Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury

Description

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.

Study Start Date

September, 23 2017

Estimated Completion Date

June 2021

Interventions

  • Other: Waitlist Control
  • Behavioral: Cognitive Behavioral Therapy for individuals with TBI

Study ID

Massachusetts General Hospital -- 2016P002823

Status

Recruiting

Trial ID

NCT03307070

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

50

Sponsor

Massachusetts General Hospital

Inclusion Criteria

    1. Adults aged 18 to 50, inclusive 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. Ability to attend in-person, outpatient sessions 6. Having been hospitalized for moderate to severe TBI that occurred 6 months to 5 years 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. Current Major Depressive Episode as assessed by the MINI 10. If taking medication for depression, must have been on stable dose for 4 weeks prior to study entry and no changes during the study.

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. Meets criteria for PTSD, substance abuse or dependence within the past six months 4. Has bipolar disorder, a primary psychotic disorder or current psychotic symptoms, or acute suicidality or homicidality 5. Currently receiving regular (? 2 times/ mo.) psychosocial treatment for depression 6. Has participated in CBT for depression within the past 6 months

Gender

All

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (4)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Lisa Sangermano 617-724-3673 lsangermano@partners.org
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Lisa Sangermano 617-724-3673 lsangermano@partners.org
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Lisa Sangermano 617-724-3673 lsangermano@partners.org
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Lisa Sangermano 617-724-3673 lsangermano@partners.org

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.