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

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ClinicalTrials.gov Identifier: NCT02458690
Recruitment Status : Active, not recruiting
First Posted : June 1, 2015
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jesse Stewart, Indiana University

Brief 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.

Condition or disease Intervention/treatment Phase
Depression Major Depressive Disorder Dysthymic Disorder Depressive Symptoms Cardiovascular Diseases Heart Diseases Coronary Artery Disease Stroke Behavioral: Beating the Blues (BtB) Behavioral: Problem Solving Treatment in Primary Care (PST-PC) Drug: Antidepressant Medications Other: Usual Care Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: eIMPACT Trial: Modernized Collaborative Care to Reduce the Excess CVD Risk of Older Depressed Patients
Actual Study Start Date : July 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: eIMPACT
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).
Behavioral: Beating the Blues (BtB)
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.
Other Names:
  • Cognitive-Behavioral Therapy (CBT)
  • Computer-Based Psychotherapy

Behavioral: Problem Solving Treatment in Primary Care (PST-PC)
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.
Other Names:
  • Cognitive-Behavioral Therapy (CBT)
  • Telephonic Psychotherapy

Drug: Antidepressant Medications
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).
Other Names:
  • Selective Serotonin Reuptake Inhibitors (SSRIs)
  • Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs)

Active Comparator: Usual Care
Patients and their primary care providers are informed of the positive depression screen, and follow-up is encouraged.
Other: Usual Care
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.
Other Name: Treatment As Usual (TAU)




Primary Outcome Measures :
  1. Change in Brachial Flow-Mediated Dilation (FMD) at 12-months [ Time Frame: 0 and 12 months ]
    Patients undergo ultrasound assessment of brachial FMD in accordance with established guidelines. After a 10-minute supine rest, high-resolution baseline images of the brachial artery will be obtained from 3 consecutive cardiac cycles. Next, the forearm cuff will be inflated to 250 mmHg for 5 minutes and then will be rapidly deflated. At 60 and 90 seconds post-deflation, images from 3 consecutive cardiac cycles will be acquired. FMD values will be computed as the % increase in brachial diameter at either 60 or 90 seconds after cuff deflation.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02458690


Locations
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United States, Indiana
IUPUI Department of Psychology
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Jesse C Stewart, Ph.D. Indiana University-Purdue University Indianapolis (IUPUI)

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Responsible Party: Jesse Stewart, Associate Professor of Psychology, Indiana University
ClinicalTrials.gov Identifier: NCT02458690    
Other Study ID Numbers: 1411802537
R01HL122245 ( U.S. NIH Grant/Contract )
First Posted: June 1, 2015    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Keywords provided by Jesse Stewart, Indiana University:
Primary Care
Older Adults
Antidepressant Medications
Cognitive-Behavioral Therapy
Computer-Based Psychotherapy
Additional relevant MeSH terms:
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Coronary Artery Disease
Heart Diseases
Disease
Depression
Depressive Disorder
Depressive Disorder, Major
Dysthymic Disorder
Cardiovascular Diseases
Pathologic Processes
Behavioral Symptoms
Coronary Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Mood Disorders
Mental Disorders
Norepinephrine
Antidepressive Agents
Serotonin
Serotonin Uptake Inhibitors
Psychotropic Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents