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Low-intensity Stepped Care for Internalizing Distress

NCT05441111 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2024-05-07

No results posted yet for this 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

Interventions

BEHAVIORAL

Common Elements Toolbox

COMET consists of the following modules: cognitive restructuring (labeled "flexible thinking"), behavioral activation (labeled "positive activities"), gratitude, and self-compassion. Participants complete these COMET modules by themselves. The format is reading psychoeducational along with completing specific activities

BEHAVIORAL

Doing What Matters in Times of Stress: An Illustrated Guide

From the WHO's website: Doing What Matters in Times of Stress: An Illustrated Guide is a stress management guide for coping with adversity. The guide aims to equip people with practical skills to help cope with stress. A few minutes each day are enough to practice the self-help techniques. The guide can be used alone or with the accompanying audio exercises. Informed by evidence and extensive field testing, the guide is for anyone who experiences stress, wherever they live and whatever their circumstances.

BEHAVIORAL

Guided self-help

Participants in the guided self-help condition are assigned an "eCoach" who provides emotional support as well as who promote adherence to the intervention

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-29
Primary Completion
2023-05-11
Completion
2023-09-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05441111 on ClinicalTrials.gov