Trial Outcomes & Findings for Stress and the Sympathetic Nervous System in Adults With Depression (NCT NCT04838262)

Last Updated: 2025-01-13

Results Overview

the percentage of days that participants reported stressors over the course of 8 days before the intervention, measured each day via self-report using ecological momentary assessment

Recruitment status

COMPLETED

Study phase

Target enrollment

94 participants

Primary outcome timeframe

8 days before intervention

Results posted on

2025-01-13

Participant Flow

This protocol was registered and approved as a Single Arm/Group Assignment Intervention Model, consistent with the description in the associated funded grant. All participants received the same intervention. Data are reported separately for each group (HA, MDD); however, the influence of depression on the outcome variables was determined statistically by the presence of a significant interaction term in the model when combining Arm/Group.

Participant milestones

Participant milestones
Measure	Non-depressed Healthy Adults (HA) HA had no history or evidence of psychiatric illness and had no family history of MDD or major psychiatric illness. HA reported cumulative exposure, perceived severity, and emotional responsiveness to commonly occurring everyday psychosocial stressors utilizing an ecological momentary assessment approach for 8 consecutive days. Sympathetic nervous system activity and blood pressure were 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.	Adults With Major Depressive Disorder (MDD) Adults with MDD had symptomatic depression that met diagnostic criteria and were not medicated. Adults with MDD reported cumulative exposure, perceived severity, and emotional responsiveness to commonly occurring everyday psychosocial stressors utilizing an ecological momentary assessment approach for 8 consecutive days. Sympathetic nervous system activity and blood pressure were 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.
Overall Study STARTED	51	43
Overall Study COMPLETED	42	39
Overall Study NOT COMPLETED	9	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Non-depressed Healthy Adults (HA) HA had no history or evidence of psychiatric illness and had no family history of MDD or major psychiatric illness. HA reported cumulative exposure, perceived severity, and emotional responsiveness to commonly occurring everyday psychosocial stressors utilizing an ecological momentary assessment approach for 8 consecutive days. Sympathetic nervous system activity and blood pressure were 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.	Adults With Major Depressive Disorder (MDD) Adults with MDD had symptomatic depression that met diagnostic criteria and were not medicated. Adults with MDD reported cumulative exposure, perceived severity, and emotional responsiveness to commonly occurring everyday psychosocial stressors utilizing an ecological momentary assessment approach for 8 consecutive days. Sympathetic nervous system activity and blood pressure were 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.
Overall Study Withdrawal by Subject	9	4

Baseline Characteristics

Stress and the Sympathetic Nervous System in Adults With Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-depressed Healthy Adults (HA) n=42 Participants HA had no history or evidence of psychiatric illness and had no family history of MDD or major psychiatric illness. HA reported cumulative exposure, perceived severity, and emotional responsiveness to commonly occurring everyday psychosocial stressors utilizing an ecological momentary assessment approach for 8 consecutive days. Sympathetic nervous system activity and blood pressure were 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.	Adults With Major Depressive Disorder (MDD) n=39 Participants Adults with MDD had symptomatic depression that met diagnostic criteria and were not medicated. Adults with MDD reported cumulative exposure, perceived severity, and emotional responsiveness to commonly occurring everyday psychosocial stressors utilizing an ecological momentary assessment approach for 8 consecutive days. Sympathetic nervous system activity and blood pressure were 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.	Total n=81 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants	39 Participants n=7 Participants	81 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	22 years STANDARD_DEVIATION 4 • n=5 Participants	22 years STANDARD_DEVIATION 5 • n=7 Participants	22 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	31 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	8 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	23 Participants n=7 Participants	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants	39 participants n=7 Participants	81 participants n=5 Participants
Patient Health Questionnaire (PHQ)-9	3.1 arbitrary units STANDARD_DEVIATION 2.9 • n=5 Participants	7.9 arbitrary units STANDARD_DEVIATION 5.4 • n=7 Participants	5.4 arbitrary units STANDARD_DEVIATION 4.9 • n=5 Participants

PRIMARY outcome

Timeframe: 8 days before intervention

Population: This protocol was registered and approved as a Single Arm/Group Assignment Intervention Model, consistent with the description in the associated funded grant. All participants received the same intervention. Data are reported separately for each group (HA, MDD); however, the influence of depression on the outcome variables was determined statistically by the presence of a significant interaction term in the model when combining Arm/Group.

the percentage of days that participants reported stressors over the course of 8 days before the intervention, measured each day via self-report using ecological momentary assessment

Outcome measures

Outcome measures
Measure	Non-depressed Healthy Adults (HA) n=42 Participants HA had no history or evidence of psychiatric illness and had no family history of MDD or major psychiatric illness. HA reported cumulative exposure, perceived severity, and emotional responsiveness to commonly occurring everyday psychosocial stressors utilizing an ecological momentary assessment approach for 8 consecutive days. Sympathetic nervous system activity and blood pressure were 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.	Adults With Major Depressive Disorder (MDD) n=39 Participants Adults with MDD had symptomatic depression that met diagnostic criteria and were not medicated. Adults with MDD reported cumulative exposure, perceived severity, and emotional responsiveness to commonly occurring everyday psychosocial stressors utilizing an ecological momentary assessment approach for 8 consecutive days. Sympathetic nervous system activity and blood pressure were 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.
Percent of Days Participants Report Stressors	36 percent of days Standard Deviation 26	40 percent of days Standard Deviation 24

PRIMARY outcome

Timeframe: 8 days before intervention

Negative affect was measured each day via self-report using ecological momentary assessment using Positive and Negative Affect Schedule (possible range 1-5 arbitrary units, AU), and negative affective reactivity score was defined as the magnitude of the change in negative affect on days when stressors occurred compared to negative affect on non-stressor days over the 8-day timeframe. A singe negative affective reactivity score was calculated for each participant using two-level multi-level modeling (within person slopes). This outcome was operationalized as described in the funded grant and does not have a scale/construct name. There is no defined/set range: more negative slopes indicate a paradoxical increase in negative affect on stressor days, whereas more positive slopes indicate a greater decline in negative affect on stressor days.

Outcome measures

Outcome measures
Measure	Non-depressed Healthy Adults (HA) n=42 Participants HA had no history or evidence of psychiatric illness and had no family history of MDD or major psychiatric illness. HA reported cumulative exposure, perceived severity, and emotional responsiveness to commonly occurring everyday psychosocial stressors utilizing an ecological momentary assessment approach for 8 consecutive days. Sympathetic nervous system activity and blood pressure were 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.	Adults With Major Depressive Disorder (MDD) n=39 Participants Adults with MDD had symptomatic depression that met diagnostic criteria and were not medicated. Adults with MDD reported cumulative exposure, perceived severity, and emotional responsiveness to commonly occurring everyday psychosocial stressors utilizing an ecological momentary assessment approach for 8 consecutive days. Sympathetic nervous system activity and blood pressure were 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.
Negative Affective Reactivity to Daily Stressors	0.24 AU stressor days/AU non-stressor days Standard Deviation 0.08	0.31 AU stressor days/AU non-stressor days Standard Deviation 0.10

PRIMARY outcome

Timeframe: 3 minutes after each laboratory-based intervention

muscle sympathetic nerve activity was measured using microneurography and the change was calculated as the difference between the mean value during baseline and during the mean value during each of three laboratory-based interventions (cold pressor test, Stroop color word test, International Affective Picture System); a larger value indicates a greater increase in sympathetic activity

Outcome measures

Outcome measures
Measure	Non-depressed Healthy Adults (HA) n=42 Participants HA had no history or evidence of psychiatric illness and had no family history of MDD or major psychiatric illness. HA reported cumulative exposure, perceived severity, and emotional responsiveness to commonly occurring everyday psychosocial stressors utilizing an ecological momentary assessment approach for 8 consecutive days. Sympathetic nervous system activity and blood pressure were 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.	Adults With Major Depressive Disorder (MDD) n=39 Participants Adults with MDD had symptomatic depression that met diagnostic criteria and were not medicated. Adults with MDD reported cumulative exposure, perceived severity, and emotional responsiveness to commonly occurring everyday psychosocial stressors utilizing an ecological momentary assessment approach for 8 consecutive days. Sympathetic nervous system activity and blood pressure were 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.
Change in Muscle Sympathetic Nerve Activity in Response to Acute Stress (Compared to Resting Baseline Activity) cold pressor test	24.1 bursts per minute Standard Deviation 12.0	21.4 bursts per minute Standard Deviation 10.9
Change in Muscle Sympathetic Nerve Activity in Response to Acute Stress (Compared to Resting Baseline Activity) Stroop color word test	-2.3 bursts per minute Standard Deviation 6.9	-2.6 bursts per minute Standard Deviation 6.5
Change in Muscle Sympathetic Nerve Activity in Response to Acute Stress (Compared to Resting Baseline Activity) International Affective Picture System	0.8 bursts per minute Standard Deviation 3.7	2.3 bursts per minute Standard Deviation 4.8

Adverse Events

Non-depressed Healthy Adults (HA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adults With Major Depressive Disorder (MDD)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jody Greaney

The University of Texas at Arlington

Phone: 8172727891

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place