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
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
-
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.