The effectiveness and cost-effectiveness of treatment by homeopaths in addition to usual care for depressed patients
| ISRCTN | ISRCTN02484593 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02484593 |
| Secondary identifying numbers | NCT 11/45 |
- Submission date
- 01/12/2012
- Registration date
- 07/01/2013
- Last edited
- 10/07/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Depression affects a large number of people in the United Kingdom and in other countries. Many experience it more than once and some suffer from long-standing depression. Established therapies offered within primary care include especially psychological and psychotherapeutic treatment, and antidepressant drugs. These treatments may help many patients, but the effect is sometimes insufficient. Also, some patients do not want to use existing treatment such as antidepressant drugs. There may be many reasons for this, such as previously experienced side-effects. Some patients choose to consult with a homeopath. There is however insufficient research evidence to draw any final conclusions for such treatment for depressed patients.
Who can participate?
Participants will be selected among those who have already agreed to participate in the South Yorkshire Cohort (SYC). They have been recruited through their general practitioners. Participants will be aged 18 to 85, and of both genders. Those included will have self-reported significant depression symptoms.
What does the study involve?
Participants are randomly allocated to Individualised treatment provided by homeopaths in addition to usual care, or usual care alone. All participants are sent a questionnaire at 6 and 12 months. Results for these two groups are compared. Some participants are also invited for an interview with a researcher in order to learn from their experience with treatment.
What are the possible benefits and risks of participating?
Those randomly selected for free treatment provided by a homeopath are offered a first consultation which includes the prescription of a homeopathic remedy, and follow-up treatment for up to 9 months. Previous researchers have found that mild or moderate temporary side-effects may be experienced by some after taking homeopathic remedies, but no serious side-effects are expected. Treatment is individualised to suit each patient. This includes the length and frequency of consultations, and the type of homeopathic remedy prescribed for each patient. Homeopaths may also offer other advice, such as to consult with a counsellor or a healthcare practitioner, or to use other supportive treatment. All included participants, whether offered treatment by a homeopath or not, may continue with other treatment as usual. All those who are taking conventional drugs must continue treatment as prescribed by their doctor.
Where is the study run from?
University of Sheffield (UK)
When is the study starting and how long is it expected to run for?
July 2013 to June 2014
Who is funding the study?
The project is self-funded. It has received funding from various funding organisations and individuals, European Central Council of Homeopaths, Homøopat Einar Larsens Minnefond (Norway), and Norske Homeopaters Landsforbund (Norway).
Who is the main contact?
Petter Viksveen
p.viksveen@sheffield.ac.uk
Contact information
Scientific
University of Sheffield
School of Health and Related Research
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
| p.viksveen@sheffield.ac.uk |
Study information
| Study design | Pragmatic trial using the cohort multiple randomised controlled trial design and a qualitative interview study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A pragmatic cohort randomized controlled trial of the clinical and cost effectiveness of treatment of depression by homeopaths in addition to usual care, compared to usual care alone |
| Study acronym | DEPSY (DEPression in South Yorkshire) |
| Study objectives | To evaluate the acceptability and the comparative clinical and cost effectiveness of the offer of adjunctive treatment provided by homeopaths for patients with self-reported depression in addition to usual care, compared to usual care alone, as well as to explore their short and long term experiences. |
| Ethics approval(s) | 1. NRES Committee Yorkshire & The Humber - Leeds Central, 15/11/2012, ref: 12/YH/0379 2. NRES Committee Yorkshire & The Humber - Leeds Bradford, 31/07/2013, ref. 12/YH/0379 |
| Health condition(s) or problem(s) studied | Self-reported depression |
| Intervention | Individualised treatment provided by homeopaths in addition to usual care, compared to usual care alone. |
| Intervention type | Other |
| Primary outcome measure | Patient Health Questionnaire (PHQ-9) at 6 months |
| Secondary outcome measures | 1. Patient Health Questionnaire (PHQ-9) at 12 months, and the following at 6 and 12 months 2. Generalized Anxiety Disorder 7-item (GAD-7) scale at 6 and 12 months 3. EuroQol (EQ-5D) at 6 and 12 months 4. Measure Yourself Medical Outcome Profile (MYMOP2) at 6 and 12 months 5. Body Mass Index (BMI) at 6 and 12 months 6. Life satisfaction score at 6 and 12 months |
| Overall study start date | 01/07/2013 |
| Completion date | 30/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Offer of treatment: 162. Control group (usual care alone): 323 |
| Key inclusion criteria | 1. Patients with self-reported depression indicated by a minimum PHQ-9 score of 10 with a minimum of two symptoms scoring 2 points including at least either question 1 (little interest or pleasure in doing things) or question 2 (feeling down, depressed, or hopeless) 2. Aged 18 to 85 years 3. Are able to speak and read English 4. Have given informed consent |
| Key exclusion criteria | 1. Patients with PHQ-9 scores below 10 or less than 2 symptoms scoring 2 points or neither question 1 nor question 2 scoring 2 points 2. Patients who report current or past psychiatric diagnosis (other than depression) including bipolar disorder, Alzheimer's disease, organic brain damage, schizophrenia, schizoaffective disorders, other psychotic disorders, or antisocial personality disorder 3. Patients who have received homeopathic treatment over the past 3 months 4. Patients who are currently involved in another health research project 5. Patients who due to reduced intellectual capacity or illiteracy are unable to read or understand study questionnaires and accompanying information |
| Date of first enrolment | 01/07/2013 |
| Date of final enrolment | 30/06/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
S1 4DA
United Kingdom
Sponsor information
University/education
Western Bank
Sheffield
S10 2TN
England
United Kingdom
| d.mcclean@sheffield.ac.uk | |
| Website | http://www.shef.ac.uk/ |
"ROR" |
https://ror.org/05krs5044 |
Funders
Funder type
Government
No information available
No information available
No information available
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 | 30/06/2017 | Yes | No | |
| Results article | results | 06/07/2017 | Yes | No |
Editorial Notes
10/07/2017: Publication reference added.
03/07/2017: Publication reference added.
05/08/2013: The following changes were made to the trial record:
1. The overall trial start date was changed from 01/03/2013 to 01/07/2013.
2. The overall trial end date was changed from 01/03/2014 to 30/06/2014.
3. The target number of participants was changed from 'Offer of treatment: 124. Control group (usual care alone): 248' to 'Offer of treatment: 162. Control group (usual care alone): 323'.
