eIMPACT-DM Pilot Trial: Depression Treatment to Reduce Diabetes Risk
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|ClinicalTrials.gov Identifier: NCT04437485|
Recruitment Status : Completed
First Posted : June 18, 2020
Last Update Posted : March 16, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Depression Major Depressive Disorder Dysthymic Disorder Depressive Symptoms Type 2 Diabetes PreDiabetes Insulin Resistance||Behavioral: Good Days Ahead (GDA) Behavioral: Problem Solving Treatment in Primary Care (PST-PC) Drug: Antidepressant Medications Other: Active Control||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||eIMPACT-DM Pilot Trial: Depression Treatment to Reduce the Excess Diabetes Risk of People With Depression and Prediabetes|
|Actual Study Start Date :||October 14, 2020|
|Actual Primary Completion Date :||August 29, 2022|
|Actual Study Completion Date :||August 29, 2022|
Experimental: eIMPACT-DM intervention
eIMPACT-DM is a 6-month, modernized, collaborative, stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for diabetes risk reduction. It is a collaborative care intervention in which a multidisciplinary team delivers established depression treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that modernizes the IMPACT intervention by harnessing technology to minimize staff and space requirements. Interventions are Good Days Ahead, Problem Solving Treatment in Primary Care, and select FDA-approved antidepressants. The treatment team consists of a depression clinical specialist, a supervising MD with expertise in primary care and IMPACT, and the patients' primary care providers (PCPs).
Behavioral: Good Days Ahead (GDA)
GDA (Empower Interactive) is an empirically supported, HIPAA compliant, computerized CBT for depression appropriate for primary care patients and people with little computer experience. GDA uses an interactive, multimedia format to deliver 9 45-minute sessions, the structure and content of which mirror face-to-face CBT. General topics include identifying and modifying automatic thoughts, using behavioral activation and other behavioral methods, identifying and modifying schemas, using effective coping strategies, and employing other core CBT methods. GDA is empirically supported - it is acceptable to patients, achieves superior depression outcomes to waitlist comparators, and yields equivalent (noninferior) depression outcomes to standard face-to-face CBT. To minimize time/transportation barriers, GDA sessions occur at the PI's lab or a location with internet access selected by the patient (patient's, family member's, or friend's home).
Behavioral: Problem Solving Treatment in Primary Care (PST-PC)
PST-PC is an established, manualized, empirically supported CBT developed for primary care. During the 6-10 30-minute sessions, patients are taught skills for solving problems contributing to depression. We will deliver PST-PC by phone, which has been found to be feasible and efficacious.
Drug: Antidepressant Medications
We first considered all FDA-approved antidepressants and excluded those with weight gain effects (tricyclics, paroxetine, mirtazapine) and those rarely used in primary care (MAOIs). Then, we used existing evidence to inform the structure. We made bupropion (an aminoketone) and fluoxetine (an SSRI) our first-line and second-line antidepressants, as meta-analyses indicate that their use is associated with weight loss. We made other SSRIs (escitalopram, sertraline) and SNRIs (desvenlafaxine, duloxetine, venlafaxine) our third-line antidepressants, given their negligible effects on weight. Our team will make recommendations to the patient's PCP, who will write prescriptions. Our team and the PCP will then collaboratively manage pharmacotherapy.
Active Comparator: Active Control
Active Control (AC) consists of depression education (study staff), symptom monitoring (study staff), and primary care for depression (clinical staff).
Other: Active Control
(1) The graduate research assistant (RA) will have a 50-minute call with AC patients to review depression materials. The RA will provide a list of Eskenazi Health mental health services and will encourage patients to follow-up with their PCP. We will then send an electronic health record message to the PCP encouraging them to address their patient's depression, note that there are no care restrictions, and provide the same list of services. (2) The RA will call AC patients every 4 weeks to assess depressive symptoms and will notify clinical staff to encourage additional care when indicated. (3) AC patients will receive current primary care for depression. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
- Change in Hemoglobin A1c at 6 months [ Time Frame: Baseline and 6 months ]Fasting blood samples will be collected, and whole blood and plasma aliquots will be frozen. A1c will be measured by an immunoturbidimetric method on a Randox Daytona Clinical Analyzer.A1c is the primary outcome because: (1) it is the gold standard measure of glycemia and a common surrogate endpoint, (2) it strongly predicts future diabetes, (3) interventions decreasing A1c improve clinical diabetes endpoints, and (4) diabetes prevention interventions targeting glycemic control result in lower rates of progression from prediabetes to type 2 diabetes. Thus, A1c is well suited to evaluate if a new intervention approach holds promise.
- Change in Homeostatic Model of Assessment (HOMA) score at 6 months [ Time Frame: Baseline and 6 months ]Fasting blood samples will be collected, and whole blood and plasma aliquots will be frozen. HOMA scores will be derived from fasting glucose (glucose oxidase method on a Randox Daytona Clinical Analyzer) and insulin (two antibody immunoassay on a Roche cobas e411 Analyzer). HOMA score is an established index of insulin resistance that correlates highly with the more invasive euglycemic clamp and is appropriate for assessing change.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Current primary care patient in Eskenazi Health
- Age ≥18 years
- Depressive disorder at screening
- Prediabetes at screening
- History of type 1 or type 2 diabetes
- Major inflammatory conditions: HIV/AIDS, chronic kidney disease, systemic inflammatory disease (e.g., rheumatoid arthritis, lupus, Crohn's disease, and ulcerative colitis), or active cancer/current cancer treatment
- Current pregnancy
- Severe cognitive impairment
- Acute risk of suicide
- History of bipolar disorder or psychosis or current use of an atypical antipsychotic medication:
- Participation in our prior eIMPACT Trial
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): NCT04437485
|United States, Indiana|
|IUPUI Department of Psychology|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Jesse C Stewart, PhD||Indiana University-Purdue University Indianapolis (IUPUI)|
|Responsible Party:||Jesse Stewart, Professor of Psychology, Indiana University|
|Other Study ID Numbers:||
R21DK123582 ( U.S. NIH Grant/Contract )
|First Posted:||June 18, 2020 Key Record Dates|
|Last Update Posted:||March 16, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Depressive Disorder, Major
Glucose Metabolism Disorders
Endocrine System Diseases
Selective Serotonin Reuptake Inhibitors
Antidepressive Agents, Second-Generation
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action