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Behavioral Intervention

Heart Rate Variability Biofeedback for Substance Use Disorder

N/A

Recruiting

Led By David Eddie, Ph.D.

Research Sponsored by Massachusetts General Hospital

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 8 weeks

Awards & highlights

Study Summary

This trialis testing a new way of helping people with substance use disorder to better regulate their emotions and improve their thinking. It uses technology to allow people to use the therapy at any time.

Who is the study for?

This trial is for adults over 18 with a substance use disorder who are in their first year of recovery aiming for total abstinence. Participants must speak English, own a smartphone, and not have severe heart rhythm problems or active psychosis.Check my eligibility

What is being tested?

The study tests if second-generation ambulatory heart rate variability biofeedback (HRVB), which helps regulate emotions and cognitive control through rhythmic breathing, can improve treatment outcomes when added to usual care for substance use disorders.See study design

What are the potential side effects?

There may be minimal side effects from HRVB as it's non-invasive; however, some individuals might experience discomfort or anxiety due to the focus on breathing patterns or using the technology.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

8-week substance use

Change craving

Change negative affect

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Heart rate variability biofeedback + treatment as usualExperimental Treatment2 Interventions

The experimental group will participate in 8 weeks of heart rate variability biofeedback practice using the Lief heart rate variability biofeedback Smart Patch and smartphone app + treatment as usual. Participants will be asked to, 1) wear the Lief Smart Patch for at least 8 hours per day, 2) do 15mins of scheduled heart rate variability biofeedback practice daily, and 3) use it as needed in response to negative affect in-the-moment.

Group II: Treatment as usual onlyActive Control1 Intervention

The control group will participate in 8 weeks of treatment as usual only.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,931 Previous Clinical Trials

13,198,345 Total Patients Enrolled

Colorado State UniversityOTHER

125 Previous Clinical Trials

38,259 Total Patients Enrolled

David Eddie, Ph.D.Principal InvestigatorMassachusetts General Hospital

Media Library

Heart rate variability biofeedback + treatment as usual (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05454657 — N/A

Substance Use Disorder Research Study Groups: Treatment as usual only, Heart rate variability biofeedback + treatment as usual

Substance Use Disorder Clinical Trial 2023: Heart rate variability biofeedback + treatment as usual Highlights & Side Effects. Trial Name: NCT05454657 — N/A

Heart rate variability biofeedback + treatment as usual (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05454657 — N/A

Frequently Asked Questions

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

Is this research endeavor actively recruiting participants?

"According to clinicaltrials.gov, this medical trail is still open for patient enrollment. It was initially put up on December 15th 2022 and most recently modified on January 6th 2023."

Answered by AI

What is the targeted recruitment number for this clinical trial?

"Yes, according to information posted on clinicaltrials.gov this trial is in the process of enrolling patients. It was initially announced on December 15th 2022 and most recently modified on January 6th 2023. A total of 100 individuals are needed at one medical centre for participation in this experiment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Pilot Study of Ambulatory Heart Rate Variability Biofeedback for Substance Use Disorder

David Eddie 2022. "A Pilot Study of Ambulatory Heart Rate Variability Biofeedback for Substance Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05454657.