Meditation for Emotional Numbing in Post-Traumatic Stress Disorder

NCT02163941 | Completed Phase 1

• 1 other identifier: IRB00070643
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Prolonged Post-traumatic Stress Disorder

Keywords

PTSD; empathy; meditation; compassion; inflammation; oxytocin; fMRI

Outcome Measures

Primary Outcomes (3)

• Social connectedness

  Self-report questionnaire assessment of social connectedness

  up to 3 months

• Empathic Accuracy

  objective performance assessing accuracy of reading others' emotions

  up to 3 months

• Social Interactions

  objective measures of time spent with others as measured by an audio sampling device

  up to 3 months

Secondary Outcomes (1)

• messenger ribonucleic acid (mRNA)

  up to 3 months

Study Arms (1)

Compassion Training

EXPERIMENTAL

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.

Behavioral: Compassion Training

Interventions

Compassion Training BEHAVIORAL

Also known as: Cognitively-Based Compassion Training, CBCT

Compassion Training

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Brain & Behavior Research Foundation: collaborator
• Mind and Life Institute, Hadley, Massachusetts: collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (4)

• 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.

  PMID: 22956676 BACKGROUND

• 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.

  PMID: 23125828 BACKGROUND

• 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.

  PMID: 18835662 BACKGROUND

• 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.

  PMID: 19615827 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Inflammation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer S Mascaro, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 16, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 2, 2016

Record last verified: 2016-07

Locations

US (1)