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

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.

Timeline

Start

2015-07

Primary completion

2019-08

Completion

2021-03

Outcome

Missed primary endpoint

registry analysis (superiority test); eIMPACT vs Usual Care; p = 0.60; ANCOVA NCT02458690 ↗

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications