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

Trial Summary

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 data supports the idea that Feedback Timing During Learning for TBI with Depression is an effective treatment?

The available research shows that Feedback Timing During Learning, which includes methods like Behavioral Activation Therapy, has mixed results for treating depression in people with traumatic brain injury (TBI). One study found that Behavioral Activation Therapy had some positive effects on depression symptoms and quality of life, even though it didn't significantly increase participation in activities or improve mood on average. Another study highlighted that feedback, such as video feedback, can improve self-awareness in people with TBI. While these findings suggest some benefits, the effectiveness of this treatment compared to other therapies like cognitive behavioral therapy is still uncertain, as existing therapies have shown mixed results. ^{1 2 3 4 5}

What safety data exists for feedback-based therapies in TBI with depression?

The research indicates that feedback-based therapies, including Behavioral Activation (BA) and Cognitive Behavioral Therapy (CBT), have been explored for treating depression in individuals with traumatic brain injury (TBI). While these therapies show promise, particularly BA for its suitability for brain impairment, the studies primarily focus on feasibility, acceptability, and potential efficacy rather than explicit safety data. The studies suggest that BA is less cognitively demanding and may be effective, but there is limited evidence on its impact on participation and mood. Safety concerns are not explicitly detailed, but the interventions are generally non-pharmacological and involve structured activities, which are typically considered safe. Further research may be needed to comprehensively assess safety outcomes. ^{1 2 3 4 6}

Is learning through feedback a promising treatment for TBI with depression?

Yes, learning through feedback is a promising treatment for TBI with depression. It helps improve self-awareness, which is important for learning and using daily life strategies. Behavioral Activation, a part of feedback therapy, encourages engaging in positive activities and shows promise in improving mood and quality of life. ^{1 2 3 4 7}

What is the purpose of this trial?

The goal of this proposal is to examine the influence of feedback timing on learning and brain function in individuals with moderate-to-severe traumatic brain injury (TBI), with and without depression.

Research Team

Ekaterina Dobryakova, PhD

Principal Investigator

Kessler Foundation

Eligibility Criteria

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

I am between the ages of 18 and 65.

Exclusion Criteria

Have you been diagnosed with Bipolar Disorder?

Have you been diagnosed with Schizophrenia?

I have taken corticosteroids in the past month.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

Self-awareness interventions that include feedback can lead to moderate improvements in self-awareness for adults with brain injuries, based on a systematic review of 12 studies, including 3 randomized controlled trials with 62 participants.

The effectiveness of these feedback interventions varied, and more research is needed to explore how they can be integrated into rehabilitation programs and their overall impact on functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feedback interventions for impaired self-awareness following brain injury: a systematic review. Schmidt, J., Lannin, N., Fleming, J., et al.[2019]

Children aged 6-13 years with moderate/severe traumatic brain injury (TBI) showed impaired generalization of learning from specific contexts to new situations, which was linked to higher rates of externalizing behavior problems as reported by parents.

The study found that while feedback learning from inconsistent information was not affected by TBI, poorer generalization of learning was a significant predictor of externalizing problems, suggesting that interventions targeting learning generalization may help address behavioral issues in these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feedback learning and behavior problems after pediatric traumatic brain injury. Königs, M., van Heurn, LW., Vermeulen, RJ., et al.[2019]

Behavioral Activation (BA) was tested in a 10-14 week study with three male participants who had significant depressive symptoms, but the intervention showed little evidence of increasing activity participation or improving average mood.

Despite the limited impact on participation and mood, some positive effects were observed in reducing depression symptoms and improving quality of life, suggesting that BA may still offer benefits for individuals with brain impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural activation therapy to improve participation in adults with depression following brain injury: A single-case experimental design study. Gertler, P., Tate, RL.[2022]

Both traditional (Activity Planning) and experiential (Activity Engagement) behavioral activation groups were found to be feasible and acceptable for adults with acquired brain injury, with 60 participants involved in the study.

The traditional Activity Planning group showed a greater reduction in anxiety and a higher percentage of participants achieving clinically meaningful improvements in activity levels compared to the experiential group and the waitlist group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mood, Activity Participation, and Leisure Engagement Satisfaction (MAPLES): results from a randomised controlled pilot feasibility trial for low mood in acquired brain injury. Kusec, A., Murphy, FC., Peers, PV., et al.[2023]

In a study involving 54 participants with traumatic brain injury (TBI), the combination of video and verbal feedback significantly reduced errors during a meal preparation task, indicating improved self-awareness compared to verbal feedback alone or experiential feedback.

The video plus verbal feedback method not only enhanced self-awareness but also did not negatively impact the participants' emotional status, suggesting it is a safe and effective rehabilitation strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video feedback on functional task performance improves self-awareness after traumatic brain injury: a randomized controlled trial. Schmidt, J., Fleming, J., Ownsworth, T., et al.[2022]

A randomized controlled trial is being set up to evaluate the effectiveness of behavioral activation treatments for depression and anxiety in 60 individuals with moderate to severe traumatic brain injury (TBI), at least 6 months post-injury.

The trial will compare an 8-session behavioral activation program, which includes both in-person and phone sessions, against a single session followed by 8 weeks of text message reminders, aiming to improve mood and activity levels in participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Activation Augmented With Mobile Technology for Depression and Anxiety in Chronic Moderate-Severe Traumatic Brain Injury: Protocol for a Randomized Controlled Trial. Hart, T., Rabinowitz, A., Vaccaro, M., et al.[2022]

In a study involving 36 individuals with traumatic brain injury (TBI), both verbal feedback and experiential feedback during meal preparation sessions led to improvements in occupational performance, as measured by the Meal Independence Rating Scale (MIRS).

However, the study found no significant enhancement in task-specific self-awareness from verbal feedback alone, suggesting that while performance improved, participants' self-perception of their abilities did not change significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exploratory study of verbal feedback on occupational performance for improving self-awareness in people with traumatic brain injury. Fleming, J., Tsi Hui Goh, A., Lannin, NA., et al.[2021]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Feedback interventions for impaired self-awareness following brain injury: a systematic review. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Feedback learning and behavior problems after pediatric traumatic brain injury. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Behavioural activation therapy to improve participation in adults with depression following brain injury: A single-case experimental design study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Mood, Activity Participation, and Leisure Engagement Satisfaction (MAPLES): results from a randomised controlled pilot feasibility trial for low mood in acquired brain injury. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Video feedback on functional task performance improves self-awareness after traumatic brain injury: a randomized controlled trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Behavioral Activation Augmented With Mobile Technology for Depression and Anxiety in Chronic Moderate-Severe Traumatic Brain Injury: Protocol for a Randomized Controlled Trial. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

An exploratory study of verbal feedback on occupational performance for improving self-awareness in people with traumatic brain injury. [2021]