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Behavioural Intervention

Osc+ for Depression (RAPID Trial)

Phase 2
Recruiting
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the two 10-day ambulatory assessment periods.
Awards & highlights

RAPID Trial Summary

This trial aims to study different subtypes of depression by looking at how people regulate their emotions and their physiological responses. The study involves assessing affect, regulation strategies, and physiological activity in young adults with depression

Who is the study for?
This trial is for young adults who have had major depressive disorder but are currently in remission, as well as healthy volunteers. Participants should be interested in monitoring their mood and bodily responses daily. People with ongoing depression or those unable to commit to the study's procedures cannot participate.Check my eligibility
What is being tested?
The study tests if heart rate variability biofeedback can help people better regulate their emotions by increasing parasympathetic nervous system activity. It involves daily self-monitoring and a remote, self-administered intervention over 10 days, comparing it against a control group.See study design
What are the potential side effects?
Since this is a non-invasive biofeedback intervention focusing on breathing exercises to improve heart rate variability, significant side effects are not expected. However, some individuals might experience frustration or stress if they struggle with the technique.

RAPID Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the two 10-day ambulatory assessment periods.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the two 10-day ambulatory assessment periods. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average level of heart rate variability
Physiological regulation success
Secondary outcome measures
Perceived regulation success

RAPID Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Osc+Experimental Treatment1 Intervention
Osc+ condition. In the Osc+ condition, participants will see an on-going record of their heart rate over time. They will be instructed to engage in paced breathing and to try to maximize their oscillation score. The paced breathing will be adapted to a rate that allows them to maximize their high amplitude heart rate oscillations.
Group II: Osc-Active Control1 Intervention
Osc- condition. In the Osc- condition, participants will also see an on-going record of their heart rate over time, and will be instructed to engage in paced breathing. However, they will be asked to try to keep their heart rate steady and avoid oscillations and will get points on an 'alertness' score that inverts the Osc+ 'oscillation' score.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Heart rate variability biofeedback
2021
N/A
~140

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,595,924 Total Patients Enrolled
24 Trials studying Depression
5,972 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,457 Total Patients Enrolled
667 Trials studying Depression
251,584 Patients Enrolled for Depression

Frequently Asked Questions

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

Does this study include individuals aged 85 and above?

"Eligible candidates for this research must fall within the age range of 18 to 27. Notably, there are a total of 114 investigations focused on individuals under 18 years old and another 642 studies targeting those above 65 years old."

Answered by AI

Are participants currently being sought for enrollment in this medical study?

"Indeed, information from clinicaltrials.gov indicates that this research study is actively enrolling volunteers. The trial was initially listed on March 22nd, 2024 and the most recent update occurred on March 28th, 2024. Enrollment aims to include 252 individuals at a single designated site."

Answered by AI

What is the current number of individuals involved in this clinical trial as participants?

"Indeed, information available on clinicaltrials.gov indicates that this investigation is actively seeking suitable candidates. The trial was first listed on March 22nd, 2024, and the latest update was made on March 28th, 2024. They aim to enroll a total of 252 participants at a single designated location."

Answered by AI

What is the safety profile of Osc+ for individuals?

"The safety rating for Osc+ is a 2, as per our evaluation at Power. This assessment aligns with the Phase 2 nature of the trial, indicating existing data on safety but no evidence yet on efficacy."

Answered by AI
~168 spots leftby Apr 2028