Adherence therapy for schizophrenia
| ISRCTN | ISRCTN76324634 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76324634 |
| Secondary identifying numbers | D1449L00035 |
- Submission date
- 28/09/2011
- Registration date
- 24/02/2012
- Last edited
- 24/02/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
University of East Anglia
Norwich
NR47TJ
United Kingdom
| richard.gray@uea.ac.uk |
Study information
| Study design | Multi centre single blind two arm randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Adherence therapy for schizophrenia: a multi centre randomised controlled trial |
| Study objectives | Drug intake behaviour would be better after Adherence Therapy compared to treatment as usual (TAU) |
| Ethics approval(s) | Ethics Committee of the University of Münster (Germany) approved on 8th December 2006, AZ 2006-485-f-S |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2007 |
| Completion date | 31/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 160 |
| Key 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. |
| Key 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) |
| Date of first enrolment | 01/05/2007 |
| Date of final enrolment | 31/03/2010 |
Locations
Countries of recruitment
- England
- Switzerland
- United Kingdom
Study participating centre
NR47TJ
United Kingdom
Sponsor information
Hospital/treatment centre
Department of Research
Evaluation and Documentation
Remterweg 69/71
Bielefeld
D-33617
Germany
| martin.driessen@evkb.de |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- AstraZeneca PLC, Pearl Therapeutics
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
