Schizophrenia Mental and Behavioural Disorders Schizophrenia
Conditions
Interventions
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 supervi
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 therapis
Sponsors
King's College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure for the primary hypothesis is the Mental Component Summary Score (MCS) of the SF-36. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Costs: CSSRI-EU 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. | — |
Countries
Germany, Italy, Netherlands, United Kingdom
Outcome results
None listed