Applying Novel Technologies and Methods to Inform the Ontology of Self-Regulation: Binge Eating and Smoking
Condition: Binge Eating; Smoking, Tobacco; Behavior
MeSH terms: Bulimia; Binge-Eating Disorder
Study type: Interventional

Summary: 
      This study aims to examine targets of self-regulatory function among two exemplar populations
      for which behavior plays a critical role in health outcomes: smokers and individual who binge
      eat (BED). This is the second phase of a study that aims to identify putative mechanisms of
      behavior change to develop an overarching "ontology" of self-regulatory processes.
    

Detailed description: 
      Health risk behavior, including poor diet, physical inactivity, tobacco and other substance
      use, causes as much as 40% of the illness, suffering, and early death related to chronic
      diseases. Non-adherence to medical regimens is an important exemplar of the challenges in
      changing health risk behavior -- and is common, costly (due to increased utilization of
      healthcare services), and associated with poor patient outcomes. This may be particularly
      evident among older adults who experience a disproportionate amount of the chronic disease
      burden in the U.S. Although an array of interventions have been shown to be effective in
      promoting health behavior change, much of this work has been siloed (focused on one disorder
      at a time).

      Additionally, interventions are typically intended to engage multiple mechanisms of behavior
      change, but the mechanisms by which they actually work are infrequently systematically
      examined. Because the need to alter health-related behavior is ubiquitous across medicine,
      understanding the extent to which the principles of effective health behavior change, and the
      mechanisms by which they work, are similar or differ across health conditions and settings is
      a critically important area of scientific inquiry. Improving medical regimen adherence and
      promoting health behavior change are also crucial issues in the changing healthcare
      landscape, where quality, value, cost and patient-centered care are central. This line of
      research may allow for great strides in crafting "precision medicine" approaches for a wide
      array of populations.

      One promising domain of putative behavior change targets is that of self-regulation -- a
      person's ability to manage cognitive, motivational and emotional resources to act in
      accordance with his/her long-term goals. In this proposal, the investigators have assembled
      an outstanding interdisciplinary team to 'scale up' this work to an unprecedented level by
      examining putative targets of behavior change within the self-regulation mechanism domain
      across contexts, populations, and assays - in 3 primary levels of analysis: (1) psychological
      (e.g., constructs such as self-efficacy; emotion regulation; response inhibition), (2)
      behavioral (e.g., tasks of reward responsiveness; temporal horizon), and (3) biological
      (structural and functional MRI of key neural circuitry). The investigators will conduct this
      work with two exemplar populations for which behavior plays a critical role in the course of
      medical regimen adherence, health, and health outcomes: (1) smokers and (2) binge eaters.

      In these groups, the investigators will evaluate the extent to which participants can engage
      and manipulate putative targets within the self-regulation domain both within and outside of
      laboratory settings. 50 smokers and 50 obese/overweight persons will participate in a lab
      study to complete the identified tasks.

      The investigators will experimentally modulate engagement of targets (e.g., stimulus set of
      palatable foods images or tobacco-related images as well as self-regulation interventions).

      Subjects will participate in a 30 minute introductory session and a single testing session at
      Stanford, which will include testing using a subset of self-regulatory tasks from the
      following list (stop-signal task, conditional motor selective stop signal task, Stroop task,
      dot pattern expectancy task, attention network task, Columbia card task, task switching,
      delay discounting task, tower of Hanoi, and emotion regulation task). The order of
      assessments will be counterbalanced across subjects. Imaging will allow an assessment of the
      degree to which the neural systems associated with each element in the ontology can be
      engaged and manipulated in the clinical samples. Imaging will be performed at the Stanford
      Center for Neurobiological Imaging, which has a research-dedicated 3T GE MRI scanner with all
      necessary accessories for stimulation and recording. In addition to task-based fMRI, the
      investigators will collect resting-state fMRI while passively viewing either a blank screen
      or a movie that may include smoking or food-related stimuli. The proposed sample size of 50
      per clinical group will provide sufficient power to detect delta=0.56 between groups, and a
      correlation of r=0.2 across the aggregated sample.

      As the investigators collect data from all participants, they will include manipulations (or
      "motivating operations") meant to modulate putative targets within the self-regulation domain
      in each clinical group - to assess the extent to which participants can shift self-regulatory
      function both in desired and undesired directions. This will be achieved by (1) exposing
      subjects to specific stimulus sets relevant to the sample that may promote engagement of
      appetitive drives (images of highly palatable foods for obese individuals, and
      tobacco-related images or smokers), and (2) exposing them to an instructional manipulation
      ("now" vs "later" cues that instruct subjects to engage with the immediate hedonistic
      properties of the stimulus or the long-term consequences of using the stimulus, respectively)
      designed to engage self-regulatory processes in the presence of these stimulus sets.
    

Intervention name(s): Now vs. Later Cue; fMRI
Intervention type(s): Behavioral; Device
Intervention description(s): As we collect data from all participants, we will include manipulations (or "motivating operations") meant to modulate putative targets within the self-regulation domain in each clinical group - to assess the extent to which we can shift self-regulatory function both in desired and undesired directions. More specifically, subjects will see a "now" cue instructing them to think of immediately using/consuming that stimulus or a "later" cue instruction them to think about the long-term consequences of using/consuming that stimulus. The latter cue is intended to down-regulate desire to use/consume the stimulus, and this down-regulation is measured by a subsequent probe asking subjects the degree to which they want to use/consume that stimulus.; Subjects will complete the tasks inside a functional magnetic resonance imaging device, allowing us to measure brain activity that while completing each task.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science