Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Hugh MacPherson
ORCID ID
Contact details
Complementary Medicine Research Group
Seebohm Rowntree Building Area 3
University of York
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 321394
hugh.macpherson@york.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acupuncture, Counselling, and Usual GP care for Depression (ACUDep): a randomised controlled trial to evaluate effectiveness and cost-effectiveness
Acronym
ACUDep
Study hypothesis
The primary aim is to determine the clinical and cost effectiveness of short courses of either acupuncture or counselling for depression when compared to usual GP care. A secondary aim is to determine whether acupuncture is more effective than counselling, and to explore patients' experiences of these two interventions for comparative purposes.
Please note, as of 12/04/2011 the anticipated end date for this trial has been updated from 30/09/2013 to 11/04/2011 as recruitment was completed earlier than expected. Follow up data is now being collected.
Ethics approval
York Research Ethics Committee, Learning and Research Centre approved on the 1st October 2009 (ref: 09/H1311/75)
Study design
Randomised three-arm active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please contact Karen Overend [ko501@york.ac.uk] to request a patient information sheet
Condition
Depression
Intervention
Patients allocated to the acupuncture and counselling groups will receive the offer of 12 sessions on a weekly basis.
The participating acupuncturists will be members of the British Acupuncture Council who have been qualified for at least three years. The acupuncture treatments will be performed according to a treatment protocol already developed for this purpose and tested in our pilot. This will allow for each patient having a customised treatment within a standardised theory-driven framework.
Counselling will be provided by members of the British Association of Counselling and Psychotherapy using primarily a non-directive approach. A manualised protocol, which was developed for the pilot, will set the parameters for the counselling. Counsellors will use empathy and advanced listening skills to help clients express feelings, clarify thoughts, and reframe difficulties, but they will not give advice or set homework.
Usual GP care will continue to be available to all patients according to need, and will be monitored in all three groups for comparative purposes.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The Patient Health Questionnaire-9 (PHQ-9) at three months, with an evaluation of whether there is an overall benefit over the twelve months. We will use the correlation between the PHQ-9 and Beck Depression Inventory-II (BDI-II) at baseline and 12 months to determine equivalent BDI-II scores at subsequent timepoints.
Secondary outcome measures
1. SF-36 Bodily Pain Subscale
2. EQ-5D
3. CARE (Consultational and Relational Empathy measure)
4. We will also collect data on NHS resource use and patients' private costs
Overall trial start date
01/11/2009
Overall trial end date
11/04/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients over 18 who have consulted their GP for depression
2. Participants must also be still be depressed at the time of recruitment, with a score of 20 or above on the Beck Depression Inventory-II
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
640
Participant exclusion criteria
1. Patients who are receiving acupuncture or counselling sessions
2. Terminal illness
3. Haemophilia
4. Hepatitis
5. Human immunodeficiency virus (HIV)
6. Pregnancy
7. Confounding psychiatric condition:
7.1. Bipolar disorder
7.2. Postpartum depression
7.3. Adjustment disorder
7.4. Psychosis
7.5. Personality disorder
8. Suffered a close personal bereavement
9. Given birth during the previous 12 months
10. Because of the specific demands of this study in terms of the need to fully comprehend detailed information, to complete questionnaires, to understand and converse readily with English speaking acupuncturists and counsellors, and to permit physical contact, we intend to exclude patients who have a significant learning disability, who are unable to converse in English, or who have dementia
Recruitment start date
01/11/2009
Recruitment end date
11/04/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Complementary Medicine Research Group
York
YO10 5DD
United Kingdom
Sponsor information
Organisation
University of York (UK)
Sponsor details
c/o Mrs S Final
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 430000
smf3@york.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
National Institute for Health Research (NIHR) (UK) - Programme Grants
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24086114
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24902735
Publication citations
-
Results
MacPherson H, Richmond S, Bland M, Brealey S, Gabe R, Hopton A, Keding A, Lansdown H, Perren S, Sculpher M, Spackman E, Torgerson D, Watt I, Acupuncture and counselling for depression in primary care: a randomised controlled trial., PLoS Med., 2013, 10, 9, e1001518, doi: 10.1371/journal.pmed.1001518.
-
Results
Hopton A, Eldred J, MacPherson H, Patients' experiences of acupuncture and counselling for depression and comorbid pain: a qualitative study nested within a randomised controlled trial., BMJ Open, 2014, 4, 6, e005144, doi: 10.1136/bmjopen-2014-005144.