A controlled trial of group behavioural therapy in the management of atopic dermatitis in adults

ISRCTN	ISRCTN17548228
DOI	https://doi.org/10.1186/ISRCTN17548228
Secondary identifying numbers	N0112154888

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 28/10/2016

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

Dr Colin Holden
Scientific

Department of Dermatology
St Helier Hospital
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom

Phone	+44 (0)20 8296 2285
Email	colin.holden@esth.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title	A controlled trial of group behavioural therapy in the management of atopic dermatitis in adults
Study objectives	The principal question the study addresses is whether or not a form of behavioural therapy known as habit reversal is effective in improving atopic dermatitis by means of reducing the scratching that is often associated with the condition. A secondary objective is to see if a dermatological education session alone gives an improvement in the condition.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Atopic dermatitis
Intervention	Participants will be allocated randomly to one of two groups. The first group will receive an hour-long educational session run by a consultant dermatologist. This will reinforce the optimal use of standard treatments for atopic dermatitis and incorporate standard advice on managing the condition. The second group will receive the educational session as well as 3 further hour-long sessions to learn and practise the habit reversal technique. These 3 sessions will be run by a Specialist Registrar in psychiatry. Homework will be set between the sessions to reinforce the technique. The severity of the atopic dermatitis will be assessed at baseline, 1 month, 3 month and six months. The two groups will be compared. The assessors will be blind to the group allocation of participants. A pilot study with 6 participants has already been carried out. Feedback from participants was requested and this has been taken into account for the purpose of the current full scale trial.
Intervention type	Other
Primary outcome measure	1. The SCORAD - an index developed by the European Task Force on Atopic Dermatitis to rate the severity of atopic dermatitis . 2. The DLQI - The Dermatology Life Quality Index. A questionnaire that assesses the impact of a number of skin conditions on daily life in preceding week. 3. The HADS - the Hospital Anxiety and Depression Scale. A self- rating scale to detract evidence of the two conditions.
Secondary outcome measures	No secondary outcome measures
Overall study start date	24/12/2004
Completion date	01/06/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Number of patients: 20 in each group
Key inclusion criteria	1. A diagnosis of atopic dermatitis by the Hanifen & Najka criteria 2. Chronicity of at least one year 3. Aged 18 years and above
Key exclusion criteria	1. Systemic therapy for atopic dermatitis in the last 6 months 2. Participants will be excluded if not English speaking
Date of first enrolment	24/12/2004
Date of final enrolment	01/06/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Dr C Holden

Carshalton
SM5 1AA
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Epsom and St Helier University Hospitals NHS Trust (UK)

No information available

NHS R&D Support Funding (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

28/10/2016: No publications found, verifying study status with principal investigator