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| ID | Type | Description | Link |
|---|---|---|---|
| 1F31MH117830-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Mind and Life Institute, Hadley, Massachusetts | OTHER |
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The purpose of this study is to assess the impact of a brief, emotion regulation intervention on the ability to perceive other people's emotions.
Decision to close enrollment was made on January 2, 2020.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindful Breathing | Experimental | Participants receive training in a mindful breathing skill to regulate their emotional distress during a stressor task. They will then receive one week of reminders to use this skill, delivered through their mobile phones. |
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| Habituation | Active Comparator | Participants receive an exposure/habituation intervention to regulate their emotional distress during a stressor task. They will then receive one week of reminders, delivered through their mobile phones. |
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| Control | Placebo Comparator | Participants complete the stressor task with no emotion regulation training. Similar to the other conditions, they will then receive one week of reminders, delivered through their mobile phones to test for placebo effects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindful Breathing | Behavioral | Training in a mindful breathing skill that reduces emotional distress |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Ability to Perceive Negative and Positive Emotional Expressions, as Measured by a Behavioral Computer-based Assessment | Emotion perception is measured by a computer-based behavioral assessment during the laboratory session. Scores for negative emotional expressions range from 0-100%, with higher scores indicating greater emotion perception accuracy. | During the laboratory experiment (week 1) |
| Changes in Emotion Perception, as Measured by a Phone-based Behavioral Assessment | Perception of positive emotional expressions and negative emotional expressions are measured by a behavioral phone-based assessment, delivered multiple times over one week via mobile phones. Scores for ratings of emotional valence range from 0-9, with higher scores as more positive emotional valence and lower scores as more negative emotional valence. | After the one week of phone-based intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Emotional Distress, as Measured by Subjective Units of Distress (SUDS) | SUDS are measured on a 10-point Likert self-report scale of Subjective Units of Distress, ranging from 0-9. Scores are changes in SUDS ratings from before hearing the tone to after the tone, with greater scores indicating greater reductions in distress (positive outcomes). SUDS score was evaluated at the beginning of the laboratory experiment, and then at the very end of the lab experiment. The change score was calculated by subtracting the beginning score from the end score. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Emotional Arousal, as Measured by Skin Conductance Response (SCR) | Changes in emotional arousal are measured physiologically with electrodermal activity. Skin conductance response measures phasic changes in electrical conductivity of skin, with a minimum threshold of 0.01μS with higher values indicating greater changes in emotional arousal. | Laboratory assessment, up to one week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Z Rosenthal, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
Will check with sponsors on Duke's policies for data sharing and may update the plan in the future.
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11 participants were considered screen failures
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindful Breathing | Participants receive training in a mindful breathing skill to regulate their emotional distress during a stressor task. They will then receive one week of reminders to use this skill, delivered through their mobile phones. Mindful Breathing: Training in a mindful breathing skill that reduces emotional distress |
| FG001 | Habituation | Participants receive an exposure/habituation intervention to regulate their emotional distress during a stressor task. They will then receive one week of reminders, delivered through their mobile phones. Habituation: An exposure procedure that reduces emotional distress through habituation |
| FG002 | Control | Participants complete the stressor task with no emotion regulation training. Similar to the other conditions, they will then receive one week of reminders, delivered through their mobile phones to test for placebo effects. Control: No emotion regulation intervention, placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindful Breathing | Participants receive training in a mindful breathing skill to regulate their emotional distress during a stressor task. They will then receive one week of reminders to use this skill, delivered through their mobile phones. Mindful Breathing: Training in a mindful breathing skill that reduces emotional distress |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | The Ability to Perceive Negative and Positive Emotional Expressions, as Measured by a Behavioral Computer-based Assessment | Emotion perception is measured by a computer-based behavioral assessment during the laboratory session. Scores for negative emotional expressions range from 0-100%, with higher scores indicating greater emotion perception accuracy. | Baseline data for one participant was not completed appropriately and was omitted from the analysis. | Posted | Mean | Standard Deviation | Percent of correct responses | During the laboratory experiment (week 1) |
|
Up to 3 weeks. Adverse events were assessed at intake, training session, and exit.
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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 | Mindful Breathing | Participants receive training in a mindful breathing skill to regulate their emotional distress during a stressor task. They will then receive one week of reminders to use this skill, delivered through their mobile phones. Mindful Breathing: Training in a mindful breathing skill that reduces emotional distress |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine (Kibby) McMahon | Duke University | 917-880-1551 | Kibby.McMahon@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2020 | Dec 17, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006185 | Habituation, Psychophysiologic |
| ID | Term |
|---|---|
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Habituation | Behavioral | An exposure procedure that reduces emotional distress through habituation |
|
| Control | Behavioral | No emotion regulation intervention, placebo |
|
| Beginning of Week one laboratory experiment, End of Week one laboratory experiment |
| Habituation |
Participants receive an exposure/habituation intervention to regulate their emotional distress during a stressor task. They will then receive one week of reminders, delivered through their mobile phones. Habituation: An exposure procedure that reduces emotional distress through habituation |
| BG002 | Control | Participants complete the stressor task with no emotion regulation training. Similar to the other conditions, they will then receive one week of reminders, delivered through their mobile phones to test for placebo effects. Control: No emotion regulation intervention, placebo |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Habituation | Participants receive an exposure/habituation intervention to regulate their emotional distress during a stressor task. They will then receive one week of reminders, delivered through their mobile phones. Habituation: An exposure procedure that reduces emotional distress through habituation |
| OG002 | Control | Participants complete the stressor task with no emotion regulation training. Similar to the other conditions, they will then receive one week of reminders, delivered through their mobile phones to test for placebo effects. Control: No emotion regulation intervention, placebo |
|
|
|
| Primary | Changes in Emotion Perception, as Measured by a Phone-based Behavioral Assessment | Perception of positive emotional expressions and negative emotional expressions are measured by a behavioral phone-based assessment, delivered multiple times over one week via mobile phones. Scores for ratings of emotional valence range from 0-9, with higher scores as more positive emotional valence and lower scores as more negative emotional valence. | Posted | Mean | Standard Deviation | units on a scale | After the one week of phone-based intervention |
|
|
|
|
| Secondary | Change in Emotional Distress, as Measured by Subjective Units of Distress (SUDS) | SUDS are measured on a 10-point Likert self-report scale of Subjective Units of Distress, ranging from 0-9. Scores are changes in SUDS ratings from before hearing the tone to after the tone, with greater scores indicating greater reductions in distress (positive outcomes). SUDS score was evaluated at the beginning of the laboratory experiment, and then at the very end of the lab experiment. The change score was calculated by subtracting the beginning score from the end score. | Posted | Mean | Standard Deviation | units on a scale | Beginning of Week one laboratory experiment, End of Week one laboratory experiment |
|
|
|
|
| Other Pre-specified | Changes in Emotional Arousal, as Measured by Skin Conductance Response (SCR) | Changes in emotional arousal are measured physiologically with electrodermal activity. Skin conductance response measures phasic changes in electrical conductivity of skin, with a minimum threshold of 0.01μS with higher values indicating greater changes in emotional arousal. | Not Posted | Laboratory assessment, up to one week | Participants |
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Habituation | Participants receive an exposure/habituation intervention to regulate their emotional distress during a stressor task. They will then receive one week of reminders, delivered through their mobile phones. Habituation: An exposure procedure that reduces emotional distress through habituation | 0 | 27 | 0 | 27 | 0 | 27 |
| EG002 | Control | Participants complete the stressor task with no emotion regulation training. Similar to the other conditions, they will then receive one week of reminders, delivered through their mobile phones to test for placebo effects. Control: No emotion regulation intervention, placebo | 0 | 27 | 0 | 27 | 0 | 27 |
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