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Stepped Care for Depression and Anxiety (COMET-DWM Trial)

Phase 2
Waitlist Available
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

COMET-DWM Trial Summary

This trial is testing an intervention to help people during times of stress. The intervention is a combination of two components: COMET and Doing what matters in times of stress. In the first step, all individuals receive COMET. In the second step, all individuals receive Doing what matters in times of stress, but are randomized to either the guided or unguided self-help version.

Who is the study for?
This trial is for individuals experiencing mild to moderate depression, anxiety, or trouble managing emotions. Participants must score at least a 6 on the K6 distress scale and have regular internet or phone access. It's not suitable for those with frequent suicidal thoughts.Check my eligibility
What is being tested?
The study tests a two-step care approach for emotional distress. First, everyone gets a single session intervention (COMET). Then they're randomly assigned to either guided self-help with support (Doing What Matters in Times of Stress) or unguided self-help without support.See study design
What are the potential side effects?
Since this trial involves psychological interventions rather than medication, side effects may include discomfort from discussing personal issues but are generally considered low-risk compared to drug treatments.

COMET-DWM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
6-week change in Kessler 6 Psychological Distress Scale (K6)
6-week change in the WHO 5 Well-being Index (WHO-5)
Secondary outcome measures
3-month change in Kessler 6 Psychological Distress Scale (K6; 0 - 24)
3-month change in the WHO 5 Well-being Index (WHO-5)
6-week change in Emotion Regulation Scale (ERQ) - Reappraisal subscale
+1 more

COMET-DWM Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: COMET + guided self-help bibliotherapyExperimental Treatment3 Interventions
Participants are given access to a single session intervention the Common Elements Toolbox (COMET) and, a week after, are given access to the World Health Organization's (WHO) "Doing what matters in times of stress: An illustrated guide" (https://www.who.int/publications/i/item/9789240003927) virtually (i.e., as a pdf) and/or in print. Each participant is assigned an "eCoach" -- an undergraduate, post-baccalaureate, or graduate research assistant -- who will meet with the participant for a 60-minute welcome call describing the intervention and 3-6 sessions of guidance focused on promoting adherence to the manual and using skills in everyday life.
Group II: COMET + unguided self-help bibliotherapyActive Control2 Interventions
Participants are given access to a single session intervention the Common Elements Toolbox (COMET) and, a week after, are given access to the World Health Organization's (WHO) "Doing what matters in times of stress: An illustrated guide" (https://www.who.int/publications/i/item/9789240003927) virtually (i.e., as a pdf) and/or in print. Participants are left to read the book on their own (i.e., without an eCoach)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Common Elements Toolbox
2020
N/A
~520
Doing What Matters in Times of Stress: An Illustrated Guide
2020
N/A
~270

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
980 Previous Clinical Trials
982,732 Total Patients Enrolled
28 Trials studying Depression
10,681 Patients Enrolled for Depression

Media Library

Common Elements Toolbox Clinical Trial Eligibility Overview. Trial Name: NCT05441111 — Phase 2
Depression Research Study Groups: COMET + unguided self-help bibliotherapy, COMET + guided self-help bibliotherapy
Depression Clinical Trial 2023: Common Elements Toolbox Highlights & Side Effects. Trial Name: NCT05441111 — Phase 2
Common Elements Toolbox 2023 Treatment Timeline for Medical Study. Trial Name: NCT05441111 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the Common Elements Toolbox have regulatory authorization from the FDA?

"Our team at Power has evaluated the safety of Common Elements Toolbox and assigned it a 2, as this is only in phase 2 trials; meaning there are limited data showing its efficacy but some evidence suggesting its security."

Answered by AI

What is the prime focus of this clinical experimentation?

"This medical trial will assess the 6-week change in Kessler 6 Psychological Distress Scale (K6) as its primary outcome, while secondary outcomes focus on changes to Emotion Regulation Scale (ERQ). This scale is subdivided into Reappraisal and Suppression subscales with higher scores indicating an adaptive strategy of emotion regulation. Additionally, 3 month results from WHO 5 Well-being Index (WHO-5) will be collected where a score of 100 represents highest life satisfaction."

Answered by AI

Does this research program have any openings for volunteers?

"According to the details posted on clinicaltrials.gov, this research endeavour is not currently recruiting participants; it was first published June 29th 2022 and last amended July 19th 2022. Nonetheless, there are over 1300 scientific trials actively looking for volunteers right now."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Low-intensity Stepped Care for Internalizing Distress
Lorenzo Lorenzo-Luaces 2022. "Low-intensity Stepped Care for Internalizing Distress". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05441111.
~91 spots leftby Apr 2025
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