Condition category
Mental and Behavioural Disorders
Date applied
25/08/2005
Date assigned
23/09/2005
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.cordis.lu/fp5/

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

Belgium

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

  1. 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.

Additional files

Editorial Notes