Perceived Stress and Negative Thoughts With Biomarkers in People With Type 2 Diabetes Mellitus and Healthy Subjects

Study Overview
=================
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.

Official Title
-----------------
Association of Perceived Stress and Negative Thoughts With Metabolic Biomarkers and Inflammatory Diseases in People With Type 2 Diabetes Mellitus and Healthy Subjects

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: Guilty feelings


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guilty feelings<br>Write for 20 minutes about a situation that in the participant's past life has caused feelings of guilt. | Behavioral: Guilty feelings<br>* Participants write for 20 minutes about situations that have caused them feelings of guilt throughout their lives.<br>|
| Placebo Comparator: Neutral feelings<br>Write for 20 minutes about a situation that in the participant's past life has caused neutral feelings. | Behavioral: Guilty feelings<br>* Participants write for 20 minutes about situations that have caused them feelings of guilt throughout their lives.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose levels | mg/dL | 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. | 
| Salivary cortisol | mg/dL | 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. | 
| Salivary Tumor Necrosis Factor alpha | mg/dL | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived stress | 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. | This variable is measured in a single day and represents the week prior to the study. | 
| Negative thoughts | Automatic negative thoughts scale (ATQ-N), range 0-90. Higher scores mean a worse outcome (more negative thoughts). | This variable is measured in a single day and represents the month prior to the study. | 
| Depression | Beck's Depression Inventory, range 0-63. Higher number indicating more severe depression. | This variable is measured in a single day and represents the week prior to the study. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress, Diabetes, Depression, Negative thoughts