Status:
COMPLETED
Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Spaulding Rehabilitation Hospital
Conditions:
Major Depressive Disorder
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 develope...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Adults aged 18 and older
- English language proficiency
- Ability to provide written, informed consent; OR consent provided by legally authorized representative with assent from subject
- Ability to see and hear (hearing or visual loss cannot impair ADLs or in-room conversation)
- Has access to a smartphone/tablet/computer with internet and video capabilities for virtual sessions
- Having been hospitalized for moderate to severe TBI that occurred at least 3 months prior to study entry
- Meeting ANY ONE of the following severity criteria, as documented in electronic medical record (EPIC) or available outside records:
- GCS 3-12 with GCS motor score ≤ 5 within 4 hours after injury
- GCS 3-12 with GCS motor score =6 within 4 hours after injury AND documented intracranial abnormalities on imaging
- GCS 13-15 within 4 hours after injury AND documented intracranial abnormalities on imaging
- Loss of consciousness (LOC) \> 30 min.
- Post-traumatic amnesia (PTA) \> 24 hours
- Out of PTA at the time of enrollment (GOAT\>75)
- 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
- Uncontrolled medical illness
- 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
- Presents with PTSD as the primary diagnosis, as determined by a clinician
- Substance use disorder, moderate or severe, within the past 6 months
- Has bipolar disorder, a primary psychotic disorder or current psychotic symptoms, or acute suicidality or homicidality
- Currently receiving regular (≥ 2 times/ mo.) psychosocial treatment for depression
- Has participated in CBT for depression within the past 6 months
- 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)
Key Trial Info
Start Date :
September 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2022
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03307070
Start Date
September 23 2017
End Date
November 28 2022
Last Update
April 10 2023
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114