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Acupuncture, Counselling, and Usual GP care for Depression (ACUDep)
ISRCTN ISRCTN63787732
DOI 10.1186/ISRCTN63787732
ClinicalTrials.gov identifier
EudraCT number
Public title Acupuncture, Counselling, and Usual GP care for Depression (ACUDep)
Scientific title Acupuncture, Counselling, and Usual GP care for Depression (ACUDep): a randomised controlled trial to evaluate effectiveness and cost-effectiveness
Acronym ACUDep
Serial number at source N/A
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.
Lay summary Not provided at time of registration
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
Countries of recruitment United Kingdom
Disease/condition/study domain Depression
Participants - 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
Participants - 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
Anticipated start date 01/11/2009
Anticipated end date 11/04/2011
Status of trial Completed
Patient information material Not available in web format, please contact Karen Overend [ko501@york.ac.uk] to request a patient information sheet
Target number of participants 640
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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
Sources of funding National Institute for Health Research (NIHR) (UK) - Programme Grants
Trial website http://www.frtcm.org/depression.htm
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24086114
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24902735
Contact name Dr  Hugh  MacPherson
  Address Complementary Medicine Research Group
Seebohm Rowntree Building Area 3
University of York
Heslington
  City/town York
  Zip/Postcode YO10 5DD
  Country United Kingdom
  Tel +44 (0)1904 321394
  Fax +44 (0)1904 321388
  Email hugh.macpherson@york.ac.uk
Sponsor University of York (UK)
  Address c/o Mrs S Final
Heslington
  City/town York
  Zip/Postcode YO10 5DD
  Country United Kingdom
  Tel +44 (0)1904 430000
  Email smf3@york.ac.uk
  Sponsor website: http://www.york.ac.uk
Date applied 09/11/2009
Last edited 09/06/2014
Date ISRCTN assigned 15/12/2009
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