A randomised controlled trial comparing psychological treatment and medical treatment for pre-menstrual syndrome (PMS)
ISRCTN | ISRCTN73540150 |
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DOI | https://doi.org/10.1186/ISRCTN73540150 |
Secondary identifying numbers | RDC00402 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 03/12/2008
- 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
Dr Jane Ussher
Scientific
Scientific
Psychology Department
UCL
Gower Street
London
WC1E 6BT
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study objectives | The primary objective of the proposed study is to evaluate the relative effectiveness of psychological versus medical treatment of women diagnosed as having moderate pre-menstrual syndrome. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Urological and genital diseases: Menstrual disorders |
Intervention | 1. Psychological treatment (Cognitive Behavioural Therapy [CBT]) 2. Standard medical treatment (Selective Serotonin reuptake inhibitors [SSRIs]). |
Intervention type | Other |
Primary outcome measure | 1. Improvement in quality of life of the patient, due to PMS being tackled in a more 'life-style' way 2. Reduction in physical and psychological symptoms premenstrually 3. Less disruption in daily activities/daily life/paid or unpaid work/leisure activities 4. Increases in patient satisfaction with care |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 24/03/1996 |
Completion date | 24/03/1999 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 120 |
Key inclusion criteria | Women will be recruited from a PMS clinic at the Elizabeth Garrett Anderson Hospital having been referred by their GP for treatment; between 20 and 45 years of age; having regular menstrual cycles (21-35 days); presently not taking hormonal or psychotropic medication, or currently experiencing a major psychiatric illness; not being pregnant or lactating within the previous 12 months; experiencing a 30% increase in two or more affective symptoms (e.g. depressed mood, irritability, anxiety/tension, aggressive feelings, and tiredness) on the Moss Menstrual Distress Questionnaire from pre and post menstruation in each of two adjusted menstrual cycles (a daily diary method of assessment). These inclusion criteria are those recommended by the National Institute of Mental Health (NIMH). It is estimated that 40-50% of patients assessed will meet these criteria, and therefore 250-300 women may need to be assessed in order to obtain a sample of 120. |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 24/03/1996 |
Date of final enrolment | 24/03/1999 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Psychology Department
London
WC1E 6BT
United Kingdom
WC1E 6BT
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive London (UK)
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | results | 01/09/2002 | Yes | No |