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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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11 February 2019 |
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Main ID: |
ISRCTN73931675 |
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Date of registration:
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18/07/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Hygienic-dietary treatment of Depression in Primary Care
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Scientific title:
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Hygienic-dietary treatment of Depression in Primary Care: a randomised study |
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Date of first enrolment:
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03/09/2012 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN73931675 |
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Study type:
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Interventional |
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Study design:
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Multicenter two-arm randomised study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Spain
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Contacts
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Name:
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Mauro
Garcia-Toro |
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Address:
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Edificio IUNICS
C/ Ctra de Valldemossa Km 7,5
07122
Palma de Mallorca
Spain |
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Telephone:
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- |
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Email:
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mauro.garcia@uib.es |
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Affiliation:
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Name:
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Address:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Major Depression
Mental and Behavioural Disorders
Depressive episode
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Intervention(s)
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Patients assigned to the active treatment group received 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 pm. 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 environmental light 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 received an identical envelope, but in this case with unspecified recommendations:
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 environmental light take precautions to avoid sunburn or sunstroke (sunscreen, hat, etc.).
4. Try to eat a healthy and balanced diet.
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Primary Outcome(s)
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Total score on self-administered 21-items Beck Inventory Depression Scale (BDI) before and after intervention.
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Secondary Outcome(s)
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1. State-Trait Anxiety Inventory (STAI) Scale
2. Client Service Receipt Inventory
3. EQ-5D Scale
All outcomes were measured in the screening visit and in the 6 and 12 follow up visits
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Secondary ID(s)
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PI11/01392
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Source(s) of Monetary Support
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Carlos III Health Institute (Spain) ref: PI11/01392
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Ethics review
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Status:
Approval date:
Contact:
Research and clinical trials ethics committee of the Balearic Islands (CEIC), December 2011, ref: 1563-11 IB-PI
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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20/12/2013 |
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URL:
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