Acupuncture, Counselling, and Usual GP care for Depression (ACUDep)

ISRCTN ISRCTN63787732
DOI https://doi.org/10.1186/ISRCTN63787732
Secondary identifying numbers N/A
Submission date
09/11/2009
Registration date
15/12/2009
Last edited
09/06/2014
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

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Hugh MacPherson
Scientific

Complementary Medicine Research Group
Seebohm Rowntree Building Area 3
University of York
Heslington
York
YO10 5DD
United Kingdom

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

Study information

Study designRandomised three-arm active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please contact Karen Overend [ko501@york.ac.uk] to request a patient information sheet
Scientific titleAcupuncture, Counselling, and Usual GP care for Depression (ACUDep): a randomised controlled trial to evaluate effectiveness and cost-effectiveness
Study acronymACUDep
Study objectivesThe 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(s)York Research Ethics Committee, Learning and Research Centre approved on the 1st October 2009 (ref: 09/H1311/75)
Health condition(s) or problem(s) studiedDepression
InterventionPatients 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 typeOther
Primary outcome measureThe 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 measures1. 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 study start date01/11/2009
Completion date11/04/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants640
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/11/2009
Date of final enrolment11/04/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Complementary Medicine Research Group
York
YO10 5DD
United Kingdom

Sponsor information

University of York (UK)
University/education

c/o Mrs S Final
Heslington
York
YO10 5DD
England
United Kingdom

Phone +44 (0)1904 430000
Email smf3@york.ac.uk
Website http://www.york.ac.uk
ROR logo "ROR" https://ror.org/04m01e293

Funders

Funder type

University/education

National Institute for Health Research (NIHR) (UK) - Programme Grants

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2013 Yes No
Results article results 05/06/2014 Yes No