Integrated Care for Traumatic Brain Injury and Substance Use Disorder

(ExpandAccess Trial)

Overseen By Russell K Gore, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shepherd Center, Atlanta GA

Disqualifiers: Other brain injury, Neurological disorder, Psychosis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if military veterans and service members with mild head injuries, sometimes combined with substance use issues, can benefit from a special treatment program. The Integrated Model of Care program combines various types of care tailored to each person’s symptoms and goals. It suits military personnel or veterans with mild traumatic brain injury (such as from repeated head impacts or blasts) who participate in the SHARE Military Initiative intensive outpatient program. Participants will complete surveys about their substance use and other symptoms before treatment, after treatment, and six months later to track progress. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative care approaches that could significantly improve their quality of life.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this integrated model of care is safe for military veterans and service members?

Research shows that the Integrated Model of Care for traumatic brain injury (TBI) and substance use disorder (SU) appears promising. A review of studies suggests it can effectively combine existing resources to better support individuals with these conditions. However, specific safety details for this model are not clearly outlined in the sources.

Although direct safety data is unavailable, clients and staff in other settings have found this type of integrated care acceptable. It often leads to improved mental health and substance use outcomes, indicating it is generally well-tolerated. The trial's "not applicable" phase status usually means it focuses on evaluating the treatment's real-world effectiveness rather than testing basic safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Integrated Model of Care for traumatic brain injury (TBI) and substance use disorder because it combines two critical areas of treatment into one comprehensive approach. Unlike traditional treatments that address TBI and substance use separately, this model offers an interdisciplinary intensive outpatient program tailored to individuals' needs. By providing support for both conditions simultaneously, the treatment aims to improve outcomes and ease the transition back into daily life. This integrated approach has the potential to enhance recovery by addressing the complex interplay between brain injuries and substance use, offering a more holistic and effective solution.

What evidence suggests that the Integrated Model of Care is effective for traumatic brain injury and substance use disorder?

Research has shown that the Integrated Model of Care, provided to participants in this trial, can help treat mild traumatic brain injury (TBI) and substance use disorder (SUD). Studies have found that this approach improves veterans' access to mental health care and encourages ongoing treatment involvement. The model is designed to be flexible and tailored to individual needs. Early results suggest it effectively addresses both trauma-related issues and substance use problems. Overall, the Integrated Model of Care appears promising for helping veterans manage symptoms and enhance their quality of life. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for military veterans and service members who have experienced a mild traumatic brain injury (mTBI), also known as a concussion, with or without substance use issues. Specific eligibility criteria are not provided.

Inclusion Criteria

US military service member or veteran

Participating in the SHARE Military Initiative intensive outpatient program

I have been diagnosed with a mild traumatic brain injury or have had repeated head injuries.

Exclusion Criteria

Active psychosis

I have a history of brain injury or progressive neurological disorder other than mild traumatic brain injury.

I am unable to give consent for medical procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intensive Outpatient Program (IOP) Treatment

Participants engage in interdisciplinary intensive outpatient program treatment for mild traumatic brain injury with individualized support for substance use

8-12 weeks

Weekly in-person sessions

Transition Support Program

Participants receive support for substance use in the transition support program following the IOP treatment

4-6 weeks

Bi-weekly in-person sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 months post-treatment

6 months

1 visit (in-person) at 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Integrated Model of Care

Trial Overview The study is testing an integrated model of care tailored to the individual's symptoms, goals, and needs. Participants will be assessed through surveys at the start and end of treatment in an outpatient program, plus six months after discharge.

How Is the Trial Designed?

Group I: Integrated Model of Care Experimental Treatment 1 Intervention

Participants will engage in interdisciplinary intensive outpatient program (IOP) treatment for mild traumatic brain injury with individualized support for substance use (SU) following which they will receive support for SU in the transition support program.

Who Is Running the Clinical Trial?

Shepherd Center, Atlanta GA

Lead Sponsor

Trials

30

Recruited

4,000+

Published Research Related to This Trial

The Integrated Care (IC) model significantly improved access to psychiatric care and engagement among veterans with comorbid PTSD and mild traumatic brain injury (mTBI), as evidenced by increased timely completion of psychiatric consults and higher rates of initiating and completing evidence-based therapies.

In a study reviewing 100 veteran charts, the IC model demonstrated better outcomes compared to the Usual Care (UC) model, suggesting that co-locating psychiatric care within rehabilitation teams can enhance treatment effectiveness for PTSD in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Access to Psychiatric Care for Posttraumatic Stress Disorder in Veterans with Mild Traumatic Brain Injury through Integrated Services. Baig, MR., Tapia, RN., Meraj, A., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8893633/

A systematic review on integrated care for traumatic brain ... A prospective longitudinal cohort study found that at 3 and 6 months post-TBI, almost 20% of patients experienced post-traumatic stress disorder ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590109525000436

Exploring Integration of Support for Co-Occurring ... An Integrated Care Model for TBI + SU was developed and flexibly applied to support client needs, including modifications to assessment, intervention, and ...

3. withpower.com withpower.com/trial/phase-brain-injuries-traumatic-1-2025-55828

Integrated Care for Traumatic Brain Injury and Substance ... The Integrated Care (IC) model significantly improved access to psychiatric care and engagement among veterans with comorbid PTSD and mild traumatic brain ...

4. jsatjournal.com jsatjournal.com/article/S2949-8759(24)00283-2/fulltext

Feasibility and outcomes of a trauma-informed model ... The findings highlight the potential of trauma-informed care as an effective intervention for individuals with co-occurring trauma and substance use disorders.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3363008/

Substance Use and Mild Traumatic Brain Injury Risk ... A novel intervention (Substance Use and Traumatic Brain Injury Risk Reduction and Prevention (STRRP)) for reducing and preventing risky behaviors

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12447207/

Exploring Integration of Support for Co-Occurring ... An Integrated Care Model for TBI + SU was developed and flexibly applied to support client needs, including modifications to assessment, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2949875924002832

Feasibility and outcomes of a trauma-informed model ... The novel TIC model was acceptable for residential clients and staff and was associated with improved mental and substance use outcomes.

8. health.maryland.gov health.maryland.gov/bha/documents/brain%20injury%20and%20substance%20use%20for%20public%20health%20administrators.pdf

The Intersection of Brain Injury and Substance Use Disorders Data from a Finnish birth cohort study have “reported multiple risk factors associated with incurring a TBI, including that if parents misused alcohol, there.