Condition category
Urological and Genital Diseases
Date applied
04/03/2009
Date assigned
17/03/2009
Last edited
02/03/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Myra Hunter

ORCID ID

Contact details

Department of Psychology
Institute of Psychiatry (at Guy’s)
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

King’s 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 measures

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

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

Kings College London (UK)

Sponsor details

Strand
London
WC2R 2LS
United Kingdom

Sponsor type

University/education

Website

http://www.iop.kcl.ac.uk/

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, Kings 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

Results - basic reporting

Publication summary

1. 2011 Protocol in http://bmjopen.bmj.com/content/early/2011/02/16/bmjopen-2010-000047.short?q=w_open_current_tab

Publication citations

Additional files

Editorial Notes