Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life (REV)
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|ClinicalTrials.gov Identifier: NCT02945371|
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : October 26, 2016
|Condition or disease||Intervention/treatment|
|Smoking Alcohol Drinking Prescription Drug Abuse Substance-Related Disorders Oral Intake Reduced||Behavioral: Person-centered inhibitory control training Behavioral: Active behavioral response training|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life|
|Study Start Date :||September 2014|
|Primary Completion Date :||April 2016|
|Study Completion Date :||May 2016|
Experimental: IC Training
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
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.
Other Name: PeCIC, ARM1
Active Comparator: Control Training
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
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.
Other Name: Active control, ARM2
- Inhibitory control performance, Task 1 [ Time Frame: 1 month ]Performance on a standard inhibitory control task (Stop-Signal) with personal risk cues
- Inhibitory control performance, Task 2 [ Time Frame: 1 month ]Performance on a standard inhibitory control task (Go/No-Go) with personal risk cues
- Inhibitory control neural activity [ Time Frame: 1 month ]Early ("proactive") engagement of the inferior frontal gyrus and dorsal anterior cingulate cortex during the inhibitory control tasks
- Far transfer to a task related to inhibitory control, Behavioral marker [ Time Frame: 1 month ]Performance on a standard risky-behavior task (Balloon Analogue Risk task)
- Far transfer to a task related to inhibitory control, Neural marker [ Time Frame: 1 month ]Neural activity during a standard risky-behavior task (Balloon Analogue Risk task)
- Health-risking behavior [ Time Frame: 1 month, 3 months ]Standard self-report questions regarding health-risking behavior related to inhibitory control (e.g., cigarette smoking, excessive alcohol intake, illicit drug use and prescription drug misuse, and excessive energy intake)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945371
|United States, Oregon|
|University of Oregon, Social and Affective Neuroscience Laboratory|
|Eugene, Oregon, United States, 97403|
|Principal Investigator:||Elliot T Berkman, PhD||University of Oregon|