Neurobehavioral Affective Control Training — N-ACT  

Emotional Distress Clinical Trial

Official title: Neurobehavioral Affective Control Training (N-ACT): A Randomized Waitlist-controlled Pilot Trial to Evaluate a Novel Transdiagnostic Cognitive Remediation Program for Emotion-related Impulsivity and Rumination

Status Not yet recruiting

Clinical Trial Summary

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.

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.

Clinical Trial Description

This randomized waitlist-controlled pilot trial will enroll adult participants reporting high levels of rumination and/or emotion-related impulsivity. The primary aim of this study is to examine the acceptability, efficacy, and feasibility of Neurobehavioral Affective Control Training (N-ACT) as a novel therapeutic approach to reduce emotion-related impulsivity and rumination in adults by improving affective inhibitory control, or more specifically, two core hot executive functions: (1) emotional response inhibition and (2) emotional working memory. Secondarily, study investigators will test anticipated transfer effects of N-ACT on other behavioral indices of executive functioning (beyond emotional response inhibition and emotional working memory) and other subjective measures of emotion dysregulation (beyond trait emotion-related impulsivity and rumination), as well as on psychopathology symptom severity and functional impairment. Finally, the investigators will conduct exploratory analyses to examine potential mechanisms that might mediate and/or moderate predicted changes in emotion dysregulation, informing future work to systematically test these effects in a sufficiently-powered sample. In addition to performing intent-to-treat analyses, the investigators will conduct sensitivity analyses to evaluate the extent to which program adherence predicts hypothesized intervention effects. ;

Related Conditions & MeSH terms

• Affective Symptoms
• Emotional Distress
• Impulsive Behavior
• Mood Lability
• Psychopathology
• Rumination

• NCT number: NCT06226467
• Study type: Interventional
• Source: University of California, Berkeley
• Contact: J.D. Allen, Ph.D.
• Phone: (510) 519-4305
• Email: calmprogram@berkeley.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Completion date: September 2025