Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
28/01/2010
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 Michael Barkham

ORCID ID

Contact details

Psychological Therapies Research Centre
17 Blenheim Terrace
Leeds
LS2 9JT
United Kingdom
+44 (0)113 2331955

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RCTC61 442034

Study information

Scientific title

Acronym

Study hypothesis

What are the clinical & economic differences between treatment as usual & practice nurse delivered self-help packages to patients with minor mental health problems.

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

GP practices

Trial type

Treatment

Patient information sheet

Condition

Minor mental health problems

Intervention

1. Practice nurse delivered self-help packages
2. Standard care

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Patient outcome measures
1.1. European Quality of Life (EuroQuol)
1.2. Clinical Outcomes in Routine Evaluation (CORE), problems and targets
2. Measures of economic effects (EQ-5D)
3. Primary care activity measures

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/1999

Overall trial end date

01/03/2002

Reason abandoned

Eligibility

Participant inclusion criteria

30 primary care practices, 15 with a GP counsellor, 15 without; 1600 patients in total

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

1600

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/03/1999

Recruitment end date

01/03/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Psychological Therapies Research Centre
Leeds
LS2 9JT
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (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

2003 results in http://www.ncbi.nih.nlm.gov/pubmed/14601351

Publication citations

Additional files

Editorial Notes