Condition category
Skin and Connective Tissue Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
28/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes

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