Low-intensity Stepped Care for Internalizing Distress

Completed · Phase 2

Conditions studied: Depression, Anxiety, Emotion Regulation

In brief

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).

Key facts

Study ID

NCT05441111

Run by

Indiana University

People needed

275

Starts

2022-06-29

Expected to finish

2023-09-22

Last updated by the study team

2024-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least mild distress: K6 score ≥ 6
• Having reasonably regular access to the internet or a telephone

You may not qualify if…

• Suicidality: on the Patient Health Questionnaire 9 (PHQ9) item 9 ("thoughts that you would be better off dead, or of hurting yourself ") ≥ 2 ("more than half the days")

Where it is running

• Indiana University — Bloomington, Indiana, United States

Full record on ClinicalTrials.gov

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