A trial platform of guided self-help for mild/moderate depression in primary care

ISRCTN ISRCTN46737488
DOI https://doi.org/10.1186/ISRCTN46737488
Secondary identifying numbers G0401181
Submission date
03/05/2005
Registration date
11/08/2005
Last edited
07/10/2009
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

Dr Karina Lovell
Scientific

School of Nursing, Midwifery & Social Work
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom

Email karina.lovell@man.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Scientific title
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedDepression
InterventionGuided self-help for depression versus usual care
Intervention typeOther
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/09/2005
Completion date31/08/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants100
Key inclusion criteriaMild/moderate depression presenting in primary care
Key exclusion criteria1. Depression not as primary diagnosis
2. Risk to self or others
Date of first enrolment01/09/2005
Date of final enrolment31/08/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

School of Nursing, Midwifery & Social Work
Manchester
M13 9PL
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

Oxford Road
Manchester
M13 9PL
England
United Kingdom

ROR logo "ROR" https://ror.org/027m9bs27

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

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 24/11/2008 Yes No