Evaluating a Novel Method of Generalizing Emotion Regulation
Condition: Problems With Emotion Regulation; Psychological Distress; Difficulties Coping With Negative Emotions; Anxiety; Depression; Borderline Personality Disorder
MeSH terms: Depression; Personality Disorders; Borderline Personality Disorder
Study type: Interventional

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.
    

Detailed description: 
      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

      -Design-In Exp. 1, the investigators will use a 2 (Learning Phase: HR v. No HR) X 2 (Testing
      Phase: Context same v. different) X 2 (Testing Phase: HR v. No HR) between-subjects factorial
      design.

      Randomization-All participants will be randomized to condition, with oversampling for HR
      groups, by using an urn randomization procedure by the off-site study statistician. Urn
      randomization will be conducted using age and gender as matching variables.

      Learning Phase (Day 1)Baseline-First, baseline subjective units of general psychological
      distress (SUDS; visual analogue scale from 0-100) and emotional arousal will be assessed
      using self-reported and psychophysiological (galvanic skin response) measures. The Study
      Coordinator will affix electrodes using standard procedures, and will use Biopac MP150
      hardware and AcKnowledge software for data acquisition. The galvanic skin response device is
      not being tested for safety or efficacy in this study, and is not being used as a diagnostic
      device. Participants will complete a five-minute baseline, sitting in a comfortable chair
      quietly without sleeping in a temperature controlled, sound attenuated room. SUDS and
      self-reported baseline emotion (SAM) will be obtained at the end of baseline.

      Next, the emotional stressor task will be administered to all participants by playing a
      stressful script which was created during the clinical assessment. Prior to hearing the
      script, participants will be instructed to listen carefully and to attempt to imagine the
      event as vividly as possible. The task proceeds as follows: (1) the stressor will be heard
      via headphones (30s), (2) participants are instructed via standardized instructions to
      imagine as vividly as possible the stressful experience (30s), (3) silence (30s), (3)
      self-report of emotional arousal and valence (SAM; 30s) will be obtained via a computer. This
      sequence will repeat a minimum of two and a maximum of four times, until habituation has
      occurred (return to mean baseline arousal). Habituation will be continuously monitored using
      a real-time monitoring program currently being used in the lab that samples arousal (GSR)
      every 500ms relative to the average baseline arousal. This method allows idiographic analyses
      of habituation to the stressor, and ensures that the HR is administered during habituation.
      Individuals who continue to have high levels of emotional arousal after completing the
      emotional stressor task will be asked to sit in silence for 10 more minutes (receiving the
      SAM every 120 seconds), and if habituation has yet to occur, they will be prompted to focus
      on their breath to help with relaxation for the next 10 minutes. Based on findings using this
      emotional stressor task suggesting that habituation occurs within 3 minutes for veterans with
      PTSD, the investigators are confident that the approach will result in habituation. Once
      habituation occurs, the HR will be heard via headphones 3 times (for a total of 6s) by
      participants randomized to hear the HR, whereas the No-HR participants will hear nothing.

      The HR will be a series of neutral novel sounds lasting 6s, and will be the same series of
      sounds being used in current lab ongoing studies testing extinction reminders. After the HR
      is played, the Study Coordinator will use standardized instructions to tell participants to
      remember this sound as a reminder of calming down. Lastly, SUDS and self-reported emotional
      arousal measure will be assessed (SAM). Physiological data will be continuously measured
      throughout this period. Although it is not expected to occur frequently, data from
      participants who do not habituate will not be used in analyses, and additional participants
      run. After completing the stressor task, there will be a 15 minute break, followed by a
      second and third administration of the stressor task using the procedures outlined above, but
      with a different personalized stressor recording each time. Investigators will randomize the
      order of the recordings that the participants described during the clinical assessment. At
      the end of the third emotional stressor task, participants will be scheduled for their
      Testing Phase one week later.

      Testing Phase (Day 2)-One week after the Learning Phase, participants will complete the
      Testing Phase for Exp. 1. Upon arrival, half of the participants will be randomly assigned to
      be tested in the original laboratory room from the Learning Phase (same room as Day 1) and
      the other half to a new room. In line with the investigators' previous learning studies using
      context manipulations, the new room in the Testing Phase will represent a very different
      context compared to the room from the Learning Phase. The novel testing room will have
      different size, lighting, and furniture. Using a scent machine, the novel room will have the
      smell of mint released during testing. In addition, to ensure that the experimenter does not
      function as a reminder of habituation from the Learning Phase, testing in the novel room will
      be done by a different experimenter than in the original Learning Phase. In both the original
      and novel testing rooms, the Testing Phase will begin with a baseline (same procedures as
      above). Next, a new recording of a personally relevant stressor will be played (same
      procedures as in Learning Phase). Participants in both rooms will be randomly assigned to
      hear the HR or hear nothing (No HR). The HR will be presented through headphones every 10
      seconds after the onset of the stressor task. Measures of psychological distress and
      emotional arousal will be obtained (same procedures as in the Learning Phase). As in the
      Learning Phase, after 10 minutes or when habituation occurs as operationalized above, the
      stressor will end and self-reported psychological distress and emotional arousal will be
      assessed.

      Experiment 2

      -In both the original and novel testing rooms, the Testing Phase will begin with a baseline
      (same procedures as above). Next, a new recording of a personally relevant stressor will be
      played (same procedures as in Learning Phase). Participants in both rooms will be randomly
      assigned to hear the HR or hear nothing (No HR). The HR will be presented through headphones
      every 10 seconds after the onset of the stressor task. Measures of psychological distress and
      emotional arousal will be obtained (same procedures as in the Learning Phase). As in the
      Learning Phase, after 10 minutes or when habituation occurs as operationalized above, the
      stressor will end and self-reported psychological distress and emotional arousal will be
      assessed. Because groups 5 and 7 from Exp. 1 will have only heard the HR during the Testing
      Phase, and it may therefore be associated with the emotional stressor but not habituation,
      these participants will not be randomized into Exp. 2. The participants in Exp. 2 will be
      randomized to either hear the HR or a sham sound delivered via the automated server and
      cellular phone platform when negative emotions are endorsed. The result is a 2 (Day 1 HR v.
      No HR) X 2 (Phone HR v. sham sound) Latin square experimental design.

      Procedure. At the conclusion of Exp. 1, the Clinical Assessor will orient participants to
      Exp. 2. Over the next week, participants receive eight calls each day (approximately one call
      every two waking hours), with each call lasting 1-2 minutes. For both experimental conditions
      (HR v. Sham), calls on the first day will be used to establish baseline levels of
      psychological distress (SUDS; 0-9), emotional valence (positive vs. negative; 1-9 scale;
      endpoints from the SAM used) and strength of emotional arousal (1-9; SAM), while no HRs will
      be delivered. On all other days, when participants report high emotional arousal (i.e., >4)
      and low valence (i.e., negative affect; <5), they will automatically hear the HR or sham
      sound based on randomization to Exp. 2 condition. The sham sound will be a series of neutral
      percussive sounds unrelated to the HR in form but equivalent on other relevant parameters
      (e.g., amplitude, length). After the HR or sham sound, all participants will provide
      self-reported psychological distress (SUDS) and emotional valence/arousal, in order to
      evaluate differential changes due to the HR or sham sound. After one week, participants will
      return to the laboratory to return the phone, receive compensation, and be debriefed. To
      further evaluate clinically meaningful changes due to the HR, the experimenter will collect
      pre-, and post-Exp. 2 assessments of symptoms of clinical outcome measures (e.g., symptoms of
      anxiety and depression When beginning Exp. 2, information will be given on how to use the
      phone (with hands-free headset), keep its battery charged, and how to call study staff.
      Phones will be restricted to study-related access and emergency numbers only. All calls will
      be conducted using a dedicated server and existing software in the lab. The software uses
      automated dialing and recorded prompts that ask participants to provide ratings on the phone
      keypad.

      First, to mitigate the possibility that the phone will be stolen, sold, or not used, the
      Study Coordinator and participants will create a plan to use the phone. Second, self-report
      scales will be the same as those from Exp. 1. Third, calls will be during times that the
      patient will normally be awake. No participant identifying information will be accessible in
      the cell phone. All data from the phone are stored in real-time in a password-protected
      computer in the lab.

      Experiment 3

      -The primary aim of Exp. 3 is to evaluate the feasibility, acceptability, and preliminary
      effect size estimates of a self-initiated HR (n = 50. on psychological distress and acute
      negative emotions by hearing the HRs over two weeks. Investigators will examine: (1)
      frequency of calls in to hear the HR within and across participants at times in their daily
      life when they are having acute negative emotions, and (2) how laboratory HR training affects
      psychological distress and emotional arousal/valence in naturalistic settings over time.

      Procedures. At the conclusion of Exp. 1, the Clinical Assessor will orient participants to
      Exp. 3. Participants will be asked to call the automated server during the next two weeks
      when they are feeling acute negative emotions. To facilitate use of the HR, the assessor will
      discuss expected upcoming stressful events, in particular those that occur daily or
      frequently, and explain how the phone can be used to cope with these stressful or emotionally
      arousing situations. Participants will also be told that they will receive three automated
      calls a day, beginning the next day. During the 2 week period, participants calling in to the
      lab will hear a brief greeting and an assessment of present SUDS, emotional arousal and
      valence. If the participant indicates emotional arousal >4 and valence < 5, the automated
      system will ask if they would like to hear the HR. If the participant does not meet these
      requirements or indicates that they do not want to hear the HR, they will instead hear a
      brief message thanking them for calling in. After the HR or thank you message, all
      participants will then be again asked to report SUDS, emotional arousal and valence, after
      which the call will end. The procedure for calls out will be identical to Exp. 2, except that
      all participants will receive 3 calls a day, have access to the HRs, and be able to choose
      whether to hear the HR. After two weeks, participants will return to the lab, give back the
      cell phone, complete an exit interview, and receive compensation.

      Exp. 3 compliance enhancement strategies are the same as in Exp. 2, except for the incentive
      structure.

      Interviews-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.
      Intelligence Quotient (IQ) will be assessed with the Peabody Picture Vocabulary Test-Third
      Edition (PPVT-III). The Treatment History Interview (THI)will be used to assess previous and
      ongoing psychiatric services received. The THI will be administered at pre- and
      post-experiment time points. All interviews will be videotaped, and investigators will
      determine the reliability of every tenth interview. Exit interviews will be conducted at the
      end of Exp. 3 to assess participants' acceptability of the HR.

      Physiological Measurement-Skin conductance will be measured using Ag-AgCl electrodes on the
      middle phalanx of the middle and ring fingers of the participant's non-dominant hand. The
      electrodes will be 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 AcKnowledge
      Software, and are stored in a database on the computer.

      Biochemical measures-Urinalyses (UA's) are conducted at diagnostic intake to rule out
      participants currently taking illicit or prescription substances known to affect
      psychophysiological arousal. The specimens will be screened on-site using the Biosite Triage
      Meter Plus.. Urine will be tested for cocaine, marijuana, opiates, methadone, amphetamines,
      barbiturates, and benzodiazepines. Results will be available within 30 minutes.
    

Intervention name(s): Habituation Reminder Training; Habituation Reminder; Habituation
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will hear a unique sound after habituating to a personal stressor.; Participants will hear the habituation reminder outside of the lab via a cellular phone.; Participants will habituate to personally-relevant stressor.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: emotion dysregulation; borderline personality disorder; anxiety; depression; negative emotions; outpatient interventions for negative emotions; psychological distress; emotion regulation problems