Feedback Timing During Learning for TBI with Depression
Trial Summary
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.
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.12345
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.12346
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.12347
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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.
Test
Participants are presented with words in a multiple-choice format outside the scanner to evaluate the influence of feedback on learning.
Follow-up
Participants are monitored for any additional insights or data collection post-experiment.
Treatment Details
Interventions
- Learning through feedback
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kessler Foundation
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Moss Rehabilitation Research Institute
Collaborator