A randomised controlled trial of light therapy in the treatment of premenstrual syndrome (PMS)

ISRCTN	ISRCTN80834259
DOI	https://doi.org/10.1186/ISRCTN80834259
Secondary identifying numbers	N0158108034

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr PMS O'Brien
Scientific

Obstetrics and Gynaecology Academic Department
Maternity Block
City General
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom

Phone	+44 (0)1782 554998

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	To assess the efficacy of light therapy in the treatment of PMS.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Urological and Genital Diseases: Premenstrual syndrome (PMS)
Intervention	Women will be recruited from PMS clinics, GP surgeries and through the media. They will record symptoms daily for two cycles. A structured clinical interview for DSM IV personality disorders (SCID) will be carried out 1 month single blind, to exclude placebo responders. Randomised to either actual or placebo light masks. They will continue to keep a daily diary.
Intervention type	Other
Primary outcome measure	Reduction in the overall score for PMS symptomatology
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/06/2002
Completion date	01/06/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	45 Years
Sex	Female
Target number of participants	Not provided at time of registration
Key inclusion criteria	Women between 18 and 45 years of age with regular menstrual cycles who meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) criteria for premenstrual dysphoric disorder (PMDD). They need to be able to write and read English.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/06/2002
Date of final enrolment	01/06/2005

Obstetrics and Gynaecology Academic Department

Stoke-on-Trent
ST4 6QG
United Kingdom

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Government

North Staffordshire Research and Development Consortium (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan