RECRUITING

Neurobehavioral Affective Control Training

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-11-22
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06226467

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Current residency in the state of California
  2. * Elevated levels of rumination and/or emotion-related impulsivity
  1. * Insufficient English language literacy to understand study procedures (as assessed by self-report)
  2. * 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
  3. * 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)
  4. * Recent (i.e., past three months) alcohol/other substance use disorders or current psychosis (as assessed by the Mini International Neuropsychiatric Interview; MINI)
  5. * 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)

Contacts and Locations

Study Contact

J.D. Allen, Ph.D.
CONTACT
(510) 519-4305
calmprogram@berkeley.edu

Principal Investigator

Sheri L. Johnson, Ph.D.
PRINCIPAL_INVESTIGATOR
University of California, Berkeley
J.D. Allen, Ph.D.
STUDY_DIRECTOR
University of California, Berkeley
Åsa Hammar, Ph.D.
STUDY_DIRECTOR
University of Bergen

Study Locations (Sites)

University of California
Berkeley, California, 94720
United States

Collaborators and Investigators

Sponsor: University of California, Berkeley

  • Sheri L. Johnson, Ph.D., PRINCIPAL_INVESTIGATOR, University of California, Berkeley
  • J.D. Allen, Ph.D., STUDY_DIRECTOR, University of California, Berkeley
  • Åsa Hammar, Ph.D., STUDY_DIRECTOR, University of Bergen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-22
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2024-11-22
Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

  • Cognitive Control
  • Cognitive Training
  • Emotion Regulation
  • Emotional Response Inhibition
  • Emotional Working Memory
  • Executive Functioning
  • Urgency
  • Self-regulation
  • Cognitive Remediation

Additional Relevant MeSH Terms

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