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Meditation for Emotional Numbing in Post-Traumatic Stress Disorder

Primary Purpose

Prolonged Post-traumatic Stress Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Compassion Training
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Prolonged Post-traumatic Stress Disorder focused on measuring PTSD, empathy, meditation, compassion, inflammation, oxytocin, fMRI

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • previously met criteria for PTSD
  • completed front-line treatment such as prolonged exposure therapy
  • continue to report emotional numbing symptoms as a chief complaint

Exclusion Criteria (at the discretion of the researchers):

  • Self-reported psychotic symptoms, current major depression, or suicidal ideation
  • Self-reported active alcohol or drug abuse within the past six months
  • Self-reported depression serious enough to require hospitalization, or that resulted in a suicide attempt, within the last year.
  • Self-reported auto-immune disease such as lupus, crohn's disease, irritable bowel syndrome, or rheumatoid arthritis.
  • Self-reported use of psychotropic medication, including antidepressants, mood stabilizers, antipsychotics or chronic benzodiazepine therapy that has changed in the past 6 weeks.
  • Self-reported use of any medication that might strongly affect your stress or immune systems, including non-steroidal anti-inflammatory agents, COX-2 inhibitors, corticosteroids, beta-blockers or statins.
  • Claustrophobia
  • Ferromagnetic implants contraindicated by functional MRI (fMRI) safety regulations

Sites / Locations

  • Emory University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Compassion Training

Arm Description

8 weeks of training in Cognitively-Based Compassion Training (CBCT). Classes will meet once per week for 2 hours and participants will be asked to meditate at home for 20 minute each day.

Outcomes

Primary Outcome Measures

Social connectedness
Self-report questionnaire assessment of social connectedness
Empathic Accuracy
objective performance assessing accuracy of reading others' emotions
Social Interactions
objective measures of time spent with others as measured by an audio sampling device

Secondary Outcome Measures

messenger ribonucleic acid (mRNA)
gene expression related to inflammation.

Full Information

First Posted
June 11, 2014
Last Updated
July 30, 2016
Sponsor
Emory University
Collaborators
Brain & Behavior Research Foundation, Mind and Life Institute, Hadley, Massachusetts
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1. Study Identification

Unique Protocol Identification Number
NCT02163941
Brief Title
Meditation for Emotional Numbing in Post-Traumatic Stress Disorder
Official Title
Meditation Training for Emotional Numbing in Post-traumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Brain & Behavior Research Foundation, Mind and Life Institute, Hadley, Massachusetts

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
For individuals suffering from posttraumatic stress disorder (PTSD), the emotional numbing and isolation that are a core aspect of their suffering and consistently impedes remediation often remains after first-line treatments are administered. Few interventions have proven successful for enhancing the empathy and social connectedness that will ultimately allow patients to flourish, and the search for target therapies is made more difficult by the fact that very little is known about the underlying physiology of emotional numbing and social isolation. The proposed study is designed to (1) investigate the hormonal, neural and immunological biomarkers related to emotional numbing, and (2) test whether cognitively-based compassion training (CBCT), an intervention designed and proven to enhance empathy, will reduce emotional numbing and increase empathy and social connectedness in veterans. To this end, thirty medically healthy males diagnosed with PTSD who continue to report emotional numbing symptoms after prolonged exposure therapy will receive 8 weeks of training in CBCT. Prior to, and again after the training, the investigators will assess patients' levels of oxytocin, inflammation, and self-reported emotional numbing and social connectedness. The investigators will also assess their neural response during a video task that assesses their ability to accurately read others' emotions. The investigators hypothesize that oxytocin, neural activity, and inflammation will predict social numbing, isolation, and empathy, and also that CBCT will positively impact the social outcomes that will pave the way toward health and well-being.
Detailed Description
Thirty otherwise medically healthy males between the ages of 25 and 55 who have previously met criteria for PTSD and have undergone prolonged exposure therapy (PET) yet continue to report emotional numbing symptoms as a chief complaint will be assessed for baseline levels of plasma oxytocin (OT), markers of pro-inflammatory cytokines, total mRNA expression in peripheral blood mononuclear cells (PBMCs), self-reported emotional numbing and social connectedness, and empathy. Real-world social connectedness will be assessed using an Electronically Activated Recorder (EAR) for two days, which will randomly record 50 second snippets of audio every 9 minutes and which will allow for quantification of time spent with others. Measures of empathy will include empathic accuracy during a dynamic empathic accuracy (EA) video task, which asks participants to rate what story-tellers are feeling while they tell positively and negatively valenced autobiographical stories. Because previous studies have shown that PTSD may interfere with subtle social processing skills and because one of the primary aims of this proposal is to uncover specific biomarkers related to self-reported emotional numbing, the investigators will also assess eye gaze and arousal covariance (correlation between skin conductance of video subject and that of study participant) during the EA task. Following baseline assessments, participants will participate in 8 weeks of CBCT, which entails twice-weekly meetings consisting of didactic information sessions and approximately 20 minutes of CBCT practice. Participants will be asked to practice at home for 20 minutes per day, and will be given a audio compact discs to guide at-home meditation. Upon completion of CBCT (Time 2), and again after 8-12 weeks (Time 3), all Time 1 assessments will be repeated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolonged Post-traumatic Stress Disorder
Keywords
PTSD, empathy, meditation, compassion, inflammation, oxytocin, fMRI

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compassion Training
Arm Type
Experimental
Arm Description
8 weeks of training in Cognitively-Based Compassion Training (CBCT). Classes will meet once per week for 2 hours and participants will be asked to meditate at home for 20 minute each day.
Intervention Type
Behavioral
Intervention Name(s)
Compassion Training
Other Intervention Name(s)
Cognitively-Based Compassion Training, CBCT
Primary Outcome Measure Information:
Title
Social connectedness
Description
Self-report questionnaire assessment of social connectedness
Time Frame
up to 3 months
Title
Empathic Accuracy
Description
objective performance assessing accuracy of reading others' emotions
Time Frame
up to 3 months
Title
Social Interactions
Description
objective measures of time spent with others as measured by an audio sampling device
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
messenger ribonucleic acid (mRNA)
Description
gene expression related to inflammation.
Time Frame
up to 3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: previously met criteria for PTSD completed front-line treatment such as prolonged exposure therapy continue to report emotional numbing symptoms as a chief complaint Exclusion Criteria (at the discretion of the researchers): Self-reported psychotic symptoms, current major depression, or suicidal ideation Self-reported active alcohol or drug abuse within the past six months Self-reported depression serious enough to require hospitalization, or that resulted in a suicide attempt, within the last year. Self-reported auto-immune disease such as lupus, crohn's disease, irritable bowel syndrome, or rheumatoid arthritis. Self-reported use of psychotropic medication, including antidepressants, mood stabilizers, antipsychotics or chronic benzodiazepine therapy that has changed in the past 6 weeks. Self-reported use of any medication that might strongly affect your stress or immune systems, including non-steroidal anti-inflammatory agents, COX-2 inhibitors, corticosteroids, beta-blockers or statins. Claustrophobia Ferromagnetic implants contraindicated by functional MRI (fMRI) safety regulations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer S Mascaro, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22956676
Citation
Mascaro JS, Rilling JK, Tenzin Negi L, Raison CL. Compassion meditation enhances empathic accuracy and related neural activity. Soc Cogn Affect Neurosci. 2013 Jan;8(1):48-55. doi: 10.1093/scan/nss095. Epub 2012 Sep 5.
Results Reference
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PubMed Identifier
23125828
Citation
Desbordes G, Negi LT, Pace TW, Wallace BA, Raison CL, Schwartz EL. Effects of mindful-attention and compassion meditation training on amygdala response to emotional stimuli in an ordinary, non-meditative state. Front Hum Neurosci. 2012 Nov 1;6:292. doi: 10.3389/fnhum.2012.00292. eCollection 2012.
Results Reference
background
PubMed Identifier
18835662
Citation
Pace TW, Negi LT, Adame DD, Cole SP, Sivilli TI, Brown TD, Issa MJ, Raison CL. Effect of compassion meditation on neuroendocrine, innate immune and behavioral responses to psychosocial stress. Psychoneuroendocrinology. 2009 Jan;34(1):87-98. doi: 10.1016/j.psyneuen.2008.08.011. Epub 2008 Oct 4.
Results Reference
background
PubMed Identifier
19615827
Citation
Pace TW, Negi LT, Sivilli TI, Issa MJ, Cole SP, Adame DD, Raison CL. Innate immune, neuroendocrine and behavioral responses to psychosocial stress do not predict subsequent compassion meditation practice time. Psychoneuroendocrinology. 2010 Feb;35(2):310-5. doi: 10.1016/j.psyneuen.2009.06.008. Epub 2009 Jul 16.
Results Reference
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Meditation for Emotional Numbing in Post-Traumatic Stress Disorder

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