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Behavioral Intervention

Project Calm for Anxiety

N/A

Recruiting

Research Sponsored by Harvard University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups

Awards & highlights

Study Summary

This trial is testing a digital intervention for mental health in Ukrainian children and adolescents. The intervention teaches techniques that have been proven effective in helping American children calm themselves and regulate their emotions. Participants will be given

Who is the study for?

This trial is for Ukrainian children and adolescents in schools who may be experiencing depression, anxiety, trauma, or behavioral issues. It aims to help them learn self-calming techniques through a digital program called Project Calm. The intervention has not been tested with this group before.Check my eligibility

What is being tested?

Project Calm is being tested as part of the school curriculum to see if it can improve mental health and well-being among students. Participants will either start the online program immediately or after a 2-month wait, allowing researchers to measure its effectiveness over time.See study design

What are the potential side effects?

Since Project Calm involves non-invasive techniques like slowed breathing and peaceful imagery, no physical side effects are expected. However, emotional discomfort could arise from addressing mental health topics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, 1-month, 2-month, 3-month, and 4-month follow-ups for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Behavior and Feelings Survey (Internalizing Subscale)

Perceived Program Acceptability and Helpfulness

Secondary outcome measures

Change in Behavior and Feelings Survey (Externalizing Subscale)

Emotion Regulation Mechanisms of Change Questions

Peabody Treatment Progress Battery's Life Satisfaction Scale

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Project CalmExperimental Treatment1 Intervention

Project Calm is a ~30-minute self-guided digital intervention designed to teach children and adolescents empirically supported emotion regulation skills to facilitate self-calming when faced with intense negative emotions. Project Calm uses vignettes, interactive activities, and engaging graphics to teach youth calming skills.

Group II: Delayed Receipt of Project Calm Control ConditionExperimental Treatment1 Intervention

No intervention for first two months; will receive Project Calm after 2-months and become a second-wave intervention condition.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Harvard UniversityLead Sponsor

230 Previous Clinical Trials

472,860 Total Patients Enrolled

17 Trials studying Anxiety

5,836 Patients Enrolled for Anxiety

John WeiszUNKNOWN

Frequently Asked Questions

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

Do I meet the necessary criteria to participate in this clinical research study?

"To be eligible for participation in this clinical trial, individuals must have a diagnosis of depression and fall within the age range of 9 to 18. The study aims to enroll approximately 1765 participants."

Answered by AI

Are participants currently being recruited for this clinical trial?

"As per the information on clinicaltrials.gov, this specific study is currently not in the active recruitment phase. The trial was initially posted on January 16th, 2024 and last modified on January 12th, 2024. However, it is worth noting that there are currently a total of 1506 other trials actively enrolling participants at present."

Answered by AI

What is the primary objective of this medical study?

"The primary outcome of this clinical trial, assessed immediately after the intervention, aims to measure the change in behavior and feelings using the Internalizing Subscale of the Behavior and Feelings Survey. Secondary outcomes include evaluating life satisfaction through the Peabody Treatment Progress Battery's Life Satisfaction Scale, assessing treatment expectations before the intervention with a 4-item measure on a 0-10 scale, and examining trauma symptoms at all time points using the Short Post-Traumatic Stress Disorder Rating Interview (SPRINT-10) where items are rated from 0 (not at all) to 4 (very much)."

Answered by AI