A controlled trial of group behavioural therapy in the management of atopic dermatitis in adults
| ISRCTN | ISRCTN17548228 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17548228 |
| Protocol serial number | N0112154888 |
| Sponsor | Department of Health |
| Funders | Epsom and St Helier University Hospitals NHS Trust (UK), NHS R&D Support Funding (UK) |
- 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
Scientific
Department of Dermatology
St Helier Hospital
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
| Phone | +44 (0)20 8296 2285 |
|---|---|
| colin.holden@esth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. The SCORAD - an index developed by the European Task Force on Atopic Dermatitis to rate the severity of atopic dermatitis . |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| 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
- United Kingdom
- England
Study participating centre
Dr C Holden
Carshalton
SM5 1AA
United Kingdom
SM5 1AA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
28/10/2016: No publications found, verifying study status with principal investigator
