Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Graham Thornicroft


Contact details

P029 Health Services Research Department
Institute of Psychiatry
King’s College London
University of London
De Crespigny Park
United Kingdom
+44 (0)20 7848 0851

Additional identifiers

EudraCT number number

Protocol/serial number

EU Contract: QLG4-CT-2001-01734.

Study information

Scientific title



Study hypothesis

Adherence therapy will improve quality of life for patients, be cost effective, and reduce carer burden.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet




Patients will receive 8 sessions of either adherence therapy or health education delivered by a trained therapist in each of the five sites. Fidelity will be maintained by group and individual supervision and monitored by examination of transcripts and recordings of interventions.

Adherence therapy
Adherence therapy is a pragmatic structured intervention drawing on the work of Kemp et al (1996; 1998) and Gray (2001). It has an emphasis on patients' personal choice and responsibility. Initially the therapist will undertake an assessment of the patient's views of their medication. The therapist and patient will then develop an individually tailored plan of therapeutic activities that they will then undertake. The intervention will conclude with a reassessment of the patients' view of medication. The intervention is manualised.

Health education
Health education draws on the work on medication education of Macpherson et al (1996) and represents best current practice. Trials are consistent in demonstrating that medication education is largely inert in terms of its effect on compliance. The control intervention is a structured intervention with the aim of increasing patients understanding of treatment. While its function in this trial is to control for therapist time, it is also necessary from an ethical standpoint that the intervention is useful, and perceived to be so by subjects, and without adverse effects. The therapist will begin by assessing patients' knowledge about medication. They will then deliver a set series of educational sessions about schizophrenia and its treatment, which do not use the techniques of the experimental intervention. The sessions are didactic rather than patient centred. The intervention is manualised.

Intervention type



Not Specified

Drug names

Primary outcome measures

The primary outcome measure for the primary hypothesis is the Mental Component Summary Score (MCS) of the SF-36.

Secondary outcome measures

Other scales to be measured at baseline and 12 months include the following:

Socio-demographic: CSRI-EU
Psychopathology: BPRS
Quality of Life: MANSA, EQ5D, SF36
Disability: WHO DAS II
Clinical status: GAF, Calgary Depression Scale
Carers QoL : EQ-EU
Insight: SAI-E
Drug attitude: DAI, Moriskey
Adherence: Adherence scale
Treatment: Medication qs from CSSRI-EU
Side effects: LUNSERS
Clinical course: Clinical course schedule

Treatment fidelity will be assessed directly at 3 months: adherence therapists in the study will be asked to tape record sessions with patients in the intervention group, and these will be rated for treatment fidelity (according to the adherence intervention protocol) by the Study Co-ordinating Centre. A random sample of control group sessions will also be recorded and examined for fidelity.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. International Statistical Classification of Diseases and Related Health Problems, Tenth edition (ICD-10) schizophrenia

2. In the judgement of the responsible clinician are in need of maintenance anti-psychotic treatment for at least a year after entry to the study

3. Clear evidence of clinical instability in the previous year, defined by one or more of the following:
a. Hospital admission on clinical (mental health) grounds
b. A change in anti-psychotic medication
c. Increased frequency of contact (planned or actual)
d. Indications of clinical instability from relatives or carers
e. Indications of clinical instability from clinical team

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Patients suffering from moderate or severe learning disabilities concurrent with schizophrenia
2. Patients suffering from organic brain disorders
3. Patients being treated by forensic psychiatric services
4. Dependence on alcohol or illicit substances
5. Unable to speak language of host country to a sufficient standard to receive intervention
6. Involved in other studies which are agreed locally to preclude inclusion
7. Lack of capacity to consent to inclusion

Recruitment start date


Recruitment end date



Countries of recruitment

Germany, Italy, Netherlands, United Kingdom

Trial participating centre

P029 Health Services Research Department
United Kingdom

Sponsor information


King's College London (UK)

Sponsor details

Institute of Psychiatry
De Crespigny Park
United Kingdom

Sponsor type




Funder type

Research organisation

Funder name

European Union (Action Line: Quality of Life-2000- Public Health). European Union contract no. QLG4-CT-2001-01734.

Alternative name(s)

Funding Body Type

Funding Body Subtype


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:
2013 results in:

Publication citations

  1. Results

    Barbui C, Kikkert M, Mazzi MA, Becker T, Bindman J, Schene A, Nosè M, Helm H, Thornicroft G, Tansella M, Comparison of patient and clinician perspectives in the assessment of antipsychotic medication adherence., Psychopathology, 2009, 42, 5, 311-317, doi: 10.1159/000232973.

  2. Results

    Patel A, McCrone P, Leese M, Amaddeo F, Tansella M, Kilian R, Angermeyer M, Kikkert M, Schene A, Knapp M, Cost-effectiveness of adherence therapy versus health education for people with schizophrenia: randomised controlled trial in four European countries., Cost Eff Resour Alloc, 2013, 11, 1, 12, doi: 10.1186/1478-7547-11-12.

Additional files

Editorial Notes