Affective Control Training for Emotional Instability

(N-ACT Trial)

Overseen By JD Allen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Berkeley

Disqualifiers: Neurological disorders, Head injuries, Substance use, Psychosis, Suicidal ideation, others

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

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Neurobehavioral Affective Control Training (N-ACT) for emotional instability?

Research shows that training emotion regulation through real-time fMRI neurofeedback can help control emotions by reducing activity in the amygdala, a brain area involved in emotion. This approach has been effective in improving emotion regulation in conditions like borderline personality disorder and depression, suggesting potential benefits for emotional instability. ^{1 2 3 4 5}

Is Affective Control Training for Emotional Instability safe for humans?

The studies reviewed focus on neurofeedback and emotional skills training, which are generally considered safe. They involve non-invasive techniques like real-time fMRI and EEG to help regulate emotions, with no significant safety concerns reported in healthy participants. ^{2 6 7 8 9}

How is the treatment N-ACT different from other treatments for emotional instability?

N-ACT is unique because it focuses on training the brain's emotional control by enhancing working memory in an emotional context, which is different from traditional therapies that may not specifically target these cognitive processes. This approach aims to improve emotion regulation by strengthening the brain networks involved in managing emotions. ^{10 11 12 13 14}

What is the purpose of this trial?

The goal of this clinical trial is to test a new cognitive training program to improve emotion regulation in adults. The investigators' primary aim is to determine whether participating in this program addresses two key features of emotion dysregulation associated with psychiatric disorders: (1) emotion-related impulsivity and (2) rumination. The investigators will further evaluate participants' perceived acceptability and feasibility of treatment procedures. Secondarily, the investigators will examine the effects of this cognitive training intervention on psychiatric symptoms and overall functioning. The researchers will compare the cognitive training program to a waitlist control. Participants will be asked to complete eight weekly sessions (over two months) involving cognitive training exercises with a "coach", in addition to a baseline assessment before starting the intervention and post-treatment assessment. Each assessment includes a combination of in-person and remote data collection using self-report questionnaires, psychophysiology, and a neuropsychological battery. Participants will also complete one week of ecological momentary assessment before and after the intervention as well as a set of follow-up questionnaires administered remotely six weeks following their final training session. Researchers will compare participants randomly assigned to complete the intervention without delay to a control group of participants randomly assigned to a two-month waitlist before joining the intervention. Before beginning cognitive training, participants in the control condition will complete an additional pre-intervention/post-waitlist assessment, which will follow parallel procedures to the initial baseline assessment.

Research Team

J.D. Allen, Ph.D.

Principal Investigator

University of California, Berkeley

Sheri L. Johnson, Ph.D.

Principal Investigator

University of California, Berkeley

Åsa Hammar, Ph.D.

Principal Investigator

University of Bergen

Eligibility Criteria

This trial is for adults with mood symptoms, emotional distress, impulsivity, and related mental health issues. Participants should be able to complete eight weekly sessions of cognitive training and various assessments. Those with severe psychiatric disorders or conditions that might interfere with the study are likely excluded.

Inclusion Criteria

Current residency in the state of California

Elevated levels of rumination and/or emotion-related impulsivity

Exclusion Criteria

Insufficient English language literacy to understand study procedures (as assessed by self-report)

Careless or inattentive responding as indicated by failing 50% or more of 'attention check' items embedded in the online screening questionnaires, overly rapid responding, or qualitative review of long strings of identical entries on screening/baseline questionnaire items that suggest data invalidity

I have had a brain tumor, neurological issues, or significant head injuries.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline assessment including self-report questionnaires, psychophysiology, and a neuropsychological battery

1 week

1 visit (in-person and remote)

Pre-intervention Ecological Momentary Assessment (EMA)

Participants complete one week of ecological momentary assessment before the intervention

1 week

Treatment

Participants undergo eight weekly sessions of cognitive training exercises with a coach

8 weeks

8 visits (in-person and remote)

Post-treatment Assessment

Participants complete a post-treatment assessment with comparable measures to baseline

1 week

1 visit (in-person)

Post-intervention Ecological Momentary Assessment (EMA)

Participants complete a second week of ecological momentary assessment after the intervention

1 week

Follow-up

Participants complete follow-up questionnaires administered remotely six weeks following their final training session

6 weeks

Treatment Details

Interventions

• Neurobehavioral Affective Control Training

Trial Overview The trial tests a new program called Neurobehavioral Affective Control Training aimed at improving emotion regulation. It involves weekly sessions over two months, comparing immediate intervention participants to a waitlisted control group.

Participant Groups

Group I: Waitlist control Experimental Treatment 1 Intervention

Participants randomly assigned to the two-month waitlist control condition will be recontacted approximately 10 weeks after the baseline in-person assessment session (Week 1) to complete a second assessment session (with comparable measures) post-waitlist, prior to starting the N-ACT program. The post-waitlist assessment session (Week 11) after the waitlist period (Weeks 2-10) will precede a series of procedures equivalent to the experimental ("N-ACT without delay") arm: One subsequent week of pre-intervention (post-waitlist) ecological momentary assessment (EMA; Week 12), then eight weeks of N-ACT (Weeks 13-20), followed by a third and final in-person (post-intervention) assessment (Week 21) with parallel procedures to the baseline and post-waitlist sessions, as well as a second week of EMA (Week 22). All study procedures are identical between the two trial arms, with the exception of an added eight-week waitlist and post-waitlist assessment for participants in the control condition.

Group II: N-ACT without delay Experimental Treatment 1 Intervention

After a baseline in-person assessment session (Week 1), participants randomly assigned to the experimental condition (i.e., "N-ACT without delay") will complete one week of pre-intervention ecological momentary assessment (EMA; Week 2), then the intervention (Weeks 3-10), followed by a post-treatment in-person assessment session with comparable measures to baseline (Week 11) and a second week of (post-intervention) EMA (Week 12).

Who Is Running the Clinical Trial?

University of California, Berkeley

Lead Sponsor

Trials

193

Recruited

716,000+

University of Bergen

Collaborator

Trials

306

Recruited

695,000+

University College, London

Collaborator

Trials

884

Recruited

38,770,000+

Findings from Research

A study using ultra-high field (7T) fMRI evaluated the reliability of brain activity related to emotion regulation across three sessions, highlighting the importance of consistent measurements for clinical biomarkers.

Key brain regions involved in emotion regulation, such as the ventrolateral and dorsolateral prefrontal cortex, demonstrated high test-retest reliability, suggesting they are strong candidates for future research on individual differences in emotion regulation and potential neurobiological markers for affective disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Test-retest reliability of emotion regulation networks using fMRI at ultra-high magnetic field. Berboth, S., Windischberger, C., Kohn, N., et al.[2021]

In a study involving 15 healthy participants, training with real-time fMRI neurofeedback significantly reduced amygdala activity during emotional regulation tasks, indicating effective emotion control (p = 0.003).

Participants receiving feedback showed greater connectivity between the amygdala and brain regions involved in emotion regulation, suggesting that rt-fMRI neurofeedback could enhance learning strategies for managing emotions, with potential applications in psychotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training emotion regulation through real-time fMRI neurofeedback of amygdala activity. Herwig, U., Lutz, J., Scherpiet, S., et al.[2019]

Affect Regulation Training (ART) significantly reduced depressive symptoms in 218 individuals with major depressive disorder compared to a waitlist control group, with a moderate effect size (d = 0.56).

Improvements in emotion regulation skills were identified as a key mechanism behind the effectiveness of ART, suggesting that enhancing these skills can be beneficial in treating depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Affect regulation training reduces symptom severity in depression - A randomized controlled trial. Berking, M., Eichler, E., Luhmann, M., et al.[2020]

In a study involving 24 female patients with borderline personality disorder (BPD), real-time fMRI neurofeedback training successfully enabled participants to downregulate their amygdala activity, which is linked to emotion regulation issues.

Post-training assessments showed a significant decrease in BPD symptoms and emotion dysregulation, indicating potential improvements in emotional stability, although further research with a control group is necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved emotion regulation after neurofeedback: A single-arm trial in patients with borderline personality disorder. Zaehringer, J., Ende, G., Santangelo, P., et al.[2021]

The study validated the nursing diagnosis 'labile emotional control' in traumatic brain injury (TBI) outpatients, identifying 'leaving a social situation' and 'expression of emotions inconsistent with the triggering factor' as the main characteristics based on feedback from 31 expert nurses.

The diagnosis received a total validation score of 0.69, indicating its relevance and importance in clinical practice, highlighting the need for training nurses to recognize these subjective emotional characteristics in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Nursing Diagnosis "Labile Emotional Control" in Traumatic Brain Injury. Santos, ACFSD., Hora Mota, EC., Santos, VD., et al.[2020]

An online training program significantly improved socioemotional skills in 448 adults, enhancing their emotional awareness, mindfulness, and emotion regulation strategies compared to a placebo control.

Sustained improvements in emotional skills were observed at a 6-month follow-up for participants who completed the training, suggesting the program may offer protective benefits against emotional challenges, particularly during stressful times like the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in mindfulness, interoceptive and emotional awareness, emotion regulation, and interpersonal emotion management following completion of an online emotional skills training program. Smith, R., Persich, MR., Chuning, AE., et al.[2023]

A study involving 26 healthy participants with high anxiety demonstrated that real-time fMRI neurofeedback training can enhance connectivity between the ventrolateral prefrontal cortex and the amygdala, leading to significant reductions in anxiety levels.

The training not only improved connectivity during the session but also allowed participants to maintain control over this pathway three days later, suggesting a promising new method for managing anxiety through self-regulation of brain circuits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Time Functional Connectivity-Informed Neurofeedback of Amygdala-Frontal Pathways Reduces Anxiety. Zhao, Z., Yao, S., Li, K., et al.[2019]

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 study involved 180 healthy individuals undergoing a stressful military training program, where those receiving amygdala electrical fingerprint neurofeedback (Amyg-EFP-NF) showed improved stress coping abilities compared to control groups.

Amyg-EFP-NF specifically targeted amygdala activity, leading to significant neural changes, including reduced alexithymia and enhanced connectivity between the amygdala and prefrontal cortex, suggesting its potential as a scalable, non-pharmacological intervention for stress management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical fingerprint of the amygdala guides neurofeedback training for stress resilience. Keynan, JN., Cohen, A., Jackont, G., et al.[2019]

A 20-day training program focused on emotional working memory significantly improved the efficiency of the brain's frontoparietal network, which is crucial for both working memory and affective cognitive control.

Participants who underwent this emotional working memory training showed enhanced emotion regulation abilities compared to those who received placebo training, indicating that this approach could be beneficial in clinical and occupational settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training the emotional brain: improving affective control through emotional working memory training. Schweizer, S., Grahn, J., Hampshire, A., et al.[2023]

A pilot intervention training military veterans in emotion regulation strategies (Focused Attention and Cognitive Reappraisal) over 5-8 weeks showed significant improvements in psychological well-being, including enhanced working memory and self-efficacy.

Neuroimaging results indicated that the training led to changes in brain connectivity, suggesting that resilience and emotional well-being can be developed through targeted training, with observable effects on brain function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cultivating Affective Resilience: Proof-of-Principle Evidence of Translational Benefits From a Novel Cognitive-Emotional Training Intervention. Dolcos, S., Hu, Y., Williams, C., et al.[2021]

Mindfulness training enhances focused attention and alters brain activity in areas like the anterior cingulate cortex and lateral prefrontal cortex, which helps individuals manage negative emotions without relying on cognitive reappraisal.

This approach reduces automatic negative self-evaluation and increases tolerance for negative feelings, promoting self-compassion and empathy, particularly beneficial for patients with affective disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The mindful brain and emotion regulation in mood disorders. Farb, NA., Anderson, AK., Segal, ZV.[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]

Functional magnetic resonance imaging (fMRI)-based neurofeedback (NF) can effectively modulate the connectivity between the prefrontal cortex and amygdala in adolescent females, which is crucial for emotion regulation.

The study found that changes in brain connectivity due to NF were associated with improvements in emotional control abilities, and that neurotransmitter levels, particularly GABA, influenced the effectiveness of the NF intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulatory effects of dynamic fMRI-based neurofeedback on emotion regulation networks in adolescent females. Zich, C., Johnstone, N., Lührs, M., et al.[2021]

References

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

Test-retest reliability of emotion regulation networks using fMRI at ultra-high magnetic field. [2021]

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

Training emotion regulation through real-time fMRI neurofeedback of amygdala activity. [2019]

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

Affect regulation training reduces symptom severity in depression - A randomized controlled trial. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Improved emotion regulation after neurofeedback: A single-arm trial in patients with borderline personality disorder. [2021]

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

Validation of the Nursing Diagnosis "Labile Emotional Control" in Traumatic Brain Injury. [2020]

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

Improvements in mindfulness, interoceptive and emotional awareness, emotion regulation, and interpersonal emotion management following completion of an online emotional skills training program. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Real-Time Functional Connectivity-Informed Neurofeedback of Amygdala-Frontal Pathways Reduces Anxiety. [2019]

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

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

9. England pubmed.ncbi.nlm.nih.gov

Electrical fingerprint of the amygdala guides neurofeedback training for stress resilience. [2019]

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

Training the emotional brain: improving affective control through emotional working memory training. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Cultivating Affective Resilience: Proof-of-Principle Evidence of Translational Benefits From a Novel Cognitive-Emotional Training Intervention. [2021]

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

The mindful brain and emotion regulation in mood disorders. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

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

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

Modulatory effects of dynamic fMRI-based neurofeedback on emotion regulation networks in adolescent females. [2021]