Contact information
Type
Scientific
Primary contact
Prof Myra Hunter
ORCID ID
Contact details
Department of Psychology
Institute of Psychiatry (at Guys)
King's College London
5th Floor
Bermondsey Wing
Guy's Campus
London
SE1 9RT
United Kingdom
+44 (0)20 7188 5408/5413/0189
myra.hunter@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PAXKAYT
Study information
Scientific title
Managing menopausal symptoms: MENOS2 - a randomised controlled trial of cognitive behavioural interventions for menopausal symptoms
Acronym
MENOS2
Study hypothesis
1. To evaluate the effectiveness of two forms of cognitive behavioural treatment (CBT) (group CBT and self-help CBT) in reducing frequency and problem rating of hot flushes and night sweats in a sample of women seeking non-medical approaches to deal with menopausal symptoms
2. To evaluate secondary impacts of CBT upon an objective measure of hot flushes, mood, self esteem and health related quality of life
3. To investigate the factors mediating improvement in hot flushes/night sweats including stress, bodily preoccupation, beliefs about menopause and hot flushes
Ethics approval
Kings College London Psychiatry, Nursing & Midwifery Research Ethics Sub-Committee gave approval on the 3rd March 2009 (ref: PNM/08/09-42)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Menopause
Intervention
The trial will include three groups:
Group CBT:
The group CBT treatment comprises 4 weekly sessions lasting 2 hours. Groups will comprise 8 - 10 women and a CBT therapist will run all the sessions. The approach is psycho-educational with individual treatment goals and an active focus upon cognitive and behavioural changes. The treatment targets cognitive and behavioural components:
1. Information and discussion about HF/NS and menopause
2. Monitoring and modifying precipitants, e.g. spicy food, alcohol
3. Relaxation and paced breathing
4. Behavioural strategies to reduce stress and deal with HF/NS
5. Cognitive therapy for unhelpful thoughts and beliefs about HF/NS and menopause
Self-help CBT:
The self-help CBT treatment comprises of a booklet containing the same information, participants work through this booklet over a 4 week period.
No treatment (control):
The no treatment group will receive no CBT treatment. They will be offered a form of CBT off-trial at the end of the trial.
Duration per participant:
3 months assessment and treatment, and 6 months follow-up post randomisation = approximately 9 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Problem rating and frequency of hot flushes and night sweats (physiologically measured and self reported) assessed at 12 weeks post-randomisation.
Secondary outcome measures
1. Problem rating and frequency of hot flushes and night sweats (self reported at follow-up, 6 months post-randomisation)
2. Mood, self-esteem, bodily preoccupation and health related quality of life, measured at baseline, 12 weeks post-randomisation and 6 months post-randomisation
Overall trial start date
01/04/2009
Overall trial end date
28/02/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women seeking non-medical alternatives to manage hot flushes/night sweats
2. English speaking
3. At least 10 hot flushes per week for at least a month
4. Aged over 18 years
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
120
Participant exclusion criteria
1. Women who cannot understand English
2. Those who are currently have major health problems that would interfere with participation in the study
3. Women under 18 years of age
Recruitment start date
01/04/2009
Recruitment end date
28/02/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Psychology
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Strand
London
WC2R 2LS
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Biomedical Research Centre for Mental Health
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
South London and Maudsley NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Institute of Psychiatry, King's College London (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22021738
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/22947108
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23591256
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24149919