Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury
Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury
The first aim of this study is to develop a structured, cognitive behavioral treatment manual
 for major depressive disorder (MDD) adapted for individuals with moderate to severe traumatic
 brain injury (TBI) (CBTx-TBI), as well as evaluate its acceptability and tolerability in an
 open 12-week pilot trial (N=10).

 The second aim is to evaluate the acceptability and tolerability of, and adherence to,
 CBTx-TBI in a randomized waitlist-controlled, 12-week pilot trial (N=40).

 A third, exploratory aim is to evaluate the potential efficacy of CBTx-TBI for MDD in the
 randomized pilot trial (N=40) and possible moderators and mediators of outcome.
The primary aim of this study is to develop a highly acceptable, manualized treatment
 (CBTx-TBI) for MDD in patients with moderate to severe TBI. After developing the manual
 (Phase 1), a nonrandomized trial (Phase 2) will be conducted to test its acceptability and
 tolerability. Based on objective and qualitative feedback from participants and input from
 mentors and consultants, the CBTx-TBI manual will be revised (Phase 3). The investigators
 will then pilot test the efficacy of the intervention to reduce depressive symptoms (IDS-C)
 after 12 weeks using the revised CBTx-TBI manual compared to a waitlist control group in a
 randomized pilot trial (Phase 4). Once the randomized pilot study is complete, the CBTx-TBI
 manual will be finalized with additional feedback from subjects, mentors, and therapists.

 For both phases of recruitment, the same study procedures will be used (unless procedures are
 modified in Phase 3). The proposed study involves the following points of contact: (1)
 Obtaining informed consent and screening (may be broken up into multiple visits), (2)
 biweekly clinician assessments of depressive and neuropsychiatric symptoms (weeks 2, 4, 6, 8,
 10), (3) weekly self-report assessments of depressive symptoms for those receiving the
 intervention, (4) 12 weekly individual CBTx-TBI sessions for those randomized to the
 intervention, (5) a comprehensive assessment at week 12 (primary endpoint), which includes
 the neuropsychological battery, and (6) a 3-month follow-up assessment for those who received
 the intervention (randomized pilot only, phase 4). Assessment visits during the 12 weeks of
 treatment may be completed by phone. The week 12 visit can be split into two parts, with the
 neuropsychological assessment occurring during the second part, in order to accommodate
 subjects' potential limitations due to fatigue.
Inclusion Criteria:

 1. Adults aged 18 and older

 2. English language proficiency

 3. Ability to provide written, informed consent; OR consent provided by legally
 authorized representative with assent from subject

 4. Ability to see and hear (hearing or visual loss cannot impair ADLs or in-room
 conversation)

 5. Has access to a smartphone/tablet/computer with internet and video capabilities for
 virtual sessions

 6. Having been hospitalized for moderate to severe TBI that occurred at least 3 months
 prior to study entry

 7. Meeting ANY ONE of the following severity criteria, as documented in electronic
 medical record (EPIC) or available outside records:

 1. GCS 3-12 with GCS motor score ≤ 5 within 4 hours after injury

 2. GCS 3-12 with GCS motor score =6 within 4 hours after injury AND documented
 intracranial abnormalities on imaging

 3. GCS 13-15 within 4 hours after injury AND documented intracranial abnormalities
 on imaging

 4. Loss of consciousness (LOC) > 30 min.

 5. Post-traumatic amnesia (PTA) > 24 hours

 8. Out of PTA at the time of enrollment (GOAT>75)

 9. Clinically significant depressive symptoms: meets criteria for Major Depressive
 Episode on the MINI or has a total score ≥ 23 on the Inventory of Depressive
 Symptomatology - Clinician rated (IDS-C)

 Exclusion Criteria:

 1. Uncontrolled medical illness

 2. Behavioral dyscontrol, defined as the presence of verbally or physically aggressive
 behavior in the past month, as evidenced in medical records, pre-screening interviews,
 or observed by any study staff

 3. Presents with PTSD as the primary diagnosis, as determined by a clinician

 4. Substance use disorder, moderate or severe, within the past 6 months

 5. Has bipolar disorder, a primary psychotic disorder or current psychotic symptoms, or
 acute suicidality or homicidality

 6. Currently receiving regular (≥ 2 times/ mo.) psychosocial treatment for depression

 7. Has participated in CBT for depression within the past 6 months

 8. Individuals with history of dementia or severe cognitive impairment that is not
 related to TBI (e.g., cognitive impairment requiring assistance with basic activities
 of daily living, such as getting ready in the morning)