A randomised controlled trial comparing psychological treatment and medical treatment for pre-menstrual syndrome (PMS)
- Conditions
- rological and genital diseases: Menstrual disordersUrological and Genital DiseasesMenstrual disorders
- Registration Number
- ISRCTN73540150
- Lead Sponsor
- HS R&D Regional Programme Register - Department of Health (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 120
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.
Not provided at time of registration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Improvement in quality of life of the patient, due to PMS being tackled in a more 'life-style' way <br>2. Reduction in physical and psychological symptoms premenstrually<br>3. Less disruption in daily activities/daily life/paid or unpaid work/leisure activities <br>4. Increases in patient satisfaction with care
- Secondary Outcome Measures
Name Time Method ot provided at time of registration