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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called Neurobehavioral Affective Control Training (N-ACT), designed to help individuals manage emotions better by reducing impulsivity and constant negative thinking. It targets those who often struggle to control their emotions, act without thinking, or dwell on negative thoughts. Participants will engage in training sessions with a coach over two months. Individuals living in California who face these emotional challenges might be suitable candidates. The trial compares this training program to a group that waits two months before starting the program. As an unphased trial, this study provides a unique opportunity to explore innovative emotional management techniques.

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 prior data suggests that this cognitive training program is safe for improving emotion regulation?

Research has shown that Neurobehavioral Affective Control Training (N-ACT) uses safe, non-invasive methods like real-time brain scans (fMRI) and brain wave monitoring (EEG) to help manage emotions. In earlier studies, healthy participants reported no major safety issues with this training, indicating that N-ACT is generally well-tolerated. Participants experienced no harmful effects, making it a promising option for those seeking to improve emotional control without the risks of more invasive treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Neurobehavioral Affective Control Training (N-ACT) technique because it offers a novel approach to managing emotional instability by directly targeting affective control through neurobehavioral training. Unlike traditional methods that may rely on medication or talk therapy alone, N-ACT focuses on enhancing emotional regulation skills through structured, real-time interventions. This technique could potentially lead to more rapid and sustainable improvements in emotional stability, offering a promising alternative to conventional treatments.

What evidence suggests that this cognitive training program is effective for improving emotion regulation?

Research shows that Neurobehavioral Affective Control Training (N-ACT), which participants in this trial may receive, might help people manage their emotions better. This program uses computer exercises to teach emotion management skills. In past studies, similar training reduced depression symptoms in people with major depressive disorder compared to those who did not receive the training. Additionally, practicing these emotional tasks made the brain's emotion-processing more efficient. These results suggest that N-ACT could help with impulsive behavior and overthinking related to emotions, common issues in emotion regulation problems. ^{1 3 5 6 7}

Who Is on the Research Team?

J.D. Allen, Ph.D.

Principal Investigator

University of California, Berkeley

Åsa Hammar, Ph.D.

Principal Investigator

University of Bergen

Sheri L. Johnson, Ph.D.

Principal Investigator

University of California, Berkeley

Are You a Good Fit for This Trial?

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

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06226467

NCT06226467 | Neurobehavioral Affective Control Training The primary aim of this study is to examine the acceptability, efficacy, and feasibility of Neurobehavioral Affective Control Training (N-ACT) as a novel ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39970439/

Protocol for a Pilot Randomized Waitlist-Controlled Trial The N-ACT program uses computerized adaptive behavioral tasks to strengthen the affective control processes theoretically and empirically linked ...

3. withpower.com withpower.com/trial/phase-affective-symptoms-2024-cc8c8

Affective Control Training for Emotional Instability Affect Regulation Training (ART) significantly reduced depressive symptoms in 218 individuals with major depressive disorder compared to a waitlist control ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06226467/neurobehavioral-affective-control-training

Neurobehavioral Affective Control Training The primary aim of this study is to examine the acceptability, efficacy, and feasibility of Neurobehavioral Affective Control Training (N-ACT) ...

5. jneurosci.org jneurosci.org/content/33/12/5301.short

Training the Emotional Brain: Improving Affective Control ... Here we show, using behavioral and fMRI measures, that 20 d of training on a novel emotional WM protocol successfully enhanced the efficiency of this ...

6. trialx.com trialx.com/clinical-trials/listings/302548/neurobehavioral-affective-control-training/

Neurobehavioral Affective Control Training Overview. The goal of this clinical trial is to test a new cognitive training program to improve emotion regulation in adults.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11888066/

Cognitive Training for Emotion-Related Impulsivity and ... This research will evaluate a novel intervention, neurobehavioral affective control training (N-ACT), which is designed to target two trait-like facets of ...