MENOS@Work Trial: A Self-help CBT Intervention for Working Women
Condition: Menopause
Study type: Interventional

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.
    

Intervention name(s): self-help CBT intervention (SHCBT)
Intervention type(s): Behavioral
Intervention description(s): See 'Arms' section
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment