Urological and genital diseases: Menstrual disorders Urological and Genital Diseases Menstrual disorders
Conditions
Interventions
1. Psychological treatment (Cognitive Behavioural Therapy [CBT])
2. Standard medical treatment (Selective Serotonin reuptake inhibitors [SSRIs]).
Sponsors
NHS R&D Regional Programme Register - Department of Health (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: Not provided at time of registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed