A trial platform of guided self-help for mild/moderate depression in primary care
| ISRCTN | ISRCTN46737488 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46737488 |
| Protocol serial number | G0401181 |
| Sponsor | University of Manchester (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- 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
Scientific
School of Nursing, Midwifery & Social Work
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
| karina.lovell@man.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Depression |
| Intervention | Guided self-help for depression versus usual care |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Clinical response at three months |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | Mild/moderate depression presenting in primary care |
| Key exclusion criteria | 1. Depression not as primary diagnosis 2. Risk to self or others |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 31/08/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
School of Nursing, Midwifery & Social Work
Manchester
M13 9PL
United Kingdom
M13 9PL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
