Contact information
Type
Scientific
Primary contact
Dr 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
PI07/0544
Study information
Scientific title
Effectiveness of hygienic-dietary recommendations as enhancers of antidepressant treatment in patients with Depression
Acronym
HD-Dep
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) approved on in February 2008 (ref: 733-06 IB-PI)
Study design
Multicentre two-arm randomised study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Depression
Intervention
Written recommendations were delivered by the psychiatrist who collaborated in the study.
There were only two recommendations options that were allocated at random.
Intervention group:
1. Go to bed when sleepy and not before 11 o'clock at night. Use the bed and bedroom only for sleep and sex (do not read, watch TV or stay in it during the day). If you do not fall asleep after 15-20 minutes get up and deal in any activity until you have the feeling of sleepiness to go back to bed. Get up early, never later than 9 am, whatever you have slept at night. Do not lie or nap during the day.
2. Walk at least 1 hour a day, at a good pace but without having short of breath or being unable to talk while walking. If you think you have a medical problem which can make your walking troublesome consult your
doctor. Use comfortable footwear for walking and after have a shower or a bath.
3. Be at least 2 hours per day exposed to sunlight, taking precautions to avoid sunburn or sunstroke (sunscreen, hat, etc.)..
4. Try to eat a healthy and balanced diet. Eat at regular hours without turning it between meals, especially sweet or sugary drinks. Eat fish at least three times per week, plus fruit, cereals, nuts and vegetables daily.
Control group:
1. Sleep the hours that your body need to feel you as the good as possible.
2. Adapt the pace of daily physical activity to meet your needs best.
3. If exposed to sunlight take precautions to avoid sunburn or sunstroke (sunscreen, hat, etc.)..
5. Try to eat a healthy and balanced diet.
The total duration of the intervention will be 6 months.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Score on Hamilton Scale for Depression (HAMD-17) obtained by blinded assessors before and after intervention.
Secondary outcome measures
1. Self-administered Beck Depression Inventory (BDI-21)
2. Clinical Global Impression scale (CGI)
3. SF-36 Health Status (Short-Form SF-36)
All outcomes were measured in the screening visit and final visit after 6 months.
Overall trial start date
11/04/2008
Overall trial end date
31/05/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients of both sexes over 18 years
2. Patients experiencing a depressive episode according to DSM-IV-TR diagnostic criteria (Major depressive disorder, Dysthymic disorder or Bipolar disorder depressive phase)
3. Patient receiving antidepressant treatment
4. Patient who has the ability to communicate and give informed consent in writing
5 . Women of childbearing age using a secure contraception
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80 patients
Participant exclusion criteria
1. Patients suffering from another disease that affects CNS (cerebral organic pathology or who has suffered any serious head injury, dementia, etc.)
2. Other psychiatric diagnosis or severe psychiatric illness (substance dependence and abuse, schizophrenia or other psychotic disorders, eating disorders, etc.), except anxious pathology or personality disorders
3. Presence of medical condition severe, uncontrolled, or potentially interfering with affective symptomatology
4. Presence of delusions or hallucinations at the time of the study
5. Significant risk of suicide
6. Pregnancy or lactation
Recruitment start date
11/04/2008
Recruitment end date
31/05/2010
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
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) - Health Research Fund (Fondo de Investigaciones Sanitarias [FIS])
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
2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20618920
Publication citations
-
Protocol
Garcia-Toro M, Ibarra O, Gili M, Salva J, Monzón S, Vives M, Serrano MJ, Garcia-Campayo J, Roca M, Effectiveness of hygienic-dietary recommendations as enhancers of antidepressant treatment in patients with depression: study protocol of a randomized controlled trial., BMC Public Health, 2010, 10, 404, doi: 10.1186/1471-2458-10-404.