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Degenerative central nervous system (CNS) diseases such as spinal cord injury (SCI) affect approximately 260,000 Americans annually [1,2]. As used current treatments are not curative, cell based therapies promise to be effective in the long-term. In cell based therapies, the diseased tissue is replaced by transplanting stem cells or other functional cells required in the body [3]. Studies have shown the capability of skin-derived precursor cells (SKPs) to differentiate in vitro into neural crest-derived cell types such as Schwann cells and other neurological cells [4]. Their proliferative capacity and differentiation potential makes them an attractive source for surgical nerve repair. The main objective of the present study was to develop protocols to maintain and expand rodent SKP cells in static culture. Serial passaging was used as a technique to successfully cultivate SKPs. These free- floating cells were seeded as single cells in tissue culture dishes, and the cells divided for a period of time, growing in aggregates. Prior to passage SKPs, cells were (1) harvested from the tissue culture dishes and (2) dissociated to break up the connection between the cells in the aggregates. The remaining cells were (3) frozen down at -192 °C for long-term storage. Two different segregation procedures were tested: chemical and enzymatic dissociation. Chemical dissociation was accomplished by changing the environmental pH of SKP aggregates. Enzymatic dissociation was carried out by analysing growth kinetics of SKPs after treatment with different enzymes. Segregation of SKPs using chemical dissociation proved to be unsuitable, causing cell death. Out of the three tested enzymes, Collagenase XI was deemed appropriate to dissociate SKPs into single cells, due to high growth rate and viability of the cells. Two freezing protocols were tested: freezing SKP cells as single cells and as aggregates. Freezing as aggregates improved cell survival through better sphere formation. Using these developed protocols, expansion of the cells was achieved over an extended culture period with high cell viability

The Factor Structure of Common Psychiatric Disorders and Their Genetic and Environmental Risk Factors in Adolescence

Factor analyses among adults have indicated that the structure of common mental disorders may be described parsimoniously with a two factor model, with mood and anxiety disorders loading on a latent internalizing factor and antisocial behavior disorders and substance use disorders loading on a latent externalizing factor. However, little is known about the structure of mental disorders among adolescents and how posttraumatic stress and its constituent subfactors, attention deficit hyperactivity disorder, and oppositional defiant disorder would fit into such a model. Similarly, little is known about the structure of genetic and environmental influences on common mental disorders. These questions were addressed via factor analyses and multivariate twin models of a sample of adolescents aged 10 - 19 years representative of the population of Colorado (n=3867) who were assessed for eight common disorders. Factor analysis results indicated that while a two factor model fit adequately, a three factor model with attention deficit hyperactivity disorder, oppositional defiant disorder and conduct disorder forming one factor of externalizing, and substance abuse/dependence symptoms and conduct disorder forming a second factor of externalizing fit better. Posttraumatic stress disorder loaded as strongly on internalizing as the more prototypical internalizing disorders, and each of its constituent subfactors loaded more strongly on internalizing than externalizing. Twin models indicated that, in contrast to a prior study among adults, neither genetic influences nor nonshared environmental influences could be constrained to two factors and that the best fitting model included three common genetic factors that do not conform to an internalizing-externalizing structure. These results suggest that the structure of adolescent psychopathology can be parsimoniously summarized by an internalizing-externalizing model with two factors of externalizing, and that the structure of both genetic and environmental influences do not conform to the phenotypic structure

Study protocol for a non-inferiority randomised controlled trial of SKY breathing meditation versus cognitive processing therapy for PTSD among veterans

Introduction Post-traumatic stress disorder (PTSD) is a debilitating, highly prevalent condition. Current clinical practice guidelines recommend trauma-focused psychotherapy (eg, cognitive processing therapy; CPT) as the first-line treatment for PTSD. However, while these treatments show clinically meaningful symptom improvement, the majority of those who begin treatment retain a diagnosis of PTSD post-treatment. Perhaps for this reason, many individuals with PTSD have sought more holistic, mind–body, complementary and integrative health (CIH) interventions. However, there remains a paucity of high-quality, active controlled efficacy studies of CIH interventions for PTSD, which precludes their formal recommendation. Methods and analyses We present the protocol for an ongoing non-inferiority parallel group randomised controlled trial (RCT) comparing the efficacy of a breathing meditation intervention (Sudarshan Kriya Yoga [SKY]) to a recommended evidence-based psychotherapy (CPT) for PTSD among veterans. Assessors are blinded to treatment group. The primary outcome measure is the PTSD Checklist-Civilian Version and a combination of clinical, self-report, experimental and physiological outcome measures assess treatment-related changes across each of the four PTSD symptom clusters (re-experiencing, avoidance, negative cognitions or mood and hyperarousal/reactivity). Once the RCT is completed, analyses will use both an intent-to-treat (using the ‘last observation carried forward’ for missing data) and a per-protocol or ‘treatment completers’ procedure, which is the most rigorous approach to non-inferiority designs. Ethics and dissemination To the best of our knowledge, this is this first non-inferiority RCT of SKY versus CPT for PTSD among veterans. The protocol is approved by the Stanford University Institutional Review Board. All participants provided written informed consent prior to participation. Results from this RCT will inform future studies including larger multi-site efficacy RCTs of SKY for PTSD and other mental health conditions, as well as exploration of cost-effectiveness and evaluation of implementation issues. Results will also inform evidence-based formal recommendations regarding CIH interventions for PTSD

Emotion dysregulation and heart rate variability improve in US veterans undergoing treatment for posttraumatic stress disorder: Secondary exploratory analyses from a randomised controlled trial

Background Emotion regulation (ER) is a key process underlying posttraumatic stress disorder (PTSD), yet, little is known about how ER changes with PTSD treatment. Understanding these effects may shed light on treatment processes. Methods We recently completed a non-inferiority design randomised controlled trial demonstrating that a breathing-based yoga practice (Sudarshan kriya yoga; SKY) was not clinically inferior to cognitive processing therapy (CPT) across symptoms of PTSD, depression, or negative affect. Here, in secondary exploratory analyses (intent-to-treat N = 85; per protocol N = 59), we examined whether self-reported ER (Difficulties in Emotion Regulation Scale; DERS) and physiological ER (heart rate variability; HRV) improved with treatment for clinically significant PTSD symptoms among US Veterans. Results DERS-Total and all six subscales improved with small-to-moderate effect sizes (d = .24–.66) following CPT or SKY, with no differences between treatment groups. Following SKY (but not CPT), HR max–min (average difference between maximum and minimum beats per minute), LF/HF (low-to-high frequency) ratio, and normalised HF-HRV (high frequency power) improved (moved towards a healthier profile; d = .42–.55). Conclusions To our knowledge, this is the first study to demonstrate that a breathing-based yoga (SKY) improved both voluntary/intentional and automatic/physiological ER. In contrast, trauma-focused therapy (CPT) only reliably improved self-reported ER. Findings have implications for PTSD treatment and interventions for emotional disorders more broadly. Trial registration Secondary analyses of ClinicalTrials.gov NCT02366403

Randomised clinical non-inferiority trial of breathing-based meditation and cognitive processing therapy for symptoms of post-traumatic stress disorder in military veterans

Objective Test whether Sudarshan Kriya Yoga (SKY) was non-inferior to cognitive processing therapy (CPT) for treating symptoms of post-traumatic stress disorder (PTSD) among veterans via a parallel randomised controlled non-inferiority trial. Setting Outpatient Veterans Affairs healthcare centre. Participants 85 veterans (75 men, 61% white, mean age 56.9) with symptoms of PTSD participated between October 2015 and March 2020: 59 participants completed the study. Interventions SKY emphasises breathing routines and was delivered in group format in a 15-hour workshop followed by two 1-hour sessions per week for 5 weeks. CPT is an individual psychotherapy which emphasises shifting cognitive appraisals and was delivered in two 1-hour sessions per week for 6 weeks. Measures The primary outcome measure was the PTSD Checklist-Civilian Version (PCL-C). The secondary measures were the Beck Depression Inventory-II (BDI-II) and Positive and Negative Affect Scale (PANAS). Results Mean PCL-C at baseline was 56.5 (±12.6). Intent-to-treat analyses showed that PCL-C scores were reduced at 6 weeks (end of treatment) relative to baseline (SKY, −5.6, d=0.41, n=41: CPT, −6.8, d=0.58, n=44). The between-treatment difference in change scores was within the non-inferiority margin of 10 points (−1.2, 95% CI −5.7 to 3.3), suggesting SKY was not inferior to CPT. SKY was also non-inferior at 1-month (CPT–SKY: −2.1, 95% CI −6.9 to 2.8) and 1-year (CPT–SKY: −1.8, 95% CI −6.6 to 2.9) assessments. SKY was also non-inferior to CPT on the BDI-II and PANAS at end of treatment and 1 month, but SKY was inferior to CPT on both BDI-II and PANAS at 1 year. Dropout rates were similar (SKY, 27%, CPT, 34%: OR=1.36, 95% CI 0.51 to 3.62, p=0.54). Conclusions SKY may be non-inferior to CPT for treating symptoms of PTSD and merits further consideration as a treatment for PTSD

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