Hygienic-dietary recommendations in patients with Depression

ISRCTN	ISRCTN59506583
DOI	https://doi.org/10.1186/ISRCTN59506583
Secondary identifying numbers	PI07/0544

Submission date: 26/03/2010
Registration date: 18/05/2010
Last edited: 14/07/2010

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 Mauro Garcia-Toro
Scientific

Edificio IUNICS
C/ Ctra de Valldemossa Km 7,5
Palma de Mallorca
07122
Spain

Email	mauro.garcia@uib.es

Study information

Study design	Multicentre two-arm randomised study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Effectiveness of hygienic-dietary recommendations as enhancers of antidepressant treatment in patients with Depression
Study acronym	HD-Dep
Study objectives	Depressed patients who follow hygienic-dietary recommendations will experience an improvement in their clinical course compared with a control group.
Ethics approval(s)	Research and clinical trials ethics committee of the Balearic Islands (CEIC) approved on in February 2008 (ref: 733-06 IB-PI)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	11/04/2008
Completion date	31/05/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	80 patients
Key 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
Key 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
Date of first enrolment	11/04/2008
Date of final enrolment	31/05/2010

Locations

Countries of recruitment

Spain

Study participating centre

Edificio IUNICS

Palma de Mallorca
07122
Spain

Sponsor information

Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Research organisation

C/ Sinesio Delgado, 8.
Madrid
28029
Spain

Email	Oficina.informacion@isciii.es
"ROR"	https://ror.org/00ca2c886

Funders

Funder type

Research organisation

Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) - Health Research Fund (Fondo de Investigaciones Sanitarias [FIS])

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?
Protocol article	protocol	09/07/2010		Yes	No