Condition category
Urological and Genital Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
03/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jane Ussher

ORCID ID

Contact details

Psychology Department
UCL
Gower Street
London
WC1E 6BT
United Kingdom

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12436805

Publication citations

  1. 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.

Additional files

Editorial Notes