Ignite Creation Date:
2024-05-06 @ 2:57 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02163941
Status:
COMPLETED
Last Update Posted:
2016-08-02
First Post:
2014-06-11
Brief Title:
Meditation for Emotional Numbing in Post-Traumatic Stress Disorder
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Meditation Training for Emotional Numbing in Post-traumatic Stress Disorder
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None