Last updated on March 2019

Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury

Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT03307070

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