Condition category
Mental and Behavioural Disorders
Date applied
28/09/2011
Date assigned
24/02/2012
Last edited
24/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Schizophrenia is a severe mental illness that requires treatment with medication. About 1 in 2 patients stop taking medication and this makes it more likely they will become mentally unwell again (experience a relapse). The aim of this study is to find out if a talking treatment called adherence therapy will improve schizophrenia patients’ compliance with treatment.

Who can participate?
Men and women who are over the age of 18 and are currently in psychiatric hospital because of their schizophrenia can take part in this research project.

What does the study involve?
People taking part in the study were randomly allocated to either get eight sessions of adherence therapy or the care they would usually receive.

What are the possible benefits and risks of participating?
Taking part in the study means some patients will get the chance to have a new treatment that may help them be better at complying with their medication.
We do not anticipate that there will be any side effects from adherence therapy.

Where is the study run from?
There are four hospitals taking part in this study, three in Germany; Bielefeld, Warstein and Lippstadt and one in Switzerland; Bern. The co-ordinating centre for the project is Bielefeld.

When is study starting and how long is it expected to run for?
The study started in May 2007 and finished recruiting in July 2010.

Who is funding the study?
The trial is funded by AstraZeneca

Who is the main contact?
Dr Michael Schultz
michael.schulz@fhdd.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Richard Gray

ORCID ID

Contact details

University of East Anglia
Norwich
NR47TJ
United Kingdom
richard.gray@uea.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

D1449L00035

Study information

Scientific title

Adherence therapy for schizophrenia: a multi centre randomised controlled trial

Acronym

Study hypothesis

Drug intake behaviour would be better after Adherence Therapy compared to treatment as usual (TAU)

Ethics approval

Ethics Committee of the University of Münster (Germany) approved on 8th December 2006, AZ 2006-485-f-S

Study design

Multi centre single blind two arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Schizophrenia

Intervention

Intervention group: Adherence therapy (AT)+ Treatment as usual
Control group: Treatment as usual

Patients in the interventions group receive eight sessions of adherence therapy as an add-on to treatment as usual. AT is started whilst the patient is in hospital and completed two weeks after discharge. AT consists of six interventions assessments, structured problems solving, a medication timeline, exploring ambivalence, testing beliefs about medication, and sticking with treatment.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Adherence - determined using drug serum levels (concentration to dose ratio)
2. Symptoms - measured using the postive and negative syndrome scale

Measured at baseline and 26 week follow-up

Secondary outcome measures

1. Attitudes to treatment - assessed using the drug attitude inventory
2. Functioning - determined using the global assessment of functioning

Measured at baseline and 26 week follow-up

Overall trial start date

01/05/2007

Overall trial end date

31/03/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients between 18 and 65 years old
2. Patients with schizophrenia will be enrolled when the initial acute psychotic symptoms are reduced (partial remission) from a clinical point of view so that they were able to provide a written informed consent
3. Clinical diagnosis of schizophrenia will be confirmed by a research diagnosis of schizophrenia, established using the International Diagnostic Checklist for ICD-10
4. Patients will be taking antipsychotic medication at the time of recruitment, and the current treating psychiatrist has recommended the individual patient to stay on antipsychotic medication for a minimum of one year.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant exclusion criteria

1. Potential study participants will be excluded if they show acute suicidal behaviours including suicidal ideas
2. Insufficient German language capacities
3. Are administered depot medication
4. Are homeless, or suffered from a current substance or alcohol dependence (not caffeine or nicotine dependence) or mental retardation according to International Classification of Diseases (ICD-10) and Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria.
5. Patients are under compulsory treatment, if they are homeless or suffer from severe medical conditions (eg. cancer, severe infection)

Recruitment start date

01/05/2007

Recruitment end date

31/03/2010

Locations

Countries of recruitment

Switzerland

Trial participating centre

University of East Anglia
Norwich
NR47TJ
United Kingdom

Sponsor information

Organisation

Clinic of Psychiatry and Psychotherapy Bethel (Germany)

Sponsor details

Department of Research
Evaluation and Documentation
Remterweg 69/71
Bielefeld
D-33617
Germany
martin.driessen@evkb.de

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

AstraZeneca (ref: D1449L00035)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

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