SmokingREVNCT02945371
Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life
A study testing Active behavioral response training in people with Smoking and Alcohol Drinking, run by University of Oregon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Alcohol Drinking, Prescription Drug Abuse
- What is being tested?
- Active behavioral response training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Beyond these criteria, participants will be recruited without exclusions based on gender, race, or ethnicity, so our sample will reflect the diversity in the local population (Lane County, Oregon) with regard to gender, race, and ethnicity.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oregon, Social and Affective Neuroscience Laboratory
Eugene, Oregon, 97403
About this study
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.
Read the detailed description
Early adversity (EA) in humans is a major contributing factor to a range of deleterious physical and mental health outcomes extending through adulthood such as depression and anxiety, obesity and heart disease, and premature death. In addition to detracting significantly from individual well being and quality of life, these conditions also consume considerable resources from federal, state, and community organizations. The mechanisms through which EA exerts its effects on these outcomes are increasingly well understood, and include neurocognitive pathways related to executive function. An intervention that can successfully target, engage with, and alter the functioning of one or more of these mechanisms would be a promising way of mitigating the impact of EA on deleterious outcomes later in life. The proposed research focuses on one such pathway-deficits in inhibitory control (IC)-and tests the feasibility and efficacy of an intervention to increase functioning in that pathway in a sample of individuals who experienced EA. The intervention is grounded in a neurally informed model of change that specifies deficits in IC as an underlying causal factor common to several health-risking behaviors (HRBs). These IC deficits emerge during development as a result of a range of EA, and, critically, can be remediated in mid-life through targeted intervention. Research from our laboratory has validated an intervention that can increase IC performance and alter its underlying neural systems in young adults (Berkman, Kahn, \& Merchant, 2014). The next step in this program of research, proposed here, is to test the efficacy of that intervention in a sample of mid-life individuals who have experienced EA and the extent to which our intervention generalizes to HRBs that are prevalent in that sample. The first Aim is to test whether the intervention alters the IC system in tasks both similar to and dissimilar from the training task in terms of both behavioral performance and neural functioning. The second Aim is to test whether alterations in the functioning of the underlying neural systems mediate the effect of the intervention on performance and disinhibition-related HRBs. The two Aims will be accomplished within the context of a single randomized controlled trial (RCT) with two arms (IC training vs. active control) and pre-post measurements of IC performance, IC neural systems, and HRBs. All participants (N = 110) come to the lab for an initial assessment of behavioral / neural measures of IC and HRBs, among other measures. Then, participants are randomly assigned to receive a Person-Centered Inhibitory Control (PeCIC) training or active control training, every other day for 3-4 weeks. The PeCIC systematically pairs IC engagement with alcohol, tobacco, and/or energy-dense food cues, depending on each participant's reports of disinhibited behavior in those domains. The active control task uses personalized cues and response time tasks but does not involve IC. Finally, participants return to the laboratory for an endpoint assessment where all baseline measures are repeated. The two Aims will be robustly tested in a series of analyses comparing the behavioral and neural change from pre- to postintervention between the groups.
- Conditions
- Smoking, Alcohol Drinking, Prescription Drug Abuse, Substance-Related Disorders, Oral Intake Reduced
- Being tested
- Person-centered inhibitory control training, Active behavioral response training
- Medical subject headings
- Smoking, Alcohol Drinking, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Person-centered inhibitory control trainingBehavioural
Also called PeCIC, ARM1
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.
Active behavioral response trainingBehavioural
Also called Active control, ARM2
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Active behavioral response training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibitory control performance, Task 1
Performance on a standard inhibitory control task (Stop-Signal) with personal risk cues
Measured: 1 month
Inhibitory control performance, Task 2
Performance on a standard inhibitory control task (Go/No-Go) with personal risk cues
Measured: 1 month
Inhibitory control neural activity
Early ("proactive") engagement of the inferior frontal gyrus and dorsal anterior cingulate cortex during the inhibitory control tasks
Measured: 1 month
Secondary outcomes (3)
Far transfer to a task related to inhibitory control, Behavioral marker
Performance on a standard risky-behavior task (Balloon Analogue Risk task)
Measured: 1 month
Far transfer to a task related to inhibitory control, Neural marker
Neural activity during a standard risky-behavior task (Balloon Analogue Risk task)
Measured: 1 month
Health-risking behavior
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)
Measured: 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startSep 2014
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elliot T Berkman, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945371
- Sponsor's protocol ID
- EPCS20613
- Acronym
- REV
- Status last verified
- Oct 2016
- First submitted
- 25 Mar 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26985399Berkman 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.
PubMed 25790099Giuliani 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.
PubMed 25984820
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life
- ClinicalTrials.gov ID
- NCT02945371
- Acronym / sponsor ID
- REV / EPCS20613
- Conditions
- Smoking, Alcohol Drinking, Prescription Drug Abuse, Substance-Related Disorders, Oral Intake Reduced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Early adversity (EA) in humans is a major contributing factor to a range of deleterious physical and mental health outcomes extending through adulthood such as depression and anxiety, obesity and heart disease, and premature death. In addition to detracting significantly from individual well being and quality of life, these conditions also consume considerable resources from federal, state, and community organizations. The mechanisms through which EA exerts its effects on these outcomes are increasingly well understood, and include neurocognitive pathways related to executive function. An intervention that can successfully target, engage with, and alter the functioning of one or more of these mechanisms would be a promising way of mitigating the impact of EA on deleterious outcomes later in life. The proposed research focuses on one such pathway-deficits in inhibitory control (IC)-and tests the feasibility and efficacy of an intervention to increase functioning in that pathway in a sample of individuals who experienced EA. The intervention is grounded in a neurally informed model of change that specifies deficits in IC as an underlying causal factor common to several health-risking behaviors (HRBs). These IC deficits emerge during development as a result of a range of EA, and, critically, can be remediated in mid-life through targeted intervention. Research from our laboratory has validated an intervention that can increase IC performance and alter its underlying neural systems in young adults (Berkman, Kahn, \& Merchant, 2014). The next step in this program of research, proposed here, is to test the efficacy of that intervention in a sample of mid-life individuals who have experienced EA and the extent to which our intervention generalizes to HRBs that are prevalent in that sample. The first Aim is to test whether the intervention alters the IC system in tasks both similar to and dissimilar from the training task in terms of both behavioral performance and neural functioning. The second Aim is to test whether alterations in the functioning of the underlying neural systems mediate the effect of the intervention on performance and disinhibition-related HRBs. The two Aims will be accomplished within the context of a single randomized controlled trial (RCT) with two arms (IC training vs. active control) and pre-post measurements of IC performance, IC neural systems, and HRBs. All participants (N = 110) come to the lab for an initial assessment of behavioral / neural measures of IC and HRBs, among other measures. Then, participants are randomly assigned to receive a Person-Centered Inhibitory Control (PeCIC) training or active control training, every other day for 3-4 weeks. The PeCIC systematically pairs IC engagement with alcohol, tobacco, and/or energy-dense food cues, depending on each participant's reports of disinhibited behavior in those domains. The active control task uses personalized cues and response time tasks but does not involve IC. Finally, participants return to the laboratory for an endpoint assessment where all baseline measures are repeated. The two Aims will be robustly tested in a series of analyses comparing the behavioral and neural change from pre- to postintervention between the groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IC Training | Experimental | Behavioral: Person-centered inhibitory control trainingThe 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. |
| Control Training | Active comparator | Behavioral: Active behavioral response trainingParticipants 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. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
- Beyond these criteria, participants will be recruited without exclusions based on gender, race, or ethnicity, so our sample will reflect the diversity in the local population (Lane County, Oregon) with regard to gender, race, and ethnicity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Person-centered inhibitory control trainingAlso: PeCIC, ARM1A 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. | Behavioural | IC Training |
| Active behavioral response trainingAlso: Active control, ARM2A 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. | Behavioural | Control Training |
Primary outcome
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
3 secondary outcomes
Far transfer to a task related to inhibitory control, Behavioral marker
Time frame: 1 month
Far transfer to a task related to inhibitory control, Neural marker
Time frame: 1 month
Health-risking behavior
Time frame: 1 month, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Background: PubMed 26985399Fisher 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.
- Background: PubMed 25790099Berkman 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.
- Background: PubMed 25984820Giuliani 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.
- Social and Affective Neuroscience (SAN) Laboratory websiteLink provided by the sponsor.
- Study recruitment websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elliot T Berkman, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active behavioral response training in people with Smoking and Alcohol Drinking, run by University of Oregon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhibitory control performance, Task 1 (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02945371, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.