Quality of Life following Adherence Therapy for People Disabled by Schizophrenia and their Carers

Completed

Conditions: Schizophrenia
Mental and Behavioural Disorders

Registration Number: ISRCTN01816159

Lead Sponsor: King's College London (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 400

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Other scales to be measured at baseline and 12 months include the following:<br><br>Socio-demographic: CSRI-EU<br>Psychopathology: BPRS<br>Quality of Life: MANSA, EQ5D, SF36<br>Disability: WHO DAS II<br>Clinical status: GAF, Calgary Depression Scale<br>Carers QoL : EQ-EU<br>Insight: SAI-E<br>Drug attitude: DAI, Moriskey<br>Adherence: Adherence scale<br>Treatment: Medication qs from CSSRI-EU<br>Side effects: LUNSERS <br>Clinical course: Clinical course schedule<br>Costs: CSSRI-EU<br><br>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.