Depression
Conditions
Interventions
This is a controlled, randomized, single-blind clinical trial with a stepped wedge design, consisting of five transition stages. The sample will consist of one hundred and twenty women, initially allo
Sponsors
Faculdade de Saúde Pública da Universidade de São Paulo
Faculdade de Saúde Pública da Universidade de São Paulo
Eligibility
Sex/Gender
Female
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: Cisgender women; over the age of 18 will be included; with a Body Mass Index (BMI) between 18.5 and 29.9 kg/m²; with some level of stress, anxiety, or depression scored on the DASS-21 scale (between “mild” and “extremely severe”) referring to the week preceding the first eligibility interview; who have not been using psychoactive medications in the last eight weeks and who do not have an active diagnosis of psychiatric disorders
Exclusion criteria
Exclusion criteria: Women with a recent history (last six months) of diagnosed mental disorders and/or frequent use of psychiatric medications and stimulant supplements (sources of caffeine or similar) will be excluded; individuals with daily coffee consumption greater than 150 ml/day in the last 30 days; participants diagnosed with active gastric or duodenal ulcer, severe gastritis, symptomatic gastroesophageal reflux disease, or any other condition that prevents coffee consumption will also be excluded; pregnancy; lactation; menopause; simultaneous involvement in similar clinical studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A significant reduction in these symptoms is expected among participants in the intervention condition, verified through the application of the Depression, Anxiety and Stress Scale DASS twenty one and through the comparison of the mean scores between the control and intervention groups. Thus, we will observe a minimum difference of zero point three in the mean scores between the groups as a parameter to identify the occurrence of the outcome | — |
Secondary
| Measure | Time frame |
|---|---|
| An improvement is expected based on an increase in Brain Derived Neurotrophic Factor BDNF, assessed through biochemical analysis of biological samples, verified by comparing the mean values between the control and intervention groups. Thus, we will observe a significant increase in urinary levels of Brain Derived Neurotrophic Factor BDNF between the groups as a parameter to identify the occurrence of the outcome | — |
Countries
BR
Contacts
Public ContactElizabeth Torres
Faculdade de Saúde Pública da Universidade de São Paulo
Outcome results
None listed