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
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Article info
Publication history
Published online: July 29, 2016
Accepted:
July 26,
2016
Received in revised form:
July 18,
2016
Received:
April 29,
2016
Identification
Copyright
© 2016 Elsevier Ireland Ltd. All rights reserved.
