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Emotional DistressN-ACTNCT06226467

Neurobehavioral Affective Control Training

A study of Emotional Distress and Impulsive Behavior, run by University of California, Berkeley at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 years
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
22 Nov 2024to 10 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California

    Berkeley, California, 94720

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Neurobehavioral Affective Control Training
Keywords
Cognitive Control, Cognitive Training, Emotion Regulation, Emotional Response Inhibition, Emotional Working Memory, Executive Functioning, Urgency, Self-regulation, Cognitive Remediation
Medical subject headings
Impulsive Behavior, Rumination Syndrome, Affective Symptoms, Emotional Regulation, Self-Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neurobehavioral Affective Control TrainingBehavioural

    Also called N-ACT

    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.

Study groups in NCT06226467
Study groupRoleWhat they receive
N-ACT without delayExperimentalAfter 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).
Receives: Behavioral: Neurobehavioral Affective Control Training
Waitlist controlOtherParticipants 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.
Receives: Behavioral: Neurobehavioral Affective Control Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (7)
  1. Emotional Response Inhibition

    Valence-specific indices of stop-signal reaction time (SSRT) will be derived from the Emotional Stop-Signal Task using standard scoring procedures (measured in milliseconds, with larger values indicating less efficient emotional response inhibition, i.e., longer latency of relevant inhibitory processing). 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 improvement in emotional response inhibition across valence (i.e., reductions in Positive SSRT and Negative SSRT, tested in the same model) compared to waitlist, as predicted, suggesting improvement in targeted aspects of affective control.

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

  2. Emotional Working Memory

    Valence-specific indices of working memory accuracy will be derived from the Memory and Affective Flexibility Task using standard scoring procedures (range: 0.00%-100%, measured as a percentage of working memory trials with correct responses over the total number of trials within each stimulus valence category, with larger values indicating more accurate working memory recall). 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 improvement in emotional working memory across valence (i.e., increases in Positive Working Memory Accuracy and Negative Working Memory Accuracy, tested in the same model) compared to waitlist, as predicted, suggesting improvement in targeted aspects of affective control.

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

  3. Affective Flexibility

    Valence-specific indices of accuracy (range: 0.00%-100%, measured as a percentage of "switch" trials with correct responses over the total number of trials within each stimulus valence category, with larger values indicating more accurate affective stimulus processing) and reaction time (RT; measured in milliseconds, with larger values indicating less efficient affective flexibility, i.e., longer latency of stimulus processing) will be derived from the Memory and Affective Flexibility Task using standard scoring procedures. A 2 (Arm/Condition: Experimental vs. Control) X 2 (Time: T1 vs. T2) MANCOVA will be used to evaluate if N-ACT completion is associated with greater pre/post improvement in affective flexibility across valence (i.e., increases in Accuracy and decreases in RT for Positive and Negative stimuli, tested in the same model) compared to waitlist, as predicted, suggesting near-transfer of trained abilities to non-targeted aspects of affective control.

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

  4. Cold Response Inhibition

    Stop-signal reaction time (SSRT) will also be derived from the traditional (i.e., non-emotional) version of the Stop-Signal Task using standard scoring procedures (measured in milliseconds, with larger values indicating less efficient cold response inhibition, i.e., longer latency of relevant inhibitory processing). A 2 (Arm/Condition: Experimental vs. Control) X 2 (Time: T1 vs. T2) MANCOVA will be used to evaluate if N-ACT completion is associated with greater pre/post improvement in cold response inhibition (i.e., reductions in SSRT) compared to waitlist, as predicted, suggesting far-transfer of trained abilities to non-targeted aspects of cold cognitive control.

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

  5. Cold Working Memory

    Cold working memory performance will be derived from the Backwards Digit Span task using standard scoring procedures (measured as mean digit span, i.e., the average number of correctly-recalled digits in reverse order from their presentation, with larger values indicating better cold working memory updating capacity). A 2 (Arm/Condition: Experimental vs. Control) X 2 (Time: T1 vs. T2) MANCOVA will be used to evaluate if N-ACT completion is associated with greater pre/post improvement in cold working memory (i.e., increases in mean digit span) compared to waitlist, as predicted, suggesting suggesting far-transfer of trained abilities to non-targeted aspects of cold cognitive control.

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

  6. Internalizing factor score

    Internalizing psychopathology will be represented as a latent variable derived from raw scores on the self-rated (range: 1-5) Inventory of Depression and Anxiety Symptoms (IDAS) using confirmatory factor analysis (CFA), which is expected to produce a single-factor solution. CFA will be used to generate aggregated, standardized Z-scores on a latent composite "Internalizing" variable at each assessment point (coded such that larger values reflect greater symptom severity). Structural equation modeling of measurement invariance (between groups and within-subjects over time) will test hypothesized treatment effects on Internalizing psychopathology as a latent construct, which is expected to decrease in magnitude from pre- (T1) to post-intervention (T2).

    Measured: (T1) Baseline (Week 1); (T2) Post-intervention (Week 11 or Week 21 for control arm)

  7. Externalizing factor score

    Externalizing psychopathology will be represented as a latent variable derived from raw scores on self-rated scales pertaining to substance use (range: 1-5) from the revised Externalizing Symptom Inventory using confirmatory factor analysis (CFA), which is expected to produce a single-factor solution. CFA will be used to generate aggregated, standardized Z-scores on a latent composite "Externalizing" variable at each assessment point (coded such that larger values reflect greater symptom severity). Structural equation modeling of measurement invariance (between groups and within-subjects over time) will test hypothesized treatment effects on substance-related Externalizing psychopathology as a latent construct, which is expected to decrease in magnitude from pre- (T1) to post-intervention (T2).

    Measured: (T1) Baseline (Week 1); (T2) Post-intervention (Week 11 or Week 21 for control arm)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2024
  2. Study start22 Nov 2024
  3. Primary completion31 Dec 2025
  4. Study completion10 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized waitlist-controlled trial or randomized delayed intervention-controlled design
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06226467
Sponsor's protocol ID
2023-01-15949
Acronym
N-ACT
Status last verified
Jan 2026
First submitted
6 Nov 2023
Last updated
20 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Measures, data, and analysis scripts will be shared through an Open Science Framework (OSF) registration.

Publications

  • 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.

    PubMed 39970439

Questions about this trial

What is this clinical trial studying?

A study of Emotional Distress and Impulsive Behavior, run by University of California, Berkeley at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emotion-related impulsivity (ERI) (time frame: (T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06226467, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.

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