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
Protocol serial number	CZG/2/121
Sponsor	University of Edinburgh (UK)
Funder	Chief Scientist Office of the Scottish Executive Health Division ref CZG/2/121 (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Margaret Maxwell
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
Email	margaret.maxwell@stir.ac.uk

Primary study design	Interventional
Study design	Patient preference trial measuring the response to either nurse led antidepressants or self-hypnosis
Secondary study design	Randomised controlled trial
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(s)	1. Changes in scores on the Beck Depression Inventory 2. Brief Symptom Inventory 3. SF-36
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	12/12/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	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

Reader in Sociology

Stirling
FK9 4LA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2009		Yes	No