Stress and the Sympathetic Nervous System in Adults With Depression
NCT04838262, Not applicable, Completed, University of Delaware; results first posted 2025-01-13
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Stress and the Sympathetic Nervous System in Adults With Depression | ClinicalTrials.gov |
| NCT number | NCT04838262 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 94 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Delaware | ClinicalTrials.gov |
| Conditions | Major Depressive Disorder | ClinicalTrials.gov |
| Interventions | Acute Stressors | ClinicalTrials.gov |
| First posted | 2021-04-09 | ClinicalTrials.gov |
| Last updated | 2025-01-13 | ClinicalTrials.gov |
| Results first posted | 2025-01-13 | ClinicalTrials.gov |
Registered outcomes 3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Percent of Days Participants Report Stressors | 8 days before intervention | 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 | ClinicalTrials.gov |
| Primary | Negative Affective Reactivity to Daily Stressors | 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. | ClinicalTrials.gov |
| Primary | Change in Muscle Sympathetic Nerve Activity in Response to Acute Stress (Compared to Resting Baseline Activity) | 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 | ClinicalTrials.gov |
Outcomes 3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Percent of Days Participants Report Stressors | 8 days before intervention | 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. | percent of days | MEAN | ClinicalTrials.gov |
| PRIMARY | Negative Affective Reactivity to Daily Stressors | 8 days before intervention | 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. | AU stressor days/AU non-stressor days | MEAN | ClinicalTrials.gov |
| PRIMARY | Change in Muscle Sympathetic Nerve Activity in Response to Acute Stress (Compared to Resting Baseline Activity) | 3 minutes after each laboratory-based intervention | 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. | bursts per minute | MEAN | ClinicalTrials.gov |
Results by group 10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Percent of Days Participants Report Stressors | Non-depressed Healthy Adults (HA) | 36 | Standard Deviation 26 | percent of days | ClinicalTrials.gov | |
| Percent of Days Participants Report Stressors | Adults With Major Depressive Disorder (MDD) | 40 | Standard Deviation 24 | percent of days | ClinicalTrials.gov | |
| Negative Affective Reactivity to Daily Stressors | Non-depressed Healthy Adults (HA) | 0.24 | Standard Deviation 0.08 | AU stressor days/AU non-stressor days | ClinicalTrials.gov | |
| Negative Affective Reactivity to Daily Stressors | Adults With Major Depressive Disorder (MDD) | 0.31 | Standard Deviation 0.10 | AU stressor days/AU non-stressor days | ClinicalTrials.gov | |
| Change in Muscle Sympathetic Nerve Activity in Response to Acute Stress (Compared to Resting Baseline Activity) | Non-depressed Healthy Adults (HA) | cold pressor test | 24.1 | Standard Deviation 12.0 | bursts per minute | ClinicalTrials.gov |
| Change in Muscle Sympathetic Nerve Activity in Response to Acute Stress (Compared to Resting Baseline Activity) | Adults With Major Depressive Disorder (MDD) | cold pressor test | 21.4 | Standard Deviation 10.9 | bursts per minute | ClinicalTrials.gov |
| Change in Muscle Sympathetic Nerve Activity in Response to Acute Stress (Compared to Resting Baseline Activity) | Non-depressed Healthy Adults (HA) | Stroop color word test | -2.3 | Standard Deviation 6.9 | bursts per minute | ClinicalTrials.gov |
| Change in Muscle Sympathetic Nerve Activity in Response to Acute Stress (Compared to Resting Baseline Activity) | Adults With Major Depressive Disorder (MDD) | Stroop color word test | -2.6 | Standard Deviation 6.5 | bursts per minute | ClinicalTrials.gov |
| Change in Muscle Sympathetic Nerve Activity in Response to Acute Stress (Compared to Resting Baseline Activity) | Non-depressed Healthy Adults (HA) | International Affective Picture System | 0.8 | Standard Deviation 3.7 | bursts per minute | ClinicalTrials.gov |
| Change in Muscle Sympathetic Nerve Activity in Response to Acute Stress (Compared to Resting Baseline Activity) | Adults With Major Depressive Disorder (MDD) | International Affective Picture System | 2.3 | Standard Deviation 4.8 | bursts per minute | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Non-depressed Healthy Adults (HA) | 51 | ClinicalTrials.gov | |
| Overall Study | STARTED | Adults With Major Depressive Disorder (MDD) | 43 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Non-depressed Healthy Adults (HA) | 42 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Adults With Major Depressive Disorder (MDD) | 39 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Non-depressed Healthy Adults (HA) | 9 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Adults With Major Depressive Disorder (MDD) | 4 | ClinicalTrials.gov |
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Non-depressed Healthy Adults (HA) | 0 | 51 | ClinicalTrials.gov |
| Total, all-cause mortality | Adults With Major Depressive Disorder (MDD) | 0 | 43 | ClinicalTrials.gov |
| Total, other adverse events | Non-depressed Healthy Adults (HA) | 0 | 51 | ClinicalTrials.gov |
| Total, other adverse events | Adults With Major Depressive Disorder (MDD) | 0 | 43 | ClinicalTrials.gov |
| Total, serious adverse events | Non-depressed Healthy Adults (HA) | 0 | 51 | ClinicalTrials.gov |
| Total, serious adverse events | Adults With Major Depressive Disorder (MDD) | 0 | 43 | ClinicalTrials.gov |
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 38897296 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Non-depressed Healthy Adults (HA) vs Adults With Major Depressive Disorder (MDD): deaths from any cause | Trial comparisons |
| Non-depressed Healthy Adults (HA) vs Adults With Major Depressive Disorder (MDD): serious adverse events | Trial comparisons |
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)