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| Name | Class |
|---|---|
| Penn State University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assessment of Daily Stress Processes | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acute Stressors | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Days Participants Report Stressors | 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 | 8 days before intervention |
| Negative Affective Reactivity to Daily Stressors | 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. | 8 days before intervention |
| Change in Muscle Sympathetic Nerve Activity in Response to Acute Stress (Compared to Resting Baseline Activity) | 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 | 3 minutes after each laboratory-based intervention |
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Inclusion Criteria:
Exclusion Criteria:
Subjects will be excluded at the discretion of the PI/collaborating clinician or for any of the following reasons:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas at Arlington | Arlington | Texas | 76010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38897296 | Derived | Darling AM, Young BE, Skow RJ, Dominguez CM, Saunders EFH, Fadel PJ, Greaney JL. Sympathetic and blood pressure reactivity in young adults with major depressive disorder. J Affect Disord. 2024 Sep 15;361:322-332. doi: 10.1016/j.jad.2024.06.053. Epub 2024 Jun 17. |
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Per the data sharing policy of the National Institute of Mental Health (NIMH), we will deposit all phenotypic, psychosocial stress, and sympathetic reactivity data from this study to the NIMH Data Archive. We will use standard data dictionaries (NIH Toolbox Cognition Battery, NIH Toolbox Emotion Battery, Patient Health Questionnaire (PHQ)-9) and will collect the data necessary to generate global unique identifiers for each study subject.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Days Participants Report Stressors | 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 | 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. | Posted | Mean | Standard Deviation | percent of days | 8 days before intervention |
|
8 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jody Greaney | The University of Texas at Arlington | 8172727891 | jody.greaney@uta.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 23, 2023 | Feb 27, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 23, 2021 | Feb 27, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 16, 2022 | May 9, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Patient Health Questionnaire (PHQ)-9 | Patient Health Questionnaire-9 (PHQ-9) severity measure for depression. Total score reported on possible range of 0 to 27. The minimal score of 0 indicates the absence of depressive symptoms. The maximal score of 27 indicates the presence of the most severe depressive symptoms. | Mean | Standard Deviation | arbitrary units |
|
| OG001 | 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. |
|
|
| Primary | Negative Affective Reactivity to Daily Stressors | 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. | 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. | Posted | Mean | Standard Deviation | AU stressor days/AU non-stressor days | 8 days before intervention |
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|
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| Primary | Change in Muscle Sympathetic Nerve Activity in Response to Acute Stress (Compared to Resting Baseline Activity) | 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 | 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. | Posted | Mean | Standard Deviation | bursts per minute | 3 minutes after each laboratory-based intervention |
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| 0 |
| 51 |
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | 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. | 0 | 43 | 0 | 43 | 0 | 43 |
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| International Affective Picture System |
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| Other |