Contact information
Type
Scientific
Primary contact
Dr Colin Holden
ORCID ID
Contact details
Department of Dermatology
St Helier Hospital
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
+44 (0)20 8296 2285
colin.holden@esth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0112154888
Study information
Scientific title
A controlled trial of group behavioural therapy in the management of atopic dermatitis in adults
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
24/12/2004
Overall trial end date
01/06/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Number of patients: 20 in each group
Participant exclusion criteria
1. Systemic therapy for atopic dermatitis in the last 6 months
2. Participants will be excluded if not English speaking
Recruitment start date
24/12/2004
Recruitment end date
01/06/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dr C Holden
Carshalton
SM5 1AA
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Epsom and St Helier University Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (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