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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 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.

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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).

Conditions Studied

Depression Anxiety Emotion Regulation

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

FieldValue
Enrollment Target 275 participants
Start Date 2022-06-29
Est. Completion 2023-09-22
Phase Phase 2

Sponsor

Indiana University

890 total trials

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What the Registry Record Tells You About NCT05441111

The ClinicalTrials.gov registry entry for NCT05441111 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 275 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (65% lower). The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.