Neurobehavioral Affective Control Training

NCT ID: NCT06226467

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-22
• Study Completion Date: 2025-09-30

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.

Conditions

Emotional Distress; Impulsive Behavior; Mood Lability; Mood Instability; Rumination; Psychopathology; Affective Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

N-ACT without delay

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).

Group Type: EXPERIMENTAL

Neurobehavioral Affective Control Training

Intervention Type: 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.

Waitlist control

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.

Group Type: OTHER

Neurobehavioral Affective Control Training

Intervention Type: 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.

Interventions

Neurobehavioral Affective Control Training

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

N-ACT

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bergen

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: collaborator

University of California, Berkeley

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheri L. Johnson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Berkeley

J.D. Allen, Ph.D.

Role: STUDY_DIRECTOR

University of California, Berkeley

Åsa Hammar, Ph.D.

Role: STUDY_DIRECTOR

University of Bergen

Locations

University of California

Berkeley, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

J.D. Allen, Ph.D.

Role: CONTACT

calmprogram@berkeley.edu

(510) 519-4305

Facility Contacts

JD Allen, PhD

Role: primary

n-act@berkeley.edu

510-519-4305

Sheri L Johnson, phd

Role: backup

sljohnson@berkeley.edu

References

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.

Reference Type: DERIVED

PMID: 39970439 (View on PubMed)

Other Identifiers

2023-01-15949

Identifier Type: -

Identifier Source: org_study_id