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Hygienic-dietary treatment of Depression in Primary Care

Hygienic-dietary treatment of Depression in Primary Care: a randomised study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN73931675
Enrollment
300
Registered
2012-07-18
Start date
2012-09-03
Completion date
Unknown
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depression Mental and Behavioural Disorders Depressive episode

Interventions

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

Sponsors

Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Total score on self-administered 21-items Beck Inventory Depression Scale (BDI) before and after intervention.

Secondary

MeasureTime frame
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

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 25, 2026