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



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:9/9/2018
Start Date:November 2015
End Date:December 2019
Contact:Jennifer Buckman, Ph.D.
Email:jbuckman@rutgers.edu
Phone:848-445-0793

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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.


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
We found this trial at
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Piscataway, New Jersey 08854
Phone: 848-445-0793
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