Condition category
Mental and Behavioural Disorders
Date applied
22/02/2007
Date assigned
04/04/2007
Last edited
20/07/2009
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 Hugh MacPherson

ORCID ID

Contact details

Department of Health Sciences
University of York
York
YO10 5DD
United Kingdom
+44 (0)1904 321394
hm18@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Aim: to conduct a pilot for a randomised controlled trial that will evaluate the effectiveness and cost-effectiveness of acupuncture for depression, when provided as adjunct to usual General Practitioner (GP) care.

Ethics approval

Ethics approval received from the York Local Research Ethic Committees (York LREC) on the 4th January 2007 (ref: 06/Q1108/56).

Study design

A pilot randomised controlled trial with three arms: acupuncture and non-directive counselling as adjuncts to usual care, and usual care alone

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Depression

Intervention

Participants will receive one of the following:
1. Acupuncture and usual care
2. Non-directive counselling and usual care
3. Usual care alone

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Beck Depression Inventory

Secondary outcome measures

1. PHQ-9 questionnaire
2. Short Form health survey (SF-36) bodily pain sub-scale
3. European Quality of life (EQ-5D) questionnaire
4. Well-Being Questionnaire 12

Overall trial start date

22/02/2007

Overall trial end date

21/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients who are being managed in primary care
2. Patients who have consulted their GP and have been diagnosed with depression
3. A depression score of 10 or above on the Patient Health Questionnaire 9 (PHQ9)
4. A Diagnostic Statistical Manual of mental disorders fourth edition (DSM IV) based screening instrument for depression
5. Are over eighteen years of age

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Diagnosed with terminal illness
2. Mobility issues: cannot travel to appointments
3. Involved with other research projects
4. Dementia, learning difficulties, and communication problems
5. Currently receiving acupuncture or counselling
6. Cannot speak sufficient English to communicate with a counsellor or acupuncture practitioner
7. Alcohol or substance abuse problems
8. Received a diagnosis of bipolar disorder, psychosis, or personality disorder

Recruitment start date

22/02/2007

Recruitment end date

21/02/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Health Sciences
York
YO10 5DD
United Kingdom

Sponsor information

Organisation

University of York (UK)

Sponsor details

(c/o Ms Sue Final)
Research Support Office
University of York
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 434401
smf3@york.ac.uk

Sponsor type

University/education

Website

http://www.york.ac.uk/

Funders

Funder type

Government

Funder name

Department of Health (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

2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19134170

Publication citations

  1. Protocol

    Schroer S, Macpherson H, Acupuncture, or non-directive counselling versus usual care for the treatment of depression: a pilot study., Trials, 2009, 10, 3, doi: 10.1186/1745-6215-10-3.

Additional files

Editorial Notes