Acupuncture for depression: a pilot for a randomised controlled trial

ISRCTN	ISRCTN59267538
DOI	https://doi.org/10.1186/ISRCTN59267538
Secondary identifying numbers	N/A

Submission date: 22/02/2007
Registration date: 04/04/2007
Last edited: 28/08/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Hugh MacPherson
Scientific

Department of Health Sciences
University of York
York
YO10 5DD
United Kingdom

Phone	+44 (0)1904 321394
Email	hm18@york.ac.uk

Study information

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
Study setting(s)	GP practice
Study type	Treatment
Scientific title	Acupuncture for depression: a pilot for a randomised controlled trial
Study objectives	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(s)	Ethics approval received from the York Local Research Ethic Committees (York LREC) on the 4th January 2007 (ref: 06/Q1108/56).
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	22/02/2007
Completion date	21/02/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	40
Key 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
Key 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
Date of first enrolment	22/02/2007
Date of final enrolment	21/02/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Health Sciences

York
YO10 5DD
United Kingdom

Sponsor information

University of York (UK)
University/education

(c/o Ms Sue Final)
Research Support Office
University of York
Heslington
York
YO10 5DD
England
United Kingdom

Phone	+44 (0)1904 434401
Email	smf3@york.ac.uk
Website	http://www.york.ac.uk/
"ROR"	https://ror.org/04m01e293

Funders

Funder type

Government

Department of Health (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	09/01/2009		Yes	No

Editorial Notes

28/08/2018: Hugh MacPherson has confirmed that the quantitative results of this pilot study were not published.
17/08/2018: No results publications found, verifying study status with principal investigator.