Acupuncture for depression: a pilot for a randomised controlled trial
| ISRCTN | ISRCTN59267538 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59267538 |
| Protocol serial number | N/A |
| Sponsor | University of York (UK) |
| Funder | Department of Health (UK) |
- 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
Scientific
Department of Health Sciences
University of York
York
YO10 5DD
United Kingdom
| Phone | +44 (0)1904 321394 |
|---|---|
| hm18@york.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A pilot randomised controlled trial with three arms: acupuncture and non-directive counselling as adjuncts to usual care, and usual care alone |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Beck Depression Inventory |
| Key secondary outcome measure(s) |
1. PHQ-9 questionnaire |
| Completion date | 21/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Department of Health Sciences
York
YO10 5DD
United Kingdom
YO10 5DD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
