Neurobehavioral Affective Control Training

Last updated: November 22, 2024
Sponsor: University of California, Berkeley
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bulimia

Treatment

Neurobehavioral Affective Control Training

Clinical Study ID

NCT06226467
2023-01-15949
  • Ages 18-65
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Current residency in the state of California

  • Elevated levels of rumination and/or emotion-related impulsivity

Exclusion

Exclusion Criteria:

  • Insufficient English language literacy to understand study procedures (as assessedby self-report)

  • Careless or inattentive responding as indicated by (a) failing 50% or more of "attention check" items embedded in the online screening questionnaires, (b) overlyrapid responding (i.e., mean response time of less than two seconds for multiplechoice items), or (c) qualitative review of long strings of identical entries onscreening/baseline questionnaire items that suggest data invalidity

  • Positive history of brain tumors, neurological disorders, or head injuries (withloss of consciousness more than five minutes and/or more than two separate instancesof clinically-significant head trauma)

  • Recent (i.e., past three months) alcohol/other substance use disorders or currentpsychosis (as assessed by the Mini International Neuropsychiatric Interview; MINI)

  • Active suicidal ideation paired with either (1) plan and/or intent or (2) lifetimehistory of suicide attempts (as assessed by the Columbia Suicide Severity RatingScale; C-SSRS)

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Neurobehavioral Affective Control Training
Phase:
Study Start date:
November 22, 2024
Estimated Completion Date:
September 30, 2025

Study Description

This randomized waitlist-controlled pilot trial will enroll adult participants who self-report 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 two types of affective inhibitory control: (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 cognitive control (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. In addition to performing intent-to-treat analyses, the investigators will conduct analyses to evaluate the extent to which program adherence predicts hypothesized intervention effects.

Connect with a study center

  • University of California

    Berkeley, California 94720
    United States

    Active - Recruiting

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