Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RDC00402
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
24/03/1996
Overall trial end date
24/03/1999
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
120
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
24/03/1996
Recruitment end date
24/03/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Psychology Department
London
WC1E 6BT
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive 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
Basic results (scientific)
Publication list
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12436805
Publication citations
-
Results
Hunter MS, Ussher JM, Browne SJ, Cariss M, Jelley R, Katz M, A randomized comparison of psychological (cognitive behavior therapy), medical (fluoxetine) and combined treatment for women with premenstrual dysphoric disorder., J Psychosom Obstet Gynaecol, 2002, 23, 3, 193-199.