Contact information
Type
Scientific
Primary contact
Dr Margaret Maxwell
ORCID ID
Contact details
Reader in Sociology
Department of Applied Social Science
Colin Bell Building
University of Stirling
Stirling
FK9 4LA
United Kingdom
+44 (0)131 650 9458
margaret.maxwell@stir.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CZG/2/121
Study information
Scientific title
Acronym
Study hypothesis
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
Reviewed and approved by National Health Service Lothian Research Ethics Committee
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
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
Depression
Intervention
A nurse led audio compact disc (CD) package on self-hypnosis versus GP prescribed antidepressant treatment (usual care).
Intervention type
Other
Phase
Not Specified
Drug names
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 trial start date
31/05/2004
Overall trial end date
12/12/2004
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
Exceptions were those with bipolar depression, psychoses, alcohol and illicit drug use and active suicidal ideas.
Recruitment start date
31/05/2004
Recruitment end date
12/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Reader in Sociology
Stirling
FK9 4LA
United Kingdom
Sponsor information
Organisation
University of Edinburgh (UK)
Sponsor details
Old College
South Bridge
Edinburgh
EH8 9YL
United Kingdom
+44 (0)131 650 0000
communications.office@ed.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office of the Scottish Executive Health Division ref CZG/2/121 (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19459090
Publication citations
-
Results
Dobbin A, Maxwell M, Elton R, A benchmarked feasibility study of a self-hypnosis treatment for depression in primary care., Int J Clin Exp Hypn, 2009, 57, 3, 293-318, doi: 10.1080/00207140902881221.