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Completed Phase 2 Interventional

Low-intensity Stepped Care for Internalizing Distress

ClinicalTrials.gov ID: NCT05441111

Public ClinicalTrials.gov record NCT05441111. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 6:33 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Combining Guided Self-help Approaches for Common Mental Disorders

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT05441111
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Indiana University
Other
Enrollment
275 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 28, 2022
Primary completion
May 10, 2023
Completion
Sep 21, 2023
Last update posted
May 6, 2024

2022 – 2023

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Indiana University Bloomington Indiana 47408

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05441111, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 6, 2024 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05441111 live on ClinicalTrials.gov.

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