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

Primary Purpose

Health Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tuned Vibroacoustic Stimulation (TVS)
no active intervention
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Health Behavior focused on measuring PTSD

Eligibility Criteria

18 Years - 58 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Western Psychiatric Institute and Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Stress incidents without TVS

TVS in response to participant initiation or stress detection

Arm Description

a fraction of physiological detected stress incidents will not trigger TVS

The majority of detected stress incidents will trigger TVS. Participants can also trigger TVS voluntarily

Outcomes

Primary Outcome Measures

Change in symptom ratings from pre- to post-
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-
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.

Secondary Outcome Measures

Change in Heart Rate Variability (HRV) during information processing tasks (composite)
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)
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)
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.

Full Information

First Posted
April 16, 2018
Last Updated
January 13, 2022
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT03529981
Brief Title
Wearable Emotion Prosthetics for Post Traumatic Stress Disorder
Acronym
EP-PTSD
Official Title
Wearable Emotion Prosthetics for Post Traumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
December 18, 2021 (Actual)
Study Completion Date
December 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Behavior
Keywords
PTSD

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
randomized, controlled factorial within subject design
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
On-demand intervention was provided on only some physiologically detected stress events
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stress incidents without TVS
Arm Type
Active Comparator
Arm Description
a fraction of physiological detected stress incidents will not trigger TVS
Arm Title
TVS in response to participant initiation or stress detection
Arm Type
Experimental
Arm Description
The majority of detected stress incidents will trigger TVS. Participants can also trigger TVS voluntarily
Intervention Type
Other
Intervention Name(s)
Tuned Vibroacoustic Stimulation (TVS)
Intervention Description
TVS is an exteroceptive cue that may reduce subjective and physiological indicators of stress and increase behavioral performance
Intervention Type
Other
Intervention Name(s)
no active intervention
Intervention Description
No intervention will be administered
Primary Outcome Measure Information:
Title
Change in symptom ratings from pre- to post-
Description
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.
Time Frame
Change in symptom ratings over the approximately two weeks of the acute intervention (pre- to post- assessment)
Title
Change in resting Heart Rate Variability (HRV) from pre- to post-
Description
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.
Time Frame
HRV will be measured during the entire study which is two weeks
Secondary Outcome Measure Information:
Title
Change in Heart Rate Variability (HRV) during information processing tasks (composite)
Description
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.
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.
Title
Galvanic skin response (GSR) during information processing tasks (composite)
Description
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.
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.
Title
prefrontal gamma band EEG during information processing tasks (composite)
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Siegle, MD
Organizational Affiliation
Western Psychiatric Institute and Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Psychiatric Institute and Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Following publication - available to all. Before publication - upon negotiation with qualified investigators
IPD Sharing Access Criteria
Before publication - available in negotiation with Greg Siegle (gsiegle@pitt.edu). After publication the location of a data repository will be listed
Citations:
PubMed Identifier
12703651
Citation
Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
Results Reference
background
PubMed Identifier
15771867
Citation
Carlson LE, Brown KW. Validation of the Mindful Attention Awareness Scale in a cancer population. J Psychosom Res. 2005 Jan;58(1):29-33. doi: 10.1016/j.jpsychores.2004.04.366.
Results Reference
background
PubMed Identifier
25103974
Citation
Cipriano G Jr, Neder JA, Umpierre D, Arena R, Vieira PJ, Chiappa AM, Ribeiro JP, Chiappa GR. Sympathetic ganglion transcutaneous electrical nerve stimulation after coronary artery bypass graft surgery improves femoral blood flow and exercise tolerance. J Appl Physiol (1985). 2014 Sep 15;117(6):633-8. doi: 10.1152/japplphysiol.00993.2013. Epub 2014 Aug 7.
Results Reference
background
PubMed Identifier
8027764
Citation
Coghill RC, Talbot JD, Evans AC, Meyer E, Gjedde A, Bushnell MC, Duncan GH. Distributed processing of pain and vibration by the human brain. J Neurosci. 1994 Jul;14(7):4095-108. doi: 10.1523/JNEUROSCI.14-07-04095.1994.
Results Reference
background
PubMed Identifier
27687118
Citation
Creswell JD. Mindfulness Interventions. Annu Rev Psychol. 2017 Jan 3;68:491-516. doi: 10.1146/annurev-psych-042716-051139. Epub 2016 Sep 28.
Results Reference
background
PubMed Identifier
16876569
Citation
Dallman MF, Pecoraro NC, La Fleur SE, Warne JP, Ginsberg AB, Akana SF, Laugero KC, Houshyar H, Strack AM, Bhatnagar S, Bell ME. Glucocorticoids, chronic stress, and obesity. Prog Brain Res. 2006;153:75-105. doi: 10.1016/S0079-6123(06)53004-3.
Results Reference
background
PubMed Identifier
9754838
Citation
Dittrich A. The standardized psychometric assessment of altered states of consciousness (ASCs) in humans. Pharmacopsychiatry. 1998 Jul;31 Suppl 2:80-4. doi: 10.1055/s-2007-979351.
Results Reference
background
PubMed Identifier
25963932
Citation
Fang J, Rong P, Hong Y, Fan Y, Liu J, Wang H, Zhang G, Chen X, Shi S, Wang L, Liu R, Hwang J, Li Z, Tao J, Wang Y, Zhu B, Kong J. Transcutaneous Vagus Nerve Stimulation Modulates Default Mode Network in Major Depressive Disorder. Biol Psychiatry. 2016 Feb 15;79(4):266-73. doi: 10.1016/j.biopsych.2015.03.025. Epub 2015 Apr 2.
Results Reference
background
PubMed Identifier
15347528
Citation
Fredrickson BL. The broaden-and-build theory of positive emotions. Philos Trans R Soc Lond B Biol Sci. 2004 Sep 29;359(1449):1367-78. doi: 10.1098/rstb.2004.1512.
Results Reference
background
PubMed Identifier
21852891
Citation
Fredrickson BL, Branigan C. Positive emotions broaden the scope of attention and thought-action repertoires. Cogn Emot. 2005 May 1;19(3):313-332. doi: 10.1080/02699930441000238.
Results Reference
background
PubMed Identifier
11934003
Citation
Fredrickson BL, Joiner T. Positive emotions trigger upward spirals toward emotional well-being. Psychol Sci. 2002 Mar;13(2):172-5. doi: 10.1111/1467-9280.00431.
Results Reference
background
PubMed Identifier
21852890
Citation
Fredrickson BL, Levenson RW. Positive Emotions Speed Recovery from the Cardiovascular Sequelae of Negative Emotions. Cogn Emot. 1998 Mar 1;12(2):191-220. doi: 10.1080/026999398379718.
Results Reference
background
PubMed Identifier
12585810
Citation
Fredrickson BL, Tugade MM, Waugh CE, Larkin GR. What good are positive emotions in crises? A prospective study of resilience and emotions following the terrorist attacks on the United States on September 11th, 2001. J Pers Soc Psychol. 2003 Feb;84(2):365-76. doi: 10.1037//0022-3514.84.2.365.
Results Reference
background
PubMed Identifier
17081672
Citation
Grossman P, Taylor EW. Toward understanding respiratory sinus arrhythmia: relations to cardiac vagal tone, evolution and biobehavioral functions. Biol Psychol. 2007 Feb;74(2):263-85. doi: 10.1016/j.biopsycho.2005.11.014. Epub 2006 Nov 1.
Results Reference
background
PubMed Identifier
23658937
Citation
Jonas DE, Cusack K, Forneris CA, Wilkins TM, Sonis J, Middleton JC, Feltner C, Meredith D, Cavanaugh J, Brownley KA, Olmsted KR, Greenblatt A, Weil A, Gaynes BN. Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder (PTSD) [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Apr. Report No.: 13-EHC011-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK137702/
Results Reference
background
PubMed Identifier
7042457
Citation
Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry. 1982 Apr;4(1):33-47. doi: 10.1016/0163-8343(82)90026-3.
Results Reference
background
PubMed Identifier
1609875
Citation
Kabat-Zinn J, Massion AO, Kristeller J, Peterson LG, Fletcher KE, Pbert L, Lenderking WR, Santorelli SF. Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders. Am J Psychiatry. 1992 Jul;149(7):936-43. doi: 10.1176/ajp.149.7.936.
Results Reference
background
PubMed Identifier
24976918
Citation
Kibler JL, Tursich M, Ma M, Malcolm L, Greenbarg R. Metabolic, autonomic and immune markers for cardiovascular disease in posttraumatic stress disorder. World J Cardiol. 2014 Jun 26;6(6):455-61. doi: 10.4330/wjc.v6.i6.455.
Results Reference
background
PubMed Identifier
23649562
Citation
Kok BE, Coffey KA, Cohn MA, Catalino LI, Vacharkulksemsuk T, Algoe SB, Brantley M, Fredrickson BL. How positive emotions build physical health: perceived positive social connections account for the upward spiral between positive emotions and vagal tone. Psychol Sci. 2013 Jul 1;24(7):1123-32. doi: 10.1177/0956797612470827. Epub 2013 May 6. Erratum In: Psychol Sci. 2016 Jun;27(6):931.
Results Reference
background
PubMed Identifier
11556941
Citation
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Results Reference
background
PubMed Identifier
25101026
Citation
Lehrer PM, Gevirtz R. Heart rate variability biofeedback: how and why does it work? Front Psychol. 2014 Jul 21;5:756. doi: 10.3389/fpsyg.2014.00756. eCollection 2014.
Results Reference
background
PubMed Identifier
26441373
Citation
Lomas T, Ivtzan I, Fu CH. A systematic review of the neurophysiology of mindfulness on EEG oscillations. Neurosci Biobehav Rev. 2015 Oct;57:401-10. doi: 10.1016/j.neubiorev.2015.09.018. Epub 2015 Oct 9.
Results Reference
background
PubMed Identifier
18799450
Citation
Ludwig DS, Kabat-Zinn J. Mindfulness in medicine. JAMA. 2008 Sep 17;300(11):1350-2. doi: 10.1001/jama.300.11.1350. No abstract available.
Results Reference
background
PubMed Identifier
21417807
Citation
Mohan A, Sharma R, Bijlani RL. Effect of meditation on stress-induced changes in cognitive functions. J Altern Complement Med. 2011 Mar;17(3):207-12. doi: 10.1089/acm.2010.0142. Epub 2011 Mar 9.
Results Reference
background
PubMed Identifier
17014296
Citation
Ong AD, Bergeman CS, Bisconti TL, Wallace KA. Psychological resilience, positive emotions, and successful adaptation to stress in later life. J Pers Soc Psychol. 2006 Oct;91(4):730-49. doi: 10.1037/0022-3514.91.4.730.
Results Reference
background
PubMed Identifier
22589633
Citation
Salleh MR. Life event, stress and illness. Malays J Med Sci. 2008 Oct;15(4):9-18.
Results Reference
background
PubMed Identifier
26320867
Citation
Schofield TP, Creswell JD, Denson TF. Brief mindfulness induction reduces inattentional blindness. Conscious Cogn. 2015 Dec;37:63-70. doi: 10.1016/j.concog.2015.08.007. Epub 2015 Aug 28.
Results Reference
background
PubMed Identifier
9881538
Citation
Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
Results Reference
background
PubMed Identifier
15996533
Citation
Swaab DF, Bao AM, Lucassen PJ. The stress system in the human brain in depression and neurodegeneration. Ageing Res Rev. 2005 May;4(2):141-94. doi: 10.1016/j.arr.2005.03.003.
Results Reference
background
PubMed Identifier
25665216
Citation
Takahashi I, Ohashi H, Yokoyama K. Optimum arousal level preservation system using biosignals. J Hum Ergol (Tokyo). 2011 Dec;40(1-2):119-28.
Results Reference
background
PubMed Identifier
10965637
Citation
Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000 Aug;68(4):615-23. doi: 10.1037//0022-006x.68.4.615.
Results Reference
background
PubMed Identifier
14769087
Citation
Tugade MM, Fredrickson BL. Resilient individuals use positive emotions to bounce back from negative emotional experiences. J Pers Soc Psychol. 2004 Feb;86(2):320-33. doi: 10.1037/0022-3514.86.2.320.
Results Reference
background
PubMed Identifier
12650237
Citation
Uttl B. North American Adult Reading Test: age norms, reliability, and validity. J Clin Exp Neuropsychol. 2002 Dec;24(8):1123-37. doi: 10.1076/jcen.24.8.1123.8375.
Results Reference
background
PubMed Identifier
3397865
Citation
Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
Results Reference
background
PubMed Identifier
23842024
Citation
Watts BV, Schnurr PP, Mayo L, Young-Xu Y, Weeks WB, Friedman MJ. Meta-analysis of the efficacy of treatments for posttraumatic stress disorder. J Clin Psychiatry. 2013 Jun;74(6):e541-50. doi: 10.4088/JCP.12r08225.
Results Reference
background
PubMed Identifier
22114078
Citation
Westbrook C, Creswell JD, Tabibnia G, Julson E, Kober H, Tindle HA. Mindful attention reduces neural and self-reported cue-induced craving in smokers. Soc Cogn Affect Neurosci. 2013 Jan;8(1):73-84. doi: 10.1093/scan/nsr076. Epub 2011 Nov 22.
Results Reference
background
PubMed Identifier
27769879
Citation
Azam MA, Katz J, Mohabir V, Ritvo P. Individuals with tension and migraine headaches exhibit increased heart rate variability during post-stress mindfulness meditation practice but a decrease during a post-stress control condition - A randomized, controlled experiment. Int J Psychophysiol. 2016 Dec;110:66-74. doi: 10.1016/j.ijpsycho.2016.10.011. Epub 2016 Oct 18.
Results Reference
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Wearable Emotion Prosthetics for Post Traumatic Stress Disorder

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