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

April 5, 2023 updated by: Lauren Fisher, Massachusetts General Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility - retention/completion rates
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
Descriptive analyses will be conducted to assess participants' satisfaction with CBT-TBI (Satisfaction with Therapy and Therapist Scale - Revised).
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy - Treatment Response [Inventory of Depressive Symptomatology - Clinician Rated (IDS-C)] (Exploratory Aim)
Time Frame: 12 weeks

The IDS-C is a 30-item clinician rated scale that assesses severity of depression. Scores range from 0 to 84, with higher scores indicative of greater depression severity.

Descriptive analyses will be performed for percentage of responders (defined as 50% improvement on the IDS-C total) and remitters (≤6 on IDS-C total) at the end of treatment. The percent of responders and remitters in each group will be computed in order to estimate an effect size for a larger trial.
12 weeks
Efficacy - Treatment Response [Inventory of Depressive Symptomatology - Clinician Rated (IDS-C)] (Exploratory Aim)
Time Frame: 12 weeks

The IDS-C is a 30-item clinician rated scale that assesses severity of depression. Scores range from 0 to 84, with higher scores indicative of greater depression severity.

Change in depressive severity (IDS-C total) scores from baseline to post-treatment will also be analyzed.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Spaulding Rehabilitation Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 23, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 18, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016P002823

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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