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临床试验/NCT01653548
NCT01653548已完成不适用

Evaluating a Novel Method of Generalizing Emotion Regulation

Duke University2 个研究点 分布在 1 个国家目标入组 372 人开始时间: 2012年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
372
试验地点
2
主要终点
Reduction in emotional arousal or speed to recovery from emotional arousal following a stressor.

研究概览

简要总结

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.

详细描述

Difficulties regulating emotional arousal in a skillful manner are common across many psychiatric disorders and may be central to some of the most severe and difficult-to-treat populations (e.g., borderline personality disorder). To immediately decrease negative affect, individuals who have difficulties regulating negative emotions often rely on maladaptive behaviors that are significant public health problems, including substance use, suicidal behavior, binging/purging, and other negatively reinforced behavior. Conventional approaches to generalization of emotion regulation skills outside the clinic (e.g., assigning therapy homework) are insufficient. New interventions are needed that directly and immediately reduce acute negative emotions and do not rely on patient compliance with homework assignments or other top-down approaches. Accordingly, 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 investigators will recruit 420 adult outpatients to enroll 250 participants who have extreme difficulties with emotion regulation to participate in 3 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).

Before being recruited into the study, potential participants will complete a phone screen-a pre-experiment screening questionnaire or an online questionnaire to assess certain exclusion and inclusion criteria. Eligible participants will be invited to the study office to provide written informed consent and receive a clinical assessment, during which full inclusion and exclusion criteria will be assessed.

Using the method developed by Pitman and colleagues and used in studies of adults with PTSD, BPD, and other diagnoses, investigators will create four negative emotional arousal scripts that will be used in a random order during Exp. 1. In brief, the Clinical Assessor will ask the participant to describe five of the most recent (i.e., past two weeks) moderate stressors in their lives. 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 assessor will then review the script, ask for any clarification, and then ask the participant to rank them from most to least stressful. Following the assessment, the clinical assessor or same sex experimenter will digitally record these scripts into .mp3 files, which will be used in random order as the emotional stressors in Exp. 1.

Experiment 1

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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)

结局指标

主要结局

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

时间窗: baseline and week 1

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

次要结局

  • Phone use feasibility(weekly from week 1-week 3)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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