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NCT05441111 · ClinicalTrials.gov registry record · Phase 2
Low-intensity Stepped Care for Internalizing Distress
A Phase 2 study of Depression and Anxiety, sponsored by Indiana University.
- Completed
- Registry status
- Phase 2
- Development phase
- 275
- Enrollment target
- 1
- Study location
NCT05441111: Completed Phase 2 study of Depression and Anxiety, sponsored by Indiana University.
NCT05441111 is a Phase 2 study of Depression and Anxiety that has completed, run by Indiana University. The registered enrollment target is 275 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05441111, a Phase 2 study of Depression and Anxiety, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 275 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to test the feasibility and efficacy of combining a single session intervention, COMET, with a self-help intervention, Doing what matters in times of stress. In step I, all individuals receive COMET. In Step II, all individuals receive Doing what matters in times of stress but are randomized 1:1 to guided (Doing what matters in times of stress with paraprofessional support) vs. unguided self-help (Doing what matters in times of stress with no support).
Primary Outcome
Changes in K6 from baseline to Week 6. The K6 is a measure of distress and the measure is scored on a scale of 0 - 24 where higher scores indicate higher distress (i.e., are negative). Thus, lower scores relative to baseline indicate more positive outcomes.
Conditions Studied
Interventions
- BEHAVIORAL Common Elements Toolbox
- BEHAVIORAL Doing What Matters in Times of Stress: An Illustrated Guide
- BEHAVIORAL Guided self-help
Study Locations (1)
Indiana
- Indiana University - Bloomington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2022-06-29 |
| Est. Completion | 2023-09-22 |
| Phase | Phase 2 |
What the finished NCT05441111 record still lists
NCT05441111 is an interventional study that assigns participants to a tested intervention. The registered 275 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (65% lower).
The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 3 interventions - of which Common Elements Toolbox is the first listed.
NCT05441111 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT05441111 about?
NCT05441111 is a clinical study titled "Low-intensity Stepped Care for Internalizing Distress". The purpose of this study is to test the feasibility and efficacy of combining a single session intervention, COMET, with a self-help intervention, Doing what matters in times of stress. In step I, all individuals receive COMET. In Step II, all individuals receive Doing what matters in times of stre...
What is the current status of trial NCT05441111?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 275 participants. The study started on 2022-06-29. Estimated completion is 2023-09-22.
What conditions does trial NCT05441111 study?
This clinical trial studies the following conditions: Depression, Anxiety, Emotion Regulation.
What interventions are being tested in trial NCT05441111?
The interventions under investigation include: Common Elements Toolbox (BEHAVIORAL), Doing What Matters in Times of Stress: An Illustrated Guide (BEHAVIORAL), Guided self-help (BEHAVIORAL).
Who is sponsoring clinical trial NCT05441111?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05441111 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05441111's enrollment target sits among peer trials
275 164th of 679 higher than 516 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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