiveness of Measures. Quantitative self-report measures were collected to provide preliminary data on their potential sensitivity to capture change within a healthcare population to inform outcome measures in a future RCT. Further information on the Secondary outcome measures is included later in the application form. (4) Acceptability of completing self-reported memory measures. (see Brief description). At the post-intervention survey, all participants were asked if they found completing the memory measures acceptable. Completion rates were also used for this assessment. Sample Size The target sample size was 40 participants, with 20 participants to be allocated to each study arm. As this was a feasibility study conducted in line with the CONSORT 2010 extension guidelines, a formal sample size calculation was not be computed. Randomisation and Allocation Method Participants were randomly allocated to the intervention and control arm using a digitally generated randomisation prior to study commencement. Allocation was completed by a researcher blinded to participant identities while participant names were be only known to the screener. Data Analysis Participant characteristics were described using means and standard deviation for continuous variables and frequencies and percentages for categorical variables. Recruitment, eligibility, retention and measure completion were be reported as percentages. Recruitment reach was estimated as the proportion of potentially eligible staff who expressed interest. Intervention attendance was described using the mean number of sessions attended and the overall attendance percentage. AIM, FIM, IAM and CSQ outcomes were summarised using mean scores and standard deviations, with recommended guidelines used to interpret outcome levels. Qualitative data was examined using reflexive thematic analysis. For the secondary objectives, analyses were conducted to examine the sensitivity of each outcome measure to detect change over time and determine their suitability for a future RCT. As this was an exploratory feasibility study, the analysis focused on the magnitude and precision of the change estimate rather than statistical significance. Effect sizes were used to conduct an a priori analysis to estimate the sample size required to ensure 80% power, with an alpha level of .05 in a future RCT. The effect size estimate was calculated as the difference in mean pre-post change between the intervention and control arms, divided by the pooled baseline standard deviation.