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NCT04437485 · ClinicalTrials.gov registry record · Phase 2
eIMPACT-DM Pilot Trial: Depression Treatment to Reduce Diabetes Risk
A Phase 2 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT04437485 is a Phase 2 study that has completed, run by Indiana University. The registered enrollment target is 46 participants.
The verdict
NCT04437485, a Phase 2 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study 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.
Interventions
- OTHER Active Control
- BEHAVIORAL Problem Solving Treatment in Primary Care (PST-PC)
- DRUG Antidepressant Medications
- BEHAVIORAL Good Days Ahead (GDA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2020-10-14 |
| Est. Completion | 2022-08-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04437485
The ClinicalTrials.gov registry entry for NCT04437485 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Active Control is the first listed.
NCT04437485 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04437485 about?
NCT04437485 is a clinical study titled "eIMPACT-DM Pilot Trial: Depression Treatment to Reduce Diabetes Risk". 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., hype...
What is the current status of trial NCT04437485?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2020-10-14. Estimated completion is 2022-08-29.
What interventions are being tested in trial NCT04437485?
The interventions under investigation include: Active Control (OTHER), Problem Solving Treatment in Primary Care (PST-PC) (BEHAVIORAL), Antidepressant Medications (DRUG), Good Days Ahead (GDA) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04437485?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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