Contact information
Type
Scientific
Primary contact
Dr Karina Lovell
ORCID ID
Contact details
School of Nursing
Midwifery & Social Work
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
karina.lovell@man.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G0401181
Study information
Scientific title
Acronym
Study hypothesis
To examine trial recruitment rates, protocol fidelity, treatment adherence, clinical outcome effect size, cost utility and acceptability of a standardised guided self help intervention within a pilot trial.
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
Depression
Intervention
Guided self-help for depression versus usual care
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Clinical response at three months
2. Cost and health resource utility
3. Trial process measures (recruitment rates: treatment fidelity, intervention effect size, acceptability)
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2005
Overall trial end date
31/08/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Mild/moderate depression presenting in primary care
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Depression not as primary diagnosis
2. Risk to self or others
Recruitment start date
01/09/2005
Recruitment end date
31/08/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Nursing, Midwifery & Social Work
Manchester
M13 9PL
United Kingdom
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19025646
Publication citations
-
Results
Lovell K, Bower P, Richards D, Barkham M, Sibbald B, Roberts C, Davies L, Rogers A, Gellatly J, Hennessy S, Developing guided self-help for depression using the Medical Research Council complex interventions framework: a description of the modelling phase and results of an exploratory randomised controlled trial., BMC Psychiatry, 2008, 8, 91, doi: 10.1186/1471-244X-8-91.