NCT02623374

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 7, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 3, 2017

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

November 25, 2015

Last Update Submit

March 2, 2017

Conditions

Menopause

Outcome Measures

Primary Outcomes (2)

  • Problematic hot flushes

    Measured using the Hot Flush Rating Scale (HFRS) by Hunter \& Liao (1995), which includes a score between 1-10 based on the mean of three 3-point Likert scales (1=no problem at all, 10=very much a problem) assessing hot flushes and night sweats (HFNS) bother, interference, and distress.

    Measurements will be taken at A1 (6 weeks postrandomisation).

  • Problematic hot flushes

    Measured using the Hot Flush Rating Scale (HFRS) by Hunter \& Liao (1995), which includes a score between 1-10 based on the mean of three 3-point Likert scales (1=no problem at all, 10=very much a problem) assessing hot flushes and night sweats (HFNS) bother, interference, and distress.

    Measurements will be taken at A2 (20 weeks postrandomisation).

Secondary Outcomes (32)

  • Problematic hot flushes (frequency)

    Measurements will be taken at A1 (6 weeks postrandomisation).

  • Problematic hot flushes (frequency)

    Measurements will be taken at A2 (20 weeks postrandomisation).

  • Menopause Representation Questionnaire (Hunter & O'Dea, 2001)

    Measurements will be taken at A1 (6 weeks postrandomisation).

  • Menopause Representation Questionnaire (Hunter & O'Dea, 2001)

    Measurements will be taken at A2 (20 weeks postrandomisation).

  • Attitude to Menopause at Work

    Measurements will be taken at A1 (6 weeks postrandomisation).

  • +27 more secondary outcomes

Other Outcomes (8)

  • Use of medical resources for menopause (visits)

    Measurements will be taken at A2 (20 weeks postrandomisation).

  • Use of medical resources for menopause (treatments for HFNS)

    Measurements will be taken at A2 (20 weeks postrandomisation).

  • Adherence, acceptability and feasibility of intervention: completion

    Measurements will be taken at A1 (6 weeks postrandomisation).

  • +5 more other outcomes

Study Arms (2)

SH-CBT

EXPERIMENTAL

This intervention will be a tailored CBT intervention adapted from the previously validated (Ayres, et al., 2012) self-help CBT intervention that comprises of a self-help booklet containing information, advice, a relaxation CD and daily diaries. This intervention lasts 4 weeks (approx. 4 hours per week) and the materials guide the individual through each chapter and exercise, including the homework set out for each chapter.

Behavioral: self-help CBT intervention (SHCBT)

No Treatment-Wait Control (NTWC)

NO INTERVENTION

Women will be offered no intervention but will complete questionnaires at the same assessment points as the intervention/treatment arm participant group (i.e. baseline (A0), 6 weeks (A1), 20 weeks (A2) post randomisation). They will be offered the SHCBT intervention off trial following the final assessment (i.e. A2).

Interventions

self-help CBT intervention (SHCBT)BEHAVIORAL

See 'Arms' section

SH-CBT

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Employed women aged 45-60 years
  • Have at least 10 problematic (score \>2 on HFRS) hot flushes per week for at least two months
  • Have a good understanding of English

You may not qualify if:

  • Men
  • Women who cannot understand English
  • Women with problematic mental health conditions that may affect participation in the study
  • Women not employed (by participating organisations)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, SE1 9RT, United Kingdom

Location

Related Publications (3)

  • Boxall C, Fenlon D, May C, Nuttall J, Hunter MS. Implementing a nurse-delivered cognitive behavioural therapy intervention to reduce the impact of hot flushes/night sweats in women with breast cancer: a qualitative process evaluation of the MENOS4 trial. BMC Nurs. 2023 Sep 15;22(1):317. doi: 10.1186/s12912-023-01441-3.

    PMID: 37715249DERIVED

  • Hardy C, Griffiths A, Norton S, Hunter MS. Self-help cognitive behavior therapy for working women with problematic hot flushes and night sweats (MENOS@Work): a multicenter randomized controlled trial. Menopause. 2018 May;25(5):508-519. doi: 10.1097/GME.0000000000001048.

    PMID: 29315132DERIVED

  • Hunter MS, Hardy C, Norton S, Griffiths A. Study protocol of a multicentre randomised controlled trial of self-help cognitive behaviour therapy for working women with menopausal symptoms (MENOS@Work). Maturitas. 2016 Oct;92:186-192. doi: 10.1016/j.maturitas.2016.07.020. Epub 2016 Jul 29.

    PMID: 27621258DERIVED

Study Officials

  • Myra S Hunter, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2015

First Posted

December 7, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 3, 2017

Record last verified: 2015-12

Locations

GB(1)