A feasibility study to test the methods and recruitment procedures towards a future randomised trial of self-hypnosis versus antidepressant medication for the management of depression
| ISRCTN | ISRCTN66084210 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66084210 |
| Secondary identifying numbers | CZG/2/121 |
- Submission date
- 02/12/2005
- Registration date
- 24/01/2006
- Last edited
- 20/01/2011
- 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 Margaret Maxwell
Scientific
Scientific
Reader in Sociology
Department of Applied Social Science
Colin Bell Building
University of Stirling
Stirling
FK9 4LA
United Kingdom
| Phone | +44 (0)131 650 9458 |
|---|---|
| margaret.maxwell@stir.ac.uk |
Study information
| Study design | Patient preference trial measuring the response to either nurse led antidepressants or self-hypnosis |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The future aim of this work was to conduct a randomised trial of nurse-taught self-hypnosis versus antidepressant drug treatment in primary care. However, an initial feasibility study was proposed to determine the feasibility and acceptability of the study and its proposed methods. |
| Ethics approval(s) | Reviewed and approved by National Health Service Lothian Research Ethics Committee |
| Health condition(s) or problem(s) studied | Depression |
| Intervention | A nurse led audio compact disc (CD) package on self-hypnosis versus GP prescribed antidepressant treatment (usual care). |
| Intervention type | Other |
| Primary outcome measure | 1. Changes in scores on the Beck Depression Inventory 2. Brief Symptom Inventory 3. SF-36 |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 31/05/2004 |
| Completion date | 12/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | Eligible patients were all those aged 18-65 with a diagnosis of depression and receiving a new prescription for antidepressants from their general practitioner (GP) |
| Key exclusion criteria | Exceptions were those with bipolar depression, psychoses, alcohol and illicit drug use and active suicidal ideas. |
| Date of first enrolment | 31/05/2004 |
| Date of final enrolment | 12/12/2004 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Reader in Sociology
Stirling
FK9 4LA
United Kingdom
FK9 4LA
United Kingdom
Sponsor information
University of Edinburgh (UK)
University/education
University/education
Old College
South Bridge
Edinburgh
EH8 9YL
Scotland
United Kingdom
| Phone | +44 (0)131 650 0000 |
|---|---|
| communications.office@ed.ac.uk | |
| Website | http://www.ed.ac.uk |
"ROR" |
https://ror.org/01nrxwf90 |
Funders
Funder type
Government
Chief Scientist Office of the Scottish Executive Health Division ref CZG/2/121 (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/07/2009 | Yes | No |
