Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury
Study Details
Study Description
Brief Summary
The first aim of this study is to develop a structured, cognitive behavioral treatment manual for major depressive disorder (MDD) adapted for individuals with moderate to severe traumatic brain injury (TBI) (CBTx-TBI), as well as evaluate its acceptability and tolerability in an open 12-week pilot trial (N=10).
The second aim is to evaluate the acceptability and tolerability of, and adherence to, CBTx-TBI in a randomized waitlist-controlled, 12-week pilot trial (N=40).
A third, exploratory aim is to evaluate the potential efficacy of CBTx-TBI for MDD in the randomized pilot trial (N=40) and possible moderators and mediators of outcome.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
The primary aim of this study is to develop a highly acceptable, manualized treatment (CBTx-TBI) for MDD in patients with moderate to severe TBI. After developing the manual (Phase 1), a nonrandomized trial (Phase 2) will be conducted to test its acceptability and tolerability. Based on objective and qualitative feedback from participants and input from mentors and consultants, the CBTx-TBI manual will be revised (Phase 3). The investigators will then pilot test the efficacy of the intervention to reduce depressive symptoms (IDS-C) after 12 weeks using the revised CBTx-TBI manual compared to a waitlist control group in a randomized pilot trial (Phase 4). Once the randomized pilot study is complete, the CBTx-TBI manual will be finalized with additional feedback from subjects, mentors, and therapists.
For both phases of recruitment, the same study procedures will be used (unless procedures are modified in Phase 3). 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 CBTx-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 (randomized pilot only, phase 4). Assessment visits during the 12 weeks of treatment may be completed by phone. 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Active Group 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
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.
|
| Other: Waitlist Control 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
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.
|
Outcome Measures
Primary Outcome Measures
- QIDS-C [administered biweekly for 12 weeks]
A 16-item, clinician rated scale assessing depression symptom severity
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults aged 18 and older
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English language proficiency
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Ability to provide written, informed consent; OR consent provided by legally authorized representative with assent from subject
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Ability to see and hear (hearing or visual loss cannot impair ADLs or in-room conversation)
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Has access to a smartphone/tablet/computer with internet and video capabilities for virtual sessions
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Having been hospitalized for moderate to severe TBI that occurred at least 3 months prior to study entry
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Meeting ANY ONE of the following severity criteria, as documented in electronic medical record (EPIC) or available outside records:
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GCS 3-12 with GCS motor score ≤ 5 within 4 hours after injury
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GCS 3-12 with GCS motor score =6 within 4 hours after injury AND documented intracranial abnormalities on imaging
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GCS 13-15 within 4 hours after injury AND documented intracranial abnormalities on imaging
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Loss of consciousness (LOC) > 30 min.
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Post-traumatic amnesia (PTA) > 24 hours
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Out of PTA at the time of enrollment (GOAT>75)
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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:
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Uncontrolled medical illness
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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
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Presents with PTSD as the primary diagnosis, as determined by a clinician
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Substance use disorder, moderate or severe, within the past 6 months
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Has bipolar disorder, a primary psychotic disorder or current psychotic symptoms, or acute suicidality or homicidality
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Currently receiving regular (≥ 2 times/ mo.) psychosocial treatment for depression
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Has participated in CBT for depression within the past 6 months
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
- Spaulding Rehabilitation Hospital
Investigators
- Principal Investigator: Lauren B Fisher, PhD, Massachusetts General Hospital
Study Documents (Full-Text)
More Information
Publications
None provided.- 2016P002823