Inclusion Criteria
1. Male and female patients over 18 years.
2. Patients experiencing a depressive episode according to DSM-IV diagnostic criteria Major Depressive Disorder, Dysthymic Disorder or Bipolar Disorder.
3. Patients receiving antidepressant treatment.
5. Patients who have the ability to communicate in Spanish and give informed written consent.
6. Women of childbearing age practicing safe contraceptive methods.
Exclusion Criteria
1. Patients suffering from another severe disease that affects the CNS (cerebral organic pathology) or who have suffered any serious head injury.
2. Other severe psychiatric illnesses (history of schizophrenia or other psychotic disorders, substance dependence or abuse and eating disorders).
3. Presence of a severe, uncontrolled, or potentially interfering medical condition.
4. Presence of delusions or hallucinations at the time of the study.
5. Significant risk of suicide. 6. Pregnancy or lactation.
1. DSM-IV criteria for Major Depressive Disorder. The 4th edition of "Diagnostic and Statistical Manual of Mental Disorders" is a widely use comprehensive classification of officially recognized psychiatric disorders [
22]
2.
The Mini International Neuropsychiatric Interview (MINI) is a short diagnostic structured interview designed to generate 17 DSM-IV or ICD10 axis I diagnosis [
23].
3. Sociodemographic and clinical questionnaire designed specifically for this study. Relevant sociodemographic information regarding gender, date of birth and age, marital status, education level and occupational status, as well as clinical data regarding age of disorder onset, number of previous episodes and current pharmacological treatment (type of agent, mean dose and time of administration) will be collected.
4.
The Beck Depression Inventory (BDI) is a test presented in multiple choice format which purports to measure presence and degree of depression. Each of the 21-items of the BDI attempts to assess a specific symptom or attitude which appear(s) to be specific to depressed patients, and which are consistent with descriptions of the depression contained in the psychiatric literature [
24].
5. The
SF-36 is a general measure that is intended to capture quality of life as well as whether an individual is healthy or not [
25]. The SF-36 is made up of 8 scales. These cover the ability to function and complete everyday activities, including physical activities and social activities. The scales also capture well-being, such as energy or fatigue and mental health.
6.
17-item Hamilton Depression Rating Scale (HAMD). This is the most commonly used severity scale in clinical practice and research with mood disorders [
26].
7.
The Global Clinical Impression rating scales (GCI) measures symptom severity, treatment response and efficacy of treatments in patients with mental disorders [
27].
Trial Procedures: Consent, Baseline Assessments, Blinding and Randomization
Collaborating researchers of the three participating institutions will identify all those potential patients who might meet the required criteria. During the recruitment visit patients will be informed of every detail of the study, answering all questions and concerns that they might have regarding their participation. Signed informed consents will then be collected (Table
1). Researchers will confirm that patients meet the criteria required for entry into the study using the Structured Interview MINI [
23]. The following two questionnaires will later be administered: Beck Depression Inventory of 21 items (BDI-21) [
24] and Questionnaire on Health Status (SF- 36) [
25]. Finally, an appointment will be arranged within a week. During this baseline interview, a blind assessor will quantify the affective symptomatology through the Hamilton 17-item scale (HAMD-17) [
26] and Clinical Global Impression scale (CGI). Subjects will then be checked to ensure that they do not show organic pathology which might induce symptoms of depression (EKG, BP, HR, BMI). The following tests will also be administered: blood count, biochemistry, coagulation studies, thyroid function tests, serology, levels of vitamins (folic acid and vitamin B12), and urine test with toxic levels, in addition to a pregnancy test if appropriate.
Sociodemographic questionnaire | | X | |
Clinic questionnaire | | X | X |
MINI Interview | X | | |
Discussion of the study information leaflet | X | | |
Signed Consent Form | X | | |
Physical parameters | | | |
• BP | | X | X |
• HR | | X | X |
• BMI | | X | X |
EKG | | X | |
Blood Test | | X | X |
Urine Test | | X | X |
Self Administered Test | | | |
• BDI-21 | X | | X |
• SF-36 | X | | X |
Test administered by Blind Raters | | | |
• HAMD-17 | | X | X |
• GCI | | X | X |
Delivery of Hygienic-dietetic recommendations | | X | |
Patients will then be randomly assigned to one of two treatment arms according to sequence of entrance, using blocks of randomization. Patients assigned to the active treatment group will receive an envelope containing a sheet of paper with the four hygienic-dietary recommendations under consideration:
1. Go to bed when sleepy and not before 11 o'clock at night. Use your bed and bedroom only for sleep and sex (do not read, watch TV or lie on the bed during the day). If you do not fall asleep after 15 or 20 minutes get up and start an activity until you feel sleepy enough to go back to bed. Get up early, never later than 9 a.m., no matter how well you have slept the night before. Do not lie down or take a nap during the day.
2. Walk at least 1 hour a day, at a good pace but without becoming short of breath or being unable to talk while walking. If you think you have a medical problem which makes walking difficult or uncomfortable consult your doctor. Use appropriate footwear for walking and have a shower or a bath afterwards.
3. Be exposed to sunlight at least 2 hours per day, taking precautions to avoid sunburn or sunstroke (sunscreen, hat, etc.).
4. Try to eat a healthy and balanced diet. Eat at regular hours without snacking between meals. Avoid especially sweet or sugary drinks. Eat fish at least three times per week, plus fruit, cereals, nuts and vegetables daily.
The control group will receive an identical envelope, but the advice will be to perform the pattern of eating, sleeping, exercise and exposure to light which they think will make them feel better:
1. Sleep the hours that you feel your body needs.
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.).
4. Try to eat a healthy and balanced diet.
After the 6th month patients will be visited and information will be sought about health resource utilization (hospitalizations, number of visits to the emergency department...) and work status. There will be a new collection of the same physical parameters, and blood and urine parameters will be studied. The following tests will again be collected: BDI-21, and SF-36. The blind rater will also repeat the questionnaires conducted at the beginning of the study: HAMD-17, and CGI.