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Wearable Emotion Prosthetics for Post Traumatic Stress Disorder (EP-PTSD)

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ClinicalTrials.gov Identifier: NCT03529981
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Greg Siegle, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE April 16, 2018
First Posted Date  ICMJE May 21, 2018
Last Update Posted Date January 13, 2021
Actual Study Start Date  ICMJE April 9, 2018
Estimated Primary Completion Date December 18, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2019)
  • Change in symptom ratings from pre- to post- [ Time Frame: Change in symptom ratings over the approximately two weeks of the acute intervention (pre- to post- assessment) ]
    Subjective affect / symptom ratings will be obtained daily. Spline fitting will be used to create a smoothed estimate of trajectory, the beginning and end points of which will be compared.
  • Change in resting Heart Rate Variability (HRV) from pre- to post- [ Time Frame: HRV will be measured during the entire study which is two weeks ]
    HRV, an index of parasympathetic reactivity, will be obtained throughout the day during the study. Increased HRV indicates increased parasympathetic reactivity, which suggests an increased physiological indicator of emotion regulation. Spline fitting will be used to create a smoothed estimate of trajectory, the beginning and end points of which will be compared.
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2018)
  • Positive Affect Score from The Positive and Negative Affect Schedule [ Time Frame: Mood ratings will be given within 5 minutes after mindfulness meditation ]
    The Positive Affect Score will be obtained after mindfulness meditation alone and after mindfulness meditation with TVS intervention. The Positive Affect Score will add the score on items 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19. Scores can range from 10-50, with the highest score representing higher levels of positive affect
  • Heart Rate Variability (HRV) during mindfulness meditation [ Time Frame: HRV will be measured during the entire study, which is a one-day study lasting between 3-4 hours. ]
    HRV, an index of parasympathetic reactivity, will be obtained during mindfulness meditation alone and during mindfulness meditation with TVS intervention. Increased HRV indicates increased parasympathetic reactivity, which suggests an increased physiological indicator of emotion regulation.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2019)
  • Change in Heart Rate Variability (HRV) during information processing tasks (composite) [ Time Frame: HRV will be measured during the approximately 1 hour of information processing tasks, which will be administered approximately 2 weeks apart, at the pre- and post- intervention assessment visits. ]
    HRV, an index of parasympathetic reactivity, will be obtained during laboratory information processing tasks (paced auditory serial attention, emotional picture viewing). Increased HRV indicates increased parasympathetic reactivity, which suggests an increased physiological indicator of emotion regulation.
  • Galvanic skin response (GSR) during information processing tasks (composite) [ Time Frame: GSR will be measured during the approximately 1 hour of information processing tasks, which will be administered approximately 2 weeks apart, at the pre- and post- intervention assessment visits. ]
    GSR, index of sympathetic reactivity, will be obtained during lab tasks before and after the intervention. Decreased GSR indicates decreased sympathetic reactivity, which suggests an increased physiological indicator of emotion regulation.
  • prefrontal gamma band EEG during information processing tasks (composite) [ Time Frame: EEG will be measured during the approximately 1 hour of information processing tasks, which will be administered approximately 2 weeks apart, at the pre- and post- intervention assessment visits. ]
    prefrontal gamma band EEG will be obtained during lab information processing tasks. Increased prefrontal gamma band EEG suggests an increased physiological indicator of emotion regulation.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2018)
  • Negative Affect Score from The Positive and Negative Affect Schedule [ Time Frame: Mood ratings will be given within 5 minutes after mindfulness meditation ]
    The Negative Affect Score will be obtained after mindfulness meditation alone and after mindfulness meditation with TVS intervention. The Negative Affect Score will add the score on items 2,4,6,7,8,11,13,15,18, and 20. Scores can range from 10-50, with lower score representing lower levels of negative affect.
  • Global local visual processing task - percent local identifications [ Time Frame: Task will be given within 30 minutes after mindfulness meditation ]
    There will be 40 images for each task. This task determines which attention is first directed, either at the local features (details, parts) or global features (the whole). Out of 40, we can determine how many local features were picked and how many global features were picked. The task will be done twice and the amount of global features vs. local features chosen will be compared with one another.
  • Mind in the Eyes Test - percent correct identifications [ Time Frame: Task will be given within 30 minutes after mindfulness meditation ]
    Participants will see a picture of a person only with the eyes present. There will be four words that describes the possible mood of the participant. The participant will be asked to choose the adjective that fits best with eye mood conveyed by picture of the person when only the eyes can be observed. This task will be done twice, and the amount of correct answers will be compared with one another
  • Heart Rate Variability (HRV) during information processing tasks (composite) [ Time Frame: HRV will be measured during the entire study, which is a one-day study lasting between 3-4 hours. ]
    HRV, an index of parasympathetic reactivity, will be obtained during tasks (Mind in the Eyes, Global-local processing tasks) after mindfulness meditation alone and mindfulness meditation with TVS intervention. Increased HRV indicates increased parasympathetic reactivity, which suggests an increased physiological indicator of emotion regulation.
  • Galvanic skin response (GSR) during mindfulness meditation [ Time Frame: GRS will be measured during the entire study, which is a one-day study lasting between 3-4 hours. ]
    GSR, index of sympathetic reactivity, will be obtained during mindfulness meditation alone and during mindfulness meditation with TVS intervention. Decreased GSR indicates decreased sympathetic reactivity, which suggests an increased physiological indicator of emotion regulation.
  • Galvanic skin response (GSR) during information processing tasks (composite) [ Time Frame: GSR will be measured during the entire study, which is a one-day study lasting between 3-4 hours. ]
    GSR, index of sympathetic reactivity, will be obtained during tasks (Mind in the Eyes, Global-local processing tasks) after mindfulness meditation alone and mindfulness meditation with TVS intervention. Decreased GSR indicates decreased sympathetic reactivity, which suggests an increased physiological indicator of emotion regulation.
  • prefrontal gamma band EEG during mindfulness meditation [ Time Frame: EEG will be measured during the entire study, which is a one-day study lasting between 3-4 hours. ]
    prefrontal gamma band EEG will be obtained during mindfulness meditation alone and during mindfulness meditation with TVS intervention. Increased prefrontal gamma EEG band indicates increased physiological indicator of emotion regulation.
  • prefrontal theta band EEG during mindfulness meditation [ Time Frame: EEG will be measured during the entire study, which is a one-day study lasting between 3-4 hours. ]
    prefrontal theta band EEG will be obtained during mindfulness meditation alone and during mindfulness meditation with TVS intervention. Increased prefrontal gamma EEG band indicates increased physiological indicator of emotion regulation.
  • prefrontal gamma band EEG during information processing tasks (composite) [ Time Frame: EEG will be measured during the entire study, which is a one-day study lasting between 3-4 hours. ]
    prefrontal gamma band EEG will be obtained during tasks (Mind in the Eyes, Global-local processing tasks) after mindfulness meditation alone and mindfulness meditation with TVS intervention. Increased prefrontal gamma band EEG suggests an increased physiological indicator of emotion regulation.
  • prefrontal theta band EEG during information processing tasks (composite) [ Time Frame: EEG will be measured during the entire study, which is a one-day study lasting between 3-4 hours. ]
    prefrontal theta band EEG will be obtained during tasks (Mind in the Eyes, Global-local processing tasks) after mindfulness meditation alone and mindfulness meditation with TVS intervention. Increased prefrontal gamma band EEG suggests an increased physiological indicator of emotion regulation.
  • Heightened state of awareness using 5-Dimensional Altered State of Consciousness questionnaire (5D-ASC) [ Time Frame: Heightened state of awareness will be measured at the end of the study, which is a one-day study lasting between 3-4 hours. ]
    Participants will answer which experience (mindfulness alone or mindfulness with TVS) they found most profound, and answer the 5D-ASC based on the more profound experience. Higher scores on the 5D-ASC indicates increased heightening state of awareness. For each question, the score is on a likert scale (1 to 5).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: May 7, 2018)
  • Moderation of primary and secondary outcomes by Trait mindfulness using Mindful Attention Awareness Scale (MAAS) [ Time Frame: Heightened state of awareness will be measured at the beginning the study, which is a one-day study lasting between 3-4 hours. ]
    MAAS will be given at the beginning of the study. It is a 15-item scale designed to assess a core characteristic of mindfulness. Score is 1-6 (average from 1-6 for 15 items). High scores is correlated with increased mindfulness. MAAS may be a predictor of objective and subjective primary and secondary outcome measures
  • Moderation of primary and secondary outcomes by modified Differential Emotions Scale (mDES) [ Time Frame: modified Differential Emotions Scale will be measured at the beginning the study, which is a one-day study lasting between 3-4 hours. ]
    For this scale, emotions scores are created by computing the mean of 10 positive and 10 negative emotions respectively. (0-4 for negative, 0-4 for positive). These scores may may be a predictor of objective and subjective primary and secondary outcome measures
  • Moderation of primary and secondary outcomes by Meditation Frequency Questionnaire (whether they meditate, and weeks/hours of meditation per week) [ Time Frame: Meditation Frequency Questionnaire will be measured at the beginning the study, which is a one-day study lasting between 3-4 hours. ]
    The questionnaire, which we have created, asks whether the participant meditates and how many minutes/hours a week do they meditate. The number of minutes/hours per week of meditation may be a predictor of objective and subjective primary and secondary outcome measures.
 
Descriptive Information
Brief Title  ICMJE Wearable Emotion Prosthetics for Post Traumatic Stress Disorder
Official Title  ICMJE Wearable Emotion Prosthetics for Post Traumatic Stress Disorder
Brief Summary

Involuntary stress reactions including hyper-reactivity and dissociation are key diagnostic features of many psychiatric disorders, are difficult to treat, and predict poor outcomes in conventional and neurobehavioral interventions. Here, we evaluate the extent to which a novel intervention, Tuned Vibroacoustic Stimulation (TVS), capitalizing on a preserved neurocircuitry for sympathetic and parasympathetic system activity can be used to modify arousal responses, overriding otherwise prepotent negative stress reactions.

PTSD has been characterized by dysregulated responses to stress as a result of severe acute or chronic trauma resulting in significantly impaired functioning, quality of life, and morbidity/mortality. Physiologically, PTSD severity has been associated with elevated sympathetic tone and low heart rate variability suggesting that parasympathetic tone is suppressed. Lower heart rate variability specifically, as a measure of parasympathetic tone, is closely associated with impaired performance and resilience. In our first study (in review), we showed that in some individuals, TVS is associated with increased heart rate variability and performance under stress along with reduced subjective stress. These results suggest that TVS could provide some therapeutic benefit in PTSD.

N=100 individuals with mild-moderate PTSD (as assessed by PCL-5/CAP5), at least half of which are military Veterans, will be assessed physiologically during active interventions. Mechanisms of attentional focus on cognitive and emotional stimuli will be assessed. Participants will also have a real-world intervention to determine if TVS helps alleviate stress, symptoms, and medication burden in the real world when stress has been identified. Success will suggest a new intervention pathway for a traditionally treatment-resistant dimension of psychopathology.

Detailed Description

This protocol will examine and elucidate a mechanistic model for tuned vibroacoustic stimulation (TVS), an exteroceptive cue that has been shown to reduce subjective and physiological indicators of stress and increase behavioral performance in healthy subjects. In this study, we will test whether TVS can reduce subjective and physiological signs of stress, improve performance, alleviate symptoms, and reduce medication burden in adults with post-traumatic stress disorder (PTSD). This protocol will also examine whether software that cues TVS in response to biological stress markers helps users detect, regulate, and develop long-term resilience to stress outside of the laboratory.

Aim 1: Examine how TVS alters calmness and stress markers. Our overall hypothesis is that TVS, in combination with some other task, increases performance on that task by decreasing stress and increasing emotion regulation.

Hypothesis 1: TVS during an attention task will lead to decreased GSR, increased HRV, and increases in prefrontal gamma and theta band EEG, along with improved behavioral performance on a focused attention, working memory and emotional information processing task. TVS will also reduce subjective stress levels.

Aim 2: Examine the extent to which software, which monitors real time biological stress markers of users, and in response, automatically signals wearable hardware to deliver TVS when user is stressed, will be able to help users detect, regulate, and develop long-term resilience to stress outside the laboratory for two weeks.

Hypothesis 2.1: Evaluate whether subjects with PTSD in the real world will use our software to detect and alert them of stress dynamically and if this is associated with stress regulation.

Hypothesis 2.2: Examine whether TVS is associated with stress regulation. Hypothesis 2.3: Examine whether TVS is associated with reduction in PTSD symptoms and, possibly, medication burden.

Over 39 million Americans suffer from excessive chronic stress, which can be psychologically and physically debilitating (Salleh, 2008). Untreated chronic stress plays a role in the development of major illnesses such as cardiovascular disease, obesity, anxiety and depression (Dallman et al., 2006; Swaab, Bao, & Lucassen, 2005). Post-traumatic stress disorder (PTSD), is a severe mental illness that impacts millions of veterans and civilians nationwide. Existing treatments for chronic stress and PTSD are often ineffective, have adverse effects, and are prohibited by cost, time-commitment, and accessibility, resulting in high rates of substance abuse and suicide (Jonas et al., 2013; Watts et al., 2013). Stress in general, and PTSD more specifically, are characterized by hyper-reactivity in the sympathetic nervous system which is associated with increased arousal and vigilance, and compromised reactivity of the parasympathetic nervous system, which helps to regulate emotion and stress responses (Kibler, Tursich, Ma, Malcolm, & Greenbarg, 2014; Lehrer & Gevirtz, 2014).

PTSD has been characterized by dysregulated responses to stress as a result of severe acute or chronic trauma resulting in significantly impaired functioning, quality of life, and morbidity/mortality. Physiologically, PTSD severity has been associated with elevated sympathetic tone and low heart rate variability suggesting that parasympathetic tone is suppressed. HRV is widely used as a biomarker for the coordinated activity of the sympathetic and parasympathetic nervous symptom. A calmer, less stressful state is typically marked by increased HRV, likely attributed to respiration based parasympathetic stimulation (Grossman & Taylor, 2007). GSR is also a reliable index for sweat gland activity and changes in activation level of the sympathetic nervous system, and GSR usually increases with higher levels of stress (Mohan, Sharma, & Bijlani, 2011). EEG changes, such as elevated prefrontal gamma and theta, have also been associated with state of relaxed alertness. Our initial data (submitted) suggest that for some individuals, TVS can boost heart rate variability and performance under stress while reducing subjective stress. These results suggest that TVS could provide some therapeutic benefit in PTSD.

Large scientific literature supports the role of vibration in regulating stress physiology (Takahashi, Ohashi, & Yokoyama, 2011; M. Uchikune, 2002; M. Uchikune, 2004). For example, slow whole-body vibration, in the 0.01 to 0.3 Hz range, is associated with increased ratings of pleasantness and increased parasympathetic tone (M. Uchikune, 2002; M. Uchikune, 2004). Stimulation at about 100 Hz has been shown to activate the posterior insula (Coghill et al., 1994) which is associated with increased attention to interoception, as promoted in many meditative traditions. Transcutaneous targets for the vibration frequencies have also been identified, including stellate ganglion and vagus nerve (Cipriano et al., 2014; Fang et al., 2016).

In this study, we will be testing the potential for TVS to increase well-being (subjective calmness, increased performance, and physiological reactivity) in the PTSD population. Positive results would suggest that reduction in symptomatology may be possible without effort, and in lieu of specific interventions with medications or psychotherapy. A wearable form of TVS technology will be examined in a real-world setting. We will use ambulatory assessment to detect physiological indications of stress unique to each user and to provide user-optimized TVS, examining whether it increases parasympathetic nervous system reactivity in response to stress, thus decreasing subjective stress just as a user's stress begins to increase.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
randomized, controlled factorial within subject design
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Health Behavior
Intervention  ICMJE
  • Other: Tuned Vibroacoustic Stimulation (TVS)
    TVS is an exteroceptive cue that may reduce subjective and physiological indicators of stress and increase behavioral performance
  • Other: no active intervention
    No intervention will be administered
Study Arms  ICMJE
  • Active Comparator: Stress incidents without TVS
    a fraction of physiological detected stress incidents will not trigger TVS
    Intervention: Other: no active intervention
  • Experimental: TVS in response to participant initiation or stress detection
    The majority of detected stress incidents will trigger TVS. Participants can also trigger TVS voluntarily
    Intervention: Other: Tuned Vibroacoustic Stimulation (TVS)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 18, 2022
Estimated Primary Completion Date December 18, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male/female who are 18 - 58 years of age
  • For PTSD participants, must meet current DSM-V criteria for PTSD based on the PCL-5 (Score > 33) and MINI PTSD Scale (administered in lab).
  • If taking psychoactive medications, must be on a stable regimen for 3 weeks or more.
  • Must have a functioning smartphone with Apple iOS or Android

Exclusion Criteria:

  • Refusal or inability to provide informed consent
  • Current suicidal or homicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment.
  • Current or recent (within the last 8 weeks) physically aggressive behavior.
  • Meets current DSM-V criteria for substance dependence ((serious substance use in DSM-V parlance, not in remission) except nicotine and caffeine), traumatic brain injury, bipolar affective disorder, schizophrenia or any psychotic disorder.
  • Has unstable or serious medical illness, including history of stroke, epileptic disorder, or unstable cardiac disease, that would interfere with participation in treatment.
  • Taking medications that could affect thinking which must be taken on the day of testing, or dependence on psychoactive drugs (prescription or non-prescription) that could affect thinking. That is, participants need to be able to think clearly to complete the proposed information processing tasks. And they need to be able to learn to be able to make use of the intervention. Examples of drugs which could affect performance on cognitive tasks or the administered physiological measures include beta-blockers, benzodiazepines, antipsychotics, stimulants (except for treatment of ADD/ADHD), narcotics, and anti--Parkinsonian drugs.
  • Severe cognitive impairment or severe trauma
  • Unable to comprehend or communicate in English, and unable to complete questionnaires written in English.
  • Having any eye problems or difficulties in corrected vision or hearing, including poor color vision
  • Having a North American Adult Reading Test (NAART) equivalent FSIQ < 85
  • Severe or poorly controlled concurrent medical disorders or require medication that could cause negative thinking

Specific Exclusions for acoustic vibration include:

-- Any electrical implant (pacemaker, vagus nerve stimulator, etc).

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 58 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Lisa Stupar 412-980-5342 StuparLM@upmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03529981
Other Study ID Numbers  ICMJE PRO17110107
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Following publication of primary results, individual anonymized data on primary outcome measures will be made available to other researchers. Before publication, primary outcome measures will be shared in negotiation with a proposed analysis plan from qualified investigators.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Following publication - available to all. Before publication - upon negotiation with qualified investigators
Access Criteria: Before publication - available in negotiation with Greg Siegle (gsiegle@pitt.edu). After publication the location of a data repository will be listed
Responsible Party Greg Siegle, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Greg Siegle, MD Western Psychiatric Institute and Clinic
PRS Account University of Pittsburgh
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP