Hygienic-dietary recommendations in patients with Depression
| ISRCTN | ISRCTN59506583 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59506583 |
| Protocol serial number | PI07/0544 |
| Sponsor | Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) |
| Funder | Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) - Health Research Fund (Fondo de Investigaciones Sanitarias [FIS]) |
- 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
Scientific
Edificio IUNICS
C/ Ctra de Valldemossa Km 7,5
Palma de Mallorca
07122
Spain
| mauro.garcia@uib.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre two-arm randomised study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Score on Hamilton Scale for Depression (HAMD-17) obtained by blinded assessors before and after intervention. |
| Key secondary outcome measure(s) |
1. Self-administered Beck Depression Inventory (BDI-21) |
| Completion date | 31/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 80 |
| 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
07122
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
