Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Change in vmPFC-insula connectivity during [restructure - flow_negative] |
Using Generalized Psychophysiological Interaction (gPPI) analysis the difference in vmPFC-insula connectivity pre-post neuromaging |
baseline Neuroimaging scan, post Neuroimaging Scan (1 week follow-up neurostimulation) |
|
Other |
Cognitive flexibility inventory (CFI) and cognitive control and flexibility inventory (CCFI) |
CFI and CCFI total scores will be used as a moderator of outcomes. The CFI is a 20-item self-report measure to monitor how often individuals engaged in cognitive behavioral thought challenging interventions. Scores consist of a total CFI score and two subscale scores. The total score ranges between 20 and 140, where higher scores indicate more cognitive flexibility. The CCFI is an 18 item measure that assesses an individual's perceived ability to exhibit control over their thoughts and behavior in a stressful situation on a scale of "1" Strongly Disagree to "7" Strongly agree with a range from 18-126. Higher scores on the CCFQ were most strongly related to greater cognitive reappraisal as well as less perseverative thinking and rumination. |
Baseline |
|
Other |
Wisconsin Card Sorting Task |
Behavioral measurement of cognitive flexibility achieved with the wisconsin card sort will be used as a moderator of outcomes |
Baseline |
|
Other |
Affect Intensity Measure (AIM) |
AIM total score will be used as a moderator of outcomes. The AIM is a 40-item questionnaire designed to measure the characteristic strength or weakness with which one experiences emotion where participants rate from "1" Never to "6" Always with higher scores meaning higher emotion intensity than lower scores. |
Baseline |
|
Primary |
High Frequency Heart Rate Variability (HF-HRV) during regulation blocks during the neurostimulation day |
Calculation of physiological data High frequency HRV (HF-HRV) during regulation blocks during the neurostimulation day accounting for baseline controlling for baseline HF-HRV |
Within a month of the initial assessment |
|
Primary |
Time to return to Heart Rate (HR) baseline measured during regulation period |
Following each negative mood induction during the neurostimulation experiment, the time it takes to return baseline HR will be calculated for each of the three regulation periods. |
Within a month of the initial assessment |
|
Primary |
Change in the ventrolateral prefrontal cortex (vlPFC) for the [restructure-flow_negative] contrast |
Change in the maximum activation in the vlPFC from pre-post neuroimaging in the contrast of interest |
baseline Neuroimaging Scan vs post Neuroimaging scan (1 week follow-up post neurostimulation) |
|
Primary |
Change in the dorsomedial prefrontal cortex (dmPFC) for the [restructure-flow_negative] contrast |
Change in the maximum activation in the dmPFC from pre-post neuroimaging in the contrast of interest |
baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation) |
|
Primary |
Change in the ventromedial prefrontal cortex (vmPFC) for the [restructure-flow_negative] contrast |
Change in the maximum activation in the vmPFC from pre-post neuroimaging in the contrast of interest |
baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation) |
|
Primary |
Change in the insular cortex for the [restructure-flow_negative] contrast |
Change in the maximum activation in the insula from pre-post neuroimaging in the contrast of interest |
baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation) |
|
Primary |
Change in dorsolateral prefrontal cortex (dlPFC)-insula connectivity during [restructure - flow_negative] |
Using Generalized Psychophysiological Interaction (gPPI) analysis the difference in dlPFC-insula connectivity pre-post neuromaging |
baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation) |
|
Primary |
Change in dorsolateral prefrontal cortex (dlPFC)-amygdala connectivity during [restructure - flow_negative] |
Using Generalized Psychophysiological Interaction (gPPI) analysis the difference in dlPFC-amygdala connectivity pre-post neuromaging |
baseline Neuroimaging Scan, post Neuroimaging Scan (1 week follow-up post neurostimulation) |
|
Secondary |
Difficulties in Emotion Regulation Scale (DERS) self-report change |
Change in self-reported DERS will be investigated immediately after the followup neuroimaging session and one month after training. DERS inclusion for study is a score of 90 or higher. Min-Max score ranges from 36-180 (with higher scores signifying more difficulties with emotion regulation) |
Baseline, 1 week follow-up after neurostimulation, 1 month follow-up |
|
Secondary |
Emotion Regulation Questionnaire (ERQ) self-report change |
Change in Self-reported use of Cognitive Restructuring (CR) as measured with the Emotion Regulation Questionnaire (ERQ) one week and one month after training. We will also examine pre-post changes in ERQ-Reappraisal scale using a similar growth model approach, accounting for severity of psychopathology and baseline. The ERQ is a 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal (6 scale items) and (2) Expressive Suppression (4 scale items). Scores for the 2 scales are reported the average score of the total items in that scale. The lower the average score on the reappraisal scale the more problems with regulating emotions. |
Baseline, 1 week follow-up after neurostimulation, 1 month follow-up |
|
Secondary |
Change in the dlPFC for the [restructure - flow_negative] contrast |
Change in the maximum activation in the dlPFC from pre-post neuroimaging in the contrast of interest |
baseline Neuroimaging scan, post Neuroimaging Scan (1 week follow-up neurostimulation) |
|
Secondary |
Change in the amygdala for the [restructure - flow_negative] contrast |
Change in the maximum activation in the amygdala from pre-post neuroimaging in the contrast of interest |
baseline Neuroimaging scan, post Neuroimaging Scan (1 week follow-up neurostimulation) |
|
Secondary |
Outcome Questionnaire (OQ-45) self-report change |
Change in self-reported psychopathology as measured by the OQ-45 one week and one month after training. The Outcome Questionnaire-45 (OQ-45) is a 45-item self-report measure used to track severity of psychopathology throughout treatment. It consists of subscales that identify three types of problems that lead to general stress: psychological symptoms, interpersonal conflicts, and problems with social roles. Items are rated on a Likert scale ranging from 0 (never) to 4 (almost always). Scores range from 0 to 180. Higher scores indicate higher psychopathological distress than lower scores. |
Baseline, 1 week follow-up after neurostimulation, 1 month follow-up |
|
Secondary |
Cognitive Skills Questionnaire (CSQ) self-report change |
Change in self-reported use of cognitive skills as measured by the CSQ one week and one month after training. The CSQ is the Unified Protocol Cognitive Skills Questionnaire (UPCSQ; unpublished) that contains 8 items that ranges from "1" Never to "5" Always or When Needed with higher scores indicating more use of tools or skills than lower scores. Scores range from 8 to 40 (highest skill use). |
Baseline, 1 week follow-up after neurostimulation, 1 month follow-up |
|
Secondary |
Self Efficacy with Emotion Regulation (PROMIS-SEME) |
Change in effective regulation as measured by PROMIS-SEME from baseline to follow up. PROMIS Self-Efficacy for Managing Emotions measures one's confidence to manage emotions such as anxiety, helplessness, and discouragement on a scale of 1 "not at all confident" to 5 "I am very confident." There are total of 25 items with a score ranging from 25 to 125. Higher scores indicate higher confidence in the ability to use emotion regulation skills. Scores are then reported using the PROMIS manual for T-scores. |
Baseline, 1 week follow-up after neurostimulation, 1 month follow-up |
|
Secondary |
Change in subjective units of distress (SUDS) |
SUDS measured after baseline, stressor and every three minutes during regulation, including at the end of regulation during the neurostimulation experiment |
Neurostimulation visit (which will occur within a month of the initial assessment) |
|
Secondary |
HF-HRV during regulation block at follow up |
Change in HF-HRV mean during regulation block of stressor task at neurostimulation visit at follow-up |
one week follow-up, 1 month follow-up |
|
Secondary |
Time to return to HR baseline measured during regulation period at follow up |
time it takes to return baseline HR will be calculated during the behavioral stressor computer task at follow up |
one week follow-up, 1 month follow-up |
|