Cognitively Augmented Behavioral Activation for Veterans With Comorbid TBI/PTSD

Veterans historically exhibit high rates of comorbid mTBI/PTSD. Given the comorbidity and
neuropsychiatric symptom overlap of these disorders, it can be difficult to determine whether
problems and disruptions in functioning are due to mTBI, PTSD, or both. Hence, it is
challenging for providers to know how to prioritize these patients' clinical issues and how
to effectively treat them. Currently, there are no evidence-based treatments for comorbid
mTBI/PTSD. Further, it is unclear to what extent existing treatments for each disorder can be
adherently and effectively implemented for the other. As such, most current treatment
recommendations suggest a holistic or integrated approach to treatment for comorbid mTBI/PTSD
targeting symptoms and functionality rather than underlying etiology. Investigators are
proposing a treatment for comorbid mTBI and PTSD that directly targets daily functioning and
quality of life.

The study design makes use of the convergent availability of resources at the two
participating Veterans Administration Health Care Systems in Portland, Oregon, and Seattle,
Washington to conduct a Randomized Controlled Trial (RCT) of CABA. The study will recruit a
total of 192 Veterans less than or equal to 55 years of age, 96 participants at each site,
enrolled at participating VA Medical Centers (VAMCs) who are diagnosed with both mTBI and
PTSD. Eligible participants will be randomly assigned to either the CABA or Treatment as
Usual (TAU) group. Participants in the CABA group will receive the CABA intervention during
the first 14 weeks of their participation in the study, whereas TAU participants will
continue to receive TAU (usual care in a PTSD specialty treatment clinic, but no CABA) during
their participation in the study. Both groups will undergo evaluations at baseline, 7 weeks
(mid-treatment), 14 weeks (post-treatment), and 39 weeks (6 month follow-up). During their
study participation, all participants will continue to receive their usual medical care.

Inclusion Criteria:

- Veterans 55 years of age enrolled at participating VA sites able to provide informed
consent.

- Diagnosis of PTSD based on the Clinician Administered PTSD Scale.

- Positive screen on the Structured Interview for Collecting Head Trauma Event
Characteristics as per the VA/Department of Defense (DoD) Clinical Practice Guideline
for Management of Concussion/mTBI; AND endorsed any of the Neurobehavioral Symptom
Inventory (NSI) cognitive symptoms items (items 13-17).

- English speaking, able to travel to the primary care clinics weekly for 10 sessions
and for the follow-up assessments, and willing to refrain from the initiation of
additional mental health treatment during the first 3 1/2 months of the active phase
of treatment if they are assigned to the CABA condition.

- Willingness to participate in audio-recorded sessions. (for treatment adherence)

Exclusion Criteria:

- Current diagnosis of moderate or severe substance (alcohol) use disorder using DSM-5
criteria within the past 30 days.

- Individuals with other psychiatric diagnoses will not be excluded except for bipolar
disorder and psychotic disorders (requirement to refrain from additional treatments
might be harmful).

- Veterans with a history indicated by medical record review of a diagnosis of moderate,
severe, or penetrating TBI, or self-reported history on the Structured Interview for
Collecting Head Trauma Event Characteristics of TBI with Post-Traumatic Amnesia (PTA)
greater than 24 hours or loss of consciousness (LOC) greater than 30 minutes.

- Active suicidal intent indicating significant clinical risk, which would suggest that
a treatment specifically targeting this intent was indicated. Clients who report
suicidal ideation without imminent risk will be admitted into the study.

- Initiated psychotropic medication, including Prazosin, within 4 weeks or changed
dosage within 2 weeks prior to the first assessment, as this would make it difficult
to determine which treatment contributed to change in the CABA condition;
additionally, started or changed dosage of sleep medication or low dosages of
tricyclic antidepressant or trazodone for pain or sleep within 1 week prior to the
first assessment. Participants could be reconsidered for eligibility after stability
on medication was achieved. Enrollees will be asked to hold the doses of the current
medications stable over the course of enrollment (though changes in medications after
enrollment will not exclude them from on-going participation).

- Auditory or visual impairments that would compromise ability to participate or
benefit.