MENOS@Work Trial: A Self-help CBT Intervention for Working Women

NCT ID: NCT02623374

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-12-31

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.

Conditions

Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SH-CBT

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.

Group Type: EXPERIMENTAL

self-help CBT intervention (SHCBT)

Intervention Type: BEHAVIORAL

See 'Arms' section

No Treatment-Wait Control (NTWC)

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

self-help CBT intervention (SHCBT)

See 'Arms' section

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

King's College London

OTHER

Sponsor Role: lead

University of Nottingham

OTHER

Sponsor Role: collaborator

Wellbeing of Women

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Myra S Hunter, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

King's College London

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 37715249 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29315132 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27621258 (View on PubMed)

Other Identifiers

WOW-RG1701

Identifier Type: -

Identifier Source: org_study_id