Evaluating a Novel Method of Generalizing Emotion Regulation (EMOGEN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Duke University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01653548
First received: July 17, 2012
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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.

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
Anxiety
Depression
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 (Subject)
Primary Purpose: Basic Science
Official Title: Evaluating a Novel Method of Generalizing Emotion Regulation

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 250
Study Start Date: August 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01653548

Contacts
Contact: Lisalynn D Kelley, AB, CCRP 919-684-6701 lisalynn.kelley@duke.edu
Contact: Mason Jenkins, BS 919-668-6764 mason.jenkins@duke.edu

Locations
United States, North Carolina
Duke University Medical Center-Civitan Bldg Recruiting
Durham, North Carolina, United States, 27705
Contact: Lisalynn D Kelley, AB, CCRP    919-684-6701    lisalynn.kelley@duke.edu   
Contact: Mason R Jenkins, BS    919-668-6764    mason.jenkins@duke.edu   
Principal Investigator: Mark Z Rosenthal, Ph.D.         
Sub-Investigator: Jose Larrauri, Ph.D.         
Sub-Investigator: Melissa L Miller, PhD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Mark Z Rosenthal, Ph.D. Duke University
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01653548     History of Changes
Other Study ID Numbers: Pro00035922, 1R01MH095806-01A1
Study First Received: July 17, 2012
Last Updated: March 27, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

Additional relevant MeSH terms:
Anxiety Disorders
Borderline Personality Disorder
Depression
Depressive Disorder
Personality Disorders
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on August 26, 2014