TY - JOUR

T1 - Study protocol of a multicentre randomised controlled trial of self-help cognitive behaviour therapy for working women with menopausal symptoms (MENOS@Work)

AU - Hunter, Myra S.

AU - Hardy, Claire

AU - Norton, Sam

AU - Griffiths, Amanda

N1 - This is the author’s version of a work that was accepted for publication in Maturitas. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. A definitive version was subsequently published in Maturitas, 92, 2016 DOI: 10.1016/j.maturitas.2016.07.020

PY - 2016/10

Y1 - 2016/10

N2 - 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.

AB - 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.

KW - Affect

KW - Cognitive Therapy/methods

KW - Cognitive behaviour therapy

KW - Female

KW - Health Knowledge, Attitudes, Practice

KW - Hot Flashes/psychology/therapy

KW - Hot flushes

KW - Humans

KW - Job Satisfaction

KW - Menopausal symptoms

KW - Menopause

KW - Menopause/psychology

KW - Middle Aged

KW - Occupational Health

KW - Presenteeism

KW - Protocol

KW - Quality of Life

KW - RCT

KW - Research Design

KW - Self Care

KW - Sick Leave

KW - Stress, Psychological/etiology

KW - Surveys and Questionnaires

KW - Sweating

KW - Vasomotor symptoms

KW - Women, Working/psychology

KW - Work

KW - Workplace/psychology

U2 - 10.1016/j.maturitas.2016.07.020

DO - 10.1016/j.maturitas.2016.07.020

M3 - Journal article

C2 - 27621258

VL - 92

SP - 186

EP - 192

JO - Maturitas

JF - Maturitas

SN - 0378-5122

ER -