eIMPACT Trial: Modernized Collaborative Care to Reduce the Excess CVD Risk of Older Depressed Patients
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Depression, Depression, Peripheral Vascular Disease, Peripheral Vascular Disease, Major Depression Disorder (MDD), Cardiology, Neurology, Endocrine |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Neurology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 10/25/2017 |
| Start Date: | July 2015 |
| End Date: | March 2020 |
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.
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.
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.
Inclusion Criteria:
- Primary care patients
- Age ≥ 50 years
- Current depressive disorder
- Elevated CVD risk
Exclusion Criteria:
- History of clinical cardiovascular disease
- Presence of the following chronic disorders: HIV/AIDS, chronic kidney disease,
systemic inflammatory disease, or past-year cancer
- History of bipolar disorder or psychosis
- Continuous (e.g., daily) treatment for a systemic inflammatory condition (e.g.,
rheumatoid arthritis, lupus, Crohn's disease, and ulcerative colitis) in the past 3
months. Nonsteroidal anti-inflammatory drug (NSAID) use is allowed, given its high
prevalence in the target population.
- • Current use of anticoagulants (Aspirin and cholesterol and blood pressure
medications are allowed)
- Acute risk of suicide
- Severe cognitive impairment
- Current pregnancy
- Ongoing depression treatment with a psychiatrist outside of the Eskenazi
Health/Midtown system (ongoing depression treatment with a Eskenazi Health/Midtown
psychiatrist is allowed, as we will be able to collaborate and coordinate depression
care)
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