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

NCT03307070 | Completed DMC

• 1 other identifier: 2016P002823
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (4)

• Feasibility - retention/completion rates

  For examining the feasibility of treatment with CBT-TBI, descriptive analyses will be conducted to assess participants' retention/completion rates across study visits.

  12 weeks

• Feasibility - drop out rates

  For examining the feasibility of treatment with CBT-TBI, descriptive analyses will be conducted to assess participants' drop-out rates across study visits.

  12 weeks

• Feasibility - randomization, recruitment rates

  For examining the feasibility of treatment with CBT-TBI, descriptive analyses will be conducted to assess rate of recruitment and randomization (number randomized/number consented).

  12 weeks

• Acceptability - satisfaction with treatment

  Descriptive analyses will be conducted to assess participants' satisfaction with CBT-TBI (Satisfaction with Therapy and Therapist Scale - Revised).

  12 weeks

Secondary Outcomes (2)

• Efficacy - Treatment Response [Inventory of Depressive Symptomatology - Clinician Rated (IDS-C)] (Exploratory Aim)

  12 weeks

• Efficacy - Treatment Response [Inventory of Depressive Symptomatology - Clinician Rated (IDS-C)] (Exploratory Aim)

  12 weeks

Study Arms (2)

Active Group

ACTIVE COMPARATOR

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

Waitlist Control

OTHER

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

Interventions

Cognitive Behavioral Therapy for individuals with TBI BEHAVIORAL

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.

Active Group

Waitlist Control OTHER

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.

Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Spaulding Rehabilitation Hospital: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 34662285 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Brain Injuries, Traumatic

Interventions

Cognitive Behavioral Therapy; Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Radiotherapy; Therapeutics; Investigative Techniques

Study Officials

• Lauren B Fisher, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Model Details: 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.

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 11, 2017
• Study Start: September 23, 2017
• Primary Completion: November 18, 2022
• Study Completion: November 28, 2022
• Last Updated: April 10, 2023

Record last verified: 2023-04

Locations

US (1)