Online EmReg Training for Emotion Regulation

Recruiting in Palo Alto (17 mi)

Overseen by Maria Kajankova

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Non-English speaking, others

No Placebo Group

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.

Trial 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 (Behavioral Intervention)
• Online EmReg (Behavioral Intervention)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Icahn School of Medicine at Mount Sinai New York, NY

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Patients Recruited

579,000+

Findings from Research

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 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]

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]