eIMPACT Trial: Modernized Collaborative Care to Reduce the Excess CVD Risk of Older Depressed Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02458690|
Recruitment Status : Active, not recruiting
First Posted : June 1, 2015
Last Update Posted : April 9, 2019
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
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.
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).
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)
- 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.
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
|United States, Indiana|
|IUPUI Department of Psychology|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Jesse C Stewart, Ph.D.||Indiana University-Purdue University Indianapolis (IUPUI)|