A randomised, controlled, single blind pilot study to evaluate the efficacy of a mindfulness stress reduction intervention as an adjunct therapy in moderate to severe psoriasis

ISRCTN	ISRCTN51850035
DOI	https://doi.org/10.1186/ISRCTN51850035
Secondary identifying numbers	N0013137386

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 10/05/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

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

Contact information

Ms Penelope Shirlaw
Scientific

Oral Medicine Department
22nd Floor, Guy's Tower
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom

Phone	+44 (0)20 7188 4399
Email	pepe.shirlaw@gstt.sthames.nhs.uk

Study information

Study design	Randomised single blind controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A randomised, controlled, single blind pilot study to evaluate the efficacy of a mindfulness stress reduction intervention as an adjunct therapy in moderate to severe psoriasis
Study objectives	A randomised, controlled, single blind pilot study to evaluate the efficacy of a mindfulness stress reduction intervention as an adjunct therapy in moderate to severe psoriasis.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Psoriasis
Intervention	Patients with moderate to severe psoriasis will be randomly assigned at a ratio of 1:1 to receive a mindfulness stress reduction audio tape or nothing (control) as an adjunct treatment to their conventional psoriasis treatment plan. The experimental group subjects will be required to listen to the tape and practice the relaxation technique 3 times a week for 8 weeks. Both groups will be seen at week 0, 4 and 8 for psoriasis severity scores, and psychological assessment scores to evaluate effect.
Intervention type	Other
Primary outcome measure	1. Psoriasis severity measured using the Psoriasis Severity Index (PASI) 2. Mental health using Hospital Anxiety and Depression Scale (HADS) 3. Mental health using Penn State Worry Questionnaire (PSWQ)
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/12/2003
Completion date	01/07/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	50
Key inclusion criteria	Approx 50 adult psoriasis patients attending St John's Institute of Dermatology as an out-patient who have had the diagnosis of psoriasis for at least one year.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/12/2003
Date of final enrolment	01/07/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Oral Medicine Department

London
SE1 9RT
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Guy's and St Thomas' NHS Trust (UK)

No information available

Results and Publications

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

Editorial Notes

10/05/2018: No publications found, study status unverified.
01/03/2016: No publications found, verifying study status with principal investigator.