Phase 2 Completed N=216 Randomized Single-blind Prevention

eIMPACT Trial: Modernized Collaborative Care to Reduce the Excess CVD Risk of Older Depressed Patients

Depression · Major Depressive Disorder · Dysthymic Disorder · Depressive Symptoms

Source: ClinicalTrials.gov NCT02458690 ↗

Enrolled (actual)

216

Serious AEs

4.2%

Results posted

Oct 2020

Primary outcomePrimary: Brachial Artery Flow-Mediated Dilation (FMD) at 12 Months — 2.28; 2.44 % increase in brachial diameter — p=0.60

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Brachial Artery Flow-Mediated Dilation (FMD) at 12 Months	2.28; 2.44	0.60
SECONDARY Depressive Symptoms at 12 Months	1.12; 1.65	<0.01 sig
SECONDARY High-Frequency Heart Rate Variability (HF HRV) at 12 Months	5.39; 5.35	0.81
SECONDARY Interleukin-6 (IL-6) at 12 Months	0.73; 0.77	0.20
SECONDARY High-Sensitivity C-Reactive Protein (hsCRP) at 12 Months	0.65; 0.74	0.09
SECONDARY β-thromboglobulin at 12 Months	185; 205	0.23
SECONDARY Platelet Factor 4 (PF4) at 12 Months	3842; 4351	0.09

Eligibility Criteria

Inclusion Criteria

Primary care patients
Age ≥ 50 years
Current depressive disorder
Elevated cardiovascular disease 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02458690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.