Plain English Summary
Background and study aims
Depression is a common and disabling mental disorder. The number of people with depression is increasing in the developed world, which has been linked to lifestyle. The most common treatments fail to solve all cases, and there is a significant percentage of depressed patients who respond poorly to these treatments. Hygienic and dietary measures have proven effective when used in conjunction with standard treatments. However, this combination has not yet been proven to be effective in routine clinical practice conditions. We are carrying out a study of 300 major depression patients to test the effect of antidepressants combined with structured hygienic and dietary recommendations in primary care.
Who can participate?
Adult patients who have depression, can understand spoken and written Spanish and are able to give written informed consent to take part in the study.
What does the study involve?
The patient will be assigned randomly one of two groups:
a) hygienic-dietary recommendations
b) unspecific hygienic-dietary recommendations (control group)
Depression, quality of life and consumption of health and social services scales will be administered.
What are the possible benefits and risks of participating?
There is no guarantee that patients participating in this study have a benefit. We hope that one of the two groups have better outcomes in terms of depressive symptoms than the other, but there are no expected side effects or safety issues.
Where is the study run from?
From three research centers of three Spanish cities:
Universitat Illes Balears in Palma de Mallorca
Grupo Aragonés de Investigación en Salud Mental in Zaragoza
Parc Sanitari Sant Joan de Deu in Barcelona
When is study starting and how long is it expected to run for?
Recruitment will begin in September 2012 and data collection is expected to end in December 2013
Who is funding the study?
Instituto de Salud Carlos III (Spanish Government)
Who is the main contact?
Professor Mauro Garcia-Toro
mauro.garcia@uib.es
Trial website
Contact information
Type
Scientific
Primary contact
Prof Mauro Garcia-Toro
ORCID ID
Contact details
Edificio IUNICS
C/ Ctra de Valldemossa Km 7,5
Palma de Mallorca
07122
Spain
-
mauro.garcia@uib.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PI11/01392
Study information
Scientific title
Hygienic-dietary treatment of Depression in Primary Care: a randomised study
Acronym
HDPC
Study hypothesis
Depressed patients who follow hygienic-dietary recommendations will experience an improvement in their clinical course compared with a control group
Ethics approval
Research and clinical trials ethics committee of the Balearic Islands (CEIC), December 2011, ref: 1563-11 IB-PI
Study design
Multicenter two-arm randomised 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
Major Depression
Intervention
Patients assigned to the active treatment group received an envelope containing a sheet of paper with the four hygienic-dietary recommendations under consideration.
1. Go to bed when sleepy and not before 11 pm. Use your bed and bedroom only for sleep and sex (do not read, watch TV or lie on the bed during the day). If you do not fall asleep after 15 or 20 minutes get up and start an activity until you feel sleepy enough to go back to bed. Get up early, never later than 9 a.m., no matter how well you have slept the night before. Do not lie down or take a nap during the day.
2. Walk at least 1 hour a day, at a good pace but without becoming short of breath or being unable to talk while walking. If you think you have a medical problem which makes walking difficult or uncomfortable consult your doctor. Use appropriate footwear for walking and have a shower or a bath afterwards.
3. Be exposed to environmental light at least 2 hours per day, taking precautions to avoid sunburn or sunstroke (sunscreen, hat, etc.).
4. Try to eat a healthy and balanced diet. Eat at regular hours without snacking between meals. Avoid especially sweet or sugary drinks. Eat fish at least three times per week, plus fruit, cereals, nuts and vegetables daily.
The control group received an identical envelope, but in this case with unspecified recommendations:
1. Sleep the hours that you feel your body needs.
2. Adapt the pace of daily physical activity to meet your needs best.
3. If exposed to environmental light take precautions to avoid sunburn or sunstroke (sunscreen, hat, etc.).
4. Try to eat a healthy and balanced diet.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Total score on self-administered 21-items Beck Inventory Depression Scale (BDI) before and after intervention.
Secondary outcome measures
1. State-Trait Anxiety Inventory (STAI) Scale
2. Client Service Receipt Inventory
3. EQ-5D Scale
All outcomes were measured in the screening visit and in the 6 and 12 follow up visits
Overall trial start date
03/09/2012
Overall trial end date
20/12/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male and female patients over 18 years
2. Patients experiencing a Major Depression episode according to DSM-IV-TR diagnostic criteria and with a Beck Depression Questionnaire total score equal or over 10
3. Patient who has the ability to communicate and give informed consent in writing
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
1. Patients suffering from another disease that affects CNS or who has suffered any serious head injury, dementia, etc
2. Other psychiatric diagnosis or severe psychiatric illness (substance dependence or abuse, schizophrenia or other psychotic disorders, eating disorders, etc.), with the exception of anxious pathology or personality disorders
3. The existence of severe, uncontrolled, medical condition, or potentially interfering with affective symptomatology
4. Presence of delusions or hallucinations at the time of the study
5. Important risk of suicide
Recruitment start date
03/09/2012
Recruitment end date
20/12/2013
Locations
Countries of recruitment
Spain
Trial participating centre
Edificio IUNICS
Palma de Mallorca
07122
Spain
Sponsor information
Organisation
Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Sponsor details
C/ Sinesio Delgado
8
Madrid
28029
Spain
-
Oficina.informacion@isciii.es
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Carlos III Health Institute (Spain) ref: PI11/01392
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
Basic results (scientific)
Publication list
1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23158080
2. 2015 results in https://www.ncbi.nlm.nih.gov/pubmed/26025368 (added 18/01/2019)
Publication citations
-
Protocol
Garcia-Toro M, Roca M, Monzón S, Vives M, Oliván B, Vicens E, Salva J, Gili M, Hygienic-dietary recommendations for major depression treatment: study protocol of a randomized controlled trial., BMC Psychiatry, 2012, 12, 201, doi: 10.1186/1471-244X-12-201.