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Evaluating a Novel Method of Generalizing Emotion Regulation (EMOGEN)

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Duke University Identifier:
First received: July 17, 2012
Last updated: June 21, 2016
Last verified: June 2016

The aim of the present project is to develop and evaluate a novel and brief method of generalizing habituation (i.e., calming down after being upset) from an original learning context in the laboratory to other contexts inside and outside the laboratory. Specifically, the primary aim of this project is to evaluate whether novel habituation reminders (HRs) introduced following personally-relevant emotional stressors reduce acute negative emotions and psychological distress outside of an original learning context. Using a team of basic and applied scientists, over 4 years the investigators expect to screen 420 adult outpatients to enroll 250 study participants who have extreme difficulties with emotion regulation. These 250 participants will be randomly assigned to one of eight experimental groups, with the experimental design leading them through 1 or 2 of 3 project experiments.

Actual enrollment: 372 adult outpatients signed consent and enrolled into the study. 222 participants were eligible and began the study. Out of the 222, 210 completed the study (as opposed to the desired 250).

Experiment 1 will evaluate whether novel auditory HRs following personally-relevant emotional stressors differentially reduce psychological distress and negative emotions (via self-report and psychophysiology), compared to no HRs, within the same and different lab contexts after a 1 week delay. Experiment 2 will evaluate whether HRs differentially reduce negative emotions, psychological distress, difficulties with emotion regulation, and psychiatric symptoms, compared to sham sounds outside the laboratory across a 1 week period, using 8x daily assessments of distress and emotions and automated HRs/shams when acute negative emotions are present. An automated server and cellular phone system will be used to assess distress and emotional states and to deliver HRs/shams. Experiment 3 will examine the feasibility, acceptability, and preliminary effect size estimates when participants self-initiate the use of HRs in their daily lives across a 2 week period when acute negative emotions are present. The specific randomization rules across the 8 groups are explained in detail in the full protocol .

Risks in this study may arise from 1) the assessment interviews and questionnaires, and 2) discussing and hearing self-reported distressing events. Initial analyses will focus on the success of randomization to groups. The investigators will examine group differences on possible covariates (e.g., demographic variables) and those that are different across conditions will be used as covariates. Preliminary analyses will examine distributional properties of primary outcome measures and correlations among outcome measures and possible covariates. The investigators will set alpha at .05 for all analyses of primary hypotheses. To examine the influence of psychiatric symptoms (compared to the HR) on primary outcomes, the investigators will examine the relationship between baseline clinically relevant psychiatric variables (e.g., symptom severity) and changes in SUDS, emotional arousal, and clinical outcomes over time and if appropriate include these variables in primary analyses. Full data analytic plans are described in the full protocol.

Condition Intervention
Problems With Emotion Regulation
Psychological Distress
Difficulties Coping With Negative Emotions
Borderline Personality Disorder
Behavioral: Habituation Reminder Training
Behavioral: Habituation Reminder
Behavioral: Habituation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Basic Science
Official Title: Evaluating a Novel Method of Generalizing Emotion Regulation

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Reduction in emotional arousal or speed to recovery from emotional arousal following a stressor. [ Time Frame: baseline and week 1 ]
    The investigators will examine psychophysiological and self-report measures of emotional stress.

Secondary Outcome Measures:
  • Phone use feasibility [ Time Frame: weekly from week 1-week 3 ]
    Feasibility will be assess by examining (1) frequency of calls to hear the HR, (2) changes in SUDS, emotional arousal/valence (Post-Pre), (3) change in daily emotional arousal assessed over time, and (4) change over time in clinical outcomes

Enrollment: 372
Study Start Date: August 2012
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HR training + Portable HR
100 subjects who receive Habituation Reminder training and who have access to the HR via a cellular phone.
Behavioral: Habituation Reminder Training
Participants will hear a unique sound after habituating to a personal stressor.
Behavioral: Habituation Reminder
Participants will hear the habituation reminder outside of the lab via a cellular phone.
Behavioral: Habituation
Participants will habituate to personally-relevant stressor.
Experimental: HR Training + no portable HR
50 subjects who receive Habituation Reminder training and who do not have access to the HR via a cellular phone.
Behavioral: Habituation Reminder Training
Participants will hear a unique sound after habituating to a personal stressor.
Behavioral: Habituation
Participants will habituate to personally-relevant stressor.
Experimental: No HR training
50 subjects who do not receive HR training.
Behavioral: Habituation
Participants will habituate to personally-relevant stressor.

  Show Detailed Description


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18-55
  • Currently receiving outpatient psychiatric treatment
  • Elevated overall score on Difficulties with Emotion Regulation Scale (Mean DERS total score >= 90)
  • Urine test negative for presence of substances (illicit substances; e.g., cocaine, opioids, methamphetamine, PCP, THC, Methadone). If urine test is positive for amphetamine, barbiturates and benzodiazepines and subjects take them as prescribed, these subjects are allowed.

Exclusion Criteria:

  • Current mania
  • Meets full criteria for any current psychotic disorder
  • Currently/chronically homeless
  • Current suicidal ideation with intent
  • Psychiatric hospitalization within past 6 months
  • Substance use disorder within past 6 months
  • Unable to read, blind, or deaf
  • PPVT < 70
  • Suicide Attempt within past 6 months
  • Not currently in outpatient psychiatric treatment (i.e. psychotherapy, medication management, etc)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01653548

United States, North Carolina
Duke University Medical Center-Civitan Bldg
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
National Institute of Mental Health (NIMH)
Principal Investigator: Mark Z Rosenthal, Ph.D. Duke University
  More Information

Gratz, K. L. & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of Psychopathology and Behavioral Assessment, 26, 41-54
Roth, A., & Fonagy, P. (2005). What works for whom? A critical review of psychotherapy research. New York, NY: Guilford

Responsible Party: Duke University Identifier: NCT01653548     History of Changes
Other Study ID Numbers: Pro00035922
1R01MH095806-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: July 17, 2012
Last Updated: June 21, 2016

Keywords provided by Duke University:
emotion dysregulation
borderline personality disorder
negative emotions
outpatient interventions for negative emotions
psychological distress
emotion regulation problems

Additional relevant MeSH terms:
Borderline Personality Disorder
Personality Disorders
Behavioral Symptoms
Mental Disorders processed this record on May 24, 2017