Emotional Brain Training for Addiction Medicine Treatment - A Pilot Study

Обзор

The goal of this clinical trial is to determine whether Emotional Brain Training (EBT), a behavioral modification method, can help manage stress and health problems related to addiction. EBT teaches skills to deactivate harmful circuits (automatic reactions) and activate healing circuits to quickly shift mood from negative to positive. Participants in the EBT group will receive focused, intensive instruction on using these skills to rewire unwanted brain circuits, with the aim of achieving lasting improvements in emotional health and quality of life. The study will assess whether EBT is an effective tool when added to standard of care (SOC), which includes medications for addiction treatment (MAT). Researchers will compare changes in stress, anxiety, and cravings after 8 weeks of EBT plus SOC versus SOC alone. Participants: * will either continue receiving standard treatments (SOC) at the Addiction Recovery Clinic (ARC) at SAC Health in San Bernardino * or receive both EBT and SOC at ARC * in the SOC group will continue monthly visits at ARC and weekly counseling * in the EBT plus SOC group will continue monthly visits and weekly counseling at ARC, along with weekly EBT group sessions by telephone * will complete online assessments at weeks 0, 4, and 8 Upon completion of the study, all participants will resume SOC

Подробное описание

Background Information and Rationale Addiction is a neuropsychological disorder defined by a persistent and intense urge to use a drug or engage in a behavior that produces a natural reward, despite significant harm and negative consequences. Repetitive substance use alters brain function, perpetuating craving and weakening self-control, while not completely negating it. Addiction is now recognized as a complex brain disorder influenced by both neurobiological and psychosocial factors. Effective treatment typically combines pharmacological approaches with behavioral interventions, such as cognitive behavioral therapy (CBT), psychotherapy, behavior modification strategies, twelve-step programs, and structured residential care.

Emotional Brain Training (EBT) is a method of self-directed neuroplasticity targeting the neural root causes of addiction, rather than substituting one addiction for another. EBT addresses three primary brain-based contributors to addiction:

1. Replacing self-regulatory failure with optimal brain-based self-regulation, even under stress. 2. Rewiring maladaptive survival and core circuits to become stress resilient. 3. Raising the brain's physiological set point from allostatic to homeostatic, supporting adaptive lifestyle changes and reliance on natural rewards.

The core therapeutic technique of EBT is a structured emotional resiliency process that rewires maladaptive circuits through:

1. Activation of stress-related survival circuits. 2. Emotional processing to shift circuits from allostatic to homeostatic states. 3. Conscious identification of maladaptive expectations. 4. Juxtaposition of adaptive expectations to promote circuit reconsolidation. 5. Delivery of a dopamine release to solidify the rewiring. This process, consistent with reconsolidation research, is repeated until maladaptive drives and responses are eliminated.

EBT uniquely targets brain circuits that control physiology. The same set of skills is applied by clinicians, in peer-to-peer support, and through self-care with mobile app support, enhancing access and scalability. Delivery occurs through small group telephonic sessions using a confidential platform that fosters learning, community, and coaching.

Group sessions are facilitated by licensed health professionals or certified coaches trained in personal and clinical EBT use. Emotional resiliency processes can be completed rapidly, ranging from two to three minutes for self-regulation to approximately twenty minutes for clinician-facilitated trauma rewiring. Practice is further reinforced through brief peer-to-peer sessions and mobile app exercises.

EBT effectiveness has been evaluated in 14 small studies, demonstrating improvements in psychological measures (such as depression, perceived stress, and self-efficacy), behavioral outcomes (including reduced addictive behaviors and increased exercise), and physiological markers (such as blood pressure and BMI).

Вмешательства

• Поведенческое Emotional Brain Training
  Emotional Brain Training (EBT) is a structured, neuroscience-based behavioral intervention that focuses on rewiring the brain's stress-related circuits to promote emotional resilience, self-regulation, and lasting behavioral change. This behavioral intervention has not been implemented in addiction treatments in the past. Unlike traditional therapies that primarily target cognitive processes or symptom management, EBT directly addresses the physiological and emotional root causes of maladaptive
• Другое Standard addiction counseling and medical therapy
  Participants will receive standard counseling (including but not limited to cognitive behavioral therapy, motivational interviewing, etc.), which does not include EBT, in addition to medications for addiction treatment (including but not limited to buprenorphine, naltrexone, bupropion, etc.).

Первичные конечные точки

• Changes in Level of Stress at 8 weeks [Срок оценки: Change between baseline(time of study enrollment) and Study completion (8 weeks).]
• Changes of Level of Anxiety at 8 weeks [Срок оценки: Change between baseline(time of study enrollment) and Study completion (8 weeks).]
• Change in Levels of Cravings [Срок оценки: Change between baseline(time of study enrollment) and Study completion (8 weeks).]

Вторичные конечные точки (3)

• Change in level of stress (week 4 to 8) [Срок оценки: Change between mid-point(week 4) and Study completion (8 weeks).]
• Change in level of anxiety (week 4 to 8) [Срок оценки: Change between mid-point(week 4) and Study completion (8 weeks).]
• Change in level of cravings (week 4 to 8) [Срок оценки: Change between mid-point(week 4) and Study completion (8 weeks).]

Критерии участия

Критерии включения

• Age 18 years old or older
• Patient can speak and read English
• Patient who receives regular MAT care at SAC Health
• Patients who have regular and reliable cellular and/or reliable internet connection
• Patients who are willing to spend average of 25 minutes per day and attend weekly group meetings
• Patients willing to actively participate in group sessions
• Opioid use disorder, at least in early remission
• Alcohol use disorder, at least in early remission
• Methamphetamine use disorder, at least in early remission
• Cocaine use disorder, at least in early remission
• Anxiolytic use disorder, at least in early remission
• Cannabis use disorder
• Tobacco use disorder

Критерии исключения

• Age <18 years old
• Patient does not speak or read English
• Patients who do not seek regular MAT care at SAC Health
• Patients with inconsistent or no access to cellular or internet connection
• Any disorder that is uncontrolled
• Any substance use disorder not in at least early remission
• Any patient with complications related to use disorder
• Patients enrolled in the Coachella Valley Rescue Mission patients a part of SAC Health
• Anyone who, in the opinion of the investigators, would be unable to participate in an 8-week trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Addiction Recovery Clinic at SAC Health — San Bernardino

Публикации

• Mellin L, Fish-dePena LE, Frassetto LA, Mitrovic I. Rewiring the stress response: A new paradigm for health care. Medical Hypothesis 9(1), 2011.
• Clay SW, Allen J, Parran T. A review of addiction. Postgrad Med. 2008 Jul 31;120(2):E01-7. doi: 10.3810/pgm.2008.07.1802. PMID 18654058
• Henden E (2017). Addiction, compulsion, and weakness of the will: A dual-process perspective.. In Heather N, Gabriel S (eds.). Addiction and Choice: Rethinking the Relationship. Oxford, UK: Oxford University Press. pp. 116-132
• "Drugs, Brains, and Behavior: The Science of addiction - Drug misuse and addiction. www.drugabuse.gov. North Bethesda, Maryland: National Institute on Drug Abuse. 13 July 2020. Retrieved 23 December 2021.
• Nestler EJ. Cellular basis of memory for addiction. Dialogues Clin Neurosci. 2013 Dec;15(4):431-43. doi: 10.31887/DCNS.2013.15.4/enestler. PMID 24459410
• Heilig M, MacKillop J, Martinez D, Rehm J, Leggio L, Vanderschuren LJMJ. Addiction as a brain disease revised: why it still matters, and the need for consilience. Neuropsychopharmacology. 2021 Sep;46(10):1715-1723. doi: 10.1038/s41386-020-00950-y. Epub 2021 Feb 22. PMID 33619327
• Ford J, Frassetto L, Mellin L. Emotional Brain Training (EBT) in Subjects after Bariatric Surgery. American Society of Bariatric Surgery, Virginia Beach 8.19.23 abstract - first place.

Идентификаторы

NCT: NCT07001371 · 0000383

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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