Condition category
Mental and Behavioural Disorders
Date applied
07/02/2007
Date assigned
14/03/2007
Last edited
16/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.iop.kcl.ac.uk/departments/?locator=342&project=10075

Contact information

Type

Scientific

Primary contact

Prof Graham Thornicroft

ORCID ID

Contact details

Health Services and Population Research (PO29)
Institute of Psychiatry
Kings College
London
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom
+44 (0)207 848 0735
g.thornicroft@iop.kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GTCUL

Study information

Scientific title

Acronym

COMO (Mental health care for dual diagnosis COMOrbidity)

Study hypothesis

Outcomes were investigated at both staff and patient levels. At the patient level, the primary hypotheses were that, compared with patients on control group care coordinators’ caseloads, patients on caseloads of the experimental group key workers, would have:
1. diminished use of in-patient services, reflected in significantly lower bed day use over an 18-month follow-up period
2. reduced alcohol and drug consumption, reflected in lower quantity of alcohol and drugs consumed over the month before interview

Secondary hypotheses were that the intervention would also be associated with significantly:
1. diminished levels of homelessness, violence, suicidal behaviour, imprisonment and detention under the Mental Health Act
2. better social functioning, particularly in relation to self care and hostile and aggressive behaviour
3. diminished symptom severity
4. increased adherence to treatment
5. greater satisfaction with services
6. lower overall costs of care

Regarding staff, the main hypotheses were that a significant increase:
1. in knowledge about dual diagnosis
2. in substance abuse intervention skills and more positive attitudes to working with this client group would be observed in staff receiving the experimental training and supervision package

Ethics approval

Institute of Psychiatry, Kings College London, Research Ethics Committee, approved in 1999, Ref: 075/99

Study design

A cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Not Specified

Patient information sheet

Condition

Severe and enduring mental illness and comorbid substance abuse or dependence

Intervention

Each cluster consisted of the clients on a particular case managers' caseload. The unit of randomisation was the case manager. The experimental group consisted of case managers (and the service users with dual diagnosis on their case load) who had been randomly allocated to receive training in dual diagnosis interventions and the control group were case managers (and the service users with dual diagnosis on their case load) who had not been allocated to receive training.

Case managers in the experimental group received a 5 day training course in detection, assessment and interventions for people with dual diagnosis that aims to increase engagement with care and increase motivation to reduce or abstain from using drugs and alcohol.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Service users: Hospital bed use over the preceding 18 months, including admission to hospitals outside the catchment area on an extra-contractual referral basis.
Other service use recorded using the Client Service Receipt Inventory
Case managers: Alcohol and Alcohol Problems Perceptions Questionnaire

Secondary outcome measures

Service users:
1. Current adherence to medication, rated using the Medication Compliance Scale, which yields a single rating for the extent to which the patient is believed to adhere to prescribed medication
2. Stage of treatment rated using the Substance Abuse Treatment Scale (SATS), which yields a single rating of the extent to which a patient with dual diagnosis is motivated for and engaged in substance misuse treatment
3. Met and unmet needs, rated using the Camberwell Assessment of Need Short Assessment Schedule (CANSAS), which elicits ratings of patients’ needs in 22 social and clinical domains
4. Social functioning, rated using the Life Skills Profile (LSP)
5. Drug and alcohol consumption and associated problems, measured using the section of the Maudsley Addictions Profile (MAP) which records consumption over a month, the Alcohol Use Disorders Identification Test (AUDIT), which screens for alcohol-related problems and may be used to categorise drinking as hazardous or harmful, and the DALI, a screening instrument for problematic drug and alcohol use developed specifically for severely mentally ill populations
6. Service satisfaction, measured by the brief global Client Satisfaction Questionnaire (CSQ-8) and the Treatment Perception Questionnaire, a short instrument developed specifically to assess satisfaction with substance misuse treatment
7. Physical symptoms, rated using the section of the MAP which enquires how often 10 common physical symptoms have been experienced in the past 30 days
8. Psychiatric symptoms, rated using the Brief Psychiatric Rating Scale (extended version)

Overall trial start date

01/09/1999

Overall trial end date

01/09/2001

Reason abandoned

Eligibility

Participant inclusion criteria

All case managers were invited to participate unless they were temporary staff or had firm plans to leave during the next 18 months.
Service user inclusion: a clinical diagnosis (made by psychiatrists and recorded in casenotes) of schizophrenia or schizoaffective disorder (ICD 10 codes F20, F25), delusional disorder and other non-affective psychotic illnesses (F22, F29) or bipolar affective disorder (F31) on the caseloads of participating case managers and in addition a rating of substance "abuse" or "dependence" on the Clinician Alcohol Use Scale (CAUS) and the Clinician Drug Use Scale (CDUS) based on DSMIII-R criteria.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

44 case managers and 220 service users

Participant exclusion criteria

Case managers excluded if they had immediate plans to leave or be absent for the study period service users were excluded if they had diagnoses other than stated above.

Recruitment start date

01/09/1999

Recruitment end date

01/09/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Health Services and Population Research (PO29)
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

Kings College London (UK)

Sponsor details

The Strand
London
WC2R 2LS
United Kingdom
+44 (0)207 836 5454
ceu@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk/

Funders

Funder type

Government

Funder name

Culyer grant. Ref: GTCUL (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

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

Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12663845

Publication citations

  1. Results

    Miles H, Johnson S, Amponsah-Afuwape S, Finch E, Leese M, Thornicroft G, Characteristics of subgroups of individuals with psychotic illness and a comorbid substance use disorder., Psychiatr Serv, 2003, 54, 4, 554-561.

Additional files

Editorial Notes