Developing effective interventions to help women to manage menopausal symptoms
| ISRCTN | ISRCTN57302613 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57302613 |
| Secondary identifying numbers | PAXKAYT |
- Submission date
- 04/03/2009
- Registration date
- 17/03/2009
- Last edited
- 29/08/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Myra Hunter
Scientific
Scientific
Department of Psychology
Institute of Psychiatry (at Guys)
King's College London
5th Floor, Bermondsey Wing
Guy's Campus
London
SE1 9RT
United Kingdom
| Phone | +44 (0)20 7188 5408/5413/0189 |
|---|---|
| myra.hunter@kcl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Managing menopausal symptoms: MENOS2 - a randomised controlled trial of cognitive behavioural interventions for menopausal symptoms |
| Study acronym | MENOS2 |
| Study objectives | 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(s) | Kings College London Psychiatry, Nursing & Midwifery Research Ethics Sub-Committee gave approval on the 3rd March 2009 (ref: PNM/08/09-42) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2009 |
| Completion date | 28/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 120 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2009 |
| Date of final enrolment | 28/02/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Psychology
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
Strand
London
WC2R 2LS
England
United Kingdom
| Website | http://www.iop.kcl.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Biomedical Research Centre for Mental Health
No information available
South London and Maudsley NHS Foundation Trust (UK)
No information available
Institute of Psychiatry, King's College London (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 23/02/2011 | Yes | No | |
| Results article | results | 01/07/2013 | Yes | No | |
| Results article | results | 01/11/2013 | Yes | No | |
| Results article | results | 01/06/2014 | Yes | No |
Editorial Notes
29/08/2018: Publication references added.
