Prolonged Post-traumatic Stress Disorder Clinical Trial
Official title:
Meditation Training for Emotional Numbing in Post-traumatic Stress Disorder
| Verified date | July 2016 |
| Source | Emory University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | May 2016 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 25 Years to 65 Years |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| United States | Emory University | Atlanta | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| Emory University | Brain & Behavior Research Foundation, Mind and Life Institute, Hadley, Massachusetts |
United States,
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. — View 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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Social connectedness | Self-report questionnaire assessment of social connectedness | up to 3 months | No |
| Primary | Empathic Accuracy | objective performance assessing accuracy of reading others' emotions | up to 3 months | No |
| Primary | Social Interactions | objective measures of time spent with others as measured by an audio sampling device | up to 3 months | No |
| Secondary | messenger ribonucleic acid (mRNA) | gene expression related to inflammation. | up to 3 months | No |