Phase 2
Completed N=46
eIMPACT-DM Pilot Trial: Depression Treatment to Reduce Diabetes Risk
Source: ClinicalTrials.gov NCT04437485 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Hemoglobin A1c at 6 Months — 4.94; 4.88 % (percentage of total hemoglobin) — p=0.64
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c at 6 Months |
4.94; 4.88 | 0.64 |
| SECONDARY Homeostatic Model of Assessment-Insulin Resistance (HOMA-IR) Score at 6 Months |
3.48; 2.38 | 0.046 sig |
| SECONDARY Depressive Symptoms |
1.11; 1.58 | 0.09 |
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
Data sourced from ClinicalTrials.gov (NCT04437485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.