CompletedNot Applicable

Neurobehavioral Affective Control Training

United States50 participantsStarted 2024-11-22

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Emotion-related impulsivity (ERI)

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

Rumination

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

Trial details

NCT IDNCT06226467

SponsorUniversity of California, Berkeley

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31