Research Article| Volume 92, P186-192, October 2016

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Study protocol of a multicentre randomised controlled trial of self-help cognitive behaviour therapy for working women with menopausal symptoms ([email protected])

  • Myra S. Hunter
    Department of Psychology (at Guy’s), Institute of Psychiatry, Psychology and Neuroscience, Kings College London, 5th Floor Bermondsey Wing, Guy’s Campus, London SE1 9RT, UK
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  • Claire Hardy
    Corresponding author.
    Department of Psychology (at Guy’s), Institute of Psychiatry, Psychology and Neuroscience, Kings College London, 5th Floor Bermondsey Wing, Guy’s Campus, London SE1 9RT, UK
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  • Sam Norton
    Department of Psychology (at Guy’s), Institute of Psychiatry, Psychology and Neuroscience, Kings College London, 5th Floor Bermondsey Wing, Guy’s Campus, London SE1 9RT, UK
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  • Amanda Griffiths
    Division of Psychiatry & Applied Psychology, School of Medicine Institute of Mental Health, University of Nottingham Innovation Park Triumph Road, Nottingham NG7 2TU, UK
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      • This is the protocol of an RCT of a self-help CBT intervention for working women with menopausal symptoms.
      • The intervention is based on an evidence-based CBT approach, adapted for working women.
      • The impact upon menopausal symptoms, quality of life and work related variables will be compared at 6 and 20 weeks post-randomisation.
      • The impact of self-help CBT and no treatment-wait control upon the impact of menopausal symptoms, quality of life and work related variables are compared at 6 and 20 weeks post-randomisation.
      • Acceptability and feasibility will be examined in a nested qualitative study.



      Hot flushes and night sweats (HFNS) – the main symptoms of the menopause transition – can reduce quality of life and are particularly difficult to manage at work. A cognitive behaviour therapy (CBT) intervention has been developed specifically for HFNS that is theoretically based and shown to reduce significantly the impact of HFNS in several randomised controlled trials (RCTs). Self-help CBT has been found to be as effective as group CBT for these symptoms, but these interventions are not widely available in the workplace. This paper describes the protocol of an RCT aiming to assess the efficacy of CBT for menopausal symptoms implemented in the workplace, with a nested qualitative study to examine acceptability and feasibility.


      One hundred menopausal working women, aged 45–60 years, experiencing bothersome HFNS for two months will be recruited from several (2–10) large organisations into a multicentre randomised controlled trial. Women will be randomly assigned to either treatment (a self-help CBT intervention lasting 4 weeks) or to a no treatment-wait control condition (NTWC), following a screening interview, consent, and completion of a baseline questionnaire. All participants will complete follow-up questionnaires at 6 weeks and 20 weeks post-randomisation. The primary outcome is the rating of HFNS; secondary measures include HFNS frequency, mood, quality of life, attitudes to menopause, HFNS beliefs and behaviours, work absence and presenteeism, job satisfaction, job stress, job performance, disclosure to managers and turnover intention. Adherence, acceptability and feasibility will be assessed at 20 weeks post-randomisation in questionnaires and qualitative interviews. Upon trial completion, the control group will also be offered the intervention.


      This is the first randomised controlled trial of a self-management intervention tailored for working women who have troublesome menopausal symptoms.

      Trial registration

      Clin.Gov NCT02623374.


      CBT (cognitive behaviour therapy), SH-CBT (self-help cognitive behaviour therapy), HFNS (hot flushes and night sweats), NTWC (no treatment-wait control), QOL (quality of life), WHQ (Women’s Health Questionnaire), WASAS (Work and Social Adjustment Scale), MRQ (Menopause Representations Scale), HFBelS (Hot Flush Beliefs Scale), HFBeS (Hot Flush Behaviour Scale), HFBelBehScale (Hot Flush Beliefs and Behaviour Scale), MAR (missing at random)


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