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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03307070
• Other study ID #: 2016P002823
• Status: Completed
• Phase: N/A
• Start date: September 23, 2017
• Est. completion date: November 28, 2022

Study information

• Verified date: April 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 28, 2022
• Est. primary completion date: November 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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.	12 weeks
Secondary	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.	12 weeks