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Misophonia is a condition in which individuals suffer a wide range of intense emotions in response to sound triggers. Emotions such as anxiety, irritability, and disgust may lead individuals to engage in avoidance behaviors to escape or suppress sound triggers. Transdiagnostic treatment may serve as a practical intervention for misophonia as it addresses a broad scope of emotions and physiological sensations. This paper presents the first reported case example of misophonia treated with a transdiagnostic treatment protocol, the Unified Protocol for Emotional Disorders in Adolescents (UP-A). In this case, the UP-A was efficacious in treating a client with autism spectrum disorder, comorbid misophonia and anxiety symptoms. The client evidenced reliable change in misophonia and related problems. Future research should investigate the efficacy of the UP-A in a larger sample of youth with misophonia, as well as assess mechanisms of change in transdiagnostic treatment of this disorder in youth.Copyright © 2022 Society of Clinical Child & Adolescent Psychology.
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Background/Objective: This continuation study follows positive results of the Phase IIb study and aims to supplement findings with additional scale data and unblinded group membership. The goal is to further assess the potential impact of COVID-19 restrictions on symptom severity in additional domains captured by the Children's Depression Rating Scale-Revised (CDRS-R);Children's Yale-Brown Obsessive Compulsive Scale (CYBOCS);Swanson, Nolan, and Pelham (SNAP-IV);Pediatric Anxiety Scale (PARS);and Clinical Global Impression Scale-Severity (CGI-S). Design(s): Data was partitioned using the date of March 11, 2020. Baseline outcome measure data was analyzed. Additionally, individual item scores were considered across the two time periods, as were treatment group assignments. Descriptive statistics were computed using SPSS 27.0 and included mean, standard deviation, variance, and distribution measures. Result(s): YGTSS mean values under consideration did not appear to change significantly between the time periods before and after COVID-19 restrictions began, with total scores of 67.2 and 66.7, respectively. Mean baseline CY-BOCS scores of 7.45 (before) and 7.55 (after) also showed similar stability to PARS (11.7 before and 12 after) and CDRS (29 before and 27.5 after), with similar stability noted in the CGI-S. Conclusion(s): While clinically, it might be typical for symptoms of Tourette's syndrome to be susceptible to stressors, this was not demonstrated in relation to the COVID-19 pandemic by any significant differences in primary tic assessments or related/comorbid disorders. There did not appear to be significant differences in YGTSS, CY-BOCS, PARS, CDRS, or CGI-S domain scores or individual item scores before or after COVID-19 restrictions were in place.
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Introduction: Social determinants of health (SDOH) including income inequality, discrimination, social exclusion, and underemployment can lead to disproportionally poor health outcomes in patients with severe mental illness. In combination with the COVID-19 pandemic, these patients are at higher risk for mental health decompensation such as stress and anxiety, which may further worsen the clinical outcomes of patients with existing chronic mental illness. Research Question or Hypothesis: 1) Did the COVID-19 pandemic and SDOH impact medication adherence and patient outcomes? 2) Is the COVID-19 pandemic correlated with higher rates of psychiatric emergency services (PES) use, hospitalization, and a new substance use disorder (SUD) diagnosis? Study Design: Single-center, IRB-approved, retrospective chart review. Method(s): Data collected on 36 psychiatric patients age >=18 enrolled in the concentrated and integrated programs from June 1, 2019 to February 28, . Demographic variables, prescription fill history, and Clinical Global Impression (CGI) scores were compared. Nominal data was analyzed using Chi-squared test and continuous data using unpaired t-test. Result(s): Average change in CGI-I scores slightly increased during the April 2021 - July 2021 period for the concentrated program versus April 2020 - July 2020 and April 2021 - July 2021 periods for the integrated program (P=0.13). Ten patients in the concentrated program compared to thirteen patients in the integrated program got worse at any point during the study period (P = 0.45). Of those that got worse, no significant differences in their SDOH were seen compared with stable patients (P > 0.05). There were no PES use or hospitalizations;however, two patients had a new SUD diagnosis. Conclusion(s): This first-time study showed neither SDOH and the COVID-19 pandemic had an impact on medication adherence or patient outcomes nor correlated with higher rates of PES use, hospitalization, or a new SUD diagnosis.
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BACKGROUND: Adjustment disorders are now primary diagnoses in the trauma and stressrelated disorders section of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Adjustment disorder with anxiety (AjDA) is the development of emotional or behavioral symptoms considered excessive in response to stressful events, significantly impairing a person's ability to function in social, occupational, and/ or other situations. Traumatic experiences related to the COVID-19 pandemic may have increased rates of adjustment disorders, especially among those whose life routines were disrupted by pandemic-associated stress and anxiety. PH94B (3b-hydroxy-androsta-4,16-dien-ol) has shown rapid-onset efficacy in the treatment of social anxiety disorder (Liebowitz et al. Am J Psychiatry. 2014). PH94B is a neuroactive steroid administered as a nasal spray that engages olfactory chemosensory neurons, activating subsets of olfactory bulb neurons that project directly to the limbic amygdala regulating fear and anxiety circuits. OBJECTIVE: To assess the efficacy, safety, and tolerability of PH94B in adults with AjDA. METHODS: This is an exploratory, phase 2A, randomized, double-blind, 4-week, placebo-controlled, 2-arm study in adults with AjDA. The primary outcome is change from baseline to week 4 in the Hamilton Anxiety Rating Scale (HAM-A) total score after intranasal administration of PH49B 4 times daily vs placebo. Patients with a DSM-5 diagnosis of AjDA confirmed by the Mini-International Neuropsychiatric Interview (MINI) with Adjustment Disorders Module and a clinician-rated HAM-A score of ≥20 at screening (Visit 1), with ≤15% decrease at baseline (Visit 2, randomization) are eligible for inclusion. Secondary outcomes include change from baseline to week 4 in the Adjustment Disorder New Module Scale (ADNM), the International Adjustment Disorder Questionnaire (IADQ), the Clinical Global Impression of Improvement (CGI-I), and the Patient Global Impression of Change (PGI-C). Change from baseline in the Hamilton Depression Rating Scale (HAM-D) was exploratory. RESULTS: A total of 40 patients will be randomized (1:1 drug to placebo). The study design features the use of the ADNM and IADQ, newly developed according to ICD-11 criteria for evaluation of AjDA. While both are validated, neither has been tested in placebo-controlled clinical trials. Both scales begin with a list of stressors (18 for ADNM and 9 for IADQ);a yes answer to any 1 stressor triggers a series of questions about the frequency and duration of a patient's reaction to the stressor (ADNM) or quantifies symptoms in response to the stressor (IADQ). CONCLUSIONS: Anxiety disorders are the most prevalent psychiatric disorders and a leading cause of disability. Anxiety and impaired functioning are increasing, particularly in response to the COVID-19 pandemic, and no pharmacologic treatment is currently approved by the FDA for AjDA. PH94B, an investigational pherine nasal spray, is also being studied for treatment of other anxiety-related disorders.
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Introduction: Stress urinary incontinence (SUI) occurs in part due to a weakened urethral rhabdosphincter. Yoga and Pilates are low-impact workouts that use bodyweight as resistance, and limited evidence shows these exercises improve pelvic muscle strength and decrease incontinence episodes. Objective: The study objective was to evaluate the effect of an 8-week web-based yoga-Pilates exercise program on SUI severity as measured by the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) and secondarily to evaluate the potential mechanism of action for yoga-Pilates through ultrasound measurement of the urethral rhabdosphincter cross-sectional area (CSA). We hypothesized that yoga-Pilates would decrease SUI severity and cause hypertrophy of the urethral rhabdosphincter. Methods: This was a prospective interventional cohort study from November 2020 through September 2021. The intervention was an 8-week home yogaPilates web-based video that tracked and prompted participation. Participants with SUI underwent in-person visits pre/post-intervention during which they completed quality of life and severity surveys and underwent pelvic exam, including POP-Q, cough stress test, Brink pelvic floor strength score, and resting 3-dimensional transperineal ultrasound [1]. Ultrasound images were masked and measured post-collection. The rhabdosphincter is located in the middle third of the urethra, so 5 CSA measurements were taken: at the midpoint and then at 2.5 mm and 5 mm cranial and caudal from the midpoint [1]. The urethral CSA was determined by subtracting luminal/submucosal area from total urethral area (Figure 1). Pre/post 24-hour voiding diaries and an automated video viewing log were also collected. The study was powered to detect a mean change of 2.0 ± 4.0 ICIQ UI-SF score units and a mean CSA increase of 0.25 ± 0.6 cm2 with 48 compliant participants. All pre/post- intervention changes were analyzed using paired t-tests with a null change of zero. Results: 78 women, ages 46.6 + 10.4 years, enrolled. 60 women completed the study. The cohort was predominantly premenopausal (67%), vaginally parous (65%), and had done yoga (76%) and/or Pilates (44%) in the past. 73% of the completers performed the exercises at least 3x/week. The ICIQ-UI SF score improved from 9.5 (95% CI 8.7-10.4) to 7.1 (95% CI 6.3-7.9) post-intervention (P < 0.001). The number of incontinence episodes decreased post-intervention from 1 (IQR 1-3) to 1 (IQR 0-1) (P < 0.001). The Brink score also improved from 7.1 (95% CI 6.6-7.7) to 7.7 (95% CI 7.2-8.2) (P = 0.013). Participants were very satisfied with the online exercises. The majority (83%) of completers also reported they were “a little better”, “much better”, or “very much better” on patient global impression of improvement. There were no significant changes in urethral measurements from pre- to post-intervention. Conclusions: Although there were no changes in the urethral rhabdosphincter, this web-based yoga-Pilates exercise program improved symptoms of SUI and decreased number of incontinence episodes in women with SUI over 8 weeks. Web-based yoga-Pilates offers women with SUI a nonsurgical treatment that can be performed at home, which is beneficial in the ongoing COVID-19 pandemic.
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Introduction: Our group first described a novel approach for hysteropexy in 2017. This procedure utilized a combined laparoscopic and vaginal approach to place a polypropylene mesh sling around the cervicouterine junction as a cerclage and attach this mesh to the sacrum. Previous outcomes comparing this technique to laparoscopic hysterectomy and sacrocervicopexy showed equivalent anatomical and subjective outcomes with decreased suturing and intraoperative time compared to traditional sacrocervicopexy at 6 weeks, 6 months and 12 months. The procedure was refined in 2019 when vaginal attachment of the mesh was replaced with a novel laparoscopic mesh attachment technique, now referred to as total laparoscopic cerclage sacrohysteropexy (TLCSH). Objective: To assess postoperative outcomes of the novel, modified TLCSH. Methods: This was a retrospective study of patients who underwent TLCSH from February 2019 to October 2021. Chart review was performed to obtain patient demographics, baseline pelvic organ prolapse quantification (POP-Q) scores and 6- week outcome data. Anatomical success was a composite of anterior, posterior and apical success. We defined anterior and posterior compartment success as Ba and Bp ≤0, respectively. Apical success was defined as C ≤ half the total vaginal length (TVL). As a more conservative measure, we also defined success as C < -4 and C ≤ -2/3 TVL. Subjective outcomes, including patient-reported pelvic organ prolapse distress inventory (POPDI-6), patient global impression of improvement (PGI-I) and satisfaction, were also assessed at 6 weeks. Data are reported as median (interquartile range) and were compared with the Wilcoxon signed rank test. Results: A total of 117 patients underwent TLCSH and 107 (91%) had a 6- week post-operative visit at a median time of 2 months (1-2). Of patients who had a 6-week visit, 9 had a telehealth visit due to COVID-19 and did not have a POP-Q assessment, and 1 patient only had point C documented and therefore was only included in the point C analysis. Pre-operative characteristics are in Table 1. Post-operative changes for points C, Ba, Bp, and GH were significantly improved (P < 0.001 for all;Table 2). Most patients (93%) had surgical success as defined by C ≤ half TVL. Using the more restrictive definitions of apical success there was 94% success with C < -4 and 35% with C ≤ -2/3 TVL. At 6 weeks, 31% of patients were stage 0, 54% stage I, and 15% stage II. There were no mesh exposures. Subjective outcomes were available for 50 (47%) patients. While only available for a portion of patients, median POPDI-6 scores improved significantly from 30 (21-50) to 4 (0-21), P < 0.001. Most patients (85%) reported that they were “very satisfied,” 12% reported “satisfied,” 2% reported “neutral;” none reported “unsatisfied” or “very unsatisfied.” The median PGI-I score was 1 (1-2), with 1 and 2 corresponding to “very much better” and “much better,” respectively. Conclusions: TLCSH results in anatomical success, in addition to decreased POPDI-6 scores and high PGI-I scores at 6 weeks. Given this novel technique, additional follow-up time with further analysis is necessary to assess whether this procedure is a durable repair for long-term prolapse reduction and patient satisfaction. (Table Presented).
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Background: Long-acting injectable antipsychotics improved markedly patient adherence to psychotropic agents during the past decade. They were used mainly for long-term treatment of schizophrenia. However their role in short term or intermittent use or their effect on quality of life was not elucidated clearly. Objectives: To assess the impact of Long Acting Antipsychotic agents on quality of life of schizophrenic patients. Methods: This is a retrospective cohort study of psychiatric patients who were taking LAIs and/or oral antipsychotic drugs at Mohammad Said Kamal Hospital for Mental Illness in Bethlehem and Mental Health Clinic of The Ministry of Health in Hebron city during the period of September 2019 to March 2020. Results: Fifty one patients were included in this study, 74% males, age 50.69 ± 11.14 years old. Average duration of psychiatric disease was 17.78 ± 11.4 years. It was found that 9.6% patients were on oral dosage form (category I), 80.4% were on LAI and oral antipsychotics (category II), and 10% were on LAIs (Category III). Chi square test showed a significant difference between the 3-categories and GAF score (functionality), p=0.003. However, there was insignificant difference between the three categories and CGI-S(severity of symptoms) scores, p=0.170. When it comes to side effects, there was a significant difference among the three categories and DIEPSS, p=0.049. Kruskal–Wallis Test showed a significant difference between patients in the three categories and number of all drugs, p=0.007. There was also a significant difference between CGI-S-normal group and CGI-S-severe symptoms group and overall number of drugs used, p=0.02. Mann-Whitney test showed a significant difference between number of all drugs used and the use of trihexphenidyl, p=0.001. Also there was a significant difference between number of antipsychotic drugs alone and thrihexphenidyl use, p=0.001. Patients were prescribed LAIs for the following reasons: non-adherence (47%), no reason at all (27.4%), patient dissatisfaction (13.7%), adherence and patient dissatisfaction (5.8%), side effects, convenience (ease of use), and availability of drug, (1.9%), for each. Conclusion: Improvement in functionality of schizophrenic patients goes along with use of LAIs either alone or in combination. LAIs improved adherence and minimizes polypharmacy.
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Background: Prader-Willi syndrome (PWS) is a rare genetic disorder associated with multiple neuroendocrine abnormalities including decreased hypothalamic oxytocin, resulting in severe hyperphagia and neuropsychiatric and behavioral issues. The CARE-PWS Phase 3 study evaluated safety and efficacy of intranasal carbetocin, a selective oxytocin receptor agonist, in participants with PWS. Methods: Subjects with genetically confirmed PWS aged 7-18 were randomized to carbetocin 9.6mg or 3.2mg or placebo (given TID by nasal spray) for an initial 8-week period. The primary endpoint assessed change through week 8 in hyperphagia (HQ-CT) or obsessive-compulsive (CY-BOCS) scores for the 9.6mg arm vs placebo, and the first secondary endpoint assessed change through week 8 in HQ-CT or CY-BOCS for the 3.2mg arm vs placebo. Secondary endpoints included assessments of behavioral distress (PADQ) and Clinical Global Impression of Change (CGI-C). Results: Due to COVID-19, enrollment was closed early with 119 subjects in the primary analysis. In the carbetocin 9.6mg arm, trends toward improvements in HQ-CT and CGI-C vs placebo were observed but did not reach statistical significance;however, the carbetocin 3.2mg arm showed a significant improvement in HQ-CT scores vs placebo (-3.14, p = 0.016). In the 3.2 mg arm, improvements vs placebo were also seen in multiple secondary endpoints including CGI-C (p = 0.027) and PADQ (p = 0.027). Trends for improvement in CY-BOCS were observed in each dose arm, but did not reach statistical significance. Recent data from the subsequent long-term follow-up period has demonstrated continued numeric improvements from baseline across multiple endpoints in each active treatment arm. Intranasal carbetocin was generally well-tolerated;the most frequently reported adverse event was flushing, which was generally mild and transient. Conclusions: In conclusion, results of the CARE-PWS Phase 3 study support that intranasal carbetocin appears to be safe and well tolerated, and reduces hyperphagia and behavioral distress in PWS.
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Introduction: SARS-CoV-2 infection causes a pulmonary disease (COVID-19) which spread worldwide in 2020, leading the World Health Organization (WHO) to declare a pandemic [1] and the Italian government firstly to declare a state of emergency, then to impose restrictive measures lasting about two months. COVID-19 pandemic generated fear, anxiety, depression and post-traumatic symptoms in the general population [2,3] as well as among subjects affected by mental disorders [4]. Little is known about which different psychopathological changes the pandemic caused among individuals affected by different psychiatric disorders. Aims: To investigate potential psychopathological changes over time during the first wave of COVID-19 pandemic comparing different psychiatric disorders. Methods: Data about demographic/clinical variables and psychopathological status were retrospectively collected. Specific psychometric scales were administered at three time points: T0 as outbreak of pandemic, T1 as lockdown period, T2 as reopening. Primary outcomes: Brief Psychiatry Rating Scale (BPRS), Clinical Global Impression (CGI), Hamilton Anxiety Rating Scale (HAM-A). Secondary outcomes: Disability Scale (DISS), Positive and Negative Syndrome Scale (PANSS), Hamilton Depression Rating Scale (HAM-D), Montgomery and Åsberg Depression Rating Scale (MADRS), Young Mania Rating Scale (YMRS), Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Descriptive analyses and linear regression models were performed. Summary of results: A total of 166 outpatients were included. Overall, psychometric scores showed a significant worsening at T1 with a mild improvement at T2 (p<0.05). Only psychotic and OC symptoms did not significantly improve at T2. Primary outcomes: time had a significant effect on the change of BPRS (F=26.56;p<0.001), CGI-severity (F=8.29;p<0.001), CGI-improvement (F=41.88;p<0.001) and HAM-A (F=33.63;p<0.001) scores. BPRS and CGI-S scores were higher among subjects affected by personality disorders (PDs) than in the depressed (MDD) and anxiety/obsessive-compulsive (OC) groups (p<0.05). PD patients also showed higher HAM-A scores than schizophrenia (SKZ) ones (p=0.02). Secondary outcomes: Time had a significant effect on the change of DISS-stress (F=40.80;p<0.001), DISS-support (F=9.26;p<0.001), HAM-D (F=9.50;p<0.001) and MADRS (F=9.40;p<0.001) scores. The time effect was not significant for DISS-disability (F=1.23;p=0.29), PANSS (F=1.37;p=0.26), YMRS (F=2.84;p=0.06) and Y-BOCS (F=0.55;p=0.59) scores. DISS-disability scores were higher in the PD group with respect to bipolar disorder (BD) (p=0.009), MDD (p<0.001) and anxiety/OCD (p=0.03) groups;SKZ and BD patients had lower DISS-stress scores than PD ones (both p values = 0.02). Conclusions: Patients affected by PDs showed to be particularly affected by the negative effects of outbreaks on mental health and perhaps they require specific clinical attention in case of traumatic events such as pandemics. Moreover, although SKZ patients reported lower anxiety levels than PD ones, the worsening of psychotic and OC symptoms should be strictly monitored by clinicians, as these aspects did not improve with the end of lockdown measures. Further studies on larger samples would allow an in-depth comparison of the psychopathological impact of pandemics between the different psychiatric diagnoses. The study has been registered on ClinicalTrials.gov with the following ID number: NCT04694482 No conflict of interest