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
Protocol serial number	N0013137386
Sponsor	Department of Health
Funder	Guy's and St Thomas' NHS Trust (UK)

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

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

Primary study design	Interventional
Study design	Randomised single blind controlled trial
Secondary study design	Randomised controlled trial
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(s)	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)
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/07/2004

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

Oral Medicine Department

London
SE1 9RT
United Kingdom

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

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