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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Cognitive Behavioral Therapy for depression that has been adapted for a population who has experienced a moderate to severe Traumatic Brain Injury. This is a 12 week long treatment for depression with weekly visits that challenges negative thoughts and behaviors. This version has been specifically developed for the study to account for specific cognitive needs of individuals who have experienced a moderate to severe TBI.
Participants will be randomized to a waitlist. They will attend biweekly study sessions for 12 weeks to track progress, but will receive their treatment as usual.
Massachusetts General Hospital
Boston, Massachusetts, United States
Feasibility - retention/completion rates
For examining the feasibility of treatment with CBT-TBI, descriptive analyses will be conducted to assess participants' retention/completion rates across study visits.
Time frame: 12 weeks
Feasibility - drop out rates
For examining the feasibility of treatment with CBT-TBI, descriptive analyses will be conducted to assess participants' drop-out rates across study visits.
Time frame: 12 weeks
Feasibility - randomization, recruitment rates
For examining the feasibility of treatment with CBT-TBI, descriptive analyses will be conducted to assess rate of recruitment and randomization (number randomized/number consented).
Time frame: 12 weeks
Acceptability - satisfaction with treatment
Descriptive analyses will be conducted to assess participants' satisfaction with CBT-TBI (Satisfaction with Therapy and Therapist Scale - Revised).
Time frame: 12 weeks
Efficacy - Treatment Response [Inventory of Depressive Symptomatology - Clinician Rated (IDS-C)] (Exploratory Aim)
The IDS-C is a 30-item clinician rated scale that assesses severity of depression. Scores range from 0 to 84, with higher scores indicative of greater depression severity. Descriptive analyses will be performed for percentage of responders (defined as 50% improvement on the IDS-C total) and remitters (≤6 on IDS-C total) at the end of treatment. The percent of responders and remitters in each group will be computed in order to estimate an effect size for a larger trial.
Time frame: 12 weeks
Efficacy - Treatment Response [Inventory of Depressive Symptomatology - Clinician Rated (IDS-C)] (Exploratory Aim)
The IDS-C is a 30-item clinician rated scale that assesses severity of depression. Scores range from 0 to 84, with higher scores indicative of greater depression severity. Change in depressive severity (IDS-C total) scores from baseline to post-treatment will also be analyzed.
Time frame: 12 weeks
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