Neurobehavioral Affective Control Training

NCT06226467 | Completed

• 1 other identifier: 2023-01-15949
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Emotion-related impulsivity (ERI)

  ERI will be measured using the self-rated Three-Factor Impulsivity Index "Feelings Trigger Action" scale using standard scoring methods (range: 1-5; larger values indicate higher levels of this characteristic). The researchers will perform a 2 (Arm/Condition: Experimental vs. Control) X 2 (Time: T1 vs. T2) Multivariate Analysis of Covariance (MANCOVA) to evaluate if N-ACT completion is associated with greater pre/post reductions in ERI scores compared to waitlist, as predicted.

  (T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11)

• Rumination

  Rumination will be measured using the self-rated "Brooding" subscale of the Ruminative Responses Scale using standard scoring methods (range: 5-20; larger values indicate higher levels of this characteristic). The researchers will perform a 2 (Arm/Condition: Experimental vs. Control) X 2 (Time: T1 vs. T2) MANCOVA to evaluate if N-ACT completion is associated with greater pre/post reductions in Rumination scores compared to waitlist, as predicted.

  (T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11)

Secondary Outcomes (7)

• Emotional Response Inhibition

  (T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11)

• Emotional Working Memory

  (T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11)

• Affective Flexibility

  (T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11)

• Cold Response Inhibition

  (T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11)

• Cold Working Memory

  (T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11)

Other Outcomes (2)

• Acceptability

  Final (i.e., eighth) N-ACT training session (Week 10 or Week 20 for control arm)

• Adherence

  Final (i.e., eighth) N-ACT training session (Week 10 or Week 20 for control arm)

Study Arms (2)

N-ACT without delay

EXPERIMENTAL

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).

Behavioral: Neurobehavioral Affective Control Training

Waitlist control

OTHER

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.

Behavioral: Neurobehavioral Affective Control Training

Interventions

Neurobehavioral Affective Control Training BEHAVIORAL

The N-ACT program comprises a series of eight training sessions, lasting one hour each, over two months. N-ACT sessions will be guided by a cognitive training "coach" (supervised by a licensed mental health clinician), who will explain intervention procedures and rationale, offer relevant psychoeducation, and use motivational interviewing principles to provide encouragement and support. In addition to coach-led content, participants will spend about half of each weekly training session (\~30 minutes) practicing two computer-based adaptive training tasks targeting affective control.

Also known as: N-ACT

N-ACT without delay; Waitlist control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current residency in the state of California
• Elevated levels of rumination and/or emotion-related impulsivity

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Berkeley: lead
• University of Bergen: collaborator
• University College, London: collaborator

Study Sites (1)

University of California

Berkeley, California, 94720, United States

Location

Related Publications (1)

• Allen KJD, Elliott MV, Ronold EH, Mason L, Rajgopal N, Hammar A, Johnson SL. Cognitive Training for Emotion-Related Impulsivity and Rumination: Protocol for a Pilot Randomized Waitlist-Controlled Trial. JMIR Res Protoc. 2025 Feb 19;14:e54221. doi: 10.2196/54221.

  PMID: 39970439 DERIVED

MeSH Terms

Conditions

Impulsive Behavior; Rumination Syndrome; Affective Symptoms; Emotional Regulation; Self-Control

Condition Hierarchy (Ancestors)

Behavior; Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders; Behavioral Symptoms; Social Behavior

Study Officials

• Sheri L. Johnson, Ph.D.

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

• J.D. Allen, Ph.D.

  University of California, Berkeley

  STUDY DIRECTOR

• Åsa Hammar, Ph.D.

  University of Bergen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized waitlist-controlled trial or randomized delayed intervention-controlled design

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: January 26, 2024
• Study Start: November 22, 2024
• Primary Completion: December 31, 2025
• Study Completion: January 10, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: De-identified data will be shared within one year after data collection ends and available for seven years.
• Access Criteria: Data will be made available to the public through OSF.

Locations

US (1)