| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN17548228 |
| Date ISRCTN assigned | 30/09/2005 |
| Local reference number(s) | N0112154888 |
| Public title | A Controlled Trial of Group Behavioural Therapy in the Management of Atopic Dermatitis in Adults |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Skin and Connective Tissue Diseases: Atopic dermatitis |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. A diagnosis of atopic dermatitis by the Hanifen & Najka criteria. 2. Chronicity of at least one year
3. Age 18 and above |
| Participants - exclusion criteria | 1. Systemic therapy for atopic dermatitis in the last 6 months.
2. Participants will be excluded if not English speaking. |
| Patient information material |
|
| Anticipated start date | 24/12/2004 |
| Anticipated end date | 01/06/2006 |
| Status of trial | Completed |
| Target number of participants | Number of patients: 20 in each group |
| Interventions | 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. |
| Primary outcome measure(s) | 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 measure(s) | See Primary outcome measures |
| Sources of funding | Epsom and St Helier University Hospitals NHS Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Colin Holden |
| Contact details | Dr C Holden
Department of Dermatology
St Helier Hospital
Wrythe Lane
Carshalton, Surrey
United Kingdom
SM5 1AA |
| Contact telephone | +44 (0)20 8296 2285 |
| Contact fax | +44 |
| Contact email | Cholden@sthelier.sghms.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN17548228 |
| Date last extracted from ISRCTN register | 17/04/2008 |
