eIMPACT-DM Pilot Trial: Depression Treatment to Reduce Diabetes Risk

NCT04437485 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 1908716624R21DK123582
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot randomized controlled trial seeks: (1) to determine the preliminary efficacy of our modernized collaborative care intervention for depression in improving the diabetes risk markers of hemoglobin A1c and insulin resistance and (2) to explore whether somatic depressive symptoms - i.e., hyperphagia (increased appetite/weight) and/or hypersomnia (increased sleep) - moderate the effect of the eIMPACT-DM intervention on diabetes risk markers.

Conditions

Depression; Major Depressive Disorder; Dysthymic Disorder; Depressive Symptoms; Type 2 Diabetes; PreDiabetes; Insulin Resistance

Keywords

Primary Care; Cognitive-Behavioral Therapy; Computer-Based Psychotherapy; Antidepressant Medications

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c at 6 Months

  Fasting blood samples were collected, and whole blood and plasma aliquots were frozen. Hemoglobin A1c will be measured by a standard method. 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. Higher hemoglobin A1c values indicate greater diabetes risk.

  6 months

Secondary Outcomes (2)

• Homeostatic Model of Assessment-Insulin Resistance (HOMA-IR) Score at 6 Months

  6 months

• Depressive Symptoms

  6 months

Study Arms (2)

eIMPACT-DM intervention

EXPERIMENTAL

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); Behavioral: Problem Solving Treatment in Primary Care (PST-PC); Drug: Antidepressant Medications

Active Control

ACTIVE COMPARATOR

Active Control (AC) consists of depression education (study staff), symptom monitoring (study staff), and primary care for depression (clinical staff).

Other: Active Control

Interventions

Good Days Ahead (GDA) BEHAVIORAL

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).

Also known as: Cognitive-Behavioral Therapy (CBT), Internet Psychotherapy

eIMPACT-DM intervention

Problem Solving Treatment in Primary Care (PST-PC) BEHAVIORAL

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.

Also known as: Cognitive-Behavioral Therapy (CBT), Telephonic Psychotherapy

eIMPACT-DM intervention

Antidepressant Medications DRUG

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.

Also known as: Bupropion, Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs)

eIMPACT-DM intervention

Active Control OTHER

(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.

Active Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current primary care patient in Eskenazi Health
• Age ≥18 years
• Depressive disorder at screening
• Prediabetes at screening

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

IUPUI Department of Psychology

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Dysthymic Disorder; Diabetes Mellitus, Type 2; Prediabetic State; Insulin Resistance

Interventions

Cognitive Behavioral Therapy; Primary Health Care; Bupropion; Selective Serotonin Reuptake Inhibitors; Serotonin and Noradrenaline Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Comprehensive Health Care; Patient Care Management; Health Services Administration; Propiophenones; Ketones; Organic Chemicals; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Results Point of Contact

• Title: Jesse C. Stewart, PhD., Principal Investigator
• Organization: Indiana University-Purdue University Indianapolis (IUPUI)

jstew@iupui.edu

317-274-6761

Study Officials

• Jesse C Stewart, PhD

  Indiana University-Purdue University Indianapolis (IUPUI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 18, 2020
• Study Start: October 14, 2020
• Primary Completion: August 29, 2022
• Study Completion: August 29, 2022
• Last Updated: November 2, 2023
• Results First Posted: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)