eIMPACT-DM Pilot Trial: Depression Treatment to Reduce Diabetes Risk
Condition: Depression; Major Depressive Disorder; Dysthymic Disorder; Depressive Symptoms; Type 2 Diabetes; PreDiabetes; Insulin Resistance
MeSH terms: Diabetes Mellitus; Insulin Resistance; Prediabetic State; Glucose Intolerance; Depression; Depressive Disorder; Depressive Disorder, Major; Dysthymic Disorder
Intervention: Good Days Ahead (GDA); Problem Solving Treatment in Primary Care (PST-PC); Antidepressant Medications; Active Control
Intervention description: 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).; 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.; 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.; (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.
Intervention MeSH terms: Norepinephrine; Bupropion; Antidepressive Agents; Serotonin; Selective Serotonin Reuptake Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary Care; Cognitive-Behavioral Therapy; Computer-Based Psychotherapy; Antidepressant Medications

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current primary care patient in Eskenazi Health

          -  Age ≥18 years

          -  Depressive disorder at screening

          -  Prediabetes at screening

        Exclusion Criteria:

          -  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