Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 3, 2023
Date Accepted: Nov 13, 2024
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
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
ABSTRACT
Background:
Inhibitory deficits are common in psychopathology. Emotion-related impulsivity (ERI) and rumination are general risk factors for psychiatric distress that are similarly associated with dysfunctional inhibition – particularly in affective contexts. A number of cognitive remediation procedures have been developed to improve inhibitory control; however, most programs focus on “cold” cognition independent of affective processing. This pilot trial will gather preliminary evidence for a new cognitive training intervention targeting “hot” affective control (i.e., inhibitory functions during elevated emotional arousal) in a transdiagnostic sample of adults who report emotion regulation problems.
Objective:
This manuscript describes a protocol for a randomized waitlist-controlled trial to assess changes in ERI and rumination after Neurobehavioral Affective Control Training (N-ACT), an eight-week cognitive training intervention designed to improve emotional response inhibition and emotional working memory. We hypothesize that N-ACT will enhance performance on behavioral tasks indexing these affective control processes. We further expect that the magnitude of affective control changes will predict complementary decreases in ERI and rumination. Finally, we hypothesize that affective control improvement will correspond to reduced psychopathology symptoms following N-ACT. Exploratory analyses will examine potential mechanisms underlying hypothesized changes across these dimensions, spanning multiple levels of analysis, e.g., behavior, psychophysiology, and self-report.
Methods:
The final sample will comprise 80 adults who report high levels of ERI and/or rumination. Participants will be randomized to (1) begin the N-ACT program without delay or (2) join a waitlist condition and then complete N-ACT. Exclusion criteria (confirmed via clinical interview) include active alcohol/substance use disorders, psychosis, and suicide risk. At baseline and post-intervention, participants will complete online measures of emotion regulation and psychiatric symptoms, as well as in-person assessment of executive functioning, pupillometry, and skin conductance. Individuals assigned to the control group will undergo an identical assessment before joining the waitlist, followed by parallel assessments before and after N-ACT. Participants will also complete ecological assessment over one week at baseline and one week after completing N-ACT, in addition to follow-up self-report measures six weeks later.
Results:
This trial is funded by support from the University of California Board of Regents and the Peder Sather foundation (10/22–9/24). Recruitment is scheduled to begin in fall 2023. We will begin data analysis once data collection is complete, which is planned to occur in fall 2024.
Conclusions:
This research aims to determine the initial acceptability, efficacy, and feasibility of N-ACT, a novel cognitive remediation approach developed to address two key contributors to psychopathology: ERI and rumination. The N-ACT program specifically uses computerized adaptive behavioral tasks to strengthen affective inhibitory control processes theoretically and empirically linked to these characteristics. We ultimately seek to determine whether enhancing affective control through cognitive training produces downstream reductions in psychiatric symptoms via improved emotion regulation. Clinical Trial: ClinicalTrials.gov: NCTXXXX (Pending). Registered via Open Science Framework (OSF) on XX/XX/XXXX (Pending).
Citation
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