Condition category
Skin and Connective Tissue Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
02/03/2016
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

Ms Penelope Shirlaw

ORCID ID

Contact details

Oral Medicine Department
22nd Floor
Guy's Tower
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom
+44 (0)20 7188 4399
pepe.shirlaw@gstt.sthames.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0013137386

Study information

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised single blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/12/2003

Overall trial end date

01/07/2004

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/12/2003

Recruitment end date

01/07/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oral Medicine Department
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

Guy's and St Thomas' NHS Trust (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

Publication citations

Additional files

Editorial Notes

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