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A Feasibility Study of a Group Talking Therapy Programme for NHS Staff With Menopausal Hot Flushes and Night Sweats.
Sponsor: Queen's University, Belfast
Summary
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.
Official title: Evaluating the Feasibility of a CBT Group Therapy Programme (MENOS Protocol ) for NHS Staff With Problematic Menopause Symptoms.
Key Details
Gender
FEMALE
Age Range
40 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2025-05-08
Completion Date
2026-01-30
Last Updated
2026-08-12
Healthy Volunteers
No
Interventions
Cognitive Behavioral therapy group programme for Menopausal Hot flushes and Night Sweats
CBT group programme for 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
No intervention
No Intervention. Treatment as usual
Locations (1)
Western Health and Social care trust. Altnagelvin Area Hospital, Glenshane Road, Derry,
Londonderry, Derry, United Kingdom