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

Study Overview
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Brief Summary
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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.

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

Conditions
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Substance Use Disorder

Intervention / Treatment
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* Behavioral: Resonance Breathing
* Behavioral: Non-Resonance Breathing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resonance Breathing<br>Breathing is paced to the cardiovascular resonance frequency where heart, respiratory, and brain signals become aligned. This can potentially positively impact cognitive-emotional functioning. | Behavioral: Resonance Breathing<br>* Breathing is paced with a pre-installed iPhone app that includes a visual pacer.<br>|
| Placebo Comparator: Non-Resonance Breathing<br>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. | Behavioral: Non-Resonance Breathing<br>* Breathing is paced with a pre-installed iPhone app that includes a visual pacer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active Substance Use (self-report questionnaire) |  | Three Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (self-report questionnaire) | Social support, financial resources, etc. | Three Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Baroreflex mechanism, Alcohol Use Disorder, Substance Use Disorder, Heart Rate Variability, Breathing