Clinical trial NCT02623374: MENOS@Work Trial: A Self-help CBT Intervention for Working Women
Official title: Menopause at Work: Improving the Experience of Menopause for Working Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: University of Nottingham
name: Wellbeing of Women
First posted: 2015-12-07
Enrollment: 124
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Problematic hot flushes
timeFrame: Measurements will be taken at A1 (6 weeks postrandomisation).
measure: Problematic hot flushes
timeFrame: Measurements will be taken at A2 (20 weeks postrandomisation).
Secondary outcomes:
measure: Problematic hot flushes (frequency)
timeFrame: Measurements will be taken at A1 (6 weeks postrandomisation).
measure: Problematic hot flushes (frequency)
timeFrame: Measurements will be taken at A2 (20 weeks postrandomisation).
measure: Menopause Representation Questionnaire (Hunter & O'Dea, 2001)
timeFrame: Measurements will be taken at A1 (6 weeks postrandomisation).
measure: Menopause Representation Questionnaire (Hunter & O'Dea, 2001)
timeFrame: Measurements will be taken at A2 (20 weeks postrandomisation).
measure: Attitude to Menopause at Work
timeFrame: Measurements will be taken at A1 (6 weeks postrandomisation).
measure: Attitude to Menopause at Work
timeFrame: Measurements will be taken at A2 (20 weeks postrandomisation).
measure: Hot Flush and Night Sweats Belief & Behaviour
timeFrame: Measurements will be taken at A1 (6 weeks postrandomisation).
measure: Hot Flush and Night Sweats Belief & Behaviour
timeFrame: Measurements will be taken at A2 (20 weeks postrandomisation).
measure: Presenteeism (Koopman et al, 2002)
timeFrame: Measurements will be taken at A1 (6 weeks postrandomisation).
measure: Presenteeism (Koopman et al, 2002)
timeFrame: Measurements will be taken at A2 (20 weeks postrandomisation).
measure: Workplace absence (duration)
timeFrame: Measurements will be taken at A1 (6 weeks postrandomisation).
measure: Workplace absence (duration)
timeFrame: Measurements will be taken at A2 (20 weeks postrandomisation).
measure: Workplace absence (spells)
timeFrame: Measurements will be taken at A1 (6 weeks postrandomisation).
measure: Workplace absence (spells)
timeFrame: Measurements will be taken at A2 (20 weeks postrandomisation).
measure: Workplace absence (arriving late/leaving early)
timeFrame: Measurements will be taken at A1 (6 weeks postrandomisation).
measure: Workplace absence (arriving late/leaving early)
timeFrame: Measurements will be taken at A2 (20 weeks postrandomisation).
measure: Menopausal symptom disclosure to manager
timeFrame: Measurements will be taken at A1 (6 weeks postrandomisation).
measure: Menopausal symptom disclosure to manager
timeFrame: Measurements will be taken at A2 (20 weeks postrandomisation).
measure: Turnover intentions
timeFrame: Measurements will be taken at A1 (6 weeks postrandomisation).
measure: Turnover intentions
timeFrame: Measurements will be taken at A2 (20 weeks postrandomisation).
measure: Job satisfaction
timeFrame: Measurements will be taken at A1 (6 weeks postrandomisation).
measure: Job satisfaction
timeFrame: Measurements will be taken at A2 (20 weeks postrandomisation).
measure: Job performance
timeFrame: Measurements will be taken A1 (6 weeks postrandomisation).
measure: Job performance
timeFrame: Measurements will be taken A2 (20 weeks postrandomisation).
measure: Job stress
timeFrame: Measurements will be taken at A1 (6 weeks postrandomisation).
measure: Job stress
timeFrame: Measurements will be taken at A2 (20 weeks postrandomisation).
measure: Perceptions of physical and emotional menopausal symptoms
timeFrame: Measurements will be taken at A1 (6 weeks postrandomisation).
measure: Perceptions of physical and emotional menopausal symptoms
timeFrame: Measurements will be taken at A2 (20 weeks postrandomisation).
measure: Sleep quality (Mundt, et al, 2002)
timeFrame: Measurements will be taken at A1 (6 weeks postrandomisation).
measure: Sleep quality (Mundt, et al, 2002)
timeFrame: Measurements will be taken at A2 (20 weeks postrandomisation).
measure: Personal resilience at work
timeFrame: Measurements will be taken at A1 (6 weeks postrandomisation).
measure: Personal resilience at work
timeFrame: Measurements will be taken at A2 (20 weeks postrandomisation).
Other outcomes:
measure: Use of medical resources for menopause (visits)
timeFrame: Measurements will be taken at A2 (20 weeks postrandomisation).
measure: Use of medical resources for menopause (treatments for HFNS)
timeFrame: Measurements will be taken at A2 (20 weeks postrandomisation).
measure: Adherence, acceptability and feasibility of intervention: completion
timeFrame: Measurements will be taken at A1 (6 weeks postrandomisation).
measure: Adherence, acceptability and feasibility of intervention: completion
timeFrame: Measurements will be taken at A2 (20 weeks postrandomisation).
measure: Adherence, acceptability and feasibility of intervention: changes in coping
timeFrame: Measurements will be taken at A1 (6 weeks postrandomisation).
measure: Adherence, acceptability and feasibility of intervention: changes in coping
timeFrame: Measurements will be taken at A2 (20 weeks postrandomisation).
measure: Adherence, acceptability and feasibility of intervention: relaxation and breathing
timeFrame: Measurements will be taken at A1 (6 weeks postrandomisation).
measure: Adherence, acceptability and feasibility of intervention: relaxation and breathing
timeFrame: Measurements will be taken at A2 (20 weeks postrandomisation).
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Myra S Hunter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hardy 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.
citation: Hunter 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.