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Behavioral Intervention

IBMT + NF for Substance Abuse

N/A
Recruiting
Research Sponsored by Arizona State University
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 the outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
Awards & highlights

Study Summary

"This trial will investigate if using neurofeedback can improve the effectiveness of integrative body-mind training."

Who is the study for?
This trial is for individuals struggling with substance abuse. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be involved in other conflicting treatments or studies.Check my eligibility
What is being tested?
The study is examining if neurofeedback (NF) can enhance the effects of integrative body-mind training (IBMT), a meditation-like practice, to help reduce substance use.See study design
What are the potential side effects?
Since NF involves monitoring brain activity and IBMT is a type of mental training, side effects may include discomfort from wearing sensors or stress due to focusing on personal thoughts during sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and the outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intervention effects on brain function using Functional Magnetic Resonance Imaging (fMRI)
Intervention effects on brain grey matter using fMRI
Intervention effects on brain white matter using fMRI
Secondary outcome measures
Intervention effects on addiction behavior using substance use questionnaires in PhenX Toolkit

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: NFExperimental Treatment1 Intervention
An evidence-based intervention - NF can not only provide real-time feedback for practice but also target the self-control networks, suggesting the possibility of augmenting IBMT effects via NF.
Group II: IBMT + NFExperimental Treatment2 Interventions
The combined IBMT and NF also show positive effects in reducing substance use.
Group III: IBMTExperimental Treatment1 Intervention
An evidence-based preventive intervention - integrative body-mind training (IBMT) has shown positive effects in reducing stress and improving self-control and brain plasticity. It has bodifulness and mindfulness components.
Group IV: Sham NFPlacebo Group1 Intervention
Sham NF has the same settings as the active NF but does not have correct parameters of stimulation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IBMT
2019
N/A
~70

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Who is running the clinical trial?

Arizona State UniversityLead Sponsor
287 Previous Clinical Trials
109,216 Total Patients Enrolled
2 Trials studying Substance Abuse
3,079 Patients Enrolled for Substance Abuse
~23 spots leftby Aug 2026
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