Contact information
Type
Scientific
Primary contact
Prof Stefan Priebe
ORCID ID
Contact details
Unit for Social and Community Psychiatry
Academic Unit
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
+44 (0)20 7540 4210
s.priebe@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
QLG5-CT-2002-01938
Study information
Scientific title
Acronym
MECCA
Study hypothesis
The MECCA study is a cluster randomised controlled trial following the same protocol in community mental health teams in six European countries. The trial tests the hypothesis that the new intervention as compared to current best standard practice - will lead to a better outcome in terms of quality of life, compliance with medication, needs for care, treatment satisfaction, and the quality of the therapeutic relationship between keyworker and patients with psychotic disorders over a one year period. Changes in psychopathology are not hypothesised to differ between the two groups. The research question regarding costs is purely exploratory.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Psychosis
Intervention
Key workers are randomly assigned to either the intervention or treatment as usual condition. Randomisation of key workers will be stratified by professional background (ASW, CPN, psychiatrist etc.) and by the number of patients within each key worker's caseload consenting to participate. Patients would be asked for informed consent prior to their key worker being randomised. Whilst the control group will receive treatment as usual in line with current best practice, the intervention group will, in addition to treatment as usual, receive an innovative intervention. The key worker asks patients about their subjective quality of life, treatment satisfaction and wishes for additional/different support using a brief questionnaire. The questionnaire (MECCA) consists of satisfaction ratings with eight life domains (satisfaction with mental and physical health, accommodation, job situation, leisure activities, friendships, relationship with family/partner, personal safety) and three aspects of treatment (satisfaction with practical help, psychological help and medication). Each satisfaction item will be rated on a 1 to 7 rating scale and followed by a question on whether the patient wishes for additional/different support in the given area reflecting subjective needs for change. The assessment is completed by the key worker and patient every two months. Key workers will enter patients answers onto a laptop or palm top computer using software specifically designed for the project, with patients ratings presented in a user-friendly colour display detailing scores on each outcome measure. It is expected that the results will directly feed into the therapeutic dialogue and be discussed by the patient and key worker together. The discussion is intended to address in particular all areas where the patients expressed dissatisfaction and ratings that have changed since the previous assessment.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Outcome in the two groups will be compared in a pre-post-design. The primary outcome is quality of life. To assess objective and subjective quality of life, the Manchester Short Assessment of Quality of Life (MANSA) will be used at baseline and follow-up (12 months).
Secondary outcome measures
Subjective outcome criteria include satisfaction with treatment, needs, treatment compliance, assessment of the therapeutic relationship and patient empowerment. Objective outcome criteria are observer rated psychopathology and costs.
Overall trial start date
01/07/2002
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Inclusion criteria for key workers are a professional qualification in mental
health and a minimum of one-year professional experience in an outpatient setting. Out of the caseload of each key worker patients who fulfil the following criteria will be identified: living in the community and treated as outpatients by community mental health teams; a history of at least 3 months of continuous care in the current service; a diagnosis of functional psychosis according to International Statistical Classification of Diseases and Related Health Problems - tenth revision (ICD-10), i.e. schizophrenia and other psychotic disorders; aged between 18 and 65 years of age; having at least one contact with their key worker every two months; capable of giving informed consent; and sufficient knowledge of the language of the host country.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
480
Participant exclusion criteria
Living in 24 hour supported hostel type of accommodation; severe physical handicap, organic psychiatric illness or primary substance abuse (however, dual diagnosis as such is not an exclusion criterion); expectation of clinicians to discharge the patient from the service within the next 12 months.
Recruitment start date
01/07/2002
Recruitment end date
31/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Unit for Social and Community Psychiatry
London
E13 8SP
United Kingdom
Sponsor information
Organisation
European Commission
Sponsor details
DGRTD-F5
Brussels
B-1049
Belgium
+32 2 299 9726
research@cec.eu.int
Sponsor type
Other
Website
Funders
Funder type
Other
Funder name
European Commission (Contract number: QLG5-CT-2002-01938)
Alternative name(s)
EC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
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
2002 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/12451967
Publication citations
-
Protocol
Priebe S, Mccabe R, Bullenkamp J, Hansson L, Rössler W, Torres-Gonzales F, Wiersma D, The impact of routine outcome measurement on treatment processes in community mental health care: approach and methods of the MECCA study., Epidemiol Psichiatr Soc, 11, 3, 198-205.