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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list