Feedback Timing During Learning for TBI with Depression

Overseen By Ekaterina Dobryakova, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Must not be taking: Corticosteroids

Disqualifiers: Neurological disease, Alcohol abuse, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the timing of feedback affects learning and brain function in individuals with moderate-to-severe traumatic brain injuries (TBI) and those with both TBI and depression. Participants will learn through feedback, a form of cognitive behavioral therapy, and researchers aim to assess its effectiveness across different groups: those with only TBI, those with TBI and depression, and healthy individuals. It suits individuals who have experienced a TBI with significant memory or consciousness issues, have been diagnosed with depression, or are healthy without brain injuries or mental health issues. As an unphased trial, this study offers a unique opportunity to contribute to foundational research that could enhance future therapies for TBI and depression.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop your current medications. However, if you have had corticosteroid treatment less than a month ago, you may be excluded from participating.

What prior data suggests that learning through feedback is safe for individuals with TBI and depression?

Research shows that treatments using feedback are generally safe for people with traumatic brain injury (TBI) and depression. Many studies have examined cognitive-behavioral therapies, which often incorporate feedback as a key component. These therapies are well-received and have proven effective in reducing symptoms of depression. One study found that people who received cognitive-behavioral therapy showed more improvement in their symptoms and expressed greater satisfaction with their care compared to those who received standard care.

Although detailed safety data specifically for feedback-based learning isn't available, using feedback in therapy is common and usually safe. This trial is labeled as "Not Applicable" for a specific phase, indicating it is more educational rather than involving a new drug or invasive treatment. Therefore, it is likely to be safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique approach to helping individuals with traumatic brain injury (TBI) and depression learn more effectively through feedback. Unlike standard treatments for TBI and depression, which often involve medication and therapy, this approach focuses on optimizing the timing of feedback during learning tasks. By tailoring feedback to individual needs, it may enhance cognitive recovery and mood improvements more efficiently. This trial aims to uncover new insights into how timely feedback can impact rehabilitation for those with TBI and depression, potentially offering a novel, non-pharmacological method to support recovery.

What evidence suggests that learning through feedback could be effective for TBI with depression?

Research has shown that learning through feedback, which participants in this trial may receive, can help manage depression, especially when combined with methods like cognitive behavioral therapy (CBT). This trial will explore different treatment arms, including those for individuals with traumatic brain injury (TBI) and major depressive disorder (MDD). Studies have found that adapting CBT for people with TBI improves their emotional health. For those with MDD, treatments like behavioral activation, which involves encouraging enjoyable activities, have sometimes been as effective as medication. These approaches help the brain learn and adapt in new ways, offering hope for people with both TBI and depression. ^{2 3 4 6 7}

Who Is on the Research Team?

Ekaterina Dobryakova, PhD

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

This trial is for English-speaking, right-handed adults aged 18-65 with traumatic brain injury (TBI), with or without depression. They must have normal or corrected-to-normal vision and not be pregnant. Excluded are those with other neurological diseases, substance abuse history, metal in the body, MRI restrictions, claustrophobia, recent corticosteroid treatment, or conditions like epilepsy.

Inclusion Criteria

Age between 18 and 65

Diagnosed with a TBI

For the past two weeks, have you felt depressed, down, sad, empty or hopeless for most of the day, nearly every day?

Exclusion Criteria

Have you been diagnosed with Bipolar Disorder?

Have you been diagnosed with Schizophrenia?

I have taken corticosteroids in the past month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Experiment

Participants study word pairs outside the MRI scanner, then perform a multiple-choice task inside the scanner with feedback presented immediately or after a delay.

1 day

1 visit (in-person)

Test

Participants are presented with words in a multiple-choice format outside the scanner to evaluate the influence of feedback on learning.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any additional insights or data collection post-experiment.

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Learning through feedback

Trial Overview The study investigates how feedback timing affects learning and brain function in individuals with TBI. It specifically looks at differences between those who have depression and those who do not when receiving learning feedback.

How Is the Trial Designed?

Group I: Traumatic Brain Injury (TBI) with MDD Experimental Treatment 1 Intervention

Individuals with moderate-to-severe injury severity, defined as post-traumatic amnesia lasting more than 24hrs, loss of consciousness lasting more than 30 min, Glasgow Coma Scale (GCS) score less than 13. In addition, individuals will have a diagnosis of major depressive disorder (MDD) as per DSM-5.

Group II: Traumatic Brain Injury (TBI) Experimental Treatment 1 Intervention

Individuals with moderate-to-severe injury severity, defined as post-traumatic amnesia lasting more than 24hrs, loss of consciousness lasting more than 30 min, Glasgow Coma Scale (GCS) score less than 13.

Group III: Major Depressive Disorder (MDD) Experimental Treatment 1 Intervention

Individuals meeting criteria for major depressive disorder (MDD) including qualifiers 'in partial remission' or 'in full remission' if they are actively in treatment for the condition and still carry the depression diagnosis.

Group IV: Healthy Individuals Experimental Treatment 1 Intervention

Healthy individuals without psychiatric and neurological conditions.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Moss Rehabilitation Research Institute

Collaborator

Trials

12

Recruited

10,100+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722924000634

Adapting Cognitive Behavioral Therapy for Depression ... This case study describes a cognitive-behavioral treatment for depression adapted for individuals with traumatic brain injury (CBT-TBI)

2. thejcn.com thejcn.com/DOIx.php?id=10.3988/jcn.2024.0148

Behavioral Activation and Brain Network Changes in ... The results showed that the efficacy of BA was comparable to that in pharmacotherapy in the acute treatment of MDD, and better than CT in ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2590109519300291

Behavioral Activation Augmented With Mobile Technology ... A randomized controlled trial for depression or anxiety after moderate to severe traumatic brain injury (TBI), which will test 2 treatments based on behavioral ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12331015/

Adapting Cognitive Behavioral Therapy for Depression ... Efforts to adapt CBT to compensate for the neuropsychiatric sequelae of TBI have shown promise in improving emotional well-being (Bradbury et al., 2008) and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4273196/

Telephone and In-Person Cognitive Behavioral Therapy for ... CBT participants reported significantly more symptom improvement (p=0.010) and greater satisfaction with depression care (p<0.001), than did the UC group. In- ...

6. mdpi.com mdpi.com/1648-9144/61/3/431

Next-Generation Cognitive-Behavioral Therapy for ... CBT is now the dominant therapy for depressive disorders and is also generally recommended in treatment guidelines for patients with major depression [20,21].

7. sciencedirect.com sciencedirect.com/science/article/pii/S0165032725012339

Cognitive behavioral therapies are evidence-based – ... CBTs were most often of a contemporary type (51 %) and the mean attrition rate post-treatment was 21 %. Fifty-nine studies (95 %) included a measure of ...