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MENOS@Work Trial: A Self-help CBT Intervention for Working Women

NCT02623374 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2017-03-03

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

self-help CBT intervention (SHCBT)

See 'Arms' section

Sponsors & Collaborators

  • University of Nottingham

    collaborator OTHER

  • Wellbeing of Women

    collaborator OTHER

  • King's College London

    lead OTHER

Principal Investigators

  • Myra S Hunter, PhD · King's College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United Kingdom

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02623374 on ClinicalTrials.gov