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Clinical Trial Summary

Cognitive behavioral therapy for major depressive disorder (MDD) was adapted for individuals with moderate to severe traumatic brain injury (TBI) (CBT-TBI). A structured, treatment manual was developed. The primary aim is to evaluate the acceptability and tolerability of, and adherence to, CBT-TBI in a randomized waitlist-controlled, 12-week pilot trial (N=40). The exploratory aim is to evaluate the potential efficacy of CBT-TBI for MDD in the randomized pilot trial (N=40) and possible moderators and mediators of outcome.


Clinical Trial Description

The primary aim of this study is to develop a highly acceptable, manualized treatment (CBT-TBI) for MDD in patients with moderate to severe TBI. Initial feasibility data from a small, open pilot will inform the randomized controlled trial. Primary analyses will examine feasibility and acceptability of the intervention. The investigators will then pilot test the efficacy of the intervention to reduce depressive symptoms (IDS-C) after 12 weeks compared to a waitlist control group. 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 CBT-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. 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. Procedures for this study were all conducted remotely after March 17, 2020. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03307070
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Completed
Phase N/A
Start date September 23, 2017
Completion date November 28, 2022

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