Evaluating the Feasibility of a CBT Group Therapy Programme (MENOS Protocol ) for NHS Staff With Problematic Menopause Symptoms.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Number of participants recruited
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •NHS (National Health Service -UK) employees born female in good general health,
- •Aged 40 - 60 years.
- •Proficient in English.
- •Experiencing menopause with problematic hot flush/night sweat symptoms for at least 2 months (scoring <2 on the Hot Flush/Night Sweat Severity Scale with a minimum frequency of 10 episodes a week).
- •Participants using HT are eligible.
排除标准
- •Any current serious physical or mental health problems.
研究组 & 干预措施
Intervention arm
CBT group programme for the menopausal symptoms of Hot Flushes/Night Sweats (using the MENOS protocol) for 6 weeks in weekly two-hour sessions. The intervention includes psychoeducation about hot flushes in menopause and the Hot Flush/Night Sweats cognitive behavioural model, plus the identification of triggers, stress management, sleep hygiene and paced breathing techniques
干预措施: Cognitive Behavioral therapy group programme for Menopausal Hot flushes and Night Sweats (Behavioral)
Control arm
The control arm received usual treatment and supports during the study. They did receive any intervention.
干预措施: No intervention (Other)
结局指标
主要结局
Number of participants recruited
时间窗: 10 weeks. Between March 22nd and June 1st 2025
This includes the number of participants who expressed interest. Number of participants screened for eligibility. Number of eligible participants. Number of participants who consented and were enrolled in study.
Number of participants allocated to the intervention retained.
时间窗: 9 weeks - includes the 6 week intervention and allocation run in time.
Number of participants allocated to intervention who started the intervention, Number who dropped out of intervention.
Number of weekly Intervention CBT sessions attended.
时间窗: Collected over the 6 weeks of the intervention.
Collected by intervention facilitator. Overall mean attendance for all participants will be calculated and a percentage will also be calculated
AIM measures. The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) [5]
时间窗: 7 weeks after start of intervention.
Completed by Intervention arm in an online survey. These measures are administered to determine the extent to which participants believe an intervention or an implementation strategy is acceptable. These are four-item measures of implementation outcomes that are considered indicators of implementation success. Scored by summing the 4 items within each scale, where 1 = "completely disagree" and 5 = "completely agree". Each measure produces a score from 4 to 20, with higher scores indicating higher acceptability, appropriateness, or feasibility. Scale Range: Each of the 4 items in each questionnaire (AIM, IAM, FIM) is rated on a 5-point Likert scale. Mean and standard deviation scores will calculated to assess the acceptability, feasibility and appropriateness of the CBT intervention for the intervention participants. Maximum raw score 20. Scores above 15 indicate high levels of the measures.
The Client Satisfaction Questionnaire (CSQ-8) [6]
时间窗: 7 weeks after start of intervention.
Completed by participants from the intervention arm in online survey. An unidimensional measure of global satisfaction with programmes with high internal reliability and Cronbach's alpha of 0.92- 0.93. Maximum raw score 32. Will be rated using scoring guidelines.
Percentage of completion of online survey measures.
时间窗: Baseline, 7 weeks and 18 weeks.
Overall completion rates by both arms of online survey measures at baseline, post-intervention and 3-months follow up post-intervention reported as percentage. Completion rates by the intervention arm of the online survey measures at baseline, post-intervention and 3-months follow up post-intervention reported as percentage. Completion rates by the control arm of the online survey measures at baseline, post-intervention and 3-months follow up post-intervention reported as percentage. Used to calculate attrition rates in both groups.
Non-validated questions on randomisation
时间窗: 7 weeks after start of intervention.
Q 1.All participants were asked if they found the random allocation to the intervention and control arms acceptable. Q2. Participants in the control arm were asked if they found allocation to the control group was acceptable. Scored on scale with 4 items (score 1-4) - No definitely not; No not really; Yes, generally, Yes definitely. Mean score calculated.
次要结局
- Hot Flush/Night Sweat (HF/NS) Rating Scale [9](Baseline, 7 weeks and 18 weeks.)
- Short Form Hot Flush Beliefs and Behaviour Scale (HFBBS) [10](Baseline, 7 weeks and 18 weeks.)
- Women's Health Questionnaire (WHQ) [11](Baseline, 7 weeks and 18 weeks.)
- Work and Social Adjustment Scale (WSAS) [12](Baseline, 7 weeks and 18 weeks.)
- Memory Function Questionnaire (MFQ) [13](Baseline, 7 weeks and 18 weeks.)
研究者
Katrina McLaughlin
Senior Lecturer, School of Psychology, Queen's University Belfast
Queen's University, Belfast
