Evaluating the Impact of an Emotion Regulation Intervention on Emotion Perception
Phase: NA
Conditions: Emotions
Sponsor: Duke University

NCT03790878  Version Date 7/01/2020 
Evaluating the Impact of an Emotion Regulation Intervention on Emotion Perception 
Purpose of the Study 
Aim 1: To evaluate the short-term impacts of an emotion regulation intervention on emotion perception 
in the laboratory. In the laboratory training session, we will compare performance on behavioral 
emotion perception tasks between participants who receive the intervention, a training in an emotion 
regulation skill (i.e. mindful breathing), and participants in the control conditions (perspective-taking 
and worry inductions). Hypothesis 1: We predict that participants in the emotion regulation intervention 
condition will show less negative bias in their performance compared to participants in the control 
conditions. We also predict that intensity of emotional distress will be associated with negative biases. 
            Aim 2: To investigate the longitudinal effects of this intervention on emotion perception outside 
the lab using experience sampling. After the laboratory training session in aim 1, participants in both 
groups will receive an auditory reminder of the emotion regulation skill (a specific tone) three times a 
day through their mobile phones for one week and then will complete emotion perception tasks. Using 
our method of generalization, the participants in the intervention group have learned to associate the 
tones with reductions in emotional distress. For this aim, we will compare changes in performance on 
the emotion perception tasks over time between the three groups. Hypothesis 2: We predict that these 
cues will lead to greater decreases in negative biases in emotion perception over time compared to the 
control conditions. We will also test whether changes in emotional distress and regulation mediate the 
longitudinal changes in emotion perception performance. 
Background & Significance 
Emotion perception problems are a transdiagnostic problem in mental health. Dysfunctional social 
processes, such as problems with perceiving and understanding other people’s emotional expressions, 
are some of the main targets of mental health treatment emphasized within the Research Domain 
Criteria (RDoC) of the National Institute of Mental Health. Recent efforts in the NIMH have included 
assessing and targeting deficits emotion perception, one of the core social cognition processes that are 
impaired in schizophrenia.(Pinkham et al., 2014) However, emerging evidence has revealed that 
problems with emotion perception are also associated with many affective and personality disorders 
that are characterized by emotion dysregulation, such as depression, anxiety disorders and borderline 
personality disorder (Daros, Zakzanis, & Ruocco, 2013; Lazarus, Cheavens, Festa, & Zachary Rosenthal, 
2014; Plana, Lavoie, Battaglia, & Achim, 2014; Schreiter, Pijnenborg, & aan het Rot, 2013). These 
problems often manifest as negative biases in emotion perception, the tendency to judge other people’s 
emotional expressions negatively (Bradley, Mogg, White, Groom, & Bono, 1999; Dyck et al., 2009; 
Joormann & Gotlib, 2006) that contribute to further emotional difficulties (Rapee & Heimberg, 1997) 
and serious psychosocial problems such as violent offending,(Jolliffe & Farrington, 2004) 
aggression(Dodge, 1993), poor relationship quality(Carton, Kessler, & Pape, 1999) and general 
psychiatric distress (Crick & Dodge, 1994). Negative biases in emotion perception may also be a 
vulnerability factor for psychopathology, as there is evidence that problems with perceiving emotions in 
facial expressions are associated persistence and relapse of depression (Bouhuys, Geerts, & Gordijn, 
1999). Therefore, there is a need for effective interventions for problems with emotion perception 
across affective and personality disorders. As these disorders are often comorbid (Grant et al., 2004), 

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effective interventions should target and treat transdiagnostic processes associated with social 
dysfunction in these disorders. 
            Novel, targeted, and transdiagnostic interventions are needed for problems emotion perception 
in affective and personality disorders. There is recent interest in clinical psychology to move away from 
labor and time-intensive treatment packages and to develop brief, accessible interventions (or “micro-
interventions”) that target transdiagnostic processes underlying dysfunction across different psychiatric 
disorders. Because mental health providers often find that personality disorders and related 
interpersonal issues often do not respond to traditional psychotherapies (Beck, Davis, & Freeman, 
2015), new approaches to interventions for social deficits are especially needed. An emerging, promising 
approach to improving social functioning is targeting psychology processes involved in social interaction 
(i.e. social cognition).(Penn, Sanna, & Roberts, 2008) Preliminary intervention efforts have 
demonstrated that remediation of problems perceiving emotional expressions are effective within 
schizophrenia (Kurtz & Richardson, 2012),  and autism spectrum disorders (Roelofs et al., 2016). 
However, these interventions treat problems that are specific to these disorders (e.g. lack of knowledge 
of social cues) and do not target and treat the problems associated with affective and personality 
disorders (e.g. negative biases). In absence of effective emotion perception treatments for these 
populations, more research is needed to identify and target psychological processes that interfere with 
social processes within affective and personality disorders. To address this gap in the literature, I 
propose targeting specific psychological states that regularly interfere with emotion perception within 
these disorders. 
            Difficulties regulating emotional distress may lead to negative biases in emotion perception. 
Difficulty reducing intense, negative emotions is a potential target for treating negative biases in 
emotion perception. First, emotion perception deficits may be a serious issue within patients with 
affective and personality disorders characterized by emotion dysregulation, problems managing and 
reducing negative emotional experiences (Gross & Muñoz, 1995). Beyond the diagnoses, problems 
managing one’s own negative emotional states interferes with many social cognitive processes, 
including perceiving and understanding other people’s emotional expressions (Decety & Lamm, 2006; 
Eisenberg, Fabes, Guthrie, & Reiser, 2000). Specifically, research in healthy samples has demonstrated 
that increases in negative emotions lead to negative biases in emotion perception tasks (Chepenik, 
Cornew, & Farah, 2007; Niedenthal, Halberstadt, & Margolin, 2000; Schmid & Schmid Mast, 2010). 
These findings can be interpreted as a mood-congruence effect, in which a person’s emotional state 
leads them to selectively attend to and encode stimuli in the environment that is consistent with that 
emotion (Forgas & Bower, 1987). Furthermore, some researchers have argued that this effect may be 
particularly common within individuals who have chronic emotion dysregulation (i.e. borderline 
personality disorder (Daros et al., 2013; Domes, Schulze, & Herpertz, 2009)), whose social behavior is 
particularly mood-dependent. In line with this argument, our previous research demonstrated that high 
activation of negative emotions decreases sensitivity to other people’s emotional expressions across 
anxiety disorders, depressive disorders, and personality disorders (McMahon, Kim, Fang, Neacsiu, & 
Rosenthal, in press). Therefore, states of unregulated, intense negative emotions (i.e. distress) may 
often impair emotion perception abilities within people diagnosed with clinically significant emotional 
difficulties. We hypothesize that training patients to regulate their distress with emotion regulation skills 
will lead to less negative biases in emotion perception compared to patients who do not receive this 
training. 

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            Mindfulness is a promising emotional regulation skill that could reduce negative biases in 
emotion perception. Identifying a brief intervention that effectively reduces negative emotions is 
necessary to investigate the impact of emotion regulation on emotion perception. Previous research has 
shown that mindfulness is a skill that is positively associated with both emotion perception ability and 
emotion regulation (Quaglia, Goodman, & Brown, 2015). First, mindfulness can be used to modulate 
experiences of negative emotions (Chambers, Gullone, & Allen, 2009; Roemer, Williston, & Rollins, 
2015). For example, one study found that a 15-minute mindful breathing induction led to less negative 
emotional responses to negatively-valenced stimuli than control condition (a worry induction) (Arch & 
Craske, 2006a). Secondly, brief mindful breathing interventions can also lead to improvements in 
emotion perception.(Tan, Lo, & Macrae, 2014) Taken together, findings suggest that mindful breathing 
can be used as an emotion regulation skill that may have beneficial impacts on emotion perception. To 
our knowledge, these relationships have yet to be tested within clinical samples with emotion 
dysregulation. Given its established effect on emotion regulation, a mindful breathing skill will be taught 
to participants as an emotion regulation skill as a micro-intervention. A useful comparison condition 
would be a micro-intervention that targets perspective-taking (Jackson, Meltzoff, & Decety, 2005), 
another social cognitive process related to perceiving other people’s emotions. Perspective-taking 
inductions may share similar mechanisms as mindfulness as another type of metacognitive intervention, 
but they do not address dysregulated emotions. Therefore, a perspective-taking micro-intervention will 
be used in this study as the active comparison condition. 
            Our team’s intervention that generalizes emotion regulation skills is a novel approach to testing if 
reducing emotional distress reduces emotion perception biases. To study the longitudinal effects of 
emotion regulation skills on emotion perception, these skills must be applied over time in patients’ daily 
lives. In almost all behavioral therapies, the learning process occurs inside a clinic setting, and patients 
are expected to transfer this learning outside the clinic setting to the natural environment. However, 
patients often find it extremely difficult to generalize newly learned adaptive responses from one 
context to another (Stokes & Osnes, 2016). A key principle that can be used to facilitate generalization 
of newly learned behavior across contexts is: stimuli that are paired with training and transported into 
relevant contexts in the natural environment can be used as functional mediators to promote 
generalization.(Stokes & Osnes, 2016) This has been tested in our lab within adults with a variety of 
psychiatric diagnoses all characterized by having high difficulties with emotion regulation. Preliminary 
findings from our NIMH-funded study with emotionally dysregulated adults, “Evaluating a Novel Method 
of Generalizing Emotion Regulation” (IRB #: Pro000035922), demonstrated that within the lab, auditory 
reminders of habituation (i.e. natural reductions in emotional arousal over time) reduced emotional 
distress (F=6.75, p=.011) and arousal (F=7.05, p=.009) significantly more than a control condition. 
Emotional distress and arousal were assessed with both self-report (e.g. Subjective Units of Distress) and 
physiological measures (e.g. galvanic skin conductance). Reminders delivered via mobile phones over 
one week also significantly reduced emotional distress compared to placebo sounds (X2=11.54, p<.001). 
These findings suggest promise for the use of novel reminders of learned emotion regulation skills to 
improve the ability to perceive other people’s emotions in real social contexts. The next steps in this 
research program is to test the effects of this intervention on other psychological processes that are 
fundamental to daily functioning, such as emotion perception. 
            In sum, this study investigates the impact of a novel, generalizable emotion regulation micro-
intervention on emotion perception biases in a transdiagnostic sample of adults. Negative biases in 

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emotion perception are present within a wide range of psychiatric populations characterized by 
emotional difficulties and may contribute to debilitating social dysfunction. These deficits call for brief, 
accessible and effective interventions that target transdiagnostic processes that lead to these emotion 
perception biases. Therefore, this study proposes to investigate if a brief, emotion regulation 
intervention reduces negative biases in emotion perception within a transdiagnostic clinical sample with 
emotion dysregulation. This study will leverage our lab’s translational method of generalizing learned 
emotion regulation skills to real social contexts through mobile-phone technology. We will compare the 
effects of this emotion regulation intervention with two comparison conditions that involve inductions 
that have been shown to increase emotional distress in response to stressful experiences: a worry 
induction and a perspective-taking induction. The findings from this study will determine whether 
problems with emotion perception can be reduced by helping patients manage their own emotional 
experiences in adaptive ways. These findings will inform larger clinical trials in larger samples and over 
longer periods of time. Therefore, this proposed project could pave the way for a new approach to 
treating emotion perception and other social processes in a wide range of clinical populations. 
Design & Procedures 
This study is funded by Duke University Bass Connections Project Teams, through Duke Institute for 
Brain Sciences (DIBS). It is also funded by the Varela Award from the Mind & Life Institute. 
Study Overview: This study will be a three-group study and will broadly follow the protocols of our 
team’s previous study, “Evaluating a Novel Method of Generalizing Emotion Regulation” 
(Pro000035922). The study will be conducted over two sessions in the lab (intake and training sessions), 
followed by one week of receiving mobile phone prompts (testing phase). In the first intake session, all 
participants will be assessed for psychiatric diagnoses and complete the emotion perception tasks. Then, 
the participants will return one week later for the training session. Participants will be a randomized to 
one of three groups: 1. Mindful Breathing, 2. Habituation, or 3. Control condition. After the training 
session, all participants will receive mobile phone prompts during the one-week testing phase. At the 
end of testing phase, all participants will complete the self-report measures of psychological functioning 
and the emotion perception tasks through an online survey.  Emotional distress will be measured 
repeatedly throughout the study. See figure for a summary of the main procedures in the study 
protocol, with measures that may be used in primary and exploratory analyses: 
  
Recruitment and Assessment.  Before being recruited into the study, potential participants will complete 
a phone screen—a pre-experiment screening questionnaire (see Phone Screen document) or complete 
an online survey done through Qualtrics to assess certain exclusion and inclusion criteria (see 
inclusion/exclusion criteria in section 5). As the phone screen collects PHI (e.g. name, email and/or 
telephone number, knowledge of psychological symptoms, etc) in order to determine eligibility for the 
study, we request the waiver of consent to collect this information prior to informed consent. 
Potentially eligible participants will come to the lab for their intake session to fully determine eligibility 
for the study (see Request for Waiver of Consent). Upon arrival, a Clinical Assessor (Kibby McMahon or 
Caitlin Fang) will review the consent form, answer any questions, and obtain written informed consent. 
The Clinical Assessor then will administer diagnostic interviews (i.e. Structured Clinical Interview for 

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DSM-5 (SCID-5)(First, Williams, Karg, & Spitzer, 2015)) and self-report instruments needed to assess all 
other inclusion/exclusion criteria (see section 5). 
  
Measures and Tasks 
            Interviews: During the intake session, diagnostic exclusions and current/past prevalence of Axis I 
and II diagnoses will be determined by the Structured Clinical Interview for Mental Disorders-I and II 
(SCID-I and II for DSM-5), interviews with demonstrated reliability used in our lab. The Treatment History 
Interview, brief version (B-THI; Linehan & Heard, 1987) will also be used at the intake session to assess 
previous and ongoing psychiatric services received and the NART will assess reading ability. All 
interviews will be videotaped or audio recorded and Dr. Rosenthal will determine the reliability of every 
tenth interview. These video and/or audio recordings will be recorded directly onto the assessor’s Duke 
computer, using a USB connected web camera that is connected to the hard drive of that computer. The 
recordings do contain PHI and thus the Duke lab computer used for recording has been encrypted with 
PGP. These video/audio files will be only temporarily stored on the local Duke computer and will be 
moved to Department of Psychiatry & Behavioral Sciences protected folder. 
            If the participant recently took part in another study at CBRTP, he or she may not be required to 
complete all portions of the SCID interviews. Specifically, if the participant completed a SCID-I diagnostic 
interview with one of our study assessors within the previous four weeks, he or she would only be 
required to complete any portions of the SCID-I not completed as part of the earlier study assessment. If 
the participant completed the SCID-II within the previous six months, he or she would not be required to 
complete the SCID-II. In those cases, data from the earlier assessments would be used for this study. 
These procedures reduce the burden on the participant by eliminating the need to duplicate lengthy 
interviews, while still ensuring that the data is current. 
 
Emotion Perception: The main outcome measure of emotion perception will be assessed with 
behavioral tasks, described below. 
(1) Emotion Perception Bias Task (EPBT). This behavioral assessment is adapted from other studies 
investigating the effects of mood on emotion perception biases (Dyck et al., 2008; Schmid & Mast, 
2010). In this task, participants will view photographs of people’s faces expressing either a negative 
emotion (e.g. angry), positive emotion (e.g. happy). These photos will be displayed to participants one at 
a time for a brief period, and then asked to judge the emotion in a multiple-choice format (e.g. “happy” 
or “angry”). At the end of this task, participants are asked to rate how confident they were in the 
accuracy of their responses on a 0-100 scale. 
(3) The Bell Lysaker Emotion Recognition Task (BLERT) (Bell, Bryson & Lysaker, 1997) measures the 
ability to identify affect cues. It is an audio-visual task designed to elicit a person's ability to discriminate 
seven emotional states (i.e. happiness, sadness, fear, disgust, surprise, anger or no emotion) given facial, 
voice-tonal and upper-body movement cues. The BLERT consists of twenty-one, 10-second vignettes 
(using the same male actor) containing one of three monologues involving a work related topic. After 
each vignette, the tape is paused and the participant circles the corresponding emotional label on an 
answer sheet. After identifying the emotion for each video, participants are asked to rate how confident 

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they were in the accuracy of their response on a 0-100 scale. Performance is indexed as the total 
number of correctly identified emotions (ranging from 0 to 21). Test scores include the total number of 
correct responses, the number of correct positive affect responses (happy and surprise), the number of 
correct negative affect responses (sadness and fear), the number of correct difficult responses and 
number of correct easy responses. 
(3) A phone-based assessment of emotion perception, adapted from procedures used in text-based 
emotion perception research in healthy populations (Cheshin, Rafaeli, & Bos, 2011). Participants receive 
standardized text messages that are previously rated for emotional valence on a 0 (very negative) to 
9(very positive) scale by independent raters. To increase ecological validity, participants are told that 
these messages have been sent by the experimenter, who is expressing an emotion through the 
message (e.g. “I just got into an argument with a friend, so I’m not having a good day”). After 
participants receive the text message, they are instructed to rate the valence of the emotion of the 
message on the same 10-point scale. This phone-based emotion perception task will only be 
administered during the one-week testing phase. See the text message script document for the text 
message content participants would receive during testing phase. 
  
            Emotion: Emotional arousal will be measured through self-report and physiological measures: (1) 
Skin conductance will be measured using Ag-AgCl electrodes, which are connected to a Biopac MP150 
device in an adjacent room. Amplified signals of analog data are converted to digital form and filtered 
using Biopac’s Acqknowledge Software and are stored in a database on the computer. (2) Subjective 
units of general psychological distress (SUDS; visual analogue scale from 0-100); (3) the Sedation Scale 
(SS), a self-report measure of emotional and general levels of arousal, and (4) the PANAS-2 (Watson, 
Clark, & Tellegen, 1988), a measure of current emotional state. 
Face-reader data collection. We have acquired new software (Facereader from Noldus) that can be used 
to analyze facial expressions from an inputted video and to output emotional experiences resultant from 
the facial analysis. This software complements the physiological data acquisition that we are doing and 
can add a new dimension to our data collection and analysis. We plan to video record participant’s faces 
during the stressor and regulation periods of the study using a Microsoft webcam that is connected 
directly to a Duke approved laptop or computer. We will ask at consent for special permission for this 
procedure. We will only record participants’ faces if consent is given. These recordings will be 
transferred right away at the end of the session on a secured server and deleted from the laptop (similar 
procedures as for assessment videos). The videos will be kept up to 6 years post study finish and deleted 
within that timeframe. 
  
             Psychological Functioning: Exploratory outcome variables will be changes in self-reported 
impairments in daily functioning and other psychiatric symptoms. These include: 
1. Difficulties in Emotion Regulation Scale (DERS) (Gratz, 2004) 
2. Interpersonal Reactivity Index (IRI),(Davis, 1980) 
3. Toronto Mindfulness Scale (TMS) (Lau, et al., 2006), 

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4. Basic Empathy Scale (BES) (Carre et al., 2013) 
5. Patient Health Questionnaire-depression module (PHQ-9) (Kroenke & Spitzer, 2002) 
6. Social Interaction Anxiety Scale (SIAS; Mattick & Clarke, 1998) 
7. NIH Toolbox Adult Social Relationship Scales (NIH SRS) (Cyranowski, 2013) 
8. Ambiguous Intentions Hostility Questionnaire (AIHQ-A; Combs et al, 2007) 
9. Early Memories Task (EMT; Mayman, 1968) 
10. Psychological Flexibility Questionnaire (PFQ; Ben-Itzhak, 2014)) 
  
            Personally-Relevant Emotional Stressor Task. Using the method used in our previous studies, we 
will create four negative emotional arousal scripts that will be used in a random order during the first 
lab session. The clinical assessor will ask the participant to describe three of the most recent stressful 
experiences in their lives within the past two weeks (a timeline that has shown to be feasible within our 
previous studies with emotionally dysregulated participants). Participants will write a description of each 
event, and the clinical assessor will work with the participant to establish a clear story for each event 
that can be recited in approximately 30 seconds. The clinical assessor will digitally record these scripts 
into .mp3 files, which will be used in random order as the emotional stressors. Each stressor is 
presented to the participant three times. Participants will be instructed to listen carefully to the 
recorded stressor via headphones (30s) and to imagine the stressful experience as vividly as possible. All 
participants will be given these instructions, but additional instructions are given according to the 
experimental condition.  
            
Experimental Procedures 
             Intake Session: After determining eligibility, participants will complete measures of social and 
psychological functioning (DERS, IRI, PANAS-2, TMS, AIHQ-A, NIH SRS, PHQ-9,  BES, EMT, SIAS, PFQ) and 
the two laboratory emotion perception tasks (BLERT, EPBT) through an online Qualtrics survey on a 
standard desktop computer in the laboratory. At this time, they will provide four recent stressful 
experiences for the personalized stressor task. 
            Training Session: All participants will come back to their lab for this session (ideally between 5-7 
days after the intake session), which will take approximately 1.5 hours. First, all participants will be 
asked about: 1) current distress and suicidal urges (i.e. Suicide Risk Protocol), 2) any changes in 
medications since the previous visit, 3) nicotine, caffeine, and alcohol use that day, 4) subjective units of 
general psychological distress (SUDS; visual analogue scale from 1-9), 5) dissociation state, assessed 
using self-report (Dissociative-Tension States Scale 4 item version-DSS-4 from the DSS-acute), 6) levels of 
arousal with the Sedation Scale, and 7) current affect with the PANAS-2.  Then, the experimenter will 
affix electrodes and will use Biopac MP150 hardware and AcKnowledge software for data acquisition. All 
participants will be assessed for baseline negative emotional arousal with psychophysiological (galvanic 
skin response) measures for five minutes. Then, participants will be randomized to one of three groups:  

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            Condition 1: Mindful Breathing. Participants assigned to this condition will first receive an 
orientation to mindful breathing, an emotion regulation skill based on Mindfulness Based Stress 
Reduction (Kabat-Zinn, 1990). The experimenter will orient them to the concept of focusing attention on 
the breath while feeling intense emotions, explaining that it’s an active skill that one can use to calm 
down when distressed. After the initial orientation, participants are instructed to participate in the 
stressor task to while practicing the mindful breathing skill. Reductions in emotional arousal will be 
continuously monitored using a real-time monitoring program that samples arousal through skin 
conductance every 500ms relative to the average baseline arousal. Emotional distress will also be 
assessed repeatedly throughout the task (SUDS). Once participants reduced their sympathetic arousal 
(returning to baseline in skin conductance) in the stressor task, a novel tone will be heard through the 
headphones. Through classical conditioning, participants learn to associate this specific sound with 
reductions in negative emotional arousal and distress. 
            Condition 2: Habituation. This comparison condition will most closely resemble the procedures of 
the previous study on generalizing emotion regulation (Pro00035922). Participants will hear each 
stressor for a minimum of 2 and a maximum of 4 times. Reductions in emotional arousal will be 
continuously monitored using a real-time monitoring program that samples arousal through skin 
conductance every 500ms relative to the average baseline arousal. Emotional distress will also be 
assessed repeatedly throughout the task (SUDS). Once participants reduced their sympathetic arousal 
(returning to baseline in skin conductance) in the stressor task, a novel tone will be heard through the 
headphones. Through classical conditioning, participants learn to associate this specific sound with 
reductions in negative emotional arousal and distress. 
            Condition 3: Control. This control condition will only present the stressor task without further 
instructions. Although emotional distress (SUDS) and sympathetic arousal (SCR) will be measured in this 
task as the first condition, participants in this condition will not hear the tones. 
  
            Immediately after the emotional stressor task, all participants will again report: 1) subjective units 
of general psychological distress (SUDS; visual analogue scale from 0-9), 2) dissociation state, assessed 
using self-report (Dissociative-Tension States Scale 4 item version-DSS-4 from the DSS-acute), 3) levels of 
arousal with the Sedation Scale, and 4) current affect with the PANAS-2. They will then complete the 
laboratory emotion perception bias task and a manipulation check. Afterward, they will be oriented to 
the mobile phone prompts they will receive during the testing phase. 
  
            Testing Phase: During the one-week testing phase, participants in both conditions will receive 
three text-message prompts through their own phones randomly each day. These prompts will function 
both as an EMA measurement of self-reported negative emotional distress, as well as the delivery 
method of the tones. We will have a specific application, processed and stored on Heroku, that will 
receive and send text messages to participants via Twilio. In each prompt, participants will be asked to 
report on their current negative emotional distress (SUDS). When participants report high distress (i.e., 
SUDS>2), they will automatically hear the tone by receiving a text message with an .mp3 file. The 
participants in the control conditions will also hear the tone despite having no previous associations 
with it, to control for potential placebo effects. After hearing this sound, participants will report again on 

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their distress, then complete the phone-based emotion perception task.  As a manipulation check, the 
participants in the emotion regulation intervention condition will be asked if they actu      ally used the 
mindful breathing skill. If the participant does not meet criterion for high distress, they will instead 
receive a text response on their phone thanking them for their response (see text message sample script 
document). 
            All participants will complete the laboratory emotion perception tasks and self-report measures 
of emotion and psychological functioning through an online Qualtrics survey at the end of this testing 
phase. They will also complete an exit questionnaire through this Qualtrics survey (see exit 
questionnaire document). 
Selection of Subjects 
 Inclusion criteria include 
(1) ages 18-55; 
(2) have a smartphone and agree to receive text-messages; 
(3) high emotion dysregulation, assessed with the Difficulties with Emotion Regulation Scale 
(DERS)(Gratz & Roemer, 2004). There is no single consensus definition of difficulties with emotion 
regulation. However, one influential contemporary model proposes a multi-dimensional approach to 
conceptualizing difficulties with emotion regulation, including difficulties with: emotional awareness, 
emotional clarity, achieving goals when upset, impulsivity when upset, unwillingness to accept negative 
affect when upset, and accessing strategies to regulate emotions when upset (Gratz & Roemer, 2004). In 
the present application, we utilize this model and accompanying measure, the Difficulties with Emotion 
Regulation Scale (DERS; Gratz & Roemer), when characterizing our sample as being individuals who have 
problems regulating emotions. The mean DERS total score across all published reports (n = 13) with 
adult psychiatric samples (n = 19) is 112.15 (SD = 22.38). Following the established protocols from 
previous studies, we will use a total score of 90 or higher in the DERS for inclusion. In our previous study 
(Pro000035922), the 208 eligible participants had a mean DERS score of 117.6 (SD=17.95) at intake. 
These participants met criteria for a variety of affective and personality disorders, including major 
depression (68.3%, 22.1% current), generalized anxiety disorder (40.4%), and borderline personality 
disorder (11.1%). Therefore, we are confident that this DERS threshold will ensure recruitment of a 
transdiagnostic, clinical sample with emotion dysregulation. 
  
            Exclusion criteria include 
(1) Current mania; 
(2) Meets criteria for any current psychotic disorder symptom; 
(3) Currently/chronically homeless; 
(4) Current suicidal ideation (see data & safety section for specific criteria); 
(5) Psychiatric hospitalization within past 6 months; 

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(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. Intelligence Quotient (IQ) will be assessed with the North American Adult 
Reading Test (NART).21-22 Subjects with a NART calculated IQ score of <90 will be excluded from the 
study. 
(7) high self-reported autistic traits, as assessed by the Autism Spectrum Quotient (Auyeung & Baron-
Cohen, 2012). If participants score more than 6 out of 10 for the total score, they are considered at risk 
for autism.           
  
 Clinical Assessment. Individuals not excluded by the phone screen will come to the lab to determine 
eligibility for the study. Upon arrival, a Clinical Assessor will review the consent form, answer any 
questions, and obtain written informed consent. Next, the Clinical Assessor will administer diagnostic 
interviews (SCID I, II for DSM-5) and self-report instruments (i.e., demographics, DERS) needed to assess 
all other inclusion/exclusion criteria Ineligible participants will be debriefed and compensated ($10) for 
their partial participation. Eligible participants will complete remaining assessments. This approach helps 
to reduce unnecessary participant burden and increase project efficiency. After inclusion/exclusion 
criteria are assessed and eligibility is confirmed, participants will schedule their next appointment 
(ideally min 1 day and max 14 days post screening). Of note, the population being seen in this study can 
have many different problems currently and in their past and sometimes the interview assessments, 
along with assessing inclusion/exclusion criteria, can last longer than expected. At the subject’s 
discretion, we may have to finish portions of the assessment interviews (non inclusion/exclusion 
portions) on a second day. If that is the case, the subject will finish the interviews or the self-report 
scales on a separate day or on Day 1 of the experiment, after the computer experiment. 
            Participants who are unable to return, unexpectedly for the training session within 14 days of the 
last day of the assessment (due to reasons such as sickness, holidays, weather related incidents, 
unexpected travel or transportation issues), but who remain in contact with the coordinator and are still 
willing and able to come in to complete the study, will be allowed to continue in the study. The assessor 
who collected their personalized scripts will check in with the subject prior to the training session to 
verify that the scripts are still valid stressors. If the training session visit occurs within one month of the 
screening assessment, all SCID-I & SCID-II data collected from assessment will still be valid (as per the 
SCID assessment standards). If the training session visit occurs more than one month after the 
assessment day, the subject will be rescreened (i.e. will sign another consent, redo DERS, all self-report, 
SCID-I, THI and scripts. We allow screen fail subjects who did not meet inclusion/exclusion criteria at the 
first visit to rescreen for the study, if it is deemed appropriate (examples include DERS<90). 
Subject Recruitment and Compensation 
Participants may be recruited using 1) flyers and posters at Duke University Medical Center (DUMC) 
campus and the surrounding Research Triangle area, 2) online advertisements used on DukeHealth.org, 
DukeList, Craigslist, the UNC Psychiatry webpage http://www.med.unc.edu/psych/research, UNC’s 
research site, Join the Conquest https://jointheconquest.org/index.php/en/, and facebook 3) direct 
referrals from local healthcare providers, Duke/UNC outpatient clinics, and other studies of depression 
5) Our IRB-approved participant registry (IRB# Pro00000853) in the CBRTP, 6) Duke Clinical Research 

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Unit (DCRU) volunteer registry, 7) ResearchMatch.org, (see below for description of the CBRTP registry, 
DCRU volunteer registry, ResearchMatch.org). 
The content of recruitment materials will be based on flyers, brochures and email/website scripts (see 
recruitment materials). 
  
Prospective participants will either 1) contact the study coordinator’s office at Duke or be called for a 
telephone screening interview, administered by a Study Coordinator/approved study team member, or 
2) they may visit the websites ClinicalTrials.gov or Dukehealth.org and see the study description or 
posting. The telephone-screening instrument (see telephone script) is designed to rule out individuals 
who clearly meet certain exclusion criteria. The Duke study coordinator or approved study staff member 
will go through the telephone script document within Qualtrics & will be directly entering potential 
participant’s responses to the telephone script electronically-thus no paper copies of the telephone 
script will exist. Because this study includes individuals with a range of psychiatric diagnoses, we expect 
most individuals will qualify at the phone screen for a face-to-face diagnostic assessment with the study 
Clinical Assessor to assess inclusion/exclusion criteria. If potential participants are ruled out via the 
phone script, their contact information will not be collected but all previous data collected prior to them 
ruling out will be kept in Qualtrics under a record number. 
  
As an aid to shorten the recruitment prescreening process, prospective participants will be directed by 
all Duke flyers & brochures to the online screen survey within Duke’s Qualtrics platform. Once on the 
Qualtrics online screen, they will read a description of the study (a modified version of the IRB approved 
phone screen) and if interested, will continue with answering the online screen questions (see online 
screen script for Qualtrics). The Qualtrics survey begins with an information statement designed to 
describe the study, risks and benefits in the absence of informed consent. If they agree to continue, they 
will then be asked their current age & if their age meets the study inclusion/exclusion criteria, they will 
continue on with the rest of the Qualtrics online screen as per Qualtrics online script. If they do not 
meet the age requirement, they will receive a message in Qualtrics indicating that they are not eligible 
and the survey will end. The results from the Qualtrics online survey will be monitored by the study 
coordinator and other study staff who will have access via a username and password. The data from the 
online survey can be imported to a SPSS or an excel .csv file which can only be accessed by the approved 
study team. Each day, study staff can check results of the online survey to see if any new potential 
participants have completed the survey and contact those people to either set up their first 
appointment or inform them that they don’t qualify for the study per inclusion/exclusion criteria. Upon 
download of the prescreening information from Qualtrics by the study coordinator or designated study 
staff, if it is noted that the subject did not complete all of the online screen questions, the plan is for the 
study coordinator/staff to contact the subject. They would thank them for starting the screen and 
prompt them to complete the online screen again or by phone (if easier, using the phone script) if they 
are still possibly interested in the study. 
  

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If the potential participant is indeed ineligible for in-person screening, the study coordinator/approved 
study team member will log in to Qualtrics and remove their contact information from the study record 
by the end of the study enrollment period. After removing the contact information, the record number 
will continue to exist in Qualtrics with only the subject’s research information. We estimate that across 
both study phases, approximately 150 online/phone screen interviews will be needed to enroll 90 
subjects to get 72 who complete the study. 
  
CBRTP Database Registry: Subjects who have previously agreed to be in our database registry (IRB# 
Pro00000853) to be considered for research studies would be contacted either to do a phone screen or 
directed to the Qualtrics online screen after reading through the phone script information to introduce 
the study and see if the individual is interested in being screened.  Those interested participants will be 
given information from CBRTP staff about the study and scheduled for an appointment. 
  
DCRU Volunteer Registry: This is a registry that the DCRU has that contains a list of potential study 
volunteers who have participated in research within the DCRU, who have said they would be interested 
in participating in other research. In exchange for a fee from our study team, a member of the DCRU 
team will identify potential research volunteers based on our study specific inclusion/exclusion that we 
give them and they will send out an email with a blurb about our study (this content is first approved by 
the IRB) and our contact information. Interested participants would then contact our study coordinator 
and complete a phone screen or go directly to the Qualtrics online screen for the study. 
  
ResearchMatch.org: ResearchMatch.org is a national electronic, web-based recruitment tool that was 
created through the Clinical & Translational Science Awards Consortium in 2009 and is maintained at 
Vanderbilt University.  There is no cost for researchers at participating institutions in the ResearchMatch 
Network to use ResearchMatch for the purposes of conducting recruitment feasibility analysis or 
participant recruitment.  The Vanderbilt IRB provides oversight for ResearchMatch as a recruitment tool 
and this has been documented within the ResearchMatch IRB Letter of Understanding (available upon 
request). We would be sending a study recruitment message to potential study volunteers through 
ResearchMatch.org. ResearchMatch requires us to confirm that the recruitment language has been IRB 
approved and that our direct study contact information has been removed (email/phone/website) 
before sending our study announcement through ResearchMatch to volunteers that appear to be a 
good match for our study. The study PI, Dr. Rosenthal, will seek approval from the institutional liaison to 
have ResearchMatch recruitment access where he is able to search for appropriate matches amongst 
the non-identifiable ResearchMatch Volunteer profiles in the system.  Our study’s recruitment content 
will be inserted into the standard ResearchMatch electronic notification that informs possible matched 
Volunteers that we have identified them as a potential match for our study. The secure ResearchMatch 
clearinghouse will route this standard ResearchMatch notification that includes the IRB approved study 
content that we enter on “Contacting Volunteers” steps available through ResearchMatch (i.e. similar to 
the content available on a flyer or poster) to each of these ResearchMatch volunteers.  These potential 
matching volunteers will have the option of replying yes, no, or not respond through a set of quick links 
available in this notification to our study announcement. By responding yes, the volunteer has 

NCT03790878  Version Date 7/01/2020 
authorized ResearchMatch to release their contact information to us.  This contact information of the 
Yes responding ResearchMatch Volunteers will be made available on our “Managing my Study” 
dashboard. Once we receive the contact information for those volunteers who respond yes, a member 
of our study staff would contact them to do a phone screen or direct them to our Qualtrics online screen 
after reading through the phone script information to introduce the study and see if the individual is 
interested in being screened. 
  
Social Media: We plan to post ads for the study on social media websites such as Facebook. We will 
create a study facebook profile and place adds using the study page profile. The language in the ads will 
follow the language approved by the IRB for internet content. We may forward the link to the online 
adds from study staff personal Facebook accounts also. 
  
Compensation. Compensation is as follows: 
$60 for individuals who are eligible and complete the full assessment 
$10 for those who are ruled out on the assessment day and complete only a partial assessment (approx 
30 minutes) 
$75 after completion of assessment and training session 
$85 after completion of full study 
 
Subject’s Capacity to Give Legally Effective Consent 
To be eligible, subjects must be able to give legal effective consent. 
Risk/Benefit Assessment 
Risks in this study may arise from 1) the assessment interviews and questionnaires, and 2) discussing 
and hearing recent personally distressing events.  
The assessment interviews and questionnaires may be stressful for some people. Some individuals may 
experience increased emotional discomfort as they discuss past or present problems during the 
assessments. During each in-person assessment, a trained professional will be available for consultation 
should discomfort become extreme. 
  
Minimizing Risks 
All participants will be asked to read, discuss, and sign written consent forms that describe the study 
procedures. Assessors will first give a narrative of the consent, and then have the subjects read it 
themselves. Following this, assessors will summarize the consent and answer any questions the subjects 
may have. The written document will not be signed until all questions and study concerns have been 
addressed. All participants will be told that they are free to withdraw from the study without penalty at 

NCT03790878  Version Date 7/01/2020 
any time. Every effort will be made to make the environment comfortable and supportive during 
assessment procedures: snacks and beverages may be offered, breaks will be taken, and the assessment 
will be stopped if the subject wishes or if stress is too high. All assessment sessions will be video 
recorded and will be supervised via regular weekly study meetings with Dr. Rosenthal and other study 
staff. However, subjects will be afforded the option during the informed written consent process to opt 
out of being audio or video recorded and still remain in the study. 
  
As a necessary aspect of participation in this study about emotion regulation, participants will be asked 
to describe and subsequently hear personally upsetting stories. This aspect of the study will be clearly 
delineated in the consent form and the study staff member obtaining consent will verbally describe this 
aspect of the study to each prospective participant.  Participants are also free to discontinue the study 
at any time.  Should a participant’s discomfort become extreme and includes strong thoughts of suicide, 
a trained professional will be available on-site during all active study hours. Because suicidal ideation is 
an exclusion criterion, we do not expect this to be likely risk. We will be using the Suicide Risk/Distress 
Protocol along with the SCID-I to assess suicidal ideation, intent, self-harm, and date of most recent 
attempt at the beginning of the assessment day and at the end. In the rare event that a high rating of 
ideation or distress occurs, the trained study staff will work with Dr. Rosenthal and the participant to 
address these suicidal thoughts and if they are deemed to be at imminent risk of suicide after the 
conversation, we will call 911 or obtain a commitment from the participant to go to the nearest hospital 
emergency room, (e.g. Duke ER). We will also use the Suicide Risk/Distress Protocol to assess ideation, 
intent and self-harm at pre and post the intake and laboratory sessions. 
  
Study-related adverse and serious events are not expected but will be closely monitored and will be 
reported to the proper authorities according to established FDA guidelines. All information gathered in 
this study will be maintained in the research record. 
  
Potential Benefits 
            Participants will be contributing to our understanding of the way that mindful breathing may 
improve the ability to perceive other people’s emotions.  As part of the study design, the participants 
randomized to receive the mindful breathing intervention and the perspective-taking induction (the 
active comparison group) will learn useful skills to help regulate their emotions or improve their 
relationships, as hypothesized. Participants randomized to the control condition (the worry induction) 
may benefit from monitoring their emotional state repeatedly throughout the study, which may 
increase emotional awareness. 
  
Costs to the Subject 
Participants will incur no costs for participating in any phase of this study. 

NCT03790878  Version Date 7/01/2020 
Data Analysis & Statistical Considerations 
For the primary outcome of biases in emotion perception, the estimates were derived from a mean 
difference between conditions. With a Type-I error rate of 5% and 72 participants (24 per group), we will 
have at least 80% power to detect a medium to large effect size (Cohen’s f = 0.38), based on previous 
research demonstrating negative biases in emotion perception using similar behavioral 
measures.(Schmid & Schmid Mast, 2010) Because we anticipate a 10% to 15% rate of dropout, 30 
participants will be randomized to each group. Therefore, this study will recruit 90 adult participants 
over the age of 18 who have high emotion dysregulation and interpersonal problems. 
            Since 2004, the CBRTP has recruited a range of adult psychiatric samples all characterized by 
problems with emotion regulation. Across studies of emotional functioning, it is estimated that our lab 
has run over 980 participants since 2004, at a rate of roughly 90 per year. In our previous NIMH project, 
over 33 months we have screened 1154 individuals and enrolled 169 participants, at a rate of 5.12 per 
month. We project enrolling 90 participants over 14 months, at a rate of 6.43 per month. Given our 
demonstrated track record of success meeting the required recruitment target in the present 
application, we expect to meet recruitment targets in the proposed project. 
  
Specific Aim 1: Aim 1 will determine if the emotion regulation intervention leads to fewer negative 
biases in emotion perception during the laboratory training session. For this aim, we will conduct 
ANCOVA analyses to study group differences in performance on the emotion perception laboratory 
tasks, controlling for their baseline scores assessed in the intake session. To compare the conditions’ 
impacts on negative biases, we will analyze group differences in 1) number of trials with neutral facial 
expressions are misclassified as negative emotions; 2) accuracy for positive emotions and negative 
emotional expressions. We will also examine the relationship between emotional distress and emotion 
perception. Hypothesis 1: Participants in our emotion regulation condition will have less negative bias in 
emotion perception (e.g. fewer neutral faces misclassified as negative, lower accuracy for negative 
emotions, higher accuracy for positive emotions) compared to participants in both the control 
conditions. Even though the perspective-taking and mindful breathing conditions may have similar 
effects (e.g. increasing attention to social cues (Olsson et al., 2016; Quaglia, Goodman, & Brown, 2016)), 
perspective-taking inductions may still lead to mood-congruent biases by increasing negative emotional 
responses (Lamm, Batson, & Decety, 2007).  Therefore, we predict that the emotion regulation 
intervention would reduce this bias significantly more than both the worry and perspective-taking 
conditions. We also predict that intensity of emotional distress will be related to negative biases in 
emotion perception. 
  
Specific Aim 2: Aim 2 will compare the changes in emotion perception over time between the emotion 
regulation breathing condition and the control conditions. For this aim, Multilevel modeling (MLM) will 
be used because it permits evaluation of longitudinal data on participants over time with trajectories for 
each participant examined as random effects. We will conduct MLM analyses to study group differences 
in changes in the laboratory emotion perception tasks assessed during intake (time 1), the training 
session (time 2) and after the testing phase (time 3). For the phone-based behavioral task, we will first 
examine the psychometric properties of this measure in this clinical sample. Then, we will analyze group 

NCT03790878  Version Date 7/01/2020 
differences in the valence of emotion perception ratings over the one-week testing phase. We will also 
examine whether changes in emotion dysregulation and distress mediate changes in negative biases 
over time. Finally, we will also explore the effects of the intervention on self-reported psychological and 
social functioning. Hypothesis 2: One week of hearing the tones via mobile phones will lead to greater 
long-term changes in negative biases emotion perception for participants in the emotion regulation 
condition compared to the participants in the control conditions. Changes in emotional regulation and 
distress over time will mediate changes in negative biases in emotion perception over time.  
             If our hypotheses are not supported and the conditions do not have significantly different effects 
on emotion perception, these findings would be indicative of trait-like deficits in emotion perception 
beyond the momentary effects of mood or perspective-taking. We would then use moderation analyses 
to explore the role of other stable factors within emotion perception performance, such as trait 
empathy (measured by the IRI) or psychiatric diagnoses. 
Data & Safety Monitoring 
The subjects will be fully informed of the nature of the study requirements prior to enrollment and 
periodically throughout the study. The subject’s well-being will be continuously monitored by the study 
team and the Principal Investigator will report all serious adverse events in an expedited manner to the 
Duke University Health System (DUHS) Institutional Review Board (IRB) office and all applicable 
regulatory authorities in accordance with the Center’s standard operating procedures. 
  
Quality assurance. Dr. Rosenthal will meet weekly with the Study Coordinator, assessors, and any 
research assistant to review any research issues that may have arisen during the past week as well as to 
monitor progress on subject recruitment and other research-related matters.  Additional meetings are 
conducted on an as-needed basis. 
  
Reporting mechanisms of AEs & SAEs to the IRB. In this study we will use the FDA’s definition of adverse 
events (AEs) and serious adverse events (SAEs). It is not expected that any such AEs or SAEs will occur in 
this experiment. However, AEs and SAEs will be assessed by a trained study coordinator and discussed at 
the weekly research staff meetings.  Any SAE will be brought to the attention of the PI as soon as 
possible and not longer than 24 hrs. Any SAE, will be reported to the Duke University Medical Center 
Institutional Review Board using the appropriate documentation within 5 days of the event. This will be 
the responsibility of the PI. The Duke University Medical Center Institutional Review Board will make a 
determination as to whether additional reporting requirements are needed. 
  
Suicide Ideation & Risk. During the assessment day, clinical assessors will assess suicidal ideation at two 
points during the interview: 
            Time One: During the Suicide Risk and Distress Protocol (pre and post assessment) 
            Time Two: While assessing Major Depressive Disorder, current and past (if the subject endorses 
Major Depressive symptoms) 

NCT03790878  Version Date 7/01/2020 
Subjects who endorse suicidal ideation but deny intent and plan will be included in the study.  Subjects 
who are at high risk for self-harm, endorsing intent and plan, will be excluded from the study.  Subjects 
who report a suicide attempt within the past 6 months, will also be excluded. For the subjects who are 
at current high risk for self-harm (i.e., intent to kill oneself is rated higher than a 4 on a 7-point scale 
while the assessor is going through the Suicide Risk and Distress Protocol or subject states that s/he is 
uncertain about being able to control suicidal impulses), assessors will complete the Suicide Assessment 
Worksheet and follow the instructions outlined in the Suicide Risk and Distress Protocol. This is also 
discussed under the minimizing risks section of this document. 
Protocol violations that could represent serious or continuing noncompliance will be brought to the 
attention of the PI as soon as possible and not longer than 24 hrs. These violations will be reported to 
the Duke University Medical Center Institutional Review Board using the appropriate documentation 
within 5 days of notification of the PIs. 
Reporting of non-study related, non-serious AEs are not reported to the IRB, and not entered on the 
study AE tracking log. 
Non-serious AEs that are deemed study related will be reported to the PI with annual reporting and 
entered into the study AE tracking log. These will be reported to the IRB as needed. 
Protocol deviations around study visit windows, skipped questions on self-report measures, missed 
therapy sessions, etc. will not be reported to the Duke IRB. Other protocol deviations will be reported to 
the PIs upon discovery and will then be reported to the Duke IRB within 2 weeks. 
In this study, if a subject experiences an SAE or study related, non-serious AE and they are not resolved 
at their final study visit, because it is a minimal risk study, we do not plan to continue to follow the event 
past their final study visit. 
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