Perceived Stress and Negative Thoughts With Biomarkers in People With Type 2 Diabetes Mellitus and Healthy Subjects
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Behavioral: Guilty feelings
- Registration Number
- NCT04387045
- Lead Sponsor
- Francisco Carlos López Marquez
- Brief Summary
The purpose of this study is to determine the effect of measured and induced negative feelings on glucose, tumor necrosis factor alpha, and cortisol levels in healthy participants and participants with type 2 diabetes mellitus.
- Detailed Description
Depression and Diabetes are two pathologies that are frequently comorbid. Stress and negative thoughts are part of both. The biological correlates of psychological and emotional life are not yet fully clarified, so in this study we wonder about the association between tumor necrosis factor alpha, cortisol, and peripheral glucose levels with depression stress, measured negative thoughts, and induced guilt.This is a randomized intervention study. At baseline, participants complete the Beck Depression Inventory, the Automatic Negative Thoughts Scale (ATQ-N), and the Perceived Stress Scale (PSS-14). The intervention consists of a written task about situations that involved feelings of guilt or neutral situations. Saliva and dextrostix samples are taken before the 20-minute written task, at the end, dextrostix and saliva samples are performed again, finally a blood sample is taken.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Written, informed consent.
- 30 to 65 years of age.
- Current diagnosis of Diabetes mellitus type 2 without diabetic foot.
- Healthy volunteers.
- Ability to read and write.
- Other current or past chronic disease diagnoses.
- Current use of antidepressants or other psychiatric medications.
- Steroid medication.
- Consumption of tobacco or alcohol in the last 24 hours.
- Previous diagnosis of autoimmune diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Guilty feelings Guilty feelings Write for 20 minutes about a situation that in the participant's past life has caused feelings of guilt. Neutral feelings Guilty feelings Write for 20 minutes about a situation that in the participant's past life has caused neutral feelings.
- Primary Outcome Measures
Name Time Method Salivary cortisol Sample collection is two times during a single day for each participant, with an interval of 20 minutes. Since it will be measured in fasting, it will take place between 8:00 a.m. and 9:00 a.m. mg/dL
Glucose levels Sample collection is two times during a single day for each participant, with an interval of 20 minutes. Since it will be measured in fasting, it will take place between 8:00 a.m. and 9:00 a.m. mg/dL
Salivary Tumor Necrosis Factor alpha Sample collection is two times during a single day for each participant, with an interval of 20 minutes. It will take place between 8:00 a.m. and 9:00 a.m. mg/dL
- Secondary Outcome Measures
Name Time Method Perceived stress This variable is measured in a single day and represents the week prior to the study. Perceived stress scale (PSS-14), range 0-40.Higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Depression This variable is measured in a single day and represents the week prior to the study. Beck's Depression Inventory, range 0-63. Higher number indicating more severe depression.
Negative thoughts This variable is measured in a single day and represents the month prior to the study. Automatic negative thoughts scale (ATQ-N), range 0-90. Higher scores mean a worse outcome (more negative thoughts).
Trial Locations
- Locations (1)
Facultad de medicina De la UADEC Unidad Torreón
🇲🇽Torreón, Coahuila De Zaragoza, Mexico