Vasomotor Symptoms Associated With MenopauseNCT07759830
A Feasibility Study of a Group Talking Therapy Programme for NHS Staff With Menopausal Hot Flushes and Night Sweats.
A study testing Cognitive Behavioral therapy group programme for Menopausal Hot flushes and Night Sweats in people with Vasomotor Symptoms Associated With Menopause, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Vasomotor Symptoms Associated With Menopause
- What is being tested?
- Cognitive Behavioral therapy group programme for Menopausal Hot flushes and Night Sweats
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 May 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Any current serious physical or mental health problems.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Western Health and Social care trust. Altnagelvin Area Hospital, Glenshane Road, Derry,
Londonderry, Derry, BT47 6SB
About this study
Official title: Evaluating the Feasibility of a CBT Group Therapy Programme (MENOS Protocol ) for NHS Staff With Problematic Menopause Symptoms.
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.
Read more
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.
Read the detailed description
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
- 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.
- 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.
- Being tested
- Cognitive Behavioral therapy group programme for Menopausal Hot flushes and Night Sweats, No intervention
- Keywords
- Menpause, Hot flushes, Night Sweats, Vasomotor symptoms, Healthcare workers, NHS workers, CBT for menopause symptoms, MENOS protocol
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral therapy group programme for Menopausal Hot flushes and Night SweatsBehavioural
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 interventionOther
No Intervention. Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 weeks after start of intervention.
Secondary outcomes (5)
Hot Flush/Night Sweat (HF/NS) Rating Scale [9]
This yields a HF/NS frequency score for the previous week, a HF/NS Severity score (Mild, Moderate or Severe) and a HF/NS problem rating (Scale 0-10). Cronbach's alpha (α) for the HF/NS problem rating measure was reported as 0.83. This measure will be used to evaluate the responsiveness of the measure to change and to calculate preliminary effect size for sample estimate for definitive future RCT.
Measured: Baseline, 7 weeks and 18 weeks.
Short Form Hot Flush Beliefs and Behaviour Scale (HFBBS) [10]
The Short Form HFBBS is a 16-item scale that includes items from the Hot Flush Beliefs Scale [50] and the Hot Flush Behaviour Scale [51]. Consists of 5 subscales. Items are scored 0-5 with items added and then divided by number of subscale score. Cronbach's alpha for the subscales was reported as: social context (α=.90), Beliefs about HF/NS (α=.73), Beliefs about coping and control (α=.78), Positive coping behaviour (α=.60), Avoidance (α=.76). This measure will be used to evaluate the responsiveness of the measure to change and to calculate preliminary effect size for sample estimate for definitive future RCT.
Measured: Baseline, 7 weeks and 18 weeks.
Women's Health Questionnaire (WHQ) [11]
A 36-item scale designed for midlife women that measures nine factors of health functioning, including somatic, menstrual, and vasomotor symptoms, as well as problems in mood, anxiety, memory, sleep, and sexual behaviour. (Cronbach's alpha (α) = 0.83). Uses Likert scale with 4 points. Scoring guidelines recommend - Subscale scores are derived by summing the symptom scores into binary scores, recoded as present or absent (Yes definitely and Yes sometimes are scored 1 and No not at all and No not much are scored 0). This long version of the measure will be used to evaluate the responsiveness of the measure to change and to calculate preliminary effect size for sample estimate for definitive future RCT.
Measured: Baseline, 7 weeks and 18 weeks.
Work and Social Adjustment Scale (WSAS) [12]
A five-item scale measures functional impairment at home, work and in social situations attributed to Menopause. 5 questions using Likert scale 0 to 8 (From not at all to very severely). Score range 0-40. Cronbach's alpha measure of internal scale consistency ranged from 0.70 to 0.94. This measure will be used to evaluate the responsiveness of the measure to change and to calculate preliminary effect size for sample estimate for definitive future RCT. WSAS scoring guidelines used to assess scores.
Measured: Baseline, 7 weeks and 18 weeks.
Memory Function Questionnaire (MFQ) [13]
Subjective self-reported memory scale. The MFQ uses 64 items rated on 7-point scales from which four factors are calculated: Frequency of forgetting; Seriousness of forgetting; Retrospective Functioning; and Mnemonics Usage. Internal consistency of the factor scores are reported as high with alpha values ranging from .94 to .83. This measure will be used to evaluate the responsiveness of the measure to change and to calculate preliminary effect size for sample estimate for definitive future RCT.
Measured: Baseline, 7 weeks and 18 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start8 May 2025
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Vasomotor Symptoms Associated With MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a feasibility study and therefore was not studying the effectiveness or treatment effect of the intervention.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrina McLaughlin, Queen's University, Belfast
- Investigators
- Katrina McLaughlin, P.hD, Principal investigator, Queen's University, BelfastOrla E Walsh, Bsc, Msc, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759830
- Sponsor's protocol ID
- 348461 (IRAS No.)
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant survey responses of completed secondary outcomes and statistical datasets will be shared (Line by line - Summed subscales for each de-identified participant). Any direct and potentially identifying information will be removed or redacted. De-identified focus group transcripts will be made available where this is consistent with ethical approval, confidentiality and applicable data protection requirements. These transcripts will be reviewed and appropriately redacted to remove direct and indirect identifiers before sharing. Where transcripts cannot be adequately de-identified to protect participant confidentiality, access may be restricted or the relevant material withheld. To protect the participants' confidentiality in this retrospectively registered study, individual demographic characteristics (such as age, pay band, profession) will be excluded from the shared data set.
Publications
13.Gilewiski MJ, Zelenski EM. The Memory Function Questionnaire. Psychopharmocol Bull, 1988; 24(4):665-72.
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.
PubMed 1198364511.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.
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.
PubMed 18554828Hunter 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.
PubMed 85636668. Morris SB. Estimating Effect Sizes From Pretest-Posttest-Control Group Designs. Organ Res Methods, 2008, 11(2), 364-386. doi.10.771/1094428106291059.
7. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77-101. doi.org/101191/1478088706qp063oa
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.
PubMed 10245370Weiner 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.
PubMed 288514594. Hunter M, Smith M. Managing hot flushes with group cognitive behaviour therapy. London: Routledge; 2014.
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.
PubMed 27777223Scott 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.
PubMed 416123771. 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of a CBT Group Therapy Programme (MENOS Protocol ) for NHS Staff With Problematic Menopause Symptoms.
- ClinicalTrials.gov ID
- NCT07759830
- Acronym / sponsor ID
- 348461 (IRAS No.)
- Keywords
- Menpause, Hot flushes, Night Sweats, Vasomotor symptoms, Healthcare workers, NHS workers, CBT for menopause symptoms, MENOS protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- 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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This was a feasibility study and therefore was not studying the effectiveness or treatment effect of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Cognitive Behavioral therapy group programme for Menopausal Hot flushes and Night SweatsCBT 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 |
| Control arm | Other | Other: No interventionThe control arm received usual treatment and supports during the study. They did receive any intervention. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Any current serious physical or mental health problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral therapy group programme for Menopausal Hot flushes and Night SweatsCBT 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 | Behavioural | Intervention arm |
| No interventionNo Intervention. Treatment as usual | Other | Control arm |
Primary outcome
Number of participants recruited
Time frame: 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.
Time frame: 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.
Time frame: 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]
Time frame: 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]
Time frame: 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.
Time frame: 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
Time frame: 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.
5 secondary outcomes
Hot Flush/Night Sweat (HF/NS) Rating Scale [9]
Time frame: Baseline, 7 weeks and 18 weeks.
Short Form Hot Flush Beliefs and Behaviour Scale (HFBBS) [10]
Time frame: Baseline, 7 weeks and 18 weeks.
Women's Health Questionnaire (WHQ) [11]
Time frame: Baseline, 7 weeks and 18 weeks.
Work and Social Adjustment Scale (WSAS) [12]
Time frame: Baseline, 7 weeks and 18 weeks.
Memory Function Questionnaire (MFQ) [13]
Time frame: Baseline, 7 weeks and 18 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background13.Gilewiski MJ, Zelenski EM. The Memory Function Questionnaire. Psychopharmocol Bull, 1988; 24(4):665-72.
- Background: PubMed 11983645Mundt 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.
- Background11.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: PubMed 18554828Rendall 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.
- Background: PubMed 8563666Hunter 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.
- Background8. Morris SB. Estimating Effect Sizes From Pretest-Posttest-Control Group Designs. Organ Res Methods, 2008, 11(2), 364-386. doi.10.771/1094428106291059.
- Background7. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77-101. doi.org/101191/1478088706qp063oa
- Background: PubMed 10245370Larsen 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.
- Background: PubMed 28851459Weiner 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.
- Background4. Hunter M, Smith M. Managing hot flushes with group cognitive behaviour therapy. London: Routledge; 2014.
- Background: PubMed 27777223Eldridge 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.
- Background: PubMed 41612377Scott 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.
- Individual participant dataSharing planned: Yes. De-identified participant survey responses of completed secondary outcomes and statistical datasets will be shared (Line by line - Summed subscales for each de-identified participant). Any direct and potentially identifying information will be removed or redacted. De-identified focus group transcripts will be made available where this is consistent with ethical approval, confidentiality and applicable data protection requirements. These transcripts will be reviewed and appropriately redacted to remove direct and indirect identifiers before sharing. Where transcripts cannot be adequately de-identified to protect participant confidentiality, access may be restricted or the relevant material withheld. To protect the participants' confidentiality in this retrospectively registered study, individual demographic characteristics (such as age, pay band, profession) will be excluded from the shared data set.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrina McLaughlin, P.hD principal investigator
Queen's University, Belfast
Orla E Walsh, Bsc, Msc principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral therapy group programme for Menopausal Hot flushes and Night Sweats in people with Vasomotor Symptoms Associated With Menopause, run by Queen's University, Belfast at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited (time frame: 10 weeks. Between March 22nd and June 1st 2025). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07759830, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.