Condition category
Mental and Behavioural Disorders
Date applied
02/12/2005
Date assigned
24/01/2006
Last edited
20/01/2011
Prospective/Retrospective
Retrospectively 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 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 measures

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

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

http://www.ed.ac.uk

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

Results - basic reporting

Publication summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19459090

Publication citations

  1. 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.

Additional files

Editorial Notes