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Project IMPACT: In-the-Moment Protection From Automatic Capture by Trigger

Primary Purpose

Substance Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resonance Breathing
Non-Resonance Breathing
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorder focused on measuring Baroreflex mechanism, Alcohol Use Disorder, Substance Use Disorder, Heart Rate Variability, Breathing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women over age 18
  • Women diagnosed with substance use disorder
  • Women participating in IOP at Center for Great Expectations, New Brunswick, NJ

Exclusion Criteria:

  • Pregnancy

Sites / Locations

  • Center of Alcohol Studies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Resonance Breathing

Non-Resonance Breathing

Arm Description

Breathing is paced to the cardiovascular resonance frequency where heart, respiratory, and brain signals become aligned. This can potentially positively impact cognitive-emotional functioning.

Breathing is paced at a non-resonance frequency. It does not align heart, respiratory, and brain signals, and thus does not impact cognitive-emotional functioning.

Outcomes

Primary Outcome Measures

Active Substance Use (self-report questionnaire)

Secondary Outcome Measures

Quality of Life (self-report questionnaire)
Social support, financial resources, etc.

Full Information

First Posted
October 13, 2015
Last Updated
March 10, 2022
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT02579317
Brief Title
Project IMPACT: In-the-Moment Protection From Automatic Capture by Trigger
Official Title
Project IMPACT: In-the-Moment Protection From Automatic Capture by Trigger
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Despite conscious intentions to remain abstinent, persons with substance use disorders often find that negative emotions and environmental cues automatically "trigger" drinking and other substance use. This study aims to test whether activating the baroreflex mechanism can be used "in the moment" to help resist drinking triggers. It consists of 3 phases (Recruitment, Intervention, Follow-up). Stage 1: Trained research staff conduct a comprehensive clinical interview and questionnaires to assess participant's mood, substance use, and triggers. Participants are paired with a Primary Research Clinician (PRC) who will work with them during the intervention. Stage 2: Approximately 4 weeks after intake into the Center for Great Expectations Intensive Outpatient program, an 8-week intervention begins. Pre-and post-intervention laboratory sessions occur at Cardiac Neuroscience Laboratory, Center of Alcohol Studies, Piscataway, NJ. Some participants take part in pre- and post-intervention neuroimaging sessions (Rutgers University Brain Imaging Center, Newark, NJ). Participants are randomized into an active intervention or control group after the pre-intervention lab session. They are given an iPhone and trained to use a paced breathing app that is pre-loaded onto the phone. Participants in both groups use their app any time they anticipate or experience a trigger to drink or use drugs. Participants are compensated for their use of the app and the time for participation. To ensure that participants are correctly performing the paced breathing task, their PRC visit with them weekly to provide coaching sessions using a computer-based biofeedback program. During the 4th week, ECG and respiration data are collected. Participants also complete questionnaires about mood and triggers, and provide feedback on the usefulness of the app. During the lab sessions, participants complete a series of questionnaires and ECG, blood pressure and respiration are collected during four 5-minute tasks (resting baseline, non-resonance breathing, resonance breathing, and visual processing/attention). During the neuroimaging sessions, participants are placed in the scanner for structural scans and four 5-minute tasks (as tasks as previously noted); ECG and blood pressure are recorded. Stage 3: Participants are re-contacted 1 and 3 months after the intervention to complete questionnaires about their quality of life across multiple domains and the usefulness of the app.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorder
Keywords
Baroreflex mechanism, Alcohol Use Disorder, Substance Use Disorder, Heart Rate Variability, Breathing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resonance Breathing
Arm Type
Experimental
Arm Description
Breathing is paced to the cardiovascular resonance frequency where heart, respiratory, and brain signals become aligned. This can potentially positively impact cognitive-emotional functioning.
Arm Title
Non-Resonance Breathing
Arm Type
Placebo Comparator
Arm Description
Breathing is paced at a non-resonance frequency. It does not align heart, respiratory, and brain signals, and thus does not impact cognitive-emotional functioning.
Intervention Type
Behavioral
Intervention Name(s)
Resonance Breathing
Intervention Description
Breathing is paced with a pre-installed iPhone app that includes a visual pacer.
Intervention Type
Behavioral
Intervention Name(s)
Non-Resonance Breathing
Intervention Description
Breathing is paced with a pre-installed iPhone app that includes a visual pacer.
Primary Outcome Measure Information:
Title
Active Substance Use (self-report questionnaire)
Time Frame
Three Months
Secondary Outcome Measure Information:
Title
Quality of Life (self-report questionnaire)
Description
Social support, financial resources, etc.
Time Frame
Three Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women over age 18 Women diagnosed with substance use disorder Women participating in IOP at Center for Great Expectations, New Brunswick, NJ Exclusion Criteria: Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Buckman, Ph.D.
Organizational Affiliation
Center of Alcohol Studies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center of Alcohol Studies
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36159943
Citation
Price JL, Bates ME, Pawlak AP, Uhouse SG, Todaro SM, Morgano J, Buckman JF. Use and perceived usefulness of a just-in-time resonance breathing intervention adjunct for substance use disorder: Contextual and physiological predictors. Front Psychiatry. 2022 Sep 7;13:945751. doi: 10.3389/fpsyt.2022.945751. eCollection 2022.
Results Reference
derived

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Project IMPACT: In-the-Moment Protection From Automatic Capture by Trigger

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