Evaluating a Novel Method of Generalizing Emotion Regulation

NCT01653548 | Completed

• 2 other identifiers: Pro000359221R01MH095806-01A1
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Problems With Emotion Regulation; Psychological Distress; Difficulties Coping With Negative Emotions; Anxiety; Depression; Borderline Personality Disorder

Keywords

emotion dysregulation; borderline personality disorder; anxiety; depression; negative emotions; outpatient interventions for negative emotions; psychological distress; emotion regulation problems

Outcome Measures

Primary Outcomes (1)

• Reduction in emotional arousal or speed to recovery from emotional arousal following a stressor.

  The investigators will examine psychophysiological and self-report measures of emotional stress.

  baseline and week 1

Secondary Outcomes (1)

• Phone use feasibility

  weekly from week 1-week 3

Study Arms (3)

HR training + Portable HR

EXPERIMENTAL

100 subjects who receive Habituation Reminder training and who have access to the HR via a cellular phone.

Behavioral: Habituation Reminder Training; Behavioral: Habituation Reminder; Behavioral: Habituation

HR Training + no portable HR

EXPERIMENTAL

50 subjects who receive Habituation Reminder training and who do not have access to the HR via a cellular phone.

Behavioral: Habituation Reminder Training; Behavioral: Habituation

No HR training

EXPERIMENTAL

50 subjects who do not receive HR training.

Behavioral: Habituation

Interventions

Habituation Reminder Training BEHAVIORAL

Participants will hear a unique sound after habituating to a personal stressor.

HR Training + no portable HR; HR training + Portable HR

Habituation Reminder BEHAVIORAL

Participants will hear the habituation reminder outside of the lab via a cellular phone.

HR training + Portable HR

Habituation BEHAVIORAL

Participants will habituate to personally-relevant stressor.

HR Training + no portable HR; HR training + Portable HR; No HR training

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Duke University Medical Center-Civitan Bldg

Durham, North Carolina, 27705, United States

Location

Related Publications (9)

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• Collins BN, Brandon TH. Effects of extinction context and retrieval cues on alcohol cue reactivity among nonalcoholic drinkers. J Consult Clin Psychol. 2002 Apr;70(2):390-7.

  PMID: 11952197 BACKGROUND

• 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

  BACKGROUND

• Milad MR, Pitman RK, Ellis CB, Gold AL, Shin LM, Lasko NB, Zeidan MA, Handwerger K, Orr SP, Rauch SL. Neurobiological basis of failure to recall extinction memory in posttraumatic stress disorder. Biol Psychiatry. 2009 Dec 15;66(12):1075-82. doi: 10.1016/j.biopsych.2009.06.026. Epub 2009 Sep 12.

  PMID: 19748076 BACKGROUND

• Roth, A., & Fonagy, P. (2005). What works for whom? A critical review of psychotherapy research. New York, NY: Guilford

  BACKGROUND

• Schmahl CG, Elzinga BM, Ebner UW, Simms T, Sanislow C, Vermetten E, McGlashan TH, Bremner JD. Psychophysiological reactivity to traumatic and abandonment scripts in borderline personality and posttraumatic stress disorders: a preliminary report. Psychiatry Res. 2004 Apr 15;126(1):33-42. doi: 10.1016/j.psychres.2004.01.005.

  PMID: 15081625 BACKGROUND

• Stokes TF, Baer DM. An implicit technology of generalization. J Appl Behav Anal. 1977 Summer;10(2):349-67. doi: 10.1901/jaba.1977.10-349.

  PMID: 16795561 BACKGROUND

• Hayes SC, Wilson KG, Gifford EV, Follette VM, Strosahl K. Experimental avoidance and behavioral disorders: a functional dimensional approach to diagnosis and treatment. J Consult Clin Psychol. 1996 Dec;64(6):1152-68. doi: 10.1037//0022-006x.64.6.1152.

  PMID: 8991302 BACKGROUND

• Brooks DC, Bouton ME. A retrieval cue for extinction attenuates spontaneous recovery. J Exp Psychol Anim Behav Process. 1993 Jan;19(1):77-89. doi: 10.1037//0097-7403.19.1.77.

  PMID: 8418218 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Borderline Personality Disorder

Interventions

Habituation, Psychophysiologic

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Personality Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mark Z Rosenthal, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 31, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 23, 2016

Record last verified: 2016-06

Locations

US (1)