Condition category
Mental and Behavioural Disorders
Date applied
03/05/2005
Date assigned
11/08/2005
Last edited
07/10/2009
Prospective/Retrospective
Prospectively 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

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

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

Additional files

Editorial Notes