Emotional Brain Training for Addiction Medicine Treatment - A Pilot Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLoma Linda University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Emotional Brain Training

    Behavioral

    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 behaviors by engaging the brain's natural neuroplasticity mechanisms. EBT integrates rapid emotional processing tools, peer-to-peer support, clinician-facilitated sessions, and mobile app-based self-care to systematically transition brain circuits from stress-reactive to stress-resilient states.

  • Standard addiction counseling and medical therapy

    Other intervention

    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.).

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Standard of Care (SOC)Active comparator 1 intervention
Group B: Emotional Brain Training (EBT) and Standard of Care (SOC)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Changes in Level of Stress at 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.

Time frame
Change between baseline(time of study enrollment) and Study completion (8 weeks).
2

Changes of Level of Anxiety at 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.

Time frame
Change between baseline(time of study enrollment) and Study completion (8 weeks).
3

Change in Levels of Cravings

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.

Time frame
Change between baseline(time of study enrollment) and Study completion (8 weeks).

Secondary outcomes

1

Change in level of stress (week 4 to 8)

Level of stress will be measured at three timepoints: baseline (week 0), midpoint (week 4), and study completion (week 8). Responses will be collected using a 10-item perceived stress scale. Each item is rated on a 5-point Likert scale ranging from "Never" to "Very Often." A composite stress score will be calculated at each timepoint, with higher scores reflecting greater perceived stress. The measure evaluates emotional and cognitive responses to stressors, such as unpredictability, lack of control, and feeling overwhelmed. Changes in stress levels will be tracked across the study duration.

Time frame
Change between mid-point(week 4) and Study completion (8 weeks).
2

Change in level of anxiety (week 4 to 8)

Anxiety will be assessed at baseline, 4 weeks, and 8 weeks using the PROMIS anxiety scale. This 8-item instrument uses a 5-point Likert scale from "Never" to "Always" to evaluate symptoms such as nervousness, tension, and difficulty focusing. A composite anxiety score will be calculated for each assessment point. Higher scores indicate more severe anxiety. Changes will be examined over time to evaluate the trajectory of anxiety symptoms during the intervention.

Time frame
Change between mid-point(week 4) and Study completion (8 weeks).
3

Change in level of cravings (week 4 to 8)

Craving levels will be measured at weeks 0, 4, and 8 using selected items from the TAPS (Tobacco, Alcohol, Prescription medication, and other Substance use) tool. Participants will report frequency of substance use and associated urges. Responses will be used to generate categorical indicators of craving intensity and frequency. Changes across timepoints will be used to determine patterns in craving reduction or escalation throughout the intervention.

Time frame
Change between mid-point(week 4) and Study completion (8 weeks).

Other outcomes

Sponsors and contacts

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Loma Linda University

Lead sponsor

University of California, San Francisco

Collaborator

Social Action for Health

Collaborator

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