Advertisement

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
    Affiliations
    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
    Search for articles by this author
  • Claire Hardy
    Correspondence
    Corresponding author.
    Affiliations
    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
    Search for articles by this author
  • Sam Norton
    Affiliations
    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
    Search for articles by this author
  • Amanda Griffiths
    Affiliations
    Division of Psychiatry & Applied Psychology, School of Medicine Institute of Mental Health, University of Nottingham Innovation Park Triumph Road, Nottingham NG7 2TU, UK
    Search for articles by this author

      Highlights

      • 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.

      Abstract

      Background

      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.

      Methods/Design

      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.

      Discussion

      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.

      Abbreviations:

      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)

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Maturitas
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

      1. Office for National Statistics. Labour Market Statistics. London: Office for National Statistics. May 2013. Available from: http://www.ons.gov.uk/ons/rel/lms/labour-market-statistics/may-2015/index.html.

        • Hunter M.S.
        • Gentry-Maharaj A.
        • Ryan A.
        • Burnell M.
        • Lanceley A.
        • Fraser L.
        • et al.
        Prevalence, frequency and problem rating of hot flushes persist in older postmenopausal women: impact of age, BMI, hysterectomy, lifestyle and mood in a cross sectional cohort study of 10,418 British women aged 54–65.
        Brit. J. Obstet. Gynaecol. 2012; 119: 40-50
        • Porter M.
        • Penney G.C.
        • Russell D.
        • Russell E.
        • Templeton A.
        A population based survey of women’s experience of the menopause.
        Brit. J. Obstet. Gynaecol. 1996; 103: 1025-1028
        • Ayers B.
        • Hunter M.S.
        Health-related quality of life of women with menopausal hot flushes and night sweats.
        Climacteric. 2012; 15: 1-5
        • Hunter M.S.
        • Liao K.L.M.
        A psychological analysis of menopausal hot flushes.
        Brit. J. Clin. Psychol. 1995; 34: 589-599
        • Smith M.J.
        • Mann E.
        • Mirza A.
        • Hunter M.S.
        Men and women’s perceptions of hot flushes within social situations: are menopausal women’s negative beliefs valid.
        Maturitas. 2011; 69: 57-62
        • Reynolds F.
        Distress and coping with hot flushes at work: implications for counsellors in occupational settings.
        Couns. Psychol. Q. 1999; 12: 353-361
        • Paul J.
        Health and Safety and the Menopause: Working Through the Change.
        Trades Union Congress, London2003 (Available from:)
        • Griffiths A.
        • MacLennan S.J.
        • Hassard J.
        Menopause and work: an electronic survey of employees’ attitudes in the UK.
        Maturitas. 2013; 76: 155-159
        • Jack G.
        • Riach K.
        • Bariola E.
        • Pitts M.
        • Schapper J.
        • Sarrel P.
        Menopause in the workplace: what employers should be doing.
        Maturitas. 2016; 85: 88-95
        • Gartoulla P.
        • Bell R.J.
        • Worsley R.
        • Davis S.R.
        Menopausal vasomotor symptoms are associated with poor self-assessed work ability.
        Maturitas. 2016; 87: 33-39
        • Geukes M.
        • van Aalst M.P.
        • Nauta M.C.
        • Oosterhof H.
        The impact of menopausal symptoms on work ability.
        Menopause. 2012; 19: 278-282
        • Whiteley J.
        • daCosta DiBonaventura M.
        • Wagner J.-S.
        • Alvir J.
        • Shah S.
        The impact of menopausal symptoms on quality of life, productivity, and economic outcomes.
        J. Women Health. 2013; 22: 983-999
        • Sarrel P.
        • Portman D.
        • Lefebvre P.
        • Lafeuille M.H.
        • Grittner A.M.
        • Fortier J.
        • et al.
        Incremental direct and indirect costs of untreated vasomotor symptoms.
        Menopause. 2014; 3: 260-266
        • Kleinman N.L.
        • Rohrbacker N.J.
        • Bushmakin A.G.
        • Whiteley J.
        • Lynch W.D.
        • Shahet S.N.
        Direct and indirect costs of women diagnosed with menopause symptoms.
        J. Occup. Environ. Med. 2013; 4: 465-470
        • Woods N.F.
        • Mitchell E.S.
        Symptom interference with work and relationships during the menopausal transition and early post-menopause: observations from the Seattle midlife women’s health study.
        Menopause. 2011; 18: 654-661
        • Salazar A.
        • Paravic T.
        Job performance and climacteric in female workers.
        Rev. Méd. Chile. 2005; 133: 315-322
      2. National Institutes of Health and Care Excellence (NICE). NICE guidance on Diagnosis and Management of Menopause, November 2015.

        • Ayers B.
        • Smith M.
        • Hellier J.
        • Mann E.
        • Hunter M.S.
        Effectiveness of group and self-help cognitive behaviour therapy to reduce problematic menopausal hot flushes and night sweats (MENOS 2): a randomized controlled trial.
        Menopause. 2012; 19: 749-759
        • Mann E.
        • Smith M.J.
        • Hellier J.
        • Hamed H.
        • Grunfeld B.
        • Hunter M.S.
        Efficacy of a cognitive behavioural intervention to treat menopausal symptoms following breast cancer treatment (MENOS 1): a randomised controlled trial.
        Lancet Oncol. 2012; 13: 309-318
        • Duijts S.F.A.
        • van Beurden M.
        • Oldenburg H.S.A.
        • Hunter M.S.
        • Kieffer J.M.
        • Stuiver M.M.
        • et al.
        Efficacy of cognitive behavioural therapy and physical exercise in alleviating treatment-induced menopausal symptoms in patients with breast cancer: results of a randomized controlled multicentre trial.
        J. Clin. Oncol. 2012; 30: 4124-4133
        • Stefanopoulou E.
        • Hunter M.S.
        Telephone-guided Self Help cognitive behaviour therapy for menopausal symptoms.
        Maturitas. 2014; 77: 73-77
      3. Position statement: non-hormonal management of menopause-associated vasomotor symptoms: 2015 position statement of the North American Menopause Society.
        Menopause. 2015; 22: 1-20
        • Hunter M.S.
        • Mann E.
        A cognitive model of menopausal hot flushes.
        J. Psychosom. Res. 2010; 69: 491-501
        • Hunter M.S.
        • Chilcot J.
        Testing a cognitive model of menopausal hot flushes and night sweats.
        J. Psychosom. Res. 2013; 74: 307-312
        • Chilcot J.
        • Norton S.
        • Hunter M.S.
        Cognitive behaviour therapy for menopausal symptoms following breast cancer treatment: who benefits and how does it work.
        Maturitas. 2014; 78: 56-61
        • Norton S.
        • Chilcot J.
        • Hunter M.S.
        Cognitive behaviour therapy for menopausal symptoms (hot flushes and night sweats): moderators and mediators of treatment effects.
        Menopause. 2014; 21: 574-578
        • Hunter M.S.
        • Smith M.
        Managing Hot Flushes and Night Sweats: A Cognitive Behavioural Self-Help Guide to the Menopause.
        Routledge, East Sussex, UK and NewYork2014
        • Hunter M.S.
        • Smith M.
        Managing Hot Flushes with Group Cognitive Behaviour Therapy: An Evidence Based Treatment Manual for Health Professionals.
        Routledge, East Sussex, UK and New York2014
        • Griffiths A.
        • MacLennan S.
        • Wong Y.Y.V.
        • Griffiths A.
        • MacLennan S.
        • Wong Y.Y.V.
        Work and the Menopause: A Guide for Managers. A Report for The British Occupational Health Research Foundation (BOHRF).
        2010 (Available from: https://www.nottingham.ac.uk/hr/guidesandsupport/equalityanddiversitypolicies/documents/workandthemenopause-aguideformanagers.pdf)
      4. Health and Safety Executive (HSE) Management Standards Indicator Tool, 2013. Available from: http://www.hse.gov.uk/stress/standards/pdfs/indicatortool.pdf.

        • Rand K.L.
        • Otte J.L.
        • Flockhart D.
        • Hayes D.
        • Storniolo A.M.
        • Stearns V.
        • et al.
        Modeling hot flushes and quality of life in breast cancer survivors.
        Climacteric. 2011; 13: 171-180
        • Carpenter J.
        • Rand K.
        Modeling the hot flash experience in breast cancer survivors.
        Menopause. 2008; 15: 469-475
        • Hunter M.S.
        • O’Dea I.
        Development of the menopause representations questionnaire.
        Psychol. Health Med. 2001; 6: 65-76
        • Rendall M.J.
        • Simmons L.M.
        • Hunter M.S.
        The Hot Flush beliefs Scale: a tool for assessing thoughts and beliefs associated with experience of menopausal hot flushes and night sweats.
        Maturitas. 2008; 60: 158-169
        • Hunter M.S.
        • Ayers B.
        • Smith M.
        The Hot Flush Behaviour Scale (HFBehS): a measure of behavioural reactions to menopausal hot flushes and night sweats.
        Menopause. 2011; 18: 1178-1183
        • Hunter M.S.
        The Women's Health Questionnaire: a measure of mid-aged women’s perceptions of their emotional and physical health.
        Psychol. Health. 1992; 7: 45-54
        • Buysse D.J.
        • Reynolds C.F.
        • Monk T.H.
        • Berman S.R.
        • Kupfer D.J.
        The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research.
        Psychiatry Res. 1989; 28: 193-213
        • Mundt J.C.
        • Marks I.M.
        • Shear M.K.
        • Greist J.M.
        The work and social adjustment scale: a simple measure in impairment functioning.
        Brit. J. Psychiat. 2002; 180: 461-464
        • Koopman C.
        • Pelletier K.R.
        • Murray J.F.
        • Sharda C.E.
        • Berger M.L.
        • Turpin R.S.
        • et al.
        Stanford presenteeism scale: health status and employee productivity.
        J. Occup. Environ. Med. 2002; 44: 14-20
        • Shore L.M.
        • Martin H.J.
        Job satisfaction and organizational commitment in relation to work performance and turnover intentions.
        Hum. Relat. 1980; 42: 625-638
        • Goldstein H.
        Multilevel Statistical Models.
        4th edn. John Wiley & Sons Ltd, Chichester, West Sussex,UK2011
        • Carpenter J.
        • Kenward M.G.
        Multiple Imputation and Its Application.
        John Wiley & Sons, Ltd, Chichester, West Sussex, UK2013
        • White I.R.
        • Horton N.J.
        • Carpenter J.
        • Pocock S.J.
        Strategy for intention to treat analysis in randomised trials with missing outcome data.
        BMJ. 2011; 342
        • Dunn G.
        • Emsley R.
        • Liu H.
        • Landau S.
        • Green J.
        • White I.
        • et al.
        Evaluation and validation of social and psychological markers in randomised trials of complex interventions in mental health: a methodological research programme.
        Health Technol. Assess. 2015; 19: 93
        • Ritchie J.
        • Lewis J.
        Qualitative Research Practice: A Guide for Social Science Students and Researchers.
        Sage, London2003
        • Griffiths A.
        • Hunter M.S.
        Psychosocial factors and menopause: the impact of menopause on personal and working life.
        in: Davies S.C. Annual Report of the Chief Medical Officer 2014, The Health of 51%. Department of Health, London2015