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

ISRCTN ISRCTN73540150
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

Psychology Department
UCL
Gower Street
London
WC1E 6BT
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesThe 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) studiedUrological and genital diseases: Menstrual disorders
Intervention1. Psychological treatment (Cognitive Behavioural Therapy [CBT])
2. Standard medical treatment (Selective Serotonin reuptake inhibitors [SSRIs]).
Intervention typeOther
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date24/03/1996
Completion date24/03/1999

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants120
Key inclusion criteriaWomen 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 criteriaNot provided at time of registration
Date of first enrolment24/03/1996
Date of final enrolment24/03/1999

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Psychology Department
London
WC1E 6BT
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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