Emory University
Atlanta, Georgia, 30322, United States
NCT Number: NCT02163941
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.
Looking for future studies?
Notify Me25 year–65 year
Male
Interventional
Phase 1
Atlanta, Georgia, 30322, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(at the discretion of the researchers):
Other names: Cognitively-Based Compassion Training, CBCT
Time frame: up to 3 months
Self-report questionnaire assessment of social connectedness
Time frame: up to 3 months
objective performance assessing accuracy of reading others' emotions
Time frame: up to 3 months
objective measures of time spent with others as measured by an audio sampling device
Time frame: up to 3 months
gene expression related to inflammation.
Emory University
Other
Meditation Training for Emotional Numbing in Post-traumatic Stress Disorder
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04150380
Inflammation, Mental Disorders
Denver, Colorado, United States
View Trial DetailsNCT05365607
Autonomic Dysfunction, Autonomic Nervous System Diseases
Aurora, Colorado, United States
View Trial DetailsNCT02024204
Anxiety Disorders, Behavior
New York, United States
View Trial DetailsNCT02723344
Brain Concussion, Brain Diseases
Aurora, Colorado, United States
View Trial Details