Randomised controlled trial of a web-based cognitive behavioural intervention for psoriasis

ISRCTN	ISRCTN01714240
DOI	https://doi.org/10.1186/ISRCTN01714240
Secondary identifying numbers	7310

Submission date: 21/05/2010
Registration date: 21/05/2010
Last edited: 29/07/2013

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

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Chris Griffiths
Scientific

Stott Lane
Salford
M6 8HD
United Kingdom

Email	chris.griffiths@srft.nhs.uk

Study information

Study design	Single centre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Scientific title
Study acronym	Web based cognitive behaviour therapy for people with psoriasis
Study objectives	Psoriasis is a chronic inflammatory skin disease affecting approximately 2-3% of the population. The condition is incurable at this stage and the course is recurrent, with periods of remission. It is believed to be a genetic disease, with the genetic tendency thought to be triggered by various environmental factors including infection, skin trauma, certain medications and stress. Previous research has shown that psoriasis patients have a high incidence of psychological distress, with studies reporting psychological disturbance in the order of 30 - 40% of patients. Psychological distress reported by psoriasis patients includes increased levels of anxiety, depression, excessive worry, reduced quality of life and impaired everyday functioning. Overall, psoriasis patients report more psychological distress than any other dermatology group.
Ethics approval(s)	MREC approved (ref: 08/H1012/17)
Health condition(s) or problem(s) studied	Topic: Skin; Subtopic: Skin (all Subtopics); Disease: Dermatology
Intervention	Cognitive behaviour therapy (CBT) in a web-based format. This method allows participants to complete the study in privacy, at their own convenience and makes the treatment more broadly accessible. Follow up length: 6 months
Intervention type	Other
Primary outcome measure	Subjective reports of self efficacy
Secondary outcome measures	1. Change in illness beliefs 2. Improved quality of life 3. Reduced alcohol consumption
Overall study start date	01/04/2009
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned sample size: 120
Key inclusion criteria	Male and female, lower age limit of 16 years
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/04/2009
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Stott Lane

Salford
M6 8HD
United Kingdom

Sponsor information

Salford Royal NHS Foundation Trust (UK)
Hospital/treatment centre

Hope Hospital
Stott Lane
Salford
M6 8HD
England
United Kingdom

Website	http://www.srht.nhs.uk
"ROR"	https://ror.org/019j78370

Funders

Funder type

Charity

Psoriasis and Psoriatic Arthritis Alliance (PAPAA) (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): PAPAA
Location: United Kingdom

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2013		Yes	No