Expanding Access to mTBI Treatment for Veterans and Service Members With Co-occurring Substance Use

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShepherd Center, Atlanta GA

About this trial

The purpose of this research is to determine whether military veterans and service members with mild traumatic brain injury with and without co-occurring substance use can complete and benefit from integrated interdisciplinary care individualized to their symptoms, goals, and needs.

Participants will complete surveys about substance use and other symptoms at the beginning and end of treatment in an intensive outpatient program and 6 months after discharge.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 18 years of age

US military service member or veteran

Diagnosis of mild traumatic brain injury (mTBI) and/or repetitive head impact/blast exposures

Participating in the SHARE Military Initiative intensive outpatient program

Disqualifiers

History of brain injury other than mTBI or progressive neurological disorder

Active psychosis

Not able to provide consent

Trial design

Design model

Single group

Treatments tested in this trial

  • Integrated Model of Care

    Other intervention

    The Integrated Model of Care was developed and piloted by the study team provide support for individuals seeking care in an interdisciplinary intensive outpatient program for mild traumatic brain injury to receive support for co-occurring substance use-related needs.

Treatment groups

360 Participants
are divided into 1 treatment group
Group A: Integrated Model of CareExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Neurobehavioral Symptom Inventory (NSI)

a 22-item, self-report questionnaire used to measure change in symptoms commonly associated with mild traumatic brain injury over time

Time frame
Study enrollment, immediately after the intervention, and at 6 months follow-up
2

Short Inventory of Problems- Revised (SIP-R)

a 17-item self-report inventory used to assess adverse consequences of substance use

Time frame
Study enrollment, immediately after the intervention, and at 6 months follow-up

Secondary outcomes

1

Life-Satisfaction Questionnaire -11 (LISAT-11)

an internationally validated 11-item self-report inventory of satisfaction within important life domains: life as a whole, vocational situation, financial situation, leisure situation, contacts with friends, sexual life, self-care management, family life, partner, physical health, and psychological health

Time frame
Study enrollment, immediately after the intervention, and at 6 months follow-up
2

Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

a 20-item self-report inventory used to assess severity of posttraumatic stress symptoms and monitoring symptom change during and after treatment

Time frame
Study enrollment, immediately after the intervention, and at 6 months follow-up
3

Patient Health Questionnaire (PHQ-8)

an eight item, self-report inventory used to screen for the presence and severity of depression

Time frame
Study enrollment, immediately after the intervention, and at 6 months follow-up
4

Generalized Anxiety Disorder Scale (GAD-7)

a seven item, self-report inventory used to screen for the presence and severity of anxiety

Time frame
Study enrollment, immediately after the intervention, and at 6 months follow-up

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: