CompletedPhase 2

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

United States46 participantsStarted 2020-10-14

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Hemoglobin A1c at 6 Months

Timeframe: 6 months

Trial details

NCT IDNCT04437485

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-29

Results submitted2023-08-24

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