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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL122245 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The objective of this randomized controlled trial is to evaluate whether the investigators modernized IMPACT intervention for depression (eIMPACT), delivered before the onset of cardiovascular disease (CVD), reduces the risk of future CVD. Participants will be primary care patients who are depressed but do not have a history of CVD. Half of the participants will receive standard depression treatment in primary care (usual care), and the other half will receive one year of eIMPACT, a collaborative stepped care program including antidepressants and computerized and telephonic cognitive-behavioral therapy. To evaluate change in CVD risk, the investigators will measure artery function using ultrasound before and after the 1-year treatment period. It is hypothesized that patients who receive the eIMPACT intervention will have greater improvements in artery function than patients who receive usual care.
Cardiovascular disease (CVD) is the number one killer of American men and women, and its economic burden is substantial and on the rise. Adults with depression are at elevated risk of CVD events and poor CVD prognosis. Unfortunately, past trials of depression treatments have not observed the anticipated cardiovascular benefits. A novel explanation for these null results is that the interventions in these trials, which all involved patients with preexisting CVD, were delivered too late in the natural history of CVD. To begin to evaluate our hypothesis that treating depression before clinical CVD onset could reduce CVD risk, the investigators are conducting a phase II randomized controlled trial of 216 primary care patients aged ≥ 50 years with a depressive disorder and CVD risk factors but no clinical CVD. Patients will be randomized to one year of eIMPACT, our modernized IMPACT intervention, or usual primary care for depression. eIMPACT is a collaborative stepped care intervention involving a multidisciplinary team delivering evidenced-based depression treatments consistent with patient preference. The investigator shave modernized our intervention by incorporating computerized cognitive-behavioral therapy and delivering other treatment components via telephone. Our central hypothesis is that eIMPACT will improve endothelial dysfunction, which is considered a barometer of CVD risk, in depressed adults by decreasing depressive symptoms, autonomic dysfunction, systemic inflammation, and platelet activation. The investigators will test our central hypothesis by carrying out these specific aims: (1) to determine whether eIMPACT reduces the excess CVD risk of depressed patients (primary outcome: endothelial dysfunction; exploratory outcome: incident CVD events) and (2) to examine candidate mechanisms underlying the effect of eIMPACT on CVD risk (secondary outcomes: depressive symptoms, autonomic dysfunction, systemic inflammation, and platelet activation). A positive trial would generate the mechanistic rationale, efficacy evidence, and effect size estimates needed to justify and design a multisite, event-driven, phase III trial to confirm eIMPACT's efficacy in reducing CVD risk. Demonstrating that depression treatment reduces CVD risk, the primary expected outcome of this line of research, would have a substantial positive impact. It would identify a novel target (depression) for CVD prevention efforts, and it would equip providers with a new disseminable and scalable tool (eIMPACT) to simultaneously treat depression and manage the CVD risk of a large cohort of high-risk patients. Collectively, these changes to clinical practice should translate into reduced CVD morbidity, mortality, and costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eIMPACT | Experimental | eIMPACT is a 12-month, modernized, collaborative, stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for cardiovascular disease risk reduction. It is a collaborative care intervention in which a multidisciplinary team delivers established depression treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that modernizes the IMPACT intervention by harnessing technology to minimize staff and space requirements. Interventions are Beating the Blues, Problem Solving Treatment in Primary Care, and select FDA-approved antidepressants. The treatment team consists of a depression clinical specialist, a supervising MD with expertise in primary care and IMPACT, and the patients' primary care providers. |
|
| Usual Care | Active Comparator | Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beating the Blues (BtB) | Behavioral | BTB is a widely used, empirically supported, stand-alone CBT program for depression designed for primary care patients and appropriate for adults with little computer experience and a 5th-6th grade reading level. BtB utilizes an interactive, multimedia format to deliver eight 50-minute, weekly therapy sessions. Although sessions are tailored to each patient's problems, general topics include challenging dysfunctional thoughts, activity scheduling, problem solving, graded exposure, task breakdown, sleep management, and relapse prevention. Patients are also assigned tailored homeworks that are customized to their needs and reviewed at the start of each session. |
| Measure | Description | Time Frame |
|---|---|---|
| Brachial Artery Flow-Mediated Dilation (FMD) at 12 Months | Brachial FMD was measured per consensus guidelines using a GE LOGIQe high-resolution ultrasound with a 15-MHz vascular transducer. After a 10-minute supine rest period, a BP cuff was placed on the forearm and inflated to 250 mmHg for five minutes. Brachial diameter was measured at pre-inflation and 60- and 90-seconds post-deflation using AccessPoint 2011 software (version 8.2). FMD was computed the maximum % increase in brachial diameter at 60- or 90-seconds post-deflation. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptoms at 12 Months | Participants completed the reliable and valid Hopkins Symptom Checklist-20 (SCL-20) to assess depressive symptoms. Total scores (mean of items responses, range: 0-4) were computed, with higher scores indicating greater depressive symptoms. | 12 months |
| High-Frequency Heart Rate Variability (HF HRV) at 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesse C Stewart, Ph.D. | Indiana University-Purdue University Indianapolis (IUPUI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IUPUI Department of Psychology | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40930184 | Derived | Williams MK, Shell AL, Wu W, MacDonald KL, Callahan CM, Nurnberger JI Jr, Crawford CA, Schuiling MD, Stewart JC. Longer-term effects of modernized collaborative care for depression on multiple mental health factors (eIMPACT): A randomized controlled trial. J Affect Disord. 2026 Jan 1;392:120272. doi: 10.1016/j.jad.2025.120272. Epub 2025 Sep 8. | |
| 40822596 | Derived | Schuiling MD, Wu W, Polanka BM, Shell AL, Williams MK, Crawford CA, MacDonald KL, Nurnberger JI Jr, Callahan CM, Stewart JC. Effect of depression treatment on subjective sleep components among primary care patients: Data from the eIMPACT trial. J Mood Anxiety Disord. 2025 Jun 3;11:100132. doi: 10.1016/j.xjmad.2025.100132. eCollection 2025 Sep. |
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| ID | Title | Description |
|---|---|---|
| FG000 | eIMPACT | eIMPACT is a 12-month, modernized, collaborative, stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for cardiovascular disease risk reduction. It is a collaborative care intervention in which a multidisciplinary team delivers established depression treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that modernizes the IMPACT intervention by harnessing technology to minimize staff and space requirements. Interventions are Beating the Blues, Problem Solving Treatment in Primary Care, and select FDA-approved antidepressants. The treatment team consists of a depression clinical specialist, a supervising MD with expertise in primary care and IMPACT, and the patients' primary care providers. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2018 |
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|
|
| Problem Solving Treatment in Primary Care (PST-PC) | Behavioral | PST-PC is a manualized, empirically supported CBT developed for use by healthcare professionals in primary care. The focus of the 6-10 30-minute sessions is teaching patients approaches for solving current problems contributing to depression. We are delivering PST-PC via telephone. |
|
|
| Antidepressant Medications | Drug | The IMPACT treatment manual provides guidelines for using antidepressants, such as selecting a medication, titrating, switching to another medication, managing side effects, and avoiding drug interactions. To optimize eIMPACT for CVD risk reduction, we have restricted the IMPACT list of antidepressants to SSRIs (sertraline, escitalopram, paroxetine, fluoxetine, citalopram), duloxetine, bupropion, and mirtazapine. These medications are FDA approved for the treatment of depression and are the safest from a cardiovascular perspective. |
|
|
| Usual Care | Other | Patients randomized to usual primary care for depression are informed of their depression diagnosis, encouraged to follow-up with their Eskenazi Health primary care provider, and provided a list of local mental health services. The patient's primary care provider will receive a letter indicating that their patient has a depressive disorder and was randomized to usual care. This letter also provides a list of local mental health services. Like those in the intervention group, usual care patients continue to have access to services that are part of usual care in the targeted systems. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists. |
|
|
HF HRV estimates were derived by spectral analysis (bandwidth: 0.15-0.40 Hz) from 1-minute epochs of electrocardiographic data obtained during the last 5 min of the 10-minute supine rest period using MindWare Technologies HRV analysis software (version 3.1.2). Mean HF HRV was computed as the average of the five estimates. To control for respiration rate, participants completed a paced-breathing computer task set to 12 breaths/minute. |
| 12 months |
| Interleukin-6 (IL-6) at 12 Months | Fasting blood samples obtained by research nurses were collected in EDTA tubes and centrifuged within 20 min. Plasma aliquots were frozen at -80 °C until the time of assay at the Indiana University Center for Diabetes and Metabolic Diseases Translation Core. Using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions, we measured levels of IL-6. | 12 months |
| High-Sensitivity C-Reactive Protein (hsCRP) at 12 Months | Fasting blood samples obtained by research nurses were collected in EDTA tubes and centrifuged within 20 min. Plasma aliquots were frozen at -80 °C until the time of assay at the Indiana University Center for Diabetes and Metabolic Diseases Translation Core. Using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions, we measured levels of hsCRP. | 12 months |
| β-thromboglobulin at 12 Months | Fasting blood samples obtained by research nurses were collected in EDTA tubes and centrifuged within 20 min. Plasma aliquots were frozen at -80 °C until the time of assay at the Indiana University Center for Diabetes and Metabolic Diseases Translation Core. Using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions, we measured levels of β-thromboglobulin. | 12 months |
| Platelet Factor 4 (PF4) at 12 Months | Fasting blood samples obtained by research nurses were collected in EDTA tubes and centrifuged within 20 min. Plasma aliquots were frozen at -80 °C until the time of assay at the Indiana University Center for Diabetes and Metabolic Diseases Translation Core. Using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions, we measured levels of PF4. | 12 months |
| 39252547 | Derived | Schuiling MD, Shell AL, Callahan CM, Nurnberger JI Jr, MacDonald KL, Considine RV, Wu W, Hirsh AT, Crawford CA, Williams MK, Lipuma TC, Gupta SK, Kovacs RJ, Rollman BL, Stewart JC. Effect of depression treatment on health behaviors and cardiovascular risk factors in primary care patients with depression and elevated cardiovascular risk: data from the eIMPACT trial. Psychol Med. 2024 Sep;54(12):3303-3316. doi: 10.1017/S0033291724001429. Epub 2024 Sep 10. |
| 37931480 | Derived | Crawford CA, Williams MK, Shell AL, MacDonald KL, Considine RV, Wu W, Rand KL, Stewart JC. Effect of modernized collaborative care for depression on brain-derived neurotrophic factor (BDNF) and depressive symptom clusters: Data from the eIMPACT trial. Psychiatry Res. 2023 Dec;330:115581. doi: 10.1016/j.psychres.2023.115581. Epub 2023 Oct 30. |
| 37209779 | Derived | Stewart JC, Patel JS, Polanka BM, Gao S, Nurnberger JI, MacDonald KL, Gupta SK, Considine RV, Kovacs RJ, Vrany EA, Berntson J, Hsueh L, Shell AL, Rollman BL, Callahan CM. Effect of modernized collaborative care for depression on depressive symptoms and cardiovascular disease risk biomarkers: eIMPACT randomized controlled trial. Brain Behav Immun. 2023 Aug;112:18-28. doi: 10.1016/j.bbi.2023.05.007. Epub 2023 May 18. |
| 35917659 | Derived | Shell AL, Gonzenbach V, Sawhney M, Crawford CA, Stewart JC. Associations between affective factors and high-frequency heart rate variability in primary care patients with depression. J Psychosom Res. 2022 Oct;161:110992. doi: 10.1016/j.jpsychores.2022.110992. Epub 2022 Jul 22. |
| FG001 | Usual Care | Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | eIMPACT | eIMPACT is a 12-month, modernized, collaborative, stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for cardiovascular disease risk reduction. It is a collaborative care intervention in which a multidisciplinary team delivers established depression treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that modernizes the IMPACT intervention by harnessing technology to minimize staff and space requirements. Interventions are Beating the Blues, Problem Solving Treatment in Primary Care, and select FDA-approved antidepressants. The treatment team consists of a depression clinical specialist, a supervising MD with expertise in primary care and IMPACT, and the patients' primary care providers. |
| BG001 | Usual Care | Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
| ||||||||||||||||
| Brachial Artery Flow-Mediated Dilation | Brachial FMD was measured per consensus guidelines using a GE LOGIQe high-resolution ultrasound with a 15-MHz vascular transducer. After a 10-minute supine rest period, a BP cuff was placed on the forearm and inflated to 250 mmHg for five minutes. Brachial diameter was measured at pre-inflation and 60- and 90-seconds post-deflation using AccessPoint 2011 software (version 8.2). FMD was computed the maximum % increase in brachial diameter at 60- or 90-seconds post-deflation. | Mean | Standard Deviation | % increase in brachial diameter |
| ||||||||||||||
| Depressive Symptoms | Participants completed the reliable and valid Hopkins Symptom Checklist-20 (SCL-20) to assess depressive symptoms. Total scores (mean of items responses, range: 0-4) were computed, with higher scores indicating greater depressive symptoms. | Mean | Standard Deviation | Score on a scale |
| ||||||||||||||
| High-Frequency Heart Rate Variability (HF HRV) | HF HRV estimates were derived by spectral analysis (bandwidth: 0.15-0.40 Hz) from 1-minute epochs of electrocardiographic data obtained during the last 5 min of the 10-minute supine rest period using MindWare Technologies HRV analysis software (version 3.1.2). Mean HF HRV was computed as the average of the five estimates. To control for respiration rate, participants completed a paced-breathing computer task set to 12 breaths/minute. | Mean | Standard Deviation | ln of ms^2/Hz |
| ||||||||||||||
| Interleukin-6 (IL-6) | Fasting blood samples obtained by research nurses were collected in EDTA tubes and centrifuged within 20 min. Plasma aliquots were frozen at -80 °C until the time of assay at the Indiana University Center for Diabetes and Metabolic Diseases Translation Core. Using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions, we measured levels of IL-6. | Mean | Standard Deviation | log10 of pg/ml |
| ||||||||||||||
| High-Sensitivity C-Reactive Protein (hsCRP) | Fasting blood samples obtained by research nurses were collected in EDTA tubes and centrifuged within 20 min. Plasma aliquots were frozen at -80 °C until the time of assay at the Indiana University Center for Diabetes and Metabolic Diseases Translation Core. Using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions, we measured levels of hsCRP. | Mean | Standard Deviation | log10 of mg/l |
| ||||||||||||||
| β-thromboglobulin | Fasting blood samples obtained by research nurses were collected in EDTA tubes and centrifuged within 20 min. Plasma aliquots were frozen at -80 °C until the time of assay at the Indiana University Center for Diabetes and Metabolic Diseases Translation Core. Using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions, we measured levels of β-thromboglobulin. | Mean | Standard Deviation | ng/ml |
| ||||||||||||||
| Platelet Factor 4 (PF4) | Fasting blood samples obtained by research nurses were collected in EDTA tubes and centrifuged within 20 min. Plasma aliquots were frozen at -80 °C until the time of assay at the Indiana University Center for Diabetes and Metabolic Diseases Translation Core. Using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions, we measured levels of PF4. | Mean | Standard Deviation | ng/ml |
|
| 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 | Brachial Artery Flow-Mediated Dilation (FMD) at 12 Months | Brachial FMD was measured per consensus guidelines using a GE LOGIQe high-resolution ultrasound with a 15-MHz vascular transducer. After a 10-minute supine rest period, a BP cuff was placed on the forearm and inflated to 250 mmHg for five minutes. Brachial diameter was measured at pre-inflation and 60- and 90-seconds post-deflation using AccessPoint 2011 software (version 8.2). FMD was computed the maximum % increase in brachial diameter at 60- or 90-seconds post-deflation. | 195 of 216 randomized participants had post-treatment brachial FMD data. Because multiple imputation was employed, all 216 randomized participants were included in this analysis. | Posted | Mean | Standard Deviation | % increase in brachial diameter | 12 months |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Depressive Symptoms at 12 Months | Participants completed the reliable and valid Hopkins Symptom Checklist-20 (SCL-20) to assess depressive symptoms. Total scores (mean of items responses, range: 0-4) were computed, with higher scores indicating greater depressive symptoms. | 200 of 216 randomized participants had post-treatment SCL-20 data. Because multiple imputation was employed, all 216 randomized participants were included in this analysis. | Posted | Mean | Standard Deviation | Score on a scale | 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | High-Frequency Heart Rate Variability (HF HRV) at 12 Months | HF HRV estimates were derived by spectral analysis (bandwidth: 0.15-0.40 Hz) from 1-minute epochs of electrocardiographic data obtained during the last 5 min of the 10-minute supine rest period using MindWare Technologies HRV analysis software (version 3.1.2). Mean HF HRV was computed as the average of the five estimates. To control for respiration rate, participants completed a paced-breathing computer task set to 12 breaths/minute. | 190 of 216 randomized participants had post-treatment SCL-20 data. Because multiple imputation was employed, all 216 randomized participants were included in this analysis. | Posted | Mean | Standard Deviation | ln of ms^2/Hz | 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Interleukin-6 (IL-6) at 12 Months | Fasting blood samples obtained by research nurses were collected in EDTA tubes and centrifuged within 20 min. Plasma aliquots were frozen at -80 °C until the time of assay at the Indiana University Center for Diabetes and Metabolic Diseases Translation Core. Using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions, we measured levels of IL-6. | 195 of 216 randomized participants had post-treatment SCL-20 data. Because multiple imputation was employed, all 216 randomized participants were included in this analysis. | Posted | Mean | Standard Deviation | log10 of pg/ml | 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | High-Sensitivity C-Reactive Protein (hsCRP) at 12 Months | Fasting blood samples obtained by research nurses were collected in EDTA tubes and centrifuged within 20 min. Plasma aliquots were frozen at -80 °C until the time of assay at the Indiana University Center for Diabetes and Metabolic Diseases Translation Core. Using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions, we measured levels of hsCRP. | 196 of 216 randomized participants had post-treatment SCL-20 data. Because multiple imputation was employed, all 216 randomized participants were included in this analysis. | Posted | Mean | Standard Deviation | log10 of mg/l | 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | β-thromboglobulin at 12 Months | Fasting blood samples obtained by research nurses were collected in EDTA tubes and centrifuged within 20 min. Plasma aliquots were frozen at -80 °C until the time of assay at the Indiana University Center for Diabetes and Metabolic Diseases Translation Core. Using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions, we measured levels of β-thromboglobulin. | Posted | Mean | Standard Deviation | ng/ml | 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Platelet Factor 4 (PF4) at 12 Months | Fasting blood samples obtained by research nurses were collected in EDTA tubes and centrifuged within 20 min. Plasma aliquots were frozen at -80 °C until the time of assay at the Indiana University Center for Diabetes and Metabolic Diseases Translation Core. Using enzyme-linked immunosorbent assay kits according to the manufacturer's instructions, we measured levels of PF4. | 195 of 216 randomized participants had post-treatment SCL-20 data. Because multiple imputation was employed, all 216 randomized participants were included in this analysis. | Posted | Mean | Standard Deviation | ng/ml | 12 months |
|
For each participant, adverse event monitoring occurred from each participant's randomization date until 9/1/20 (the date of the last EHR for all randomized participants). Thus, the adverse event monitoring period varied across participants but averaged 3.5 years.
Potential adverse events are identified by conducting EHR searches every 6 months and by reviewing self-report adverse event questionnaires from mid-treatment, post-treatment, and the annual follow-up calls. We investigate, rate, and write up all events plausibly related to depression, depression treatment, suicidal ideation, or any study procedures. We adjudicate all deaths. For all other captured events, we provide counts and will investigate further if there is evidence of group imbalance.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | eIMPACT | eIMPACT is a 12-month, modernized, collaborative, stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for cardiovascular disease risk reduction. It is a collaborative care intervention in which a multidisciplinary team delivers established depression treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that modernizes the IMPACT intervention by harnessing technology to minimize staff and space requirements. Interventions are Beating the Blues, Problem Solving Treatment in Primary Care, and select FDA-approved antidepressants. The treatment team consists of a depression clinical specialist, a supervising MD with expertise in primary care and IMPACT, and the patients' primary care providers. | 5 | 107 | 5 | 107 | 3 | 107 |
| EG001 | Usual Care | Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists. | 8 | 109 | 4 | 109 | 1 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for depression/suicidal ideation | Psychiatric disorders | Systematic Assessment |
| ||
| Emergency department visit for depression/suicidal ideation | Psychiatric disorders | Systematic Assessment |
| ||
| Suspected drug overdose | Psychiatric disorders | Systematic Assessment |
| ||
| Diabetic ketoacidosis | Endocrine disorders | Systematic Assessment |
| ||
| Study procedures, including depression treatment | Psychiatric disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Passive suicidal ideation | Psychiatric disorders | Systematic Assessment |
| ||
| Diarrhea following study-initiated suicidal ideation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Petechiae on hand/wrist due to blood pressure cuff inflation during brachial FMD assessment | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jesse C. Stewart, PhD., Principal Investigator | Indiana University-Purdue University Indianapolis (IUPUI) | 317-274-6761 | jstew@iupui.edu |
| Aug 31, 2020 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 13, 2018 | Aug 31, 2020 | ICF_001.pdf |
| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| D019263 | Dysthymic Disorder |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D003324 | Coronary Artery Disease |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D011320 | Primary Health Care |
| D017367 | Selective Serotonin Reuptake Inhibitors |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D014179 | Neurotransmitter Uptake Inhibitors |
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018377 | Neurotransmitter Agents |
| D018490 | Serotonin Agents |
| D045505 | Physiological Effects of Drugs |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
| OG001 | Usual Care | Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists. |
|
|
|
| Usual Care |
Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists. |
|
|
|
| Usual Care |
Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists. |
|
|
|
|
|
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| Usual Care |
Patients and their primary care providers are informed of the depressive disorder diagnosis, and follow-up is encouraged. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists. |
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