Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life

NCT02945371 | Completed

• 1 other identifier: EPCS20613
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

Insufficient inhibitory control is one pathway through which early adversity is related to a range of problems including excessive alcohol use, tobacco use, and unhealthy eating. The proposed research leverages a neurally informed model of inhibitory control and how it can be improved to test the efficacy of a person-centered inhibitory control intervention in a sample of mid-life individuals with early adversity. The knowledge obtained by this study could be scaled into a flexible, low-cost, and wide-ranging intervention to remediate some of the effects of early adversity on inhibitory control and thus a number of prevalent health risking behaviors.

Conditions

Smoking; Alcohol Drinking; Prescription Drug Abuse; Substance-Related Disorders; Oral Intake Reduced

Outcome Measures

Primary Outcomes (3)

• Inhibitory control performance, Task 1

  Performance on a standard inhibitory control task (Stop-Signal) with personal risk cues

  1 month

• Inhibitory control performance, Task 2

  Performance on a standard inhibitory control task (Go/No-Go) with personal risk cues

  1 month

• Inhibitory control neural activity

  Early ("proactive") engagement of the inferior frontal gyrus and dorsal anterior cingulate cortex during the inhibitory control tasks

  1 month

Secondary Outcomes (3)

• Far transfer to a task related to inhibitory control, Behavioral marker

  1 month

• Far transfer to a task related to inhibitory control, Neural marker

  1 month

• Health-risking behavior

  1 month, 3 months

Study Arms (2)

IC Training

EXPERIMENTAL

The experimental arm (ARM1) is a "person-centered inhibitory control" training intervention, or PeCIC. Between the baseline and endpoint sessions, participants come to our lab 12 times to participate in the training sessions. Each participant is randomly assigned to either the PeCIC training or an active control training. The training sessions will take place approx. every other day for 24 days. Beginning 2-3 days after the baseline session, the experimental group (will come to our behavioral testing lab to receive the PeCIC training. At 11 sessions spaced one every other day, participants will complete one 8-min run of a modified stop-signal task. The cue on each trial (preceding the "go" signal arrow) will be an image of a personalized risk-cue (PRC) or a neural image.

Behavioral: Person-centered inhibitory control training

Control Training

ACTIVE COMPARATOR

Participants in the active control group (ARM2) of the PeCIC intervention will come to the behavioral testing laboratory to complete an 8-min control task every other day for 12 sessions. This control task is identical to the PeCIC except the auditory stop cues are omitted. All other procedures, settings, and schedules are identical to those in the experimental group. The only difference between the groups is that the active control does not practice IC.

Behavioral: Active behavioral response training

Interventions

Person-centered inhibitory control training BEHAVIORAL

A brief, computer-based, multisession training aimed at increasing the connection between environmental risk cues (e.g., cigarettes) and engagement of the brain network for inhibitory control.

Also known as: PeCIC, ARM1

IC Training

Active behavioral response training BEHAVIORAL

A brief computer-based, multisession training aimed at training behavioral responses to personalized environmental risk cues (e.g., cigarettes) that does not engage the inhibitory control network of the brain.

Also known as: Active control, ARM2

Control Training

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 35-55
• Experience of early adversity (EA) before age 18 (EA is be defined as a score of 4 or higher on the Adverse Childhood Experiences (ACEs) questionnaire \[Felitti, Anda, Nordenberg, Williamson, Spitz, Edwards, et al., 1998\])
• IC difficulties such as disinhibited alcohol use, tobacco use, or food intake during adulthood. IC difficulties will be self-reported based on questions from the self-control questionnaire (Tangney, Baumeister, \& Boone, 2004) modified to be specific to alcohol, tobacco, and energy-dense food intake (e.g., "I am self-indulgent with unhealthy food at times", "I refuse alcohol when offered") using a 4-point Likert-style scale.

You may not qualify if:

• Individuals over age 55 will be excluded because of established functional and structural neural changes that begin to escalate at that time (Good, Johnsrude, Ashburner, Henson, Friston, \& Frackowiak, 2001; Grady, Springer, Hongwanishkul, McIntosh, \& Winocur, 2006)
• Given the high rates of morbidity for such disorders among people with high EA, we will not exclude based on past diagnoses for any of those disorders or based on current drug and alcohol use. However, we will exclude individuals who do not pass a urine toxicology screen during either of the functional magnetic resonance imaging (fMRI) sessions to ensure that the neuroimaging data are as homogeneous and reliable as possible.
• Participants who cannot undergo an MRI scan will be excluded; contraindications include metal implants (e.g., braces, pins) or metal fragments, pacemakers or other electronic medical implants, claustrophobia, pregnancy, and weight greater than 550 lbs.

Sponsors & Collaborators

• University of Oregon: lead

Study Sites (1)

University of Oregon, Social and Affective Neuroscience Laboratory

Eugene, Oregon, 97403, United States

Location

Related Publications (3)

• Fisher PA, Berkman ET. Designing Interventions Informed by Scientific Knowledge About Effects of Early Adversity: A Translational Neuroscience Agenda for Next Generation Addictions Research. Curr Addict Rep. 2015 Dec 1;2(4):347-353. doi: 10.1007/s40429-015-0071-x. Epub 2015 Sep 28.

  PMID: 26985399 BACKGROUND

• Berkman ET, Lukinova E, Menshikov I, Myagkov M. Sociality as a natural mechanism of public goods provision. PLoS One. 2015 Mar 19;10(3):e0119685. doi: 10.1371/journal.pone.0119685. eCollection 2015.

  PMID: 25790099 BACKGROUND

• Giuliani NR, Tomiyama AJ, Mann T, Berkman ET. Prediction of daily food intake as a function of measurement modality and restriction status. Psychosom Med. 2015 Jun;77(5):583-90. doi: 10.1097/PSY.0000000000000187.

  PMID: 25984820 BACKGROUND

Related Links

• Social and Affective Neuroscience (SAN) Laboratory website
• Study recruitment website

MeSH Terms

Conditions

Smoking; Alcohol Drinking; Substance-Related Disorders

Interventions

26S proteasome non-ATPase regulatory subunit 13; JPT1 protein, human

Condition Hierarchy (Ancestors)

Behavior; Drinking Behavior; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Elliot T Berkman, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2016
• First Posted: October 26, 2016
• Study Start: September 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)