Hygienic-dietary treatment of Depression in Primary Care
- Conditions
- Major DepressionMental and Behavioural DisordersDepressive episode
- Registration Number
- ISRCTN73931675
- Lead Sponsor
- Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 300
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total score on self-administered 21-items Beck Inventory Depression Scale (BDI) before and after intervention.
- Secondary Outcome Measures
Name Time Method <br> 1. State-Trait Anxiety Inventory (STAI) Scale<br> 2. Client Service Receipt Inventory<br> 3. EQ-5D Scale<br><br> All outcomes were measured in the screening visit and in the 6 and 12 follow up visits<br>