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

Primary Purpose

Major Depressive Disorder, Traumatic Brain Injury

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive Behavioral Therapy for individuals with TBI

Waitlist Control

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
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
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)

Exclusion Criteria:

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)

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Active Group

Waitlist Control

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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.

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.

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).

Acceptability - satisfaction with treatment

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

Secondary Outcome Measures

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

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.

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

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.

Full Information

NCT ID

NCT03307070

First Posted

October 4, 2017

Last Updated

April 5, 2023

Sponsor

Massachusetts General Hospital

Collaborators

Spaulding Rehabilitation Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03307070

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

September 23, 2017 (Actual)

Primary Completion Date

November 18, 2022 (Actual)

Study Completion Date

November 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Spaulding Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder, Traumatic Brain Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Group

Arm Type

Active Comparator

Arm Description

Arm Title

Waitlist Control

Arm Type

Other

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy for individuals with TBI

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Waitlist Control

Intervention Description

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 Measure Information:

Title

Feasibility - retention/completion rates

Description

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

Time Frame

12 weeks

Title

Feasibility - drop out rates

Description

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

Time Frame

12 weeks

Title

Feasibility - randomization, recruitment rates

Description

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).

Time Frame

12 weeks

Title

Acceptability - satisfaction with treatment

Description

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

12 weeks

Title

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

Description

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lauren B Fisher, PhD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34662285

Citation

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.

Results Reference

derived

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

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