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

NCT07759830 | Completed

• 1 other identifier: 348461 (IRAS No.)
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Menpause; Hot flushes; Night Sweats; Vasomotor symptoms; Healthcare workers; NHS workers; CBT for menopause symptoms; MENOS protocol

Outcome Measures

Primary Outcomes (7)

• Number of participants recruited

  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.

  10 weeks. Between March 22nd and June 1st 2025

• Number of participants allocated to the intervention retained.

  Number of participants allocated to intervention who started the intervention, Number who dropped out of intervention.

  9 weeks - includes the 6 week intervention and allocation run in time.

• Number of weekly Intervention CBT sessions attended.

  Collected by intervention facilitator. Overall mean attendance for all participants will be calculated and a percentage will also be calculated

  Collected over the 6 weeks of the intervention.

• AIM measures. The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) [5]

  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.

  7 weeks after start of intervention.

• The Client Satisfaction Questionnaire (CSQ-8) [6]

  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.

  7 weeks after start of intervention.

• Percentage of completion of online survey measures.

  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.

  Baseline, 7 weeks and 18 weeks.

• Non-validated questions on randomisation

  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.

  7 weeks after start of intervention.

Secondary Outcomes (5)

• 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.

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral therapy group programme for Menopausal Hot flushes and Night Sweats

Control arm

OTHER

The control arm received usual treatment and supports during the study. They did receive any intervention.

Other: No intervention

Interventions

Cognitive Behavioral therapy group programme for Menopausal Hot flushes and Night Sweats BEHAVIORAL

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

Intervention arm

No intervention OTHER

No Intervention. Treatment as usual

Control arm

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Any current serious physical or mental health problems.

Sponsors & Collaborators

• Queen's University, Belfast: lead

Study Sites (1)

Western Health and Social care trust. Altnagelvin Area Hospital, Glenshane Road, Derry,

Londonderry, Derry, BT47 6SB, United Kingdom

Location

Related Publications (13)

• 13.Gilewiski MJ, Zelenski EM. The Memory Function Questionnaire. Psychopharmocol Bull, 1988; 24(4):665-72.

  BACKGROUND

• Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.

  PMID: 11983645 BACKGROUND

• 11.Hunter MS. The Women's Health Questionnaire: a measure of mid-aged women's perceptions of their emotional and physical health. Psychol & Health, 1992;7:45-54. doi:10:1080/08870449208404294.

  BACKGROUND

• Rendall MJ, Simonds LM, Hunter MS. The Hot Flush Beliefs Scale: a tool for assessing thoughts and beliefs associated with the experience of menopausal hot flushes and night sweats. Maturitas. 2008 Jun 20;60(2):158-69. doi: 10.1016/j.maturitas.2008.05.001. Epub 2008 Jun 12.

  PMID: 18554828 BACKGROUND

• Hunter MS, Liao KL. A psychological analysis of menopausal hot flushes. Br J Clin Psychol. 1995 Nov;34(4):589-99. doi: 10.1111/j.2044-8260.1995.tb01493.x.

  PMID: 8563666 BACKGROUND

• 8. Morris SB. Estimating Effect Sizes From Pretest-Posttest-Control Group Designs. Organ Res Methods, 2008, 11(2), 364-386. doi.10.771/1094428106291059.

  BACKGROUND

• 7. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77-101. doi.org/101191/1478088706qp063oa

  BACKGROUND

• Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

  PMID: 10245370 BACKGROUND

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

  PMID: 28851459 BACKGROUND

• 4. Hunter M, Smith M. Managing hot flushes with group cognitive behaviour therapy. London: Routledge; 2014.

  BACKGROUND

• Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.

  PMID: 27777223 BACKGROUND

• Scott J, Hancock J, Rogers M, McBurnie J, Mattick K. Menopause and the healthcare workforce: a scoping review and stakeholder consultation. BMC Health Serv Res. 2026 Jan 29;26(1):286. doi: 10.1186/s12913-025-13906-z.

  PMID: 41612377 BACKGROUND

• 1. Ali S, Duggal S, Hextell L, Jones E, Mobeen M, Moore E, et al. Menopause and the NHS workforce qualitative report [Internet]. 2023. [Cited 2026, May 3]. Available from URL.

  BACKGROUND

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katrina McLaughlin, P.hD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

• Orla E Walsh, Bsc, Msc

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer, School of Psychology, Queen's University Belfast

Model Details: This was a feasibility study and therefore was not studying the effectiveness or treatment effect of the intervention.

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 12, 2026
• Study Start: May 8, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning after publication of the primary study results and held for 5 years.
• Access Criteria: Shared for scientifically appropriate purposes through an appropriate open-access repository, subject to participant consent, ethical approval, confidentiality, and applicable data protection requirements. Transcripts that cannot be adequately de-identified will not be publicly released or may be subject to controlled access.

Locations

GB (1)