A randomised controlled trial comparing psychological treatment and medical treatment for pre-menstrual syndrome (PMS)

ISRCTN	ISRCTN73540150
DOI	https://doi.org/10.1186/ISRCTN73540150
Protocol serial number	RDC00402
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive London (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Jane Ussher
Scientific

Psychology Department
UCL
Gower Street
London
WC1E 6BT
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	24/03/1999

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

Psychology Department

London
WC1E 6BT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2002		Yes	No