Clinical trial NCT06226467: Neurobehavioral Affective Control Training
Official title: Neurobehavioral Affective Control Training (N-ACT): A Randomized Waitlist-controlled Pilot Trial to Evaluate a Novel Cognitive Remediation Program for Emotion-related Impulsivity and Rumination
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotional Distress
Impulsive Behavior
Mood Lability
Mood Instability
Rumination
Psychopathology
Affective Symptoms
Keywords: Cognitive Control
Cognitive Training
Emotion Regulation
Emotional Response Inhibition
Emotional Working Memory
Executive Functioning
Urgency
Self-regulation
Cognitive Remediation
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: University of Bergen
name: University College, London
First posted: 2024-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized waitlist-controlled trial or randomized delayed intervention-controlled design
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 (a) failing 50% or more of "attention check" items embedded in the online screening questionnaires, (b) overly rapid responding (i.e., mean response time of less than two seconds for multiple choice items), or (c) qualitative review of long strings of identical entries on screening/baseline questionnaire items that suggest data invalidity
* Positive history of brain tumors, neurological disorders, or head injuries (with loss of consciousness more than five minutes and/or more than two separate instances of clinically-significant head trauma)
* Recent (i.e., past three months) alcohol/other substance use disorders or current psychosis (as assessed by the Mini International Neuropsychiatric Interview; MINI)
* Active suicidal ideation paired with either (1) plan and/or intent or (2) lifetime history of suicide attempts (as assessed by the Columbia Suicide Severity Rating Scale; C-SSRS)

Primary outcomes:
measure: Emotion-related impulsivity (ERI)
timeFrame: (T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11)
measure: Rumination
timeFrame: (T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11)
Secondary outcomes:
measure: Emotional Response Inhibition
timeFrame: (T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11)
measure: Emotional Working Memory
timeFrame: (T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11)
measure: Affective Flexibility
timeFrame: (T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11)
measure: Cold Response Inhibition
timeFrame: (T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11)
measure: Cold Working Memory
timeFrame: (T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11)
measure: Internalizing factor score
timeFrame: (T1) Baseline (Week 1); (T2) Post-intervention (Week 11 or Week 21 for control arm)
measure: Externalizing factor score
timeFrame: (T1) Baseline (Week 1); (T2) Post-intervention (Week 11 or Week 21 for control arm)
Other outcomes:
measure: Acceptability
timeFrame: Final (i.e., eighth) N-ACT training session (Week 10 or Week 20 for control arm)
measure: Adherence
timeFrame: Final (i.e., eighth) N-ACT training session (Week 10 or Week 20 for control arm)
Locations:
city: Berkeley
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, Berkeley
name: Sheri L. Johnson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Berkeley
name: J.D. Allen, Ph.D.
role: STUDY_DIRECTOR
affiliation: University of Bergen
name: Åsa Hammar, Ph.D.
role: STUDY_DIRECTOR
References: