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
Contact information
Dr Hugh MacPherson
Scientific
Scientific
Complementary Medicine Research Group
Seebohm Rowntree Building Area 3
University of York
Heslington
York
YO10 5DD
United Kingdom
| Phone | +44 (0)1904 321394 |
|---|---|
| hugh.macpherson@york.ac.uk |
Study information
| Study design | Randomised three-arm active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact Karen Overend [ko501@york.ac.uk] to request a patient information sheet |
| Scientific title | Acupuncture, Counselling, and Usual GP care for Depression (ACUDep): a randomised controlled trial to evaluate effectiveness and cost-effectiveness |
| Study acronym | ACUDep |
| Study objectives | 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(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) studied | 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 |
| 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 study start date | 01/11/2009 |
| Completion date | 11/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 640 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2009 |
| Date of final enrolment | 11/04/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Complementary Medicine Research Group
York
YO10 5DD
United Kingdom
YO10 5DD
United Kingdom
Sponsor information
University of York (UK)
University/education
University/education
c/o Mrs S Final
Heslington
York
YO10 5DD
England
United Kingdom
| Phone | +44 (0)1904 430000 |
|---|---|
| smf3@york.ac.uk | |
| Website | http://www.york.ac.uk |
"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 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? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2013 | Yes | No | |
| Results article | results | 05/06/2014 | Yes | No |
