An interventional study of Computerized Neurobehavioral Intervention in Anxiety and Depression, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-06-20.
Sponsored by Stanford University · Not applicable, Interventional, and Basic science
The present study will explore the effectiveness of a computer based neurobehavioral intervention in alleviating symptoms and improving emotion regulation in psychiatric populations. It will increase understanding of psychopathology at a neural-circuit level and aid development of new non-pharmacological treatment for emotion regulatory deficits.
5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's enrollment of 28 is below the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Stanford University is the lead sponsor of 2,161 studies on the registry; 428 are open to participants now.
Of its 268 completed or terminated interventional studies of FDA-regulated products, 207 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will log into a personalized website and engage in computerized tasks online.
Behavioral: Computerized Neurobehavioral Intervention
Participants will log into a personalized website and engage in computerized tasks online.
Behavioral: Computerized Neurobehavioral Intervention
Targeted, computerized interventions completed from the participants' own home on a computer.
Reaction Time to Facial Affect Identification During Emotional Conflict
A standardized set of facial emotions (fear and happy) were presented for a duration of about 1 second in quick succession (a new face every 3-5 seconds). Across each face was written an emotional word ("FEAR" or "HAPPY"), which could be either congruent or incongruent with the facial expression. The participant was instructed to identify the facial emotion as quickly as possible and ignore the overlaid emotion word. The outcome measure of interest was the average speed (across all trials presented) within which an individual could correctly identify the facial emotion as a function of time (pre or post-intervention), treatment arm (control or intervention), facial affect (fear or happy), and congruency of word and facial affect (congruent or incongruent).
Time frame: Baseline, 3-month
Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict
The degree of differential BOLD signal change (T2\*-weighted contrast in a defined region of the brain as measured by functional magnetic resonance imaging) within each individual, averaged across trials, during facial affect identification (fear or happy) and induction of emotional conflict (when the emotion word "FEAR" or "HAPPY" was either congruent or incongruent with the facial expression). We examined the differential degree of amygdala BOLD signal change as a function of emotion type (fear or happy), congruency (congruent or incongruent), and hemisphere (left or right) at baseline and 3 months.
Time frame: Baseline, 3 Months
| Milestone | Neurobehavioral Computerized Tasks | Engaging Computerized Tasks |
|---|---|---|
| Started | 14 | 14 |
| Completed | 13 | 14 |
| Not completed | 1 | 0 |
A standardized set of facial emotions (fear and happy) were presented for a duration of about 1 second in quick succession (a new face every 3-5 seconds). Across each face was written an emotional word ("FEAR" or "HAPPY"), which could be either congruent or incongruent with the facial expression. The participant was instructed to identify the facial emotion as quickly as possible and ignore the overlaid emotion word. The outcome measure of interest was the average speed (across all trials presented) within which an individual could correctly identify the facial emotion as a function of time (pre or post-intervention), treatment arm (control or intervention), facial affect (fear or happy), and congruency of word and facial affect (congruent or incongruent).
| milliseconds | Engaging Computerized Tasks | Neurobehavioral Computerized Tasks |
|---|---|---|
| Baseline Congruent Fear | 802.15 ± 155.14 | 889.14 ± 135.65 |
| Baseline Incongruent Fear | 848.79 ± 142.18 | 937.97 ± 151.94 |
| Baseline Congruent Happy | 764.08 ± 130.52 | 868.45 ± 131.05 |
| Baseline Incongruent Happy | 830.06 ± 142.29 | 961.49 ± 134.32 |
| 3 Month Congruent Fear | 814.58 ± 158.56 | 872.84 ± 178.04 |
| 3 Month Incongruent Fear | 863.80 ± 144.65 | 909.89 ± 193.45 |
| 3 Month Congruent Happy | 796.54 ± 130.62 | 824.36 ± 196.77 |
| 3 Month Incongruent Happy | 878.40 ± 175.54 | 890.90 ± 196.22 |
The degree of differential BOLD signal change (T2\*-weighted contrast in a defined region of the brain as measured by functional magnetic resonance imaging) within each individual, averaged across trials, during facial affect identification (fear or happy) and induction of emotional conflict (when the emotion word "FEAR" or "HAPPY" was either congruent or incongruent with the facial expression). We examined the differential degree of amygdala BOLD signal change as a function of emotion type (fear or happy), congruency (congruent or incongruent), and hemisphere (left or right) at baseline and 3 months.
| Percentage of BOLD signal change | Neurobehavioral Computerized Tasks | Engaging Computerized Tasks |
|---|---|---|
| Baseline Left Amygdala Fear | 0.21 ± 0.93 | 0.16 ± 0.54 |
| Baseline Left Amygdala Happy | 0.25 ± 1.05 | -0.29 ± 0.79 |
| Baseline Right Amygdala Fear | 0.04 ± 1.24 | 0.02 ± 0.60 |
| Baseline Right Amygdala Happy | -0.30 ± 0.86 | -0.23 ± 0.85 |
| 3 Month Left Amygdala Fear | 0.13 ± 0.85 | 0.38 ± 0.79 |
| 3 Month Left Amygdala Happy | -0.03 ± 0.76 | 0.18 ± 1.02 |
| 3 Month Right Amygdala Fear | 0.05 ± 0.66 | 0.21 ± 0.92 |
| 3 Month Right Amygdala Happy | -0.10 ± 0.85 | 0.05 ± 0.85 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Engaging Computerized Tasks | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Neurobehavioral Computerized Tasks | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | Engaging Computerized Tasks | Neurobehavioral Computerized Tasks | Total |
|---|---|---|---|
| Mean | 35 ± 10 | 36 ± 12 | 35.5 ± 11 |
| Sex: Female, Male(Participants) | Engaging Computerized Tasks | Neurobehavioral Computerized Tasks | Total |
|---|---|---|---|
| Female | 11 | 10 | 21 |
| Male | 3 | 4 | 7 |
| Race (NIH/OMB)(Participants) | Engaging Computerized Tasks | Neurobehavioral Computerized Tasks | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 4 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 1 | 0 | 1 |
| White | 9 | 8 | 17 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Engaging Computerized Tasks | Neurobehavioral Computerized Tasks | Total |
|---|---|---|---|
| United States | 14 | 14 | 28 |
The record gives a start of Jan 2011, a primary completion of Jan 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2019, 6 years 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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