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

Enrolling by invitation

Phase 2 Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • Usual care Other
    Intervention Desc: Patients randomized to usual primary care for depression are informed of their depression diagnosis, encouraged to follow-up with their 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.
    ARM 1: Kind: Experimental
    Label: Usual Care
    Description: Patients and their primary care providers are informed of the positive depression screen, and follow-up is encouraged.
  • Beating the Blues (BtB) Behavioral
    Other Names: Cognitive-Behavioral Therapy (CBT); Computer-Based Psychotherapy
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: eIMPACT
    Description: eIMPACT is a collaborative stepped care intervention involving a multidisciplinary team delivering evidenced-based treatments consistent with patient preference. Intervention approaches include antidepressant medications, a computerized cognitive-behavioral therapy called Beating the Blues (BtB), and telephonic cognitive-behavioral therapy called Problem Solving Treatment in Primary Care (PST-PC).
  • Problem Solving Treatment in Primary Care (PST-PC) Behavioral
    Other Names: Cognitive-Behavioral Therapy (CBT); Telephonic Psychotherapy
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: eIMPACT
    Description: eIMPACT is a collaborative stepped care intervention involving a multidisciplinary team delivering evidenced-based treatments consistent with patient preference. Intervention approaches include antidepressant medications, a computerized cognitive-behavioral therapy called Beating the Blues (BtB), and telephonic cognitive-behavioral therapy called Problem Solving Treatment in Primary Care (PST-PC).
  • Antidepressant Medications Drug
    Other Names: Selective Serotonin Reuptake Inhibitors (SSRIs); Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs)
    Intervention Desc: 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. The depression clinical specialist (DCS) will work with the patient's primary care provider to develop a plan that follows the IMPACT algorithm. Primary care providers will manage prescriptions. To optimize eIMPACT for CVD risk reduction, we will restrict the list of antidepressants to SSRIs (except paroxetine) and serotonin-norepinephrine reuptake inhibitors (SNRIs).
    ARM 1: Kind: Experimental
    Label: eIMPACT
    Description: eIMPACT is a collaborative stepped care intervention involving a multidisciplinary team delivering evidenced-based treatments consistent with patient preference. Intervention approaches include antidepressant medications, a computerized cognitive-behavioral therapy called Beating the Blues (BtB), and telephonic cognitive-behavioral therapy called Problem Solving Treatment in Primary Care (PST-PC).

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in Brachial Flow-Mediated Dilation (FMD) at 12-months 0 and 12 months No

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