Condition category
Mental and Behavioural Disorders
Date applied
01/12/2012
Date assigned
07/01/2013
Last edited
07/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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 from 18 to 85 years, and of both genders. Those included will have self-reported significant depression symptoms.

What does the study involve?
In this study we are planning to evaluate patients' experiences of the use of homeopathy as an addition to usual care. The participants will be randomly allocated to Individualised treatment provided by homeopaths in addition to usual care, compared to usual care alone. Both those who are offered treatment and those who are not, will be sent the questionnaire at 6 and 12 months. Results for these two groups will be compared. Some participants will also be invited for a qualitative 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 will be offered: a first consultation which will include 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 will be 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?
The study will be carried out by researchers at the University of Sheffield.

When is the study starting and how long is it expected to run for?
It is expected to start by July 2013 and last for 12 months. Participants will be recruited for 1-2 months.

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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Petter Viksveen

ORCID ID

Contact details

University of Sheffield
School of Health and Related Research
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
-
p.viksveen@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NCT 11/45

Study information

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

Acronym

DEPSY

Study hypothesis

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.

DEPSY (DEPression in South Yorkshire)

On 05/08/2013 the following changes were made to the trial record:
The anticipated start date was changed from 01/03/2013 to 01/07/2013
The anticipated end date was changed from 01/03/2014 to 30/06/2014
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'

Ethics approval

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

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

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Self-reported depression

Intervention

Individualised treatment provided by homeopaths in addition to usual care, compared to usual care alone.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/07/2013

Overall trial end date

30/06/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Offer of treatment: 162. Control group (usual care alone): 323

Participant 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

Recruitment start date

01/07/2013

Recruitment end date

30/06/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Sheffield
Sheffield
S1 4DA
United Kingdom

Sponsor information

Organisation

University of Sheffield (UK)

Sponsor details

Western Bank
Sheffield
S10 2TN
United Kingdom
-
d.mcclean@sheffield.ac.uk

Sponsor type

University/education

Website

http://www.shef.ac.uk/

Funders

Funder type

Government

Funder name

Investigator initiated and funded (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

European Central Council of Homeopaths (EU)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Homøopat Einar Larsens Minnefond (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Norske Homeopaters Landsforbund (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes