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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Engaging computerized tasks | Active Comparator | Participants will log into a personalized website and engage in computerized tasks online. |
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| Neurobehavioral computerized tasks | Experimental | Participants will log into a personalized website and engage in computerized tasks online. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized Neurobehavioral Intervention | Behavioral | Targeted, computerized interventions completed from the participants' own home on a computer. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Baseline, 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Greg Fonzo, PhD | Stanford University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, Department of Psychiatry and Behavioral Sciences | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neurobehavioral Computerized Tasks | Participants will log into a personalized website and engage in computerized tasks online. Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer. |
| FG001 | Engaging Computerized Tasks | Participants will log into a personalized website and engage in computerized tasks online. Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Engaging Computerized Tasks | Participants will log into a personalized website and engage in computerized tasks online. Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer. |
| BG001 | Neurobehavioral Computerized Tasks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Participants who complete the protocol were included in the analysis. | Posted | Mean | Standard Deviation | milliseconds | Baseline, 3-month |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Engaging Computerized Tasks | Participants will log into a personalized website and engage in computerized tasks online. Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amit Etkin | Stanford University | 650-725-5736 | amitetkin@stanford.edu |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Participants will log into a personalized website and engage in computerized tasks online. Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Participants will log into a personalized website and engage in computerized tasks online. Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer. |
| OG001 | Neurobehavioral Computerized Tasks | Participants will log into a personalized website and engage in computerized tasks online. Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer. |
|
|
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| Primary | 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. | Posted | Mean | Standard Deviation | Percentage of BOLD signal change | Baseline, 3 Months |
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|
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Neurobehavioral Computerized Tasks | Participants will log into a personalized website and engage in computerized tasks online. Computerized Neurobehavioral Intervention: Targeted, computerized interventions completed from the participants' own home on a computer. | 0 | 14 | 0 | 14 | 0 | 14 |
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| Baseline Right Amygdala Fear |
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| Baseline Right Amygdala Happy |
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| 3 Month Left Amygdala Fear |
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| 3 Month Left Amygdala Happy |
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| 3 Month Right Amygdala Fear |
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| 3 Month Right Amygdala Happy |
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