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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2003 results in http://www.ncbi.nih.nlm.gov/pubmed/14601351