CompletedPhase 2

Low-intensity Stepped Care for Internalizing Distress

United States275 participantsStarted 2022-06-29

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * At least mild distress: K6 score ≥ 6 * Having reasonably regular access to the internet or a telephone Exclusion Criteria: * 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")

What they're measuring

6-week change in Kessler 6 Psychological Distress Scale (K6)

Timeframe: 6 weeks

6-week change in the WHO 5 Well-being Index (WHO-5)

Timeframe: 6 weeks

Trial details

NCT IDNCT05441111

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-11

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