RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Heart rate variability biofeedback (HRVB) is an biobehavioral intervention involving rhythmic breathing at resonance frequency that stimulates cardiovascular regulatory systems to help individuals better regulate affect and bolster cognitive control. This intervention has already shown its potential as a substance use disorder (SUD) treatment tool, but practical limitations of its accessibility, labor intensiveness, and cost have previously prevented this intervention from going to scale. Second-generation, ambulatory HRVB technology, however, has overcome these limitations and now allows patients to practice HRVB in-the-moment when its needed most. This study is testing the efficacy of second-generation, ambulatory HRVB for the first time with individuals with SUD.

Official Title

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

Quick Facts

Study Start:2022-12-15
Study Completion:2024-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05454657

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥18 years of age
  2. * Own a smartphone
  3. * English proficiency
  4. * DSM 5 diagnosis of substance use disorder
  5. * In the first year of a current substance use disorder recovery attempt with a goal of total alcohol and other drug abstinence
  1. * Medical history of severe cardiac arrhythmia
  2. * Active psychosis

Contacts and Locations

Study Contact

David Eddie, Ph.D.
CONTACT
617-643-9194
deddie@mgh.harvard.edu
Marina Nguyen, B.A.
CONTACT
617-732-8140
mnguyen64@mgh.harvard.edu

Principal Investigator

David Eddie, Ph.D.
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114-4714
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • David Eddie, Ph.D., PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-15
Study Completion Date2024-07

Study Record Updates

Study Start Date2022-12-15
Study Completion Date2024-07

Terms related to this study

Keywords Provided by Researchers

  • Heart rate variability biofeedback
  • Just in time
  • Autonomic nervous system
  • Substance use disorder
  • Addiction recovery

Additional Relevant MeSH Terms

  • Substance Use Disorders