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Efficacy of Yoga vs Cognitive Behavioral Therapy vs Stress Education for the Treatment of Generalized Anxiety Disorder: A Randomized Clinical Trial

Simon, Naomi M; Hofmann, Stefan G; Rosenfield, David; Hoeppner, Susanne S; Hoge, Elizabeth A; Bui, Eric; Khalsa, Sat Bir S
Importance/UNASSIGNED:Generalized anxiety disorder (GAD) is common, impairing, and undertreated. Although many patients with GAD seek complementary and alternative interventions, including yoga, data supporting yoga's efficacy or how it compares to first-line treatments are lacking. Objectives/UNASSIGNED:To assess whether yoga (Kundalini yoga) and cognitive behavioral therapy (CBT) for GAD are each more effective than a control condition (stress education) and whether yoga is noninferior to CBT for the treatment of GAD. Design, Setting, and Participants/UNASSIGNED:For this randomized, 3-arm, controlled, single-blind (masked independent raters) clinical trial, participants were recruited from 2 specialty academic centers starting December 1, 2013, with assessment ending October 25, 2019. Primary analyses, completed by February 12, 2020, included superiority testing of Kundalini yoga and CBT vs stress education and noninferiority testing of Kundalini yoga vs CBT. Interventions/UNASSIGNED:Participants were randomized to Kundalini yoga (n = 93), CBT for GAD (n = 90), or stress education (n = 43), which were each delivered to groups of 4 to 6 participants by 2 instructors during twelve 120-minute sessions with 20 minutes of daily homework. Main Outcomes and Measures/UNASSIGNED:The primary intention-to-treat outcome was acute GAD response (Clinical Global Impression-Improvement Scale score of much or very much improved) after 12 weeks as assessed by trained independent raters. Results/UNASSIGNED:Of 538 participants who provided consent and were evaluated, 226 (mean [SD] age, 33.4 [13.5] years; 158 [69.9%] female) with a primary diagnosis of GAD were included in the trial. A total of 155 participants (68.6%) completed the posttreatment assessment. Completion rates did not differ (Kundalini yoga, 60 [64.5%]; CBT, 67 [74.4%]; and stress education, 28 [65.1%]: χ2 = 2.39, df = 2, P = .30). Response rates were higher in the Kundalini yoga group (54.2%) than in the stress education group (33.%) (odds ratio [OR], 2.46 [95% CI, 1.12-5.42]; P = .03; number needed to treat, 4.59 [95% CI, 2.52-46.19]) and in the CBT group (70.8%) compared with the stress education group (33.0%) (OR, 5.00 [95% CI, 2.12-11.82]; P < .001; number needed to treat, 2.62 [95% CI, 1.91-5.68]). However, the noninferiority test did not find Kundalini yoga to be as effective as CBT (difference, 16.6%; P = .42 for noninferiority). Conclusions and Relevance/UNASSIGNED:In this trial, Kundalini yoga was efficacious for GAD, but the results support CBT remaining first-line treatment. Trial Registration/UNASSIGNED:ClinicalTrials.gov Identifier: NCT01912287.
PMID: 32805013
ISSN: 2168-6238
CID: 4614372

The pain of grief: Exploring the concept of psychological pain and its relation to complicated grief, depression, and risk for suicide in bereaved adults

Frumkin, Madelyn R; Robinaugh, Donald J; LeBlanc, Nicole J; Ahmad, Zeba; Bui, Eric; Nock, Matthew K; Simon, Naomi M; McNally, Richard J
OBJECTIVE:Emotional or psychological pain is a core symptom of complicated grief (CG), yet its correlates are largely unexamined among bereaved individuals. METHOD/METHODS:Bereaved adults (N = 135) completed self-reports regarding psychological pain, CG, depression, and suicidality. We assessed correlations among these variables and tested whether psychological pain was elevated among individuals with CG and individuals with current or past suicidal thoughts and behaviors. Using logistic regression, we also assessed psychological pain, depression, and CG symptom severity as predictors of suicide risk. RESULTS:Psychological pain was strongly associated with both CG and depression severity and was elevated among subjects reporting current or past suicidality. CG and depression were not statistically significant predictors of suicidal ideation after accounting for the effects of psychological pain. CONCLUSIONS:Psychological pain is strongly associated with bereavement-related psychopathology and warrants further investigation in studies examining the nature and treatment of CG.
PMID: 32662088
ISSN: 1097-4679
CID: 4539292

Associations between resting-state functional connectivity and treatment response in a randomized clinical trial for posttraumatic stress disorder

Sheynin, Jony; Duval, Elizabeth R; King, Anthony P; Angstadt, Mike; Phan, K Luan; Simon, Naomi M; Rauch, Sheila A M; Liberzon, Israel
BACKGROUND:Alterations in resting-state functional connectivity (rsFC) have been reported in posttraumatic stress disorder (PTSD). Here, we examined pre- and post-treatment rsFC during a randomized clinical trial to characterize alterations and examine predictors of treatment response. METHODS:Sixty-four combat veterans with PTSD were randomly assigned to prolonged exposure (PE) plus placebo, sertraline plus enhanced medication management, or PE plus sertraline. Symptom assessment and resting-state functional magnetic resonance imaging (fMRI) scans occurred before and after treatment. Twenty-nine trauma-exposed combat veterans without PTSD served as a control group at intake. Seed-based and region of interest (ROI)-to-ROI connectivities, as well as an exploratory connectome-based approach were used to analyze rsFC patterns. Based on previously reported findings, analyses focused on Salience Network (SN) and Default-Mode Network (DMN). RESULTS:At intake, patients with PTSD showed greater DMN-dorsal attention network (DAN) connectivity (between ventromedial prefrontal cortex and superior parietal lobule; family-wise error corrected p = .011), greater SN-DAN connectivity (between insula and middle frontal gyrus; corrected p = .003), and a negative correlation between re-experiencing symptoms and within-DMN connectivity (between posterior cingulate cortex (PCC) and middle temporal gyrus; corrected p < .001). We also found preliminary evidence for associations between rsFC and treatment response. Specifically, high responders (≥50% PTSD symptom improvement), compared with low responders, had greater SN-DMN segregation (i.e., less pre-treatment amygdala-PCC connectivity; p = .011) and lower pre-treatment global centrality (p = .042). CONCLUSIONS:Our findings suggest neural abnormalities in PTSD and may inform future research examining neural biomarkers of PTSD treatment response.
PMCID:7722156
PMID: 32668087
ISSN: 1520-6394
CID: 4880702

Acute Stress Disorder and the COVID-19 Pandemic

Madanes, Sharon B.; Levenson-Palmer, Rose; Szuhany, Kristin L.; Malgaroli, Matteo; Jennings, Emma L.; Anbarasan, Deepti; Simon, Naomi M.
ISI:000565745900005
ISSN: 0048-5713
CID: 4780732

Anhedonia is central for the association between quality of life, metacognition, sleep, and affective symptoms in generalized anxiety disorder: A complex network analysis

Barthel, Abigail L; Pinaire, Megan A; Curtiss, Joshua E; Baker, Amanda W; Brown, Mackenzie L; Hoeppner, Susanne S; Bui, Eric; Simon, Naomi M; Hofmann, Stefan G
BACKGROUND:Poor quality of life, sleep problems, anhedonia, and negative metacognitions are common in anxiety and depression. To examine the nature of the relationship between these features and the role of metacognitions, anhedonia, and quality of life in anxiety and depression, we conducted a complex network analysis with items of self-report measures assessing quality of life, sleep, negative thinking styles, anxiety, and depression. METHODS:Participants were 226 treatment seeking individuals with a primary DSM-5 diagnosis of generalized anxiety disorder. Node centrality, strength, expected influence, community, and bridge estimation were calculated using partial correlation coefficients and glasso regularization. RESULTS:Results revealed that anhedonia was the most central node followed by quality of life nodes. Moreover, anhedonia exhibited the highest strength and expected influence, which were both stable, reliable metrics within the network. Metacognitions were not central nodes in the network, but were strong bridge symptoms between communities. LIMITATIONS/CONCLUSIONS:The results are limited by the cross-sectional nature of the data and the administration of self-report scales at one time-point, despite different rating anchors. CONCLUSION/CONCLUSIONS:These findings suggest that anhedonia is a crucial element for the association between quality of life, sleep problems, and negative cognitions.
PMID: 33065810
ISSN: 1573-2517
CID: 4637192

Mental Health Disorders Related to COVID-19-Related Deaths

Simon, Naomi M; Saxe, Glenn N; Marmar, Charles R
PMID: 33044510
ISSN: 1538-3598
CID: 4632452

Suicide Risk Automated Detection Using Computational Linguistic Markers From Patients' Communication With Therapists [Meeting Abstract]

Malgaroli, Matteo; Hull, Thomas Derrick; Bantilan, Niels; Ray, Bonnie; Simon, Naomi
ISI:000535308201330
ISSN: 0006-3223
CID: 4560982

Residual symptoms of PTSD following Sertraline plus enhanced medication management, Sertraline plus PE, and PE plus placebo

Tripp, Jessica C; Norman, Sonya B; Kim, H Myra; Venners, Margaret R; Martis, Brian; Simon, Naomi M; Stein, Murray B; Allard, Carolyn B; Rauch, Sheila A M
Although prolonged exposure (PE) and SSRI antidepressants are effective in treating posttraumatic stress disorder (PTSD), previous studies have shown that some symptoms tend to persist. The current study compared sertraline hydrochloride plus enhanced medication management (EMM), PE plus placebo, or PE plus sertraline hydrochloride in the likelihood of each individual PTSD symptom persisting in veterans with a PTSD diagnosis. We compared the likelihood of individual PTSD symptoms persisting in those with versus without a PTSD diagnosis at posttreatment. We found no significant differences across conditions in which symptoms were likely to persist posttreatment. Among those without a PTSD diagnosis at posttreatment, sleeping difficulties (63.0%), hypervigilance (47.3%), and nightmares (45.0%) were most likely to persist. Findings indicate no consistent differences in residual symptoms between PE and medications, and shared decision making with patients is encouraged in selecting treatments. Gold standard treatments (e.g., CBT-I) may be warranted for residual symptoms like insomnia.
PMID: 32763541
ISSN: 1872-7123
CID: 4557162

Development of wellness programs during the COVID-19 pandemic response

Spray, Amanda M.; Patel, Nikhil A.; Sood, Ashvin; Wu, Stephanie X.; Simon, Naomi M.; Podbury, Rachel; Vasserman, Ariela; Caravella, Rachel A.; Silverman, Yona; Pochtar, Randi; Liaw, K. Ron Li; Ackerman, Marra G.
Health care workers are on the front lines of the recent pandemic, facing significant challenges to their physical and mental health. This article details the efforts undertaken by a health care system and two academically affiliated hospital systems to provide emotional support to their frontline staff. The multipronged approach describes coordinating efforts to decrease duplication of services and to increase centralization of information. This included enhancing pathways for faculty, staff, and trainees to obtain individual and group treatment and to have access to highquality self-help resources. Continuous feedback has been elicited to ensure that efforts are consistent with expressed needs and in turn services undergo modifications as needed. This article seeks to provide an overview of how one health system has thus far approached the important issue of staff support as well as the challenges experienced and lessons learned along the way.
SCOPUS:85087423070
ISSN: 0048-5713
CID: 4543512

Emotion Regulation Flexibility in Generalized Anxiety Disorder

Conroy, Kristina; Curtiss, Joshua E; Barthel, Abigail L; Lubin, Rebecca; Wieman, Sarah; Bui, Eric; Simon, Naomi M; Hofmann, Stefan G
Background/UNASSIGNED:People differ in their affective styles, which refers to habitual use of emotion regulation (ER) strategies. Previous research has shown that mental health is associated with an individual's adaptive flexibility of emotion regulation strategies rather than any one particular ER strategy. Methods/UNASSIGNED:The present study employed a person-centered approach using latent profile analyses to distinguish patients with generalized anxiety disorder based on their responses on an affective styles measure. Results/UNASSIGNED:Results of the latent profile analysis supported a three-class solution. Class 1 (26% of participants) identified individuals with the lowest scores of each affective style; class 2 (10%) included individuals with the highest scores of each style; and class 3 (64%) consisted of individuals who scored in the mid-range of each affective style. Greater ER flexibility was associated with better emotional functioning and quality of life. Conclusions/UNASSIGNED:Patients with GAD differ in ER flexibility. The vast majority of patients appear to have only moderate or low ER flexibility. Those individuals with high ER flexibility show a greater quality of life and less emotional distress.
PMCID:7357573
PMID: 32661451
ISSN: 0882-2689
CID: 4526932