Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Glyn Lewis


Contact details

Psychological Medicine
University of Wales College of Medicine
Monmouth House
Heath Park
CF14 4XN
United Kingdom
+44 (0)29 2074 4394

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


Study hypothesis

To evaluate the cost-effectiveness, under service conditions, of case finding followed by computer-generated patient-specific clinical practice guidelines, compared with locally-agreed guidelines only, for the management of common mental disorders in primary care. The self-administered computerised assessment included
1. The Revised Clinical Interview Schedule (CIS-R), and
2. A social assessment covering sociodemographic characteristics, any current difficulties in housing, employment, finance and personal relationships, and the availability of social support.
In the course of this project, the previous version of the computer program entitled PROQSY (PROgrammable Questionnaire System) was upgraded so as to be compatible with Windows 95 and subsequent versions. Further modifications were also made. These included a method for detecting errors in the questionnaire files (or scripts), an integral randomisation command and new commands to provide more variety in the type face when generating the output for clinicians. The clinical practice guidelines were based on those developed by the World Health Organisation (WHO) for the management of psychiatric disorders in primary care (ICD10-PHC, Goldberg, 1994). These guidelines were discussed with the GPs in all 5 practices and they were given opportunities to alter any of the advice given in the guidelines. We also provided them with a list of local voluntary sector organisations and self-help groups and established whether the GPs regarded these as a useful organisations for patients. These groups were then incorporated in the guidelines.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet


Schizophrenia and other psychoses


Cases of common mental disorder were identified by case-finding questionnaire and then randomly allocated within practices to
1. An intervention group, in which the GP was given the results of a detailed self-administered computerised psycho-social assessment, combined with patient-specific treatment recommendations, or
2. A control group, in which the GP was not given any additional information or advice, but who had access to a copy of locally agreed clinical practice guidelines.
Randomisation was performed by the computer which administered the questionnaires and generated the advice for the GP. The randomisation was therefore concealed from the research assistant and the subject.

Intervention type



Not Applicable

Drug names

Primary outcome measure

12-item General Health Questionnaire (GHQ12)

Outcome was assessed at 6 weeks and 6 months. The subjects were sent the questionnaires by post and were reminded by telephone if they did not respond.

Secondary outcome measures

1. Quality of life assessed with 6 questions
2. Satisfaction with treatment assessed with 1 question: If a friend were in need of similar help from a general practitioner would you recommend your GP to him/her?
3. Number of consultations in primary care assessed both by asking the subjects, and also by recording the number of consultations in the primary care notes of the subjects
4. In 2 of the practices we recorded the psychotropic medication prescriptions for all those in the trial.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Five general practices in Bristol and Cardiff participated in the study.
2. Eligible subjects were consecutive general practitioner (GP) attenders who were aged 16 years and over who completed the general health questionnaire (GHQ-12).
3. Subjects who had a positive GHQ score (i.e. >3) and who achieved a score of 12 or more on the CIS-R (Computerised Interview Schedule [Reduced]) were randomised.

Participant type


Age group




Target number of participants

762 individuals from 5 practices (added 01/12/09)

Participant exclusion criteria

1. A previous diagnosis of a psychotic illness
2. A mental handicap or cognitive impairment
3. Language or literacy difficulties
4. A severe or terminal physical illness

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Psychological Medicine
CF14 4XN
United Kingdom

Sponsor information


Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
United Kingdom

Sponsor type




Funder type


Funder name

NHS Primary and Secondary Care Interface National Research and Development Programme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

2004 results in

Publication citations

  1. Results

    Thomas HV, Lewis G, Watson M, Bell T, Lyons I, Lloyd K, Weich S, Sharp D, Computerised patient-specific guidelines for management of common mental disorders in primary care: a randomised controlled trial., Br J Gen Pract, 2004, 54, 508, 832-837.

Additional files

Editorial Notes