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

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.

Conditions

• Vasomotor Symptoms Associated With Menopause

Interventions

BEHAVIORAL

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

OTHER

No intervention

No Intervention. Treatment as usual

Sponsors & Collaborators

• Queen's University, Belfast

  lead OTHER

Principal Investigators

• Katrina McLaughlin, P.hD · Queen's University, Belfast

• Orla E Walsh, Bsc, Msc · Queen's University, Belfast

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-08

Primary Completion

2026-01-30

Completion

2026-01-30

Countries

• United Kingdom

Study Locations