What side effects are associated with this type of intervention?

Common treatments for Traumatic Brain Injury (TBI) that focus on emotion regulation, such as cognitive-behavioral therapy (CBT), generally have minimal side effects. Patients may experience temporary increases in anxiety or emotional distress as they confront and process traumatic memories. Other potential side effects include fatigue, frustration, or emotional exhaustion due to the intensive nature of the therapy. However, these side effects are typically mild and transient, and the overall benefits of improved emotional regulation and reduced symptoms of TBI often outweigh these temporary discomforts.

What prior FDA approvals exist?

The provided context does not mention specific FDA-approved treatments for Traumatic Brain Injury (TBI). However, it does highlight the importance of cognitive-behavioral therapy (CBT) for patients with a history of TBI, particularly for conditions like PTSD. The Online EmReg trial focuses on training clinicians to deliver emotion regulation interventions, which aligns with the broader use of psychotherapeutic approaches such as CBT in managing emotional and psychological symptoms associated with TBI.

What other types of research exist?

Promising novel alternatives to Online EmReg for treating TBI patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in improving cognitive function and mood in TBI patients; 2) Cognitive Behavioral Therapy (CBT) delivered via videoconference, which has demonstrated feasibility and patient satisfaction; and 3) Biofeedback-assisted relaxation training, which has been effective in reducing pain and improving overall well-being in patients with chronic conditions, including TBI.

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Behavioral Intervention

Online EmReg Training for Emotion Regulation

N/A

Recruiting

Led By Maria Kajankova, PhD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find the best way to train clinicians to use an online program that helps people manage their emotions. It compares a brief training with a more comprehensive training that includes additional support. The goal is to see which method helps clinicians deliver the program more effectively.

Who is the study for?

This trial is for licensed psychologists, social workers, or mental health counselors with CBT training and experience treating people with TBI. They must be able to provide group treatment online, have at least 3 patients suitable for EmReg based on emotion regulation difficulties, and commit to study tasks. Those already trained in EmReg or unwilling to do telehealth are excluded.

What is being tested?

The trial tests two ways of training clinicians: Standard Training (a workshop) versus Extended Training (workshop plus bi-weekly consultations). The goal is to find the best method for teaching Online EmReg implementation and measure patient improvement using clinician-administered DERS.

What are the potential side effects?

Since this trial focuses on training methods rather than medical interventions, traditional side effects aren't applicable. However, participants may experience stress or time constraints due to study commitments like training sessions and data collection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Performance Evaluation (via Role Plays)

Provider Self-Efficacy Scale Score

Secondary study objectives

Acceptability of Intervention Measure (AIM)

Difficulties in Emotion Regulation Scale (DERS)

Feasibility of Intervention Measure (FIM) Scale

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Extended TrainingExperimental Treatment2 Interventions

Participants assigned to this arm will complete the same 3-hour training workshop on the intervention as Arm #1. After completing the training, participants will also be asked to implement the intervention into their routine clinical practice. However, participants in this group will be asked to attend bi-weekly consultation sessions with members of the study team for 3 months following training.

Group II: Standard TrainingActive Control1 Intervention

Participants assigned to this arm will complete a 3-hour training workshop on the intervention. After completing the training, participants will be asked to implement the intervention into their routine clinical practice.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Traumatic Brain Injury (TBI) include cognitive-behavioral therapy (CBT) and other emotion regulation interventions. These treatments work by helping patients develop strategies to manage cognitive and emotional challenges resulting from TBI. CBT, for example, focuses on changing negative thought patterns and behaviors, which can improve emotional regulation and reduce symptoms of anxiety and depression. This is crucial for TBI patients as emotional dysregulation can significantly impact their quality of life and hinder recovery. Training clinicians to effectively deliver these interventions, as studied in the Online EmReg trial, ensures that patients receive consistent and effective care, ultimately aiding in their rehabilitation and improving long-term outcomes.

Treatment for posttraumatic stress disorder in patients with a history of traumatic brain injury: A systematic review.Critical appraisal of systematic reviews of executive function treatments in TBI.