Emotions
Conditions
Keywords
Emotion Dysregulation, Empathy, Emotion Perception
Brief summary
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.
Detailed description
Decision to close enrollment was made on January 2, 2020.
Interventions
BEHAVIORALMindful Breathing
Training in a mindful breathing skill that reduces emotional distress
BEHAVIORALHabituation
An exposure procedure that reduces emotional distress through habituation
BEHAVIORALControl
No emotion regulation intervention, placebo
Sponsors
National Institute of Mental Health (NIMH)
Mind and Life Institute, Hadley, Massachusetts
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. ages 18-55; 2. have a smartphone and agree to receive text-messages; 3. have difficulty with their relationships or social interactions; 4. high emotion dysregulation, assessed with the Difficulties with Emotion Regulation Scale (DERS)(Gratz & Roemer, 2004) with scores over 90.
Exclusion criteria
1. Current mania; 2. Meets full criteria for any current psychotic disorder; 3. Currently/chronically homeless; 4. Current suicidal ideation; 5. Psychiatric hospitalization within past 6 months; 6. Unable to read, blind or deaf. Our previous study recruited only participants who were currently in treatment, but this study will include both participants who are currently in treatment, as well as those who are not in treatment. 7. high self-reported autistic traits, as assessed by the Autism Spectrum Quotient (Auyeung & Baron-Cohen, 2012).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Ability to Perceive Negative and Positive Emotional Expressions, as Measured by a Behavioral Computer-based Assessment | During the laboratory experiment (week 1) | 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. |
| Changes in Emotion Perception, as Measured by a Phone-based Behavioral Assessment | After the one week of phone-based intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Emotional Distress, as Measured by Subjective Units of Distress (SUDS) | Beginning of Week one laboratory experiment, End of Week one laboratory experiment | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in Emotional Arousal, as Measured by Skin Conductance Response (SCR) | Laboratory assessment, up to one week | 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. |
Countries
United States
Participant flow
Pre-assignment details
11 participants were considered screen failures
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| 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 | 27 |
| 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 | 27 |
| Total | 80 |
Baseline characteristics
| Characteristic | Total | Mindful Breathing | Habituation | Control |
|---|---|---|---|---|
| Age, Continuous | 25 years STANDARD_DEVIATION 6.77 | 27.56 years STANDARD_DEVIATION 7.56 | 23.77 years STANDARD_DEVIATION 7.03 | 23.77 years STANDARD_DEVIATION 20 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 3 Participants | 4 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants | 23 Participants | 23 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 25 Participants | 7 Participants | 8 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 2 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 3 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 33 Participants | 13 Participants | 11 Participants | 9 Participants |
| Region of Enrollment United States | 80 participants | 26 participants | 27 participants | 27 participants |
| Sex: Female, Male Female | 64 Participants | 20 Participants | 24 Participants | 20 Participants |
| Sex: Female, Male Male | 16 Participants | 6 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 0 / 26 | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 26 | 0 / 27 | 0 / 27 |
Outcome results
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.
Time frame: After the one week of phone-based intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindful Breathing | Changes in Emotion Perception, as Measured by a Phone-based Behavioral Assessment | 5.19 units on a scale | Standard Deviation 2.57 |
| Habituation | Changes in Emotion Perception, as Measured by a Phone-based Behavioral Assessment | 5.3 units on a scale | Standard Deviation 2.54 |
| Control | Changes in Emotion Perception, as Measured by a Phone-based Behavioral Assessment | 5.23 units on a scale | Standard Deviation 2.59 |
p-value: 0.396Multilevel modeling
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.
Time frame: During the laboratory experiment (week 1)
Population: Baseline data for one participant was not completed appropriately and was omitted from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindful Breathing | The Ability to Perceive Negative and Positive Emotional Expressions, as Measured by a Behavioral Computer-based Assessment | 77.31 Percent of correct responses | Standard Deviation 14.36 |
| Habituation | The Ability to Perceive Negative and Positive Emotional Expressions, as Measured by a Behavioral Computer-based Assessment | 81.93 Percent of correct responses | Standard Deviation 17.94 |
| Control | The Ability to Perceive Negative and Positive Emotional Expressions, as Measured by a Behavioral Computer-based Assessment | 84.85 Percent of correct responses | Standard Deviation 16 |
p-value: 0.018ANCOVA
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.
Time frame: Beginning of Week one laboratory experiment, End of Week one laboratory experiment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindful Breathing | Change in Emotional Distress, as Measured by Subjective Units of Distress (SUDS) | 1.14 units on a scale | Standard Deviation 1.21 |
| Habituation | Change in Emotional Distress, as Measured by Subjective Units of Distress (SUDS) | 0.61 units on a scale | Standard Deviation 0.9 |
| Control | Change in Emotional Distress, as Measured by Subjective Units of Distress (SUDS) | 0.56 units on a scale | Standard Deviation 0.95 |
p-value: 0.002Multilevel modeling
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.
Time frame: Laboratory assessment, up to one week