Emotional Brain Training for Addiction Medicine Treatment - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Changes in Level of Stress at 8 weeks
研究概览
简要总结
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
详细描述
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:
- Replacing self-regulatory failure with optimal brain-based self-regulation, even under stress.
- Rewiring maladaptive survival and core circuits to become stress resilient.
- 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:
- Activation of stress-related survival circuits.
- Emotional processing to shift circuits from allostatic to homeostatic states.
- Conscious identification of maladaptive expectations.
- Juxtaposition of adaptive expectations to promote circuit reconsolidation.
- Delivery of a dopamine release to solidify the rewiring. This process, consistent with reconsolidation research, is repeated until maladaptive drives and responses are eliminated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard of Care (SOC)
Participants will receive SOC, which includes medications for addiction therapy (MAT) (including but not limited to buprenorphine, naltrexone, bupropion, etc.) weekly counseling, and monthly clinic visits with addiction specialists.
干预措施: Standard addiction counseling and medical therapy (Other)
Emotional Brain Training (EBT) and Standard of Care (SOC)
This group will receive all the components of SOC plus EBT counseling:
A. The components below will be completed daily and is estimated to take 25 minutes:
i. [10 1-minute spiral ups (SU) - an EBT specific, app-directed methodology of emotional regulation], plus; ii. 5 minutes via telephone for a group peer connection iii. 10 minutes online/phone app coursework/video
B. Once a week: participants will participate in a 60 minute small-group telephone meeting for accountability and support C. Once a week: participants will participate in at least 3 30-minute Spiral Up (SU) groups/week to practice the skills. These are available online daily.
干预措施: Emotional Brain Training (Behavioral)
Emotional Brain Training (EBT) and Standard of Care (SOC)
This group will receive all the components of SOC plus EBT counseling:
A. The components below will be completed daily and is estimated to take 25 minutes:
i. [10 1-minute spiral ups (SU) - an EBT specific, app-directed methodology of emotional regulation], plus; ii. 5 minutes via telephone for a group peer connection iii. 10 minutes online/phone app coursework/video
B. Once a week: participants will participate in a 60 minute small-group telephone meeting for accountability and support C. Once a week: participants will participate in at least 3 30-minute Spiral Up (SU) groups/week to practice the skills. These are available online daily.
干预措施: Standard addiction counseling and medical therapy (Other)
结局指标
主要结局
Changes in Level of Stress at 8 weeks
时间窗: Change between baseline(time of study enrollment) and Study completion (8 weeks).
Level of stress will be measured by comparing scores from baseline to study completion. Responses will be collected using a 10-item survey assessing perceived stress, administered at enrollment and at eight weeks post-enrollment. Each item uses a 5-point Likert scale ranging from "Never" to "Very Often." Scores will be summed to create a composite stress score, with higher scores indicating greater perceived stress. This measurement evaluates how often participants experience emotional and cognitive responses to stressors such as lack of control, feeling overwhelmed, or being unable to cope.
Changes of Level of Anxiety at 8 weeks
时间窗: Change between baseline(time of study enrollment) and Study completion (8 weeks).
Level of anxiety will be assessed using a standardized PROMIS anxiety scale. Participants will complete the survey at baseline and again at the end of the eight-week study period. The survey consists of 8 items rated on a 5-point Likert scale from "Never" to "Always." Items measure frequency of symptoms such as nervousness, tension, and difficulty concentrating due to anxiety. A composite score will be calculated, with higher values reflecting more severe anxiety symptoms.
Change in Levels of Cravings
时间窗: Change between baseline(time of study enrollment) and Study completion (8 weeks).
Level of cravings will be measured using selected items from the TAPS (Tobacco, Alcohol, Prescription medication, and other Substance use) assessment tool. Participants will report frequency of use and urges related to substance use at baseline and again at the end of the eight-week period. Responses will be categorized to identify changes in craving intensity and frequency. Increased scores suggest more frequent or intense cravings, while lower scores indicate a reduction in craving-related behaviors or urges.
次要结局
- Change in level of stress (week 4 to 8)(Change between mid-point(week 4) and Study completion (8 weeks).)
- Change in level of anxiety (week 4 to 8)(Change between mid-point(week 4) and Study completion (8 weeks).)
- Change in level of cravings (week 4 to 8)(Change between mid-point(week 4) and Study completion (8 weeks).)