An interventional study of Cognitive Behavioral Therapy for individuals with TBI and Waitlist Control in Major Depressive Disorder and Traumatic Brain Injury, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-10.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.
This study's enrollment of 62 is below the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Meeting ANY ONE of the following severity criteria, as documented in electronic medical record (EPIC) or available outside records:
Exclusion Criteria:
Participants who are randomized to begin the Cognitive Behavioral Therapy for individuals with TBI immediately after screening. This treatment is a version of Cognitive Behavioral Therapy (CBT) adapted specifically for patients who have experienced a moderate to severe Traumatic Brain Injury (TBI).
Behavioral: Cognitive Behavioral Therapy for individuals with TBI
Participants who are randomized to be put on a waitlist after screening. After 12 weeks of being on the waitlist, participants will be offered the Cognitive Behavioral Therapy for individuals with TBI
Other: Waitlist Control
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.
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
Documents are hosted by the registry — open the source record to download them.
Ran from Sep 2017 to primary completion in Nov 2022, 61 months.
Of 612 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's 61 months is above that.
Counting every sponsor, half of 652 studies reached it within 30 months; a quarter within 16 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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