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

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ClinicalTrials.gov Identifier: NCT03307070
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Spaulding Rehabilitation Hospital
Information provided by (Responsible Party):
Lauren Fisher, Massachusetts General Hospital

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
Major Depressive Disorder Traumatic Brain Injury Behavioral: Cognitive Behavioral Therapy for individuals with TBI Other: Waitlist Control Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Phase I of the study is an open trial with a single arm. Phase II of the study is a randomized, waitlist controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury
Actual Study Start Date : September 23, 2017
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


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.

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.




Primary Outcome Measures :
  1. QIDS-C [ Time Frame: administered biweekly for 12 weeks ]
    A 16-item, clinician rated scale assessing depression symptom severity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults aged 18 to 65, 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 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. 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. Presents with PTSD as the primary diagnosis, as determined by a clinician
  4. Substance abuse or dependence within the past six 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307070


Contacts
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Contact: Garrett Thomas, BA 617-724-3222 gthomas12@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Garrett Thomas    617-724-3222    gthomas12@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Spaulding Rehabilitation Hospital
Investigators
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Principal Investigator: Lauren B Fisher, PHD Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Lauren Fisher, Massachusetts General Hospital:
Study Protocol  [PDF] October 3, 2017
Statistical Analysis Plan  [PDF] October 10, 2017


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Responsible Party: Lauren Fisher, Clinical Psychologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03307070     History of Changes
Other Study ID Numbers: 2016P002823
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Wounds and Injuries
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System