Online EmReg Training for Emotion Regulation

Overseen By Annell Ovalles, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Non-English speaking, others

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

Compensation: Varies

Number of Visits: 1

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the Online EmReg treatment for emotion regulation?

Research shows that emotion regulation training, including affect-focused methods and structured skill training, can significantly improve emotion regulation abilities. A meta-analysis found a large effect size (g = 0.82) for these methods, indicating their effectiveness in enhancing emotion regulation. ^{1 2 3 4 5}

Is Online EmReg Training for Emotion Regulation safe for humans?

The studies suggest that using neurofeedback and virtual reality for emotion regulation, like in the Emo-regulator system, is generally safe for humans. Participants in these studies did not report any significant safety concerns, and the methods were well-tolerated. ^{2 6 7 8 9}

How is the Online EmReg treatment different from other emotion regulation treatments?

Online EmReg is unique because it offers emotion regulation training through an online platform, which can be more accessible and convenient compared to traditional in-person therapy. It focuses on enhancing emotion regulation skills, potentially using structured psychoeducation and skills training, which are shown to have positive outcomes in improving emotion regulation. ^{1 2 4 10 11}

Research Team

Maria Kajankova

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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.

Inclusion Criteria

A computer and internet to conduct group treatment via telehealth

I am trained and experienced in Cognitive Behavioral Therapy.

Licensed psychologist, social worker, or mental health counselor

Exclusion Criteria

Non-English speaking

I am not willing to participate in group treatments online.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants complete a 3-hour on-demand training workshop on the intervention

1 day

1 visit (virtual)

Implementation

Participants implement the intervention into their routine clinical practice. Extended Training group attends bi-weekly consultation sessions for 3 months.

3 months

Bi-weekly consultations (virtual) for Extended Training group

Follow-up

Participants are monitored for effectiveness and satisfaction with the intervention

up to 15 months

Treatment Details

Interventions

• Consultation Sessions
• Online EmReg

Trial Overview 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.

Participant Groups

Group I: Extended Training Experimental Treatment 2 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 Training Active Control 1 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.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Findings from Research

A systematic review of 10 studies and a meta-analysis of 26 studies involving 84 clients showed that therapist methods for emotion regulation (ER) significantly improve patients' ability to manage their emotions, with a large effect size of 0.82 from pre- to post-treatment.

Both affect-focused methods and structured skills training are effective in enhancing emotion regulation, highlighting the importance of considering cultural backgrounds in therapy to tailor approaches for individual patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing emotion regulation. Iwakabe, S., Nakamura, K., Thoma, NC.[2023]

The Emo-regulator, a training system combining virtual reality and EEG-based neurofeedback, effectively improved emotion regulation in subjects over a two-week period, as evidenced by enhanced ability to down-regulate negative emotions.

Participants reported above-average usability of the Emo-regulator, indicating that it not only helps in emotional management but is also user-friendly, promoting the use of cognitive reappraisal techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emo-regulator: An emotion-regulation training system fusing virtual reality and EEG-based neurofeedback. Yu, M., Bai, Y., Li, Y.[2023]

The CanCope Mind (CM) intervention, an Internet-based adaptation of the Unified Protocol, significantly improved emotion regulation strategies in cancer survivors, with moderate-to-large effect sizes (SMDs from 0.44 to 0.88) observed at post-intervention and maintained at 3-month follow-up.

Compared to the lifestyle-focused control group, CM participants showed greater improvements in key areas such as beliefs about emotions, mindfulness, and cognitive reappraisal, suggesting that this targeted approach may enhance emotional functioning and well-being in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting emotional regulation using an Internet-delivered psychological intervention for cancer survivors: A randomized controlled trial. Smith, IS., Bind, MA., Weihs, KL., et al.[2023]

The Czech translation of the Emotion Regulation Skills Questionnaire (ERSQ) is a reliable tool for measuring nine emotion regulation skills in a clinical sample of 427 patients, showing strong internal consistency and a robust eight-dimensional factor structure.

The study identified key emotional regulation skills, particularly Modification, Bodily sensations, and Readiness for confrontation, as central to effective emotion regulation, highlighting the questionnaire's utility in understanding and treating mood and neurotic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Czech version of the Emotion Regulation Skills Questionnaire (ERSQ): Psychometric evaluation and network model in an adult clinical sample. Klocek, A., Řiháček, T., Cígler, H.[2022]

In a study involving 432 inpatients with major depressive disorder (MDD), integrating emotion regulation training (CBT-ERT) with routine cognitive behavioral therapy (CBT) led to significantly better outcomes, with response rates of 84.9% for CBT-ERT compared to 75.5% for CBT alone.

Participants receiving CBT-ERT not only showed greater reductions in depression symptoms but also improved their emotional well-being and regulation skills, highlighting the importance of addressing emotion regulation in treating MDD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotion regulation skills training enhances the efficacy of inpatient cognitive behavioral therapy for major depressive disorder: a randomized controlled trial. Berking, M., Ebert, D., Cuijpers, P., et al.[2022]

Participants in the study were able to voluntarily enhance their positive emotional states using real-time functional MRI neurofeedback, which suggests that emotion regulation networks can be actively modulated.

The training led to increased activity in key brain regions associated with emotion regulation, such as the insula and amygdala, indicating potential therapeutic applications for treating neurological and psychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-regulating positive emotion networks by feedback of multiple emotional brain states using real-time fMRI. Li, Z., Tong, L., Wang, L., et al.[2018]

The study demonstrated that healthy participants could effectively down-regulate activity in the right amygdala using real-time functional MRI (rtfMRI) neurofeedback while exposed to negative emotional stimuli, suggesting a potential method for emotion regulation.

This approach, which involved four training sessions with six participants, indicates that rtfMRI neurofeedback could be a promising tool for treating emotional disorders by targeting the overactive amygdala, which is often dysregulated in such conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time neurofeedback using functional MRI could improve down-regulation of amygdala activity during emotional stimulation: a proof-of-concept study. Brühl, AB., Scherpiet, S., Sulzer, J., et al.[2021]

In a study involving 48 healthy female participants, real-time functional MRI neurofeedback (rt-fMRI-NF) training showed that providing feedback on amygdala activation during exposure to aversive scenes can help improve the down-regulation of amygdala activity.

Participants who received amygdala feedback demonstrated a significant ability to down-regulate amygdala activation in a subsequent test without feedback, suggesting that this neurofeedback training may be beneficial for individuals with emotion dysregulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Down-regulation of amygdala activation with real-time fMRI neurofeedback in a healthy female sample. Paret, C., Kluetsch, R., Ruf, M., et al.[2021]

In a study involving 13 participants, real-time fMRI was used to train individuals to self-regulate their emotional brain networks, showing that they could effectively upregulate areas like the insula and amygdala after a short training period.

The successful upregulation of these emotion networks was associated with increased activation in other brain regions, such as the precuneus and medial prefrontal cortex, indicating the potential for fMRI-based neurofeedback to be developed as a therapeutic tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback: A promising tool for the self-regulation of emotion networks. Johnston, SJ., Boehm, SG., Healy, D., et al.[2009]

The 18-item version of the Cognitive Emotion Regulation Questionnaire (CERQ-18) demonstrated better internal structure and reliability compared to the 27-item version (CERQ-27) in a study involving the Argentinean population.

Both versions of the CERQ showed similar associations with the Difficulties in Emotion Regulation Scale (DERS), but the CERQ-18 is recommended for use due to its more consistent psychometric properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric Analysis of Two Brief Versions of the CERQ in the Argentinean Population: CERQ-18 and CERQ-27. Dominguez-Lara, S., Moretti, L., Ezequiel Flores-Kanter, P., et al.[2023]

A deep multimodal fusion model was successfully trained to estimate emotion dysregulation in adults using a small sample of 248 participants, demonstrating a strong correlation (average Pearson r = 0.55) with established measures of emotional regulation.

The study suggests that the Multimodal Developmental Profile, combined with this innovative methodology, can provide a valid and reliable assessment of emotion dysregulation, paving the way for future research and applications in psychometry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic Assessment of Emotion Dysregulation in American, French, and Tunisian Adults and New Developments in Deep Multimodal Fusion: Cross-sectional Study. Parra, F., Benezeth, Y., Yang, F.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Enhancing emotion regulation. [2023]

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

Emo-regulator: An emotion-regulation training system fusing virtual reality and EEG-based neurofeedback. [2023]

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

Targeting emotional regulation using an Internet-delivered psychological intervention for cancer survivors: A randomized controlled trial. [2023]

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

Czech version of the Emotion Regulation Skills Questionnaire (ERSQ): Psychometric evaluation and network model in an adult clinical sample. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Emotion regulation skills training enhances the efficacy of inpatient cognitive behavioral therapy for major depressive disorder: a randomized controlled trial. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Self-regulating positive emotion networks by feedback of multiple emotional brain states using real-time fMRI. [2018]

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

Real-time neurofeedback using functional MRI could improve down-regulation of amygdala activity during emotional stimulation: a proof-of-concept study. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Down-regulation of amygdala activation with real-time fMRI neurofeedback in a healthy female sample. [2021]

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

Neurofeedback: A promising tool for the self-regulation of emotion networks. [2009]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

Psychometric Analysis of Two Brief Versions of the CERQ in the Argentinean Population: CERQ-18 and CERQ-27. [2023]

11. Canada pubmed.ncbi.nlm.nih.gov

Automatic Assessment of Emotion Dysregulation in American, French, and Tunisian Adults and New Developments in Deep Multimodal Fusion: Cross-sectional Study. [2022]