Anxiety, Depression
Conditions
Keywords
Computerized neurobehavioral intervention
Brief summary
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.
Interventions
Targeted, computerized interventions completed from the participants' own home on a computer.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* current anxiety or depression symptoms * internet access
Exclusion criteria
* lifetime psychotic disorder, past-year substance dependence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reaction Time to Facial Affect Identification During Emotional Conflict | Baseline, 3-month | 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). |
| Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict | Baseline, 3 Months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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. | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | Engaging Computerized Tasks | Total | Neurobehavioral Computerized Tasks |
|---|---|---|---|
| Age, Continuous | 35 years STANDARD_DEVIATION 10 | 35.5 years STANDARD_DEVIATION 11 | 36 years STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 17 Participants | 8 Participants |
| Region of Enrollment United States | 14 participants | 28 participants | 14 participants |
| Sex: Female, Male Female | 11 Participants | 21 Participants | 10 Participants |
| Sex: Female, Male Male | 3 Participants | 7 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
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.
Time frame: Baseline, 3 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engaging Computerized Tasks | Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict | Baseline Left Amygdala Fear | 0.21 Percentage of BOLD signal change | Standard Deviation 0.93 |
| Engaging Computerized Tasks | Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict | Baseline Left Amygdala Happy | 0.25 Percentage of BOLD signal change | Standard Deviation 1.05 |
| Engaging Computerized Tasks | Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict | Baseline Right Amygdala Fear | 0.04 Percentage of BOLD signal change | Standard Deviation 1.24 |
| Engaging Computerized Tasks | Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict | Baseline Right Amygdala Happy | -0.30 Percentage of BOLD signal change | Standard Deviation 0.86 |
| Engaging Computerized Tasks | Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict | 3 Month Left Amygdala Fear | 0.13 Percentage of BOLD signal change | Standard Deviation 0.85 |
| Engaging Computerized Tasks | Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict | 3 Month Left Amygdala Happy | -0.03 Percentage of BOLD signal change | Standard Deviation 0.76 |
| Engaging Computerized Tasks | Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict | 3 Month Right Amygdala Fear | 0.05 Percentage of BOLD signal change | Standard Deviation 0.66 |
| Engaging Computerized Tasks | Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict | 3 Month Right Amygdala Happy | -0.10 Percentage of BOLD signal change | Standard Deviation 0.85 |
| Neurobehavioral Computerized Tasks | Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict | 3 Month Right Amygdala Happy | 0.05 Percentage of BOLD signal change | Standard Deviation 0.85 |
| Neurobehavioral Computerized Tasks | Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict | Baseline Left Amygdala Fear | 0.16 Percentage of BOLD signal change | Standard Deviation 0.54 |
| Neurobehavioral Computerized Tasks | Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict | 3 Month Left Amygdala Fear | 0.38 Percentage of BOLD signal change | Standard Deviation 0.79 |
| Neurobehavioral Computerized Tasks | Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict | Baseline Left Amygdala Happy | -0.29 Percentage of BOLD signal change | Standard Deviation 0.79 |
| Neurobehavioral Computerized Tasks | Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict | 3 Month Right Amygdala Fear | 0.21 Percentage of BOLD signal change | Standard Deviation 0.92 |
| Neurobehavioral Computerized Tasks | Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict | Baseline Right Amygdala Fear | 0.02 Percentage of BOLD signal change | Standard Deviation 0.6 |
| Neurobehavioral Computerized Tasks | Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict | 3 Month Left Amygdala Happy | 0.18 Percentage of BOLD signal change | Standard Deviation 1.02 |
| Neurobehavioral Computerized Tasks | Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict | Baseline Right Amygdala Happy | -0.23 Percentage of BOLD signal change | Standard Deviation 0.85 |
Comparison: A linear mixed model was used to test the null hypothesis that the two treatment groups would display no differential changes in amygdala BOLD signal from baseline to 3 months as a main effect or in interaction with facial affect type (fear or happy) or by brain hemisphere (left or right).p-value: 0.156Mixed Models Analysis
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).
Time frame: Baseline, 3-month
Population: Participants who complete the protocol were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engaging Computerized Tasks | Reaction Time to Facial Affect Identification During Emotional Conflict | Baseline Congruent Fear | 802.15 milliseconds | Standard Deviation 155.14 |
| Engaging Computerized Tasks | Reaction Time to Facial Affect Identification During Emotional Conflict | Baseline Incongruent Fear | 848.79 milliseconds | Standard Deviation 142.18 |
| Engaging Computerized Tasks | Reaction Time to Facial Affect Identification During Emotional Conflict | Baseline Congruent Happy | 764.08 milliseconds | Standard Deviation 130.52 |
| Engaging Computerized Tasks | Reaction Time to Facial Affect Identification During Emotional Conflict | Baseline Incongruent Happy | 830.06 milliseconds | Standard Deviation 142.29 |
| Engaging Computerized Tasks | Reaction Time to Facial Affect Identification During Emotional Conflict | 3 Month Congruent Fear | 814.58 milliseconds | Standard Deviation 158.56 |
| Engaging Computerized Tasks | Reaction Time to Facial Affect Identification During Emotional Conflict | 3 Month Incongruent Fear | 863.80 milliseconds | Standard Deviation 144.65 |
| Engaging Computerized Tasks | Reaction Time to Facial Affect Identification During Emotional Conflict | 3 Month Congruent Happy | 796.54 milliseconds | Standard Deviation 130.62 |
| Engaging Computerized Tasks | Reaction Time to Facial Affect Identification During Emotional Conflict | 3 Month Incongruent Happy | 878.40 milliseconds | Standard Deviation 175.54 |
| Neurobehavioral Computerized Tasks | Reaction Time to Facial Affect Identification During Emotional Conflict | 3 Month Incongruent Happy | 890.90 milliseconds | Standard Deviation 196.22 |
| Neurobehavioral Computerized Tasks | Reaction Time to Facial Affect Identification During Emotional Conflict | Baseline Congruent Fear | 889.14 milliseconds | Standard Deviation 135.65 |
| Neurobehavioral Computerized Tasks | Reaction Time to Facial Affect Identification During Emotional Conflict | 3 Month Congruent Fear | 872.84 milliseconds | Standard Deviation 178.04 |
| Neurobehavioral Computerized Tasks | Reaction Time to Facial Affect Identification During Emotional Conflict | Baseline Incongruent Fear | 937.97 milliseconds | Standard Deviation 151.94 |
| Neurobehavioral Computerized Tasks | Reaction Time to Facial Affect Identification During Emotional Conflict | 3 Month Congruent Happy | 824.36 milliseconds | Standard Deviation 196.77 |
| Neurobehavioral Computerized Tasks | Reaction Time to Facial Affect Identification During Emotional Conflict | Baseline Congruent Happy | 868.45 milliseconds | Standard Deviation 131.05 |
| Neurobehavioral Computerized Tasks | Reaction Time to Facial Affect Identification During Emotional Conflict | 3 Month Incongruent Fear | 909.89 milliseconds | Standard Deviation 193.45 |
| Neurobehavioral Computerized Tasks | Reaction Time to Facial Affect Identification During Emotional Conflict | Baseline Incongruent Happy | 961.49 milliseconds | Standard Deviation 134.32 |
Comparison: A linear mixed model was utilized to test the null hypothesis that the intervention groups would show equivalent performance change on the outcome measure from baseline to the 3 month time points.p-value: 0.004Mixed Models Analysis