Clinical trial NCT03307070: Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury
Official title: Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Traumatic Brain Injury
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Spaulding Rehabilitation Hospital
First posted: 2017-10-11
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study is a randomized, waitlist controlled trial. All participants randomized to waitlist were offered the opportunity to receive the intervention after completion of the waitlist.
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

1. Adults aged 18 and older
2. English language proficiency
3. Ability to provide written, informed consent; OR consent provided by legally authorized representative with assent from subject
4. Ability to see and hear (hearing or visual loss cannot impair ADLs or in-room conversation)
5. Has access to a smartphone/tablet/computer with internet and video capabilities for virtual sessions
6. Having been hospitalized for moderate to severe TBI that occurred at least 3 months prior to study entry
7. Meeting ANY ONE of the following severity criteria, as documented in electronic medical record (EPIC) or available outside records:

   1. GCS 3-12 with GCS motor score ≤ 5 within 4 hours after injury
   2. GCS 3-12 with GCS motor score =6 within 4 hours after injury AND documented intracranial abnormalities on imaging
   3. GCS 13-15 within 4 hours after injury AND documented intracranial abnormalities on imaging
   4. Loss of consciousness (LOC) \> 30 min.
   5. Post-traumatic amnesia (PTA) \> 24 hours
8. Out of PTA at the time of enrollment (GOAT\>75)
9. 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 Criteria:

1. Uncontrolled medical illness
2. 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
3. Presents with PTSD as the primary diagnosis, as determined by a clinician
4. Substance use disorder, moderate or severe, within the past 6 months
5. Has bipolar disorder, a primary psychotic disorder or current psychotic symptoms, or acute suicidality or homicidality
6. Currently receiving regular (≥ 2 times/ mo.) psychosocial treatment for depression
7. Has participated in CBT for depression within the past 6 months
8. 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)

Primary outcomes:
measure: Feasibility - retention/completion rates
timeFrame: 12 weeks
measure: Feasibility - drop out rates
timeFrame: 12 weeks
measure: Feasibility - randomization, recruitment rates
timeFrame: 12 weeks
measure: Acceptability - satisfaction with treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Efficacy - Treatment Response [Inventory of Depressive Symptomatology - Clinician Rated (IDS-C)] (Exploratory Aim)
timeFrame: 12 weeks
measure: Efficacy - Treatment Response [Inventory of Depressive Symptomatology - Clinician Rated (IDS-C)] (Exploratory Aim)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Lauren B Fisher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fisher LB, Tuchman S, Curreri AJ, Markgraf M, Nyer MB, Cassano P, Iverson GL, Fava M, Zafonte RD, Pedrelli P. Transitioning From In-Person to Remote Clinical Research on Depression and Traumatic Brain Injury During the COVID-19 Pandemic: Study Modifications and Preliminary Feasibility From a Randomized Controlled Pilot Study. JMIR Form Res. 2021 Dec 1;5(12):e28734. doi: 10.2196/28734.