Status:
COMPLETED
eIMPACT-DM Pilot Trial: Depression Treatment to Reduce Diabetes Risk
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Depression
Major Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 hemog...
Detailed Description
Diabetes affects 31 million (12%) U.S. adults, and another 82 million (34%) adults have prediabetes, a precursor to diabetes. The ramifications of diabetes are grave and include cardiovascular disease...
Eligibility Criteria
Inclusion
- Current primary care patient in Eskenazi Health
- Age ≥18 years
- Depressive disorder at screening
- Prediabetes at screening
Exclusion
- 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
Key Trial Info
Start Date :
October 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2022
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04437485
Start Date
October 14 2020
End Date
August 29 2022
Last Update
November 2 2023
Active Locations (1)
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1
IUPUI Department of Psychology
Indianapolis, Indiana, United States, 46202