Condition category
Mental and Behavioural Disorders
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
20/07/2010
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 Jason Luty

ORCID ID

Contact details

Cambridgeshire and Peterborough Mental Health Partnership NHS Trust
Drug and Alcohol Service
Mill House
Brookfield Hospital
Cambridge
CB1 3DF
United Kingdom
+44 (0)7976731389
sl006h3607@blueyonder.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0610147759

Study information

Scientific title

Acronym

Study hypothesis

To develop a short interview for members of the general public that will reduce the stigmatised views towards people with substance use disorders (heroin addiction).

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Mental and Behavioural Disorders: Addiction

Intervention

Subjects will be recruited by adverts in local newspapers in Cambridge and invitation letters to local people chosen at random using random addresses generated using the wild-card function of the BT 0n-line directory. This technique has previously been used by the author in respect to the surveys quoted earlier. Respondents will be asked to telephone the principle investigator with a contact telephone number or address. The attitudes to mental illness questionnaire will then be sent to interested parties along with an information sheet. People who return the completed questionnaire will then be telephoned and an interview arranged a few weeks later either at Mill House, the subject's home or another safe location convenient to both parties. Whenever possible two subjects will be chosen from each household. Written informed consent will be obtained prior to starting the interview. The interview will involve a short series of questions and will last around 10 minutes. These questions are based in the principles of motivational interviewing. This technique has been widely shown to be effective in producing changes in behaviour and attitudes in addicted people including smokers, alcoholics and heroin addicts. It has also been used to increase compliance with antihypertensive medication in non-addicted people. A series of questions has been devised such as "What are the major problems preventing rehabilitation of heroin addicts in treatment", "What can society can to encourage heroin addicts to return to paid employment?" "How do you think housing problems can prevent people recovering from heroin addiction". The process of considering these questions is thought to produce changes in people's outlook and attitudes rather than the precise answers that are given. Subjects will not be given any specific information in answer to these questions unless they ask the investigator. Two versions of the interview will be used. One relating to heroin addiction, the other to diabetes. This will generate an experimental group and a control group (who were interviewed using the same questions adapted for diabetes). As far as possible motivational questions will be interchangeable between heroin addiction and diabetes. Subjects will be randomly assigned to receive either interview using a block randomisation technique performed by a third party (Dr Luty's staff grade at the Taylor Centre). Subjects will be randomised several days prior to the interview. When two subjects are recruited from the same household then each will receive a different interview in order to act as paired controls. At the end of the interview subjects will be asked to complete two versions of the attitude to mental illness questionnaire - one in respect to a hypothetical heroin addict and the other to a hypothetical diabetic). Diabetes was chosen as sufferers also inject drugs. However the validation study for the attitudes to mental illness questionnaire show people have a much more positive attitude to them than heroin addicts. The Attitudes to Mental Illness Questionnaire has recently been validated by the principle investigator in a large sample of the UK general public and is reliable and simple to administer. The self-completion questionnaire contains a short vignette describing a hypothetic patient. This is followed by 5 short questions to which the subject is asked to choose answers (e.g. John has been injecting heroin daily for 1 year - 1. Do you think that this would damage John's career? Strongly agree/Agree/Neutral/Disagree/Strongly disagree/Don't know). The questionnaire produces scores from -10 to +10. The responses from the above survey of over 800 people gave a mean score of -5.38 standard error 0.53) for a hypothetical heroin addict and 5.82 (standard error 0.11) for a hypothetical diabetic. A follow up will take place at 3 months with subjects being posted the questionnaire and asked to complete the questionnaire once again. Subjects will be contacted with a follow-up questionnaire once again. Subjects will be contacted with a follow-up telephone call for those who fail to respond. Subjects will be paid £15 each for time and inconvenience and to cover any travelling expenses. In the event that interviews are conducted off Hospital sites the location of the interview and contact details will be logged with the Principle Investigator's base as per the Lone Working Policy. The Methadone Alliance has been consulted in regard to the above project. This is a national organisation which represents and promotes the welfare of recovering heroin users.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

12/07/2004

Overall trial end date

12/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

100 subjects (50 in each group)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

12/07/2004

Recruitment end date

12/01/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cambridgeshire and Peterborough Mental Health Partnership NHS Trust
Cambridge
CB1 3DF
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

Cambridge Consortium - Cambridgeshire and Peterborough Mental Health Partnership NHS Trust (UK) Own account NHS R&D Support Funding

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

2009 results in http://pb.rcpsych.org/cgi/reprint/33/6/212.pdf

Publication citations

Additional files

Editorial Notes