Depression Mental and Behavioural Disorders Depressive episode
Conditions
Interventions
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
Sponsors
Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score on Hamilton Scale for Depression (HAMD-17) obtained by blinded assessors before and after intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Spain
Outcome results
None listed