MenopauseNCT02623374
MENOS@Work Trial: A Self-help CBT Intervention for Working Women
A study testing self-help CBT intervention (SHCBT) in people with Menopause, run by King's College London at 1 site in United Kingdom.
Trial summary
The study will be a randomised controlled trial (RCT) of a brief self-help CBT intervention (SHCBT), compared with a no treatment-wait control (NTWC) who do not receive the intervention, on the impact of hot flushes experienced by menopausal women in work settings. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- self-help CBT intervention (SHCBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Dec 2016
- 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 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Employed women aged 45-60 years
- Have at least 10 problematic (score >2 on HFRS) hot flushes per week for at least two months
- Have a good understanding of English
Who cannot join
- Men
- Women who cannot understand English
- Women with problematic mental health conditions that may affect participation in the study
- Women not employed (by participating organisations)
- Women outside the inclusion age range and symptom criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Menopause at Work: Improving the Experience of Menopause for Working Women
The study will be a randomised controlled trial (RCT) of a brief self-help CBT intervention (SHCBT), compared with a no treatment-wait control (NTWC) who do not receive the intervention, on the impact of hot flushes experienced by menopausal women in work settings. The study involves samples from a minimum of two large employers (who have already expressed an interest in taking part) and randomly allocating at least 50 eligible women to the SHCBT intervention and another 50 to a NTWC condition (i.e. a minimum of 100 participants in total). Both groups will complete baseline questionnaires (A0), and follow up assessments at 6 weeks (A1) and 20 weeks (A2) post-randomisation. Questionnaires will be completed online or paper and pencil, providing data on the outcomes of interest to assess the interventions effectiveness and feasibility. Participants of the treatment group will also be invited to take part in an evaluation interview at A2. The NTWC will be offered the intervention off-trial.
Read the detailed description
While some women go through the menopause without any problems, about 25% have troublesome symptoms that affect their daily lives. Hot flushes and night sweats are the main menopausal symptoms and cause physical discomfort, embarrassment and interfere with sleep. Menopausal symptoms have also been reported as problematic by women when at work. In the UK there are over 3.5 million working women aged between 50 and 65 (the majority of whom will be in the menopause transition or postmenopause), yet there is a general lack of awareness about menopause in work settings. Some women take hormone replacement therapy (HRT) to help them to manage working life, but many prefer non-medical options. While there are effective non-medical interventions (such as cognitive behaviour therapy) to help women to manage and cope with menopausal symptoms, these are not yet widely available on the NHS or in the workplace.
In a recent study of 896 women's experiences of working through the menopausal transition in the UK, Griffiths and colleagues (2013) found that the menopausal transition caused difficulties for them, mainly due to troublesome hot flushes, poor concentration, tiredness, poor memory, feeling low/depressed and lowered confidence. Some women were also concerned that their work performance had been negatively affected. Those who were taking HRT did so mainly to help them to cope at work but over 30% of these had side effects or felt that HRT had not helped. The majority of women were unwilling to disclose menopause-related health problems to line managers, most of whom were men or younger than them. Four major areas of need were identified: (i) greater awareness among managers about menopause as a possible occupational health issue, (ii) flexible working hours, (iii) access to information and sources of support at work, and (iv) attention to workplace temperature and ventilation. The authors concluded that employers should be aware that menopausal transition can cause difficulty for some women at work, and that much can be done to support them. The proposed research will aim to target (iii).
Hunter and colleagues (2012) have developed a brief non-medical treatment to help women to manage hot flushes and night sweats, based on cognitive behaviour therapy (CBT), to help women to manage menopausal symptoms. They have evaluated group and self-help forms of the interventions, and found them to be highly effective in reducing how problematic the symptoms are rated. Women receive information and advice to help them to develop strategies to reduce stress, to deal with hot flushes and to improve sleep disrupted by night sweats. In recent randomised controlled trials, women who received the CBT intervention benefited from improvements in hot flushes and night sweats, sleep and perception of memory and concentration, and ability to cope, resulting in benefits to quality of life compared to those who received usual care. Interestingly, the self-help CBT (containing the same information in a booklet with a relaxation CD) was as effective as the group CBT.
The proposed research builds upon these findings and aims to develop and examine the feasibility and impact of an adapted self-help CBT intervention (SHCBT) based on Hunter's early work to help management symptoms and improve the quality of life for working menopausal women.
- Conditions
- Menopause
- Being tested
- self-help CBT intervention (SHCBT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-help CBT intervention (SHCBT)Behavioural
See 'Arms' section
| Study group | Role | What they receive |
|---|---|---|
| SH-CBT | Experimental | This intervention will be a tailored CBT intervention adapted from the previously validated (Ayres, et al., 2012) self-help CBT intervention that comprises of a self-help booklet containing information, advice, a relaxation CD and daily diaries. This intervention lasts 4 weeks (approx. 4 hours per week) and the materials guide the individual through each chapter and exercise, including the homework set out for each chapter. Receives: Behavioral: self-help CBT intervention (SHCBT) |
| No Treatment-Wait Control (NTWC) | No intervention | Women will be offered no intervention but will complete questionnaires at the same assessment points as the intervention/treatment arm participant group (i.e. baseline (A0), 6 weeks (A1), 20 weeks (A2) post randomisation). They will be offered the SHCBT intervention off trial following the final assessment (i.e. A2). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Problematic hot flushes
Measured using the Hot Flush Rating Scale (HFRS) by Hunter \& Liao (1995), which includes a score between 1-10 based on the mean of three 3-point Likert scales (1=no problem at all, 10=very much a problem) assessing hot flushes and night sweats (HFNS) bother, interference, and distress.
Measured: Measurements will be taken at A1 (6 weeks postrandomisation).
Problematic hot flushes
Measured using the Hot Flush Rating Scale (HFRS) by Hunter \& Liao (1995), which includes a score between 1-10 based on the mean of three 3-point Likert scales (1=no problem at all, 10=very much a problem) assessing hot flushes and night sweats (HFNS) bother, interference, and distress.
Measured: Measurements will be taken at A2 (20 weeks postrandomisation).
Secondary outcomes (32)
Problematic hot flushes (frequency)
Measured using the Hot Flush Rating Scale (HFRS) by Hunter \& Liao (1995), which gives provides a retrospective recording of the frequency of HFNS and the average severity of the HFNW for the previous week (1=mild, 2=moderate, 3=severe).
Measured: Measurements will be taken at A1 (6 weeks postrandomisation).
Problematic hot flushes (frequency)
Measured using the Hot Flush Rating Scale (HFRS) by Hunter \& Liao (1995), which gives provides a retrospective recording of the frequency of HFNS and the average severity of the HFNW for the previous week (1=mild, 2=moderate, 3=severe).
Measured: Measurements will be taken at A2 (20 weeks postrandomisation).
Menopause Representation Questionnaire (Hunter & O'Dea, 2001)
designed to assess women's attributions (identity) of symptoms to the menopause (20 items) and beliefs subscales (cognitive representations) about the menopause (17 items). The belief items are scored on 5-point scales from strongly agree (5) to strongly disagree (1), and mean scores are calculated for beliefs subscales. The identity subscale items are scored from 0 to 2 and summed.
Measured: Measurements will be taken at A1 (6 weeks postrandomisation).
Menopause Representation Questionnaire (Hunter & O'Dea, 2001)
designed to assess women's attributions (identity) of symptoms to the menopause (20 items) and beliefs subscales (cognitive representations) about the menopause (17 items). The belief items are scored on 5-point scales from strongly agree (5) to strongly disagree (1), and mean scores are calculated for beliefs subscales. The identity subscale items are scored from 0 to 2 and summed.
Measured: Measurements will be taken at A2 (20 weeks postrandomisation).
Attitude to Menopause at Work
This measures attitude to menopause and work and whether women feel that their job performance has been affected by menopausal symptoms, and whether they feel that menopause has negatively affected manager's and colleagues views of competence at work (Griffiths, et al., 2010). Contains 2 items scored on 5-point scales (agree (5) to strongly disagree (1)).
Measured: Measurements will be taken at A1 (6 weeks postrandomisation).
Attitude to Menopause at Work
This measures attitude to menopause and work .e. whether women feel that their job performance has been affected by menopausal symptoms, and whether they feel that menopause has negatively affected manager's and colleagues views of competence at work (Griffiths, et al., 2010). Contains 2 items scored on 5-point scales (agree (5) to strongly disagree (1)).
Measured: Measurements will be taken at A2 (20 weeks postrandomisation).
Hot Flush and Night Sweats Belief & Behaviour
16 items to measure beliefs about hot flushes and night sweats (HFNS) and behavioural reactions to cope with HFNS using a 6-point scale from strongly disagree (0) to strongly agree (5). This is a shortened and combined version of Hot Flush Belief \& Behaviour Scale (Rendall, et al, 2008; Hunter et al, 2011)
Measured: Measurements will be taken at A1 (6 weeks postrandomisation).
Hot Flush and Night Sweats Belief & Behaviour
16 items to measure beliefs about hot flushes and night sweats (HFNS) and behavioural reactions to cope with HFNS using a 6-point scale from strongly disagree (0) to strongly agree (5). This is a shortened and combined version of Hot Flush Belief \& Behaviour Scale (Rendall, et al, 2008; Hunter et al, 2011)
Measured: Measurements will be taken at A2 (20 weeks postrandomisation).
Presenteeism (Koopman et al, 2002)
Stanford Presenteeism Scale (SPS6, Koopman, et al 2002) is used to measure workplace presenteeism, comprises of 6 items that are summed to produce a total presenteeism score. Each item asks the respondent to indicate their work experience over the last month using a 5-point scale (1=strongly disagree, 5=strongly agree).
Measured: Measurements will be taken at A1 (6 weeks postrandomisation).
Presenteeism (Koopman et al, 2002)
Stanford Presenteeism Scale (SPS6, Koopman, et al 2002) is used to measure workplace presenteeism, comprises of 6 items that are summed to produce a total presenteeism score. Each item asks the respondent to indicate their work experience over the last month using a 5-point scale (1=strongly disagree, 5=strongly agree).
Measured: Measurements will be taken at A2 (20 weeks postrandomisation).
Workplace absence (duration)
Participants asked to provide detail of number of days they have taken off from work over the last 4 weeks because of the menopause.
Measured: Measurements will be taken at A1 (6 weeks postrandomisation).
Workplace absence (duration)
Participants asked to provide detail of number of days they have taken off from work over the last 4 weeks because of the menopause.
Measured: Measurements will be taken at A2 (20 weeks postrandomisation).
Workplace absence (spells)
Participants asked to provide detail of average length of spells of absence from work over the last 4 weeks because of the menopause.
Measured: Measurements will be taken at A1 (6 weeks postrandomisation).
Workplace absence (spells)
Participants asked to provide detail of average length of spells of absence from work over the last 4 weeks because of the menopause.
Measured: Measurements will be taken at A2 (20 weeks postrandomisation).
Workplace absence (arriving late/leaving early)
Participants asked to provide detail of any time over the last 4 weeks been late to work of left work early because of the menopause.
Measured: Measurements will be taken at A1 (6 weeks postrandomisation).
Workplace absence (arriving late/leaving early)
Participants asked to provide detail of any time over the last 4 weeks been late to work of left work early because of the menopause.
Measured: Measurements will be taken at A2 (20 weeks postrandomisation).
Menopausal symptom disclosure to manager
Menopausal symptom disclosure to managers is measured using a single dichotomous item ('yes' or 'no'; Griffiths, et al, 2010, 2013) and whether participants have told their manager about any reduced working hours (i.e. arriving late, leaving early) due to their menopausal symptoms (if appropriate) 'yes', 'no', 'sometimes').
Measured: Measurements will be taken at A1 (6 weeks postrandomisation).
Menopausal symptom disclosure to manager
Menopausal symptom disclosure to managers is measured using a single dichotomous item ('yes' or 'no'; Griffiths, et al, 2010, 2013) and whether participants have told their manager about any reduced working hours (i.e. arriving late, leaving early) due to their menopausal symptoms (if appropriate) 'yes', 'no', 'sometimes').
Measured: Measurements will be taken at A2 (20 weeks postrandomisation).
Turnover intentions
Work turnover intentions are measured with 4 items (Shore and Martin, 1980), to assess how likely the individual is to leave their organisation). Each item contains 5 response options indicating low (1) to high (5) intentions to remain in their organisation that can be averaged to provide an overall score. Two further items are used to measure the degree to which the individual has considered reducing their working hours or leaving the workforce altogether ('yes', 'no', 'sometimes').
Measured: Measurements will be taken at A1 (6 weeks postrandomisation).
Turnover intentions
Work turnover intentions are measured with 4 items (Shore and Martin, 1980), to assess how likely the individual is to leave their organisation). Each item contains 5 response options indicating low (1) to high (5) intentions to remain in their organisation that can be averaged to provide an overall score. Two further items are used to measure the degree to which the individual has considered reducing their working hours or leaving the workforce altogether ('yes', 'no', 'sometimes').
Measured: Measurements will be taken at A2 (20 weeks postrandomisation).
Job satisfaction
A single-item 7-point Likert scale (1=extremely dissatisfied, 4=neither dissatisfied or satisfied, 7=extremely satisfied) to indicate an individual's level of contentment with their job (Griffiths et al, 2010,2013).
Measured: Measurements will be taken at A1 (6 weeks postrandomisation).
Job satisfaction
A single-item 7-point Likert scale (1=extremely dissatisfied, 4=neither dissatisfied or satisfied, 7=extremely satisfied) to indicate an individual's level of contentment with their job (Griffiths et al, 2010,2013).
Measured: Measurements will be taken at A2 (20 weeks postrandomisation).
Job performance
A single self-report item. Participants are asked to rate their performance compared to others in a similar role or position to themselves usinf a 5-point Likert scale (1=poor, 5=excellent).
Measured: Measurements will be taken A1 (6 weeks postrandomisation).
Job performance
A single self-report item. Participants are asked to rate their performance compared to others in a similar role or position to themselves usinf a 5-point Likert scale (1=poor, 5=excellent).
Measured: Measurements will be taken A2 (20 weeks postrandomisation).
Job stress
A single, self-report item asking participants to indicate on a 4-point Likert scale how stressful they find their job (1=not stressful, 4=extremely stressful) (Houdmont et al, 2012).
Measured: Measurements will be taken at A1 (6 weeks postrandomisation).
Job stress
A single, self-report item asking participants to indicate on a 4-point Likert scale how stressful they find their job (1=not stressful, 4=extremely stressful) (Houdmont et al, 2012).
Measured: Measurements will be taken at A2 (20 weeks postrandomisation).
Perceptions of physical and emotional menopausal symptoms
Women's Health Questionnaire (Hunter, 1992) used to assess participant perceptions of symptoms using a 4-point Likert scale. Includes 37 items.
Measured: Measurements will be taken at A1 (6 weeks postrandomisation).
Perceptions of physical and emotional menopausal symptoms
Women's Health Questionnaire (Hunter, 1992) used to assess participant perceptions of symptoms using a 4-point Likert scale. Includes 37 items.
Measured: Measurements will be taken at A2 (20 weeks postrandomisation).
Sleep quality (Mundt, et al, 2002)
Single item from Pittsburgh Sleep Quality Index (PSQI) (Buysse et al., 1989) that measures quality of sleep over the last month using a 5-point likert scale (very good=5 to very bad = 1).
Measured: Measurements will be taken at A1 (6 weeks postrandomisation).
Sleep quality (Mundt, et al, 2002)
Single item from Pittsburgh Sleep Quality Index (PSQI) (Buysse et al., 1989) that measures quality of sleep over the last month using a 5-point likert scale (very good=5 to very bad = 1).
Measured: Measurements will be taken at A2 (20 weeks postrandomisation).
Personal resilience at work
Single item that measures participants' self-perceived level of resilience in the work context (Hardy et al, in prep) used using a 9-point scale (1=low resilience to 9=high resilience).
Measured: Measurements will be taken at A1 (6 weeks postrandomisation).
Personal resilience at work
Single item that measures participants' self-perceived level of resilience in the work context (Hardy et al, in prep) used using a 9-point scale (1=low resilience to 9=high resilience).
Measured: Measurements will be taken at A2 (20 weeks postrandomisation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham, Wellbeing of Women
- Responsible party
- Sponsor
- Investigators
- Myra S Hunter, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623374
- Sponsor's protocol ID
- WOW-RG1701
- Status last verified
- Dec 2015
- First submitted
- 25 Nov 2015
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boxall C, Fenlon D, May C, Nuttall J, Hunter MS. Implementing a nurse-delivered cognitive behavioural therapy intervention to reduce the impact of hot flushes/night sweats in women with breast cancer: a qualitative process evaluation of the MENOS4 trial. BMC Nurs. 2023 Sep 15;22(1):317. doi: 10.1186/s12912-023-01441-3.
PubMed 37715249Hardy C, Griffiths A, Norton S, Hunter MS. Self-help cognitive behavior therapy for working women with problematic hot flushes and night sweats (MENOS@Work): a multicenter randomized controlled trial. Menopause. 2018 May;25(5):508-519. doi: 10.1097/GME.0000000000001048.
PubMed 29315132Hunter MS, Hardy C, Norton S, Griffiths A. Study protocol of a multicentre randomised controlled trial of self-help cognitive behaviour therapy for working women with menopausal symptoms (MENOS@Work). Maturitas. 2016 Oct;92:186-192. doi: 10.1016/j.maturitas.2016.07.020. Epub 2016 Jul 29.
PubMed 27621258
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menopause at Work: Improving the Experience of Menopause for Working Women
- ClinicalTrials.gov ID
- NCT02623374
- Acronym / sponsor ID
- WOW-RG1701
- Conditions
- Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- University of Nottingham, Wellbeing of Women
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Dec 2015 (estimated)
- 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 study will be a randomised controlled trial (RCT) of a brief self-help CBT intervention (SHCBT), compared with a no treatment-wait control (NTWC) who do not receive the intervention, on the impact of hot flushes experienced by menopausal women in work settings. The study involves samples from a minimum of two large employers (who have already expressed an interest in taking part) and randomly allocating at least 50 eligible women to the SHCBT intervention and another 50 to a NTWC condition (i.e. a minimum of 100 participants in total). Both groups will complete baseline questionnaires (A0), and follow up assessments at 6 weeks (A1) and 20 weeks (A2) post-randomisation. Questionnaires will be completed online or paper and pencil, providing data on the outcomes of interest to assess the interventions effectiveness and feasibility. Participants of the treatment group will also be invited to take part in an evaluation interview at A2. The NTWC will be offered the intervention off-trial.
Detailed description
While some women go through the menopause without any problems, about 25% have troublesome symptoms that affect their daily lives. Hot flushes and night sweats are the main menopausal symptoms and cause physical discomfort, embarrassment and interfere with sleep. Menopausal symptoms have also been reported as problematic by women when at work. In the UK there are over 3.5 million working women aged between 50 and 65 (the majority of whom will be in the menopause transition or postmenopause), yet there is a general lack of awareness about menopause in work settings. Some women take hormone replacement therapy (HRT) to help them to manage working life, but many prefer non-medical options. While there are effective non-medical interventions (such as cognitive behaviour therapy) to help women to manage and cope with menopausal symptoms, these are not yet widely available on the NHS or in the workplace.
In a recent study of 896 women's experiences of working through the menopausal transition in the UK, Griffiths and colleagues (2013) found that the menopausal transition caused difficulties for them, mainly due to troublesome hot flushes, poor concentration, tiredness, poor memory, feeling low/depressed and lowered confidence. Some women were also concerned that their work performance had been negatively affected. Those who were taking HRT did so mainly to help them to cope at work but over 30% of these had side effects or felt that HRT had not helped. The majority of women were unwilling to disclose menopause-related health problems to line managers, most of whom were men or younger than them. Four major areas of need were identified: (i) greater awareness among managers about menopause as a possible occupational health issue, (ii) flexible working hours, (iii) access to information and sources of support at work, and (iv) attention to workplace temperature and ventilation. The authors concluded that employers should be aware that menopausal transition can cause difficulty for some women at work, and that much can be done to support them. The proposed research will aim to target (iii).
Hunter and colleagues (2012) have developed a brief non-medical treatment to help women to manage hot flushes and night sweats, based on cognitive behaviour therapy (CBT), to help women to manage menopausal symptoms. They have evaluated group and self-help forms of the interventions, and found them to be highly effective in reducing how problematic the symptoms are rated. Women receive information and advice to help them to develop strategies to reduce stress, to deal with hot flushes and to improve sleep disrupted by night sweats. In recent randomised controlled trials, women who received the CBT intervention benefited from improvements in hot flushes and night sweats, sleep and perception of memory and concentration, and ability to cope, resulting in benefits to quality of life compared to those who received usual care. Interestingly, the self-help CBT (containing the same information in a booklet with a relaxation CD) was as effective as the group CBT.
The proposed research builds upon these findings and aims to develop and examine the feasibility and impact of an adapted self-help CBT intervention (SHCBT) based on Hunter's early work to help management symptoms and improve the quality of life for working menopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SH-CBT | Experimental | Behavioral: self-help CBT intervention (SHCBT)This intervention will be a tailored CBT intervention adapted from the previously validated (Ayres, et al., 2012) self-help CBT intervention that comprises of a self-help booklet containing information, advice, a relaxation CD and daily diaries. This intervention lasts 4 weeks (approx. 4 hours per week) and the materials guide the individual through each chapter and exercise, including the homework set out for each chapter. |
| No Treatment-Wait Control (NTWC) | No intervention | –Women will be offered no intervention but will complete questionnaires at the same assessment points as the intervention/treatment arm participant group (i.e. baseline (A0), 6 weeks (A1), 20 weeks (A2) post randomisation). They will be offered the SHCBT intervention off trial following the final assessment (i.e. A2). |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Employed women aged 45-60 years
- Have at least 10 problematic (score >2 on HFRS) hot flushes per week for at least two months
- Have a good understanding of English
Key exclusion criteria (5 listed)
- Men
- Women who cannot understand English
- Women with problematic mental health conditions that may affect participation in the study
- Women not employed (by participating organisations)
- Women outside the inclusion age range and symptom criteria.
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 |
|---|---|---|
| self-help CBT intervention (SHCBT)See 'Arms' section | Behavioural | SH-CBT |
Primary outcome
Problematic hot flushes
Time frame: Measurements will be taken at A1 (6 weeks postrandomisation).
Measured using the Hot Flush Rating Scale (HFRS) by Hunter \& Liao (1995), which includes a score between 1-10 based on the mean of three 3-point Likert scales (1=no problem at all, 10=very much a problem) assessing hot flushes and night sweats (HFNS) bother, interference, and distress.
Problematic hot flushes
Time frame: Measurements will be taken at A2 (20 weeks postrandomisation).
Measured using the Hot Flush Rating Scale (HFRS) by Hunter \& Liao (1995), which includes a score between 1-10 based on the mean of three 3-point Likert scales (1=no problem at all, 10=very much a problem) assessing hot flushes and night sweats (HFNS) bother, interference, and distress.
32 secondary outcomes
Problematic hot flushes (frequency)
Time frame: Measurements will be taken at A1 (6 weeks postrandomisation).
Problematic hot flushes (frequency)
Time frame: Measurements will be taken at A2 (20 weeks postrandomisation).
Menopause Representation Questionnaire (Hunter & O'Dea, 2001)
Time frame: Measurements will be taken at A1 (6 weeks postrandomisation).
Menopause Representation Questionnaire (Hunter & O'Dea, 2001)
Time frame: Measurements will be taken at A2 (20 weeks postrandomisation).
Attitude to Menopause at Work
Time frame: Measurements will be taken at A1 (6 weeks postrandomisation).
Attitude to Menopause at Work
Time frame: Measurements will be taken at A2 (20 weeks postrandomisation).
Hot Flush and Night Sweats Belief & Behaviour
Time frame: Measurements will be taken at A1 (6 weeks postrandomisation).
Hot Flush and Night Sweats Belief & Behaviour
Time frame: Measurements will be taken at A2 (20 weeks postrandomisation).
Presenteeism (Koopman et al, 2002)
Time frame: Measurements will be taken at A1 (6 weeks postrandomisation).
Presenteeism (Koopman et al, 2002)
Time frame: Measurements will be taken at A2 (20 weeks postrandomisation).
Workplace absence (duration)
Time frame: Measurements will be taken at A1 (6 weeks postrandomisation).
Workplace absence (duration)
Time frame: Measurements will be taken at A2 (20 weeks postrandomisation).
Workplace absence (spells)
Time frame: Measurements will be taken at A1 (6 weeks postrandomisation).
Workplace absence (spells)
Time frame: Measurements will be taken at A2 (20 weeks postrandomisation).
Workplace absence (arriving late/leaving early)
Time frame: Measurements will be taken at A1 (6 weeks postrandomisation).
Workplace absence (arriving late/leaving early)
Time frame: Measurements will be taken at A2 (20 weeks postrandomisation).
Menopausal symptom disclosure to manager
Time frame: Measurements will be taken at A1 (6 weeks postrandomisation).
Menopausal symptom disclosure to manager
Time frame: Measurements will be taken at A2 (20 weeks postrandomisation).
Turnover intentions
Time frame: Measurements will be taken at A1 (6 weeks postrandomisation).
Turnover intentions
Time frame: Measurements will be taken at A2 (20 weeks postrandomisation).
Job satisfaction
Time frame: Measurements will be taken at A1 (6 weeks postrandomisation).
Job satisfaction
Time frame: Measurements will be taken at A2 (20 weeks postrandomisation).
Job performance
Time frame: Measurements will be taken A1 (6 weeks postrandomisation).
Job performance
Time frame: Measurements will be taken A2 (20 weeks postrandomisation).
Job stress
Time frame: Measurements will be taken at A1 (6 weeks postrandomisation).
Job stress
Time frame: Measurements will be taken at A2 (20 weeks postrandomisation).
Perceptions of physical and emotional menopausal symptoms
Time frame: Measurements will be taken at A1 (6 weeks postrandomisation).
Perceptions of physical and emotional menopausal symptoms
Time frame: Measurements will be taken at A2 (20 weeks postrandomisation).
Sleep quality (Mundt, et al, 2002)
Time frame: Measurements will be taken at A1 (6 weeks postrandomisation).
Sleep quality (Mundt, et al, 2002)
Time frame: Measurements will be taken at A2 (20 weeks postrandomisation).
Personal resilience at work
Time frame: Measurements will be taken at A1 (6 weeks postrandomisation).
Personal resilience at work
Time frame: Measurements will be taken at A2 (20 weeks postrandomisation).
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 3 Mar 2017.
- Derived from this study: PubMed 37715249Boxall C, Fenlon D, May C, Nuttall J, Hunter MS. Implementing a nurse-delivered cognitive behavioural therapy intervention to reduce the impact of hot flushes/night sweats in women with breast cancer: a qualitative process evaluation of the MENOS4 trial. BMC Nurs. 2023 Sep 15;22(1):317. doi: 10.1186/s12912-023-01441-3.
- Derived from this study: PubMed 29315132Hardy C, Griffiths A, Norton S, Hunter MS. Self-help cognitive behavior therapy for working women with problematic hot flushes and night sweats (MENOS@Work): a multicenter randomized controlled trial. Menopause. 2018 May;25(5):508-519. doi: 10.1097/GME.0000000000001048.
- Derived from this study: PubMed 27621258Hunter MS, Hardy C, Norton S, Griffiths A. Study protocol of a multicentre randomised controlled trial of self-help cognitive behaviour therapy for working women with menopausal symptoms (MENOS@Work). Maturitas. 2016 Oct;92:186-192. doi: 10.1016/j.maturitas.2016.07.020. Epub 2016 Jul 29.
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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.
Myra S Hunter, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-help CBT intervention (SHCBT) in people with Menopause, run by King's College London 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 3 inclusion and 5 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 3 Mar 2017. 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?
Problematic hot flushes (time frame: Measurements will be taken at A1 (6 weeks postrandomisation).). The study lists 2 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 NCT02623374, which also lists 3 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 3 Mar 2017; AzTrials last refreshed its copy on 4 Nov 2026.