eIMPACT Trial: Modernized Collaborative Care to Reduce the Excess CVD Risk of Older Depressed Patients
Condition: Depression; Major Depressive Disorder; Dysthymic Disorder; Depressive Symptoms; Cardiovascular Diseases; Heart Diseases; Coronary Artery Disease; Stroke
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Heart Diseases; Depression; Depressive Disorder; Depressive Disorder, Major; Dysthymic Disorder
Intervention: Beating the Blues (BtB); Problem Solving Treatment in Primary Care (PST-PC); Antidepressant Medications; Usual Care
Intervention description: 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.; 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.; 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.; 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.
Intervention MeSH terms: Dopamine; Norepinephrine; Antidepressive Agents; Serotonin; Selective Serotonin Reuptake Inhibitors; Dopamine Uptake Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 216.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Primary Care; Older Adults; Computerized and Telephonic Psychotherapy; Cognitive-Behavioral Therapy; Antidepressant Medications

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.
    

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)