A randomised controlled trial of the efficacy of patients receiving a brief supervised self-help training package by practice nurses in primary care settings.

ISRCTN ISRCTN37811364
DOI https://doi.org/10.1186/ISRCTN37811364
Secondary identifying numbers RCTC61 442034
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
28/01/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Michael Barkham
Scientific

Psychological Therapies Research Centre
17 Blenheim Terrace
Leeds
LS2 9JT
United Kingdom

Phone +44 (0)113 2331955

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Scientific title
Study objectivesWhat are the clinical & economic differences between treatment as usual & practice nurse delivered self-help packages to patients with minor mental health problems.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMinor mental health problems
Intervention1. Practice nurse delivered self-help packages
2. Standard care
Intervention typeOther
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/03/1999
Completion date01/03/2002

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants1600
Key inclusion criteria30 primary care practices, 15 with a GP counsellor, 15 without; 1600 patients in total
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/03/1999
Date of final enrolment01/03/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Psychological Therapies Research Centre
Leeds
LS2 9JT
United Kingdom

Sponsor information

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Northern and Yorkshire (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2003 Yes No