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

Francisco Carlos López Marquez

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Guilty feelings

Study type: Interventional

Funder types: Other

Identifiers

NCT04387045

C.B/02-01-17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Guilty feelings

Experimental group

Description:

Write for 20 minutes about a situation that in the participant's past life has caused feelings of guilt.

Treatment:

Behavioral: Guilty feelings

Neutral feelings

Placebo Comparator group

Description:

Write for 20 minutes about a situation that in the participant's past life has caused neutral feelings.

Treatment:

Behavioral: Guilty feelings