Stress and the Sympathetic Nervous System in Adults With Depression

NCT ID: NCT04838262

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2023-04-27

Brief Summary

To test our hypotheses, we will enroll healthy adults having no history of mood disorders and adults with major depressive disorder (MDD) having a broad range of depressive symptom severity. After screening, subjects will meet with the research coordinator or an investigator for a discussion, with opportunity for questions, before applicable consent forms are obtained. Daily stress processes will be assessed using an ecological momentary assessment approach for 8 consecutive days. On the last day of the daily stress assessment, we will directly measure muscle sympathetic nerve activity, blood pressure, and heart rate during acute laboratory-based cognitive, emotional, and physiological interventions to induce a stress response. A venous blood sample will be taken for measurements of metabolic and renal health and systemic inflammation.

Aim 1: To examine the effect of daily psychosocial stressor exposure on acute sympathetic stress reactivity in MDD. Two stressor exposure indicators will be calculated: stressor frequency (i.e., percentage of interview days during which at least one stressor occurred) and total stress (i.e., total number of stressors reported across all interview days) and will be related to the magnitude of responsiveness to the acute stress interventions. We hypothesize that the slope of this relation will be steeper in adults with MDD compared to healthy non-depressed adults.

Aim 2: To determine the relation between negative affective reactivity to daily psychosocial stressor exposure and acute sympathetic stress reactivity in MDD. Negative affective reactivity will be calculated as the change in affect on days when stressors occurred compared to one's typical affect on non-stressor days and will be related to the magnitude of responsiveness to the acute stress interventions. We hypothesize that the slope of this relation will be steeper in adults with MDD compared to healthy non-depressed adults.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Assessment of Daily Stress Processes

Subjects will report cumulative exposure, perceived severity, and emotional responsiveness to commonly occurring everyday psychosocial stressors utilizing an ecological momentary assessment approach for 8 consecutive days.

Group Type: EXPERIMENTAL

Acute Stressors

Intervention Type: OTHER

Sympathetic nervous system activity and blood pressure will be measured before, during, and after several acute laboratory-based cognitive (Stroop Color Word Test), emotional (International Affective Picture System), and physiological (Cold Pressor Test) stressors.

Interventions

Acute Stressors

Sympathetic nervous system activity and blood pressure will be measured before, during, and after several acute laboratory-based cognitive (Stroop Color Word Test), emotional (International Affective Picture System), and physiological (Cold Pressor Test) stressors.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All participants will be 18-30 yrs.
• Healthy non-depressed men and women will have no history or evidence of psychiatric illness and will not have a family history of MDD or major psychiatric illness.
• Men and women with MDD will have symptomatic depression that meets diagnostic criteria and will be non-medicated.
• The capacity and willingness to provide written informed consent, to attend all study related visits, and to comply with the study protocol.

Exclusion Criteria

Subjects will be excluded at the discretion of the PI/collaborating clinician or for any of the following reasons:

• psychiatric illness aside from MDD (including current or past psychotic disorders, bipolar disorder, schizophrenia or schizoaffective disorder, panic disorder, post-traumatic stress disorder, obsessive compulsive disorder)
• subthreshold depression
• current use of psychotropic medications (including major classes of antidepressants, anxiolytics, antipsychotics, mood stabilizers)
• active suicidal or homicidal ideation
• active substance dependence or eating disorders
• current use of any medications that could alter sympathetic reactivity
• diagnosed or suspected cardiovascular, renal, or metabolic disease (hypertension, heart disease, diabetes, hyperlipidemia)
• autonomic disorders
• tobacco use (including electronic cigarettes)
• obesity (body mass index > 30 kg/m2)
• breastfeeding or pregnancy
• <18 or >30 yrs

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Penn State University

OTHER

Sponsor Role: collaborator

University of Delaware

OTHER

Sponsor Role: lead

Responsible Party

Jody Greaney

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The University of Texas at Arlington

Arlington, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

MH123928

Identifier Type: -

Identifier Source: org_study_id