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1.
Headache ; 63(3): 418-428, 2023 03.
Article in English | MEDLINE | ID: mdl-36942409

ABSTRACT

OBJECTIVE: To assess cardiovascular (CV) safety of erenumab in clinical trial patients associated with degree of CV risk. BACKGROUND: Hypertension has been considered a theoretical risk associated with the inhibition of the calcitonin gene-related peptide pathway in migraine management, particularly in a patient population with pre-existing CV risk factors. METHODS: Data pooled from four double-blind, randomized trials were used to assess blood pressure (BP) changes and CV safety in patients grouped based on 10-year risk of cardiac, cerebrovascular, and peripheral artery disease as no-risk-factors, low-risk (>0% to ≤10%), moderate-risk (>10% to ≤20%), and high-risk (>20%) categories. CV safety was assessed as ischemic cardiovascular and cerebrovascular adverse events (ICCAE). RESULTS: There was no apparent difference between placebo- (N = 1032) and erenumab-treatment groups (70 mg, N = 885; 140 mg, N = 504) in clinical worsening of BP category from baseline to Months 1-3 (14% [143/1032] placebo vs. 13% [114/885] and 14% [71/504] for erenumab 70 and 140 mg, respectively) regardless of baseline BP category. The adverse event (AE) profile of erenumab was similar across CV risk categories throughout the long-term analysis. Erenumab-treated patients with high and moderate 10-year CV risk (N = 107) did not experience any ICCAEs during the double-blind treatment period; there was a single ICCAE (a cerebral dural venous sinus thrombosis) observed in the low-risk erenumab group (N = 273). There were no increases in AEs during the long-term extensions of up to 5 years (N = 2499; 3482 patient-years of exposure to erenumab) with exposure-adjusted incidence rates of cardio/cerebrovascular disorder AEs of 0.4, 0.5, 0.0, and 1.1 (per 100 patient-years) for no risk factor (N = 1805), low (N = 492), moderate (N = 121), and high (N = 81) 10-year CV risk groups, respectively. CONCLUSIONS: Ischemic CV and cerebrovascular AEs were uncommon and the incidence rates were similar across the 10-year CV risk categories. This analysis helps provide more detail on the CV safety of erenumab.


Subject(s)
Epilepsy , Migraine Disorders , Humans , Calcitonin Gene-Related Peptide Receptor Antagonists/adverse effects , Migraine Disorders/drug therapy , Migraine Disorders/chemically induced , Antibodies, Monoclonal, Humanized/adverse effects , Epilepsy/drug therapy , Double-Blind Method , Treatment Outcome
2.
J Consult Clin Psychol ; 91(1): 14-28, 2023 Jan.
Article in English | MEDLINE | ID: mdl-36729494

ABSTRACT

OBJECTIVE: Treatments for adults with eating disorders (EDs) only work in about 50% of individuals, and for some diagnoses (e.g., anorexia nervosa; atypical anorexia nervosa), there are no existing evidence-based treatments. Part of the reason that treatments may only work in a subset of individuals is because of the high heterogeneity present in the EDs, even within diagnoses. Manualized treatments delivered in a standard format may not always address the most relevant symptoms for a specific individual. METHOD: The current open series trial recruited participants with transdiagnostic ED diagnoses (N = 79) to investigate the feasibility, acceptability, and initial clinical efficacy of a 10-session network-informed personalized treatment for eating disorders. This treatment uses idiographic (i.e., one-person) network models of ecological momentary assessment symptom data to match participants to evidence-based modules of treatment. RESULTS: We found that network-informed personalized treatment was highly feasible with low dropout rates, was rated as highly acceptable, and had strong initial clinical efficacy. ED severity decreased from pre- to posttreatment and at 1-year follow-up with a large effect size. ED cognitions, behaviors, clinical impairment, worry, and depression also decreased from pre- to posttreatment. CONCLUSIONS: These data suggest that network-informed personalized treatment has high acceptability and feasibility and can decrease ED and related pathology, possibly serving as a feasible alternative to existing treatments. Future randomized controlled trials comparing network-informed personalized treatment for ED to existing gold standard treatments are needed. Additionally, more research is needed on this type of personalized treatment both in the EDs, as well as in additional forms of psychopathology, such as depression. (PsycInfo Database Record (c) 2023 APA, all rights reserved).


Subject(s)
Anorexia Nervosa , Feeding and Eating Disorders , Adult , Humans , Anorexia Nervosa/therapy , Cognition , Feeding and Eating Disorders/therapy , Psychopathology , Treatment Outcome
3.
ASAIO J ; 69(2): 174-182, 2023 02 01.
Article in English | MEDLINE | ID: mdl-35421002

ABSTRACT

The Jarvik 2000 bridge to transplant investigational device exemption study was a multicentered, prospective study of 150 UNOS status I patients implanted with the Jarvik 2000 between 2005 and 2012. During the study period, there were numerous modifications of the system that included converting from pin to cone bearings. Results were analyzed for three cohorts: total (n = 150), pin (n = 128), and cone (n = 22). Baseline demographics included age (52 ± 13), gender (79% male), size (BSA 1.98), and etiology (37% idiopathic dilated cardiomyopathy; 43% Ischemic). Seventy percent of patients were either INTERMACS 1 or 2. The primary endpoint-defined as successful transplantation or listing at 180 days (prespecified at 65%; 95% lower CI: 57%)-was successfully achieved for the total cohort (67.3%; 95% CI: 59.5%-74.3%; p = 0.006). In subgroup analysis of the more contemporary, cone-bearing group, the primary endpoint was met in 91% (95% CI: 72%-97.5%; p = 0.001). Compared with pin patients, cone-bearing patients had less hemolysis as well as decreased end-organ dysfunction. Functional and quality of life scores improved after implantation independent type of bearing. In conclusion, despite a particularly sick patient population, the Jarvik 2000 was shown to be effective in supporting the advanced HF patient.


Subject(s)
Heart Failure , Heart Transplantation , Heart-Assist Devices , Female , Humans , Male , Heart Failure/surgery , Prospective Studies , Quality of Life , Treatment Outcome , United States
5.
Behav Ther ; 53(3): 535-545, 2022 05.
Article in English | MEDLINE | ID: mdl-35473655

ABSTRACT

Disordered eating (DE) poses a large societal burden, yet limited research has examined DE from a developmental epidemiological perspective. It is important to consider how demographics influence DE symptoms to inform prevention and early intervention programs across diverse subpopulations. Therefore, we conducted network analyses using a large nationally representative epidemiological sample of high school students (Youth Risk Behavior Survey, United States; n = 59,582) to identify the most important symptoms and symptom relationships among six DE behaviors. We compared networks by sex, grade, and race to identify differences in symptom networks. Dieting for weight loss was highly central across networks. Networks significantly differed across sex, grade, and race. Our results suggest that dieting for weight loss may be an early intervention target for eating disorders, regardless of demographic and developmental factors. In addition, sex, race, and age should be accounted for when researching and developing prevention programs for DE and eating disorders. Public health officials, as well as mental health professionals, should present a more balanced message about dieting and weight loss to high school students to prevent the detrimental impact of DE on physical and mental health. Notably, this study is the first large, nationwide epidemiological sample using DE symptoms in network analysis.


Subject(s)
Feeding and Eating Disorders , Students , Adolescent , Demography , Feeding and Eating Disorders/epidemiology , Humans , Surveys and Questionnaires , United States/epidemiology , Weight Loss
6.
J Interpers Violence ; 37(15-16): NP13226-NP13244, 2022 08.
Article in English | MEDLINE | ID: mdl-33794702

ABSTRACT

Evidence consistently indicates associations between eating disorders (EDs) and childhood emotional, physical, and sexual abuse, but the relationship between EDs and abuse occurring later in development has largely been unexplored. Therefore, the objective of this study was to examine associations between past-year abuse and ED symptoms among college students. Participants represented 12 U.S. colleges and universities participating in the Healthy Bodies Study (HBS) between 2013 and 2015 (N = 10,204; Mage = 23.38 years). Students self-reported experiences of emotional, physical, and sexual abuse over the past year. Cognitive ED symptoms (i.e., dietary restraint, shape/weight overvaluation, body dissatisfaction) were measured via the Short-Eating Disorder Examination-Questionnaire (S-EDE-Q), and behavioral ED symptoms (i.e., binge eating, purging) were measured via items from the full EDE-Q. Regression models that adjusted for demographics and weight status were conducted to examine associations between past-year abuse and ED symptoms. Past-year emotional, physical, and sexual abuse each exhibited independent associations with ED symptoms. When mutually adjusting for emotional, physical, and sexual abuse, past-year emotional abuse was associated with higher levels of dietary restraint (b = 0.20, p = .02), shape/weight overvaluation (b = 0.85, p < .001), body dissatisfaction (b = 0.63, p < .001), binge eating (prevalence ratio [PR] = 1.23, p = .002), and purging (PR = 1.68, p < .001), and past-year sexual abuse was associated with shape/weight overvaluation (b = 0.35, p = .03) and purging (PR = 1.71, p = .009) but no other ED symptoms. No associations were observed for past-year physical abuse in mutually adjusted models. In summary, past-year emotional abuse emerged as a key correlate of all ED symptoms examined in this sample of U.S. college students, while past-year sexual abuse also emerged as a key correlate of shape/weight overvaluation and purging. Findings emphasize the need to screen for abuse and implement abuse prevention efforts on college campuses.


Subject(s)
Child Abuse , Feeding and Eating Disorders , Sex Offenses , Adult , Child , Child Abuse/psychology , Feeding and Eating Disorders/epidemiology , Humans , Students/psychology , Universities , Young Adult
7.
Eat Weight Disord ; 27(5): 1855-1867, 2022 Jun.
Article in English | MEDLINE | ID: mdl-34787832

ABSTRACT

PURPOSE: Network studies of eating disorder (ED) symptoms have identified central and bridge symptoms in Western samples, yet few network models of ED symptoms have been tested in non-Western samples, especially among preadolescents. The current study tested a network model of ED symptoms in Iranian preadolescents (ages 9 to 13), as well as a model of co-occurring social anxiety disorder (SAD) and ED symptoms. METHOD: Preadolescent boys (n = 405) and girls (n = 325) completed the Children Eating Attitudes Test-20 and Social Anxiety Scale for Children. We estimated two network models (ED and ED/SAD networks) and identified central and bridge symptoms, as well as tested if these models differed by sex. RESULTS: We found that discomfort eating sweets were the most central symptoms in ED networks. Concern over being judged was central in networks including both ED and SAD symptoms. Additionally, concern over being judged was the strongest bridge symptoms. Networks did not differ by sex. CONCLUSION: Future research is needed to test if interventions focused on bridge symptoms (i.e., concern over being judged) as primary intervention points target comorbid ED-SAD pathology in preadolescents at risk for ED and SAD. LEVEL OF EVIDENCE: Level III; Evidence obtained from well-designed observational study, including case-control design for relevant aspects of the study.


Subject(s)
Feeding and Eating Disorders , Phobia, Social , Adolescent , Anxiety , Child , Fear , Feeding and Eating Disorders/diagnosis , Female , Humans , Iran , Male
8.
J Psychopathol Clin Sci ; 131(1): 58-72, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34941316

ABSTRACT

Eating disorders (EDs) are serious psychiatric illnesses with high mortality and societal cost. Despite their severity, there are few evidence-based treatments, and only 50% of individuals respond to existing treatments. This low response rate may be due to the fact that EDs are highly heterogeneous disorders. Precision treatments are needed that can intervene on individual maintenance factors. The first step in such treatment development is identification of central treatment targets, both at the group (i.e., on average) and individual level. The current study (N = 102 individuals with an ED) utilized intensive longitudinal data to model several types of group-level and individual network models. Overall, we identified several group-level central symptoms, with the most common central symptoms of fear of weight gain, desire for thinness, feeling like one is overeating, thinking about dieting, and feeling guilty. We also found that these symptoms, specifically fear of weight gain, a desire to be thinner, thinking about dieting, feeling like one is overeating, and feeling guilty, predicted ED severity at a 1- and 6-month follow-up. We modeled 97 individual networks and found that central symptoms were highly heterogeneous, regardless of ED diagnosis. This work adds to the growing literature using intensive longitudinal data to model ED pathology and implicates fear of weight gain, thinking about dieting, and feelings of guilt as symptoms needing further treatment development work. Additionally, this work contributes essential knowledge on how group and individual network modeling can be used to conceptualize the maintenance of EDs on average and at the individual level. (PsycInfo Database Record (c) 2022 APA, all rights reserved).


Subject(s)
Feeding and Eating Disorders , Emotions , Fear/psychology , Feeding and Eating Disorders/diagnosis , Humans , Hyperphagia , Thinness/psychology
9.
J Eat Disord ; 9(1): 147, 2021 Nov 04.
Article in English | MEDLINE | ID: mdl-34736538

ABSTRACT

BACKGROUND: Eating disorders (EDs) are severe mental illnesses, with high morbidity, mortality, and societal burden. EDs are extremely heterogenous, and only 50% of patients currently respond to first-line treatments. Personalized and effective treatments for EDs are drastically needed. METHODS: The current study (N = 34 participants with an ED diagnosis collected throughout the United States) aimed to investigate best methods informing how to select personalized treatment targets utilizing idiographic network analysis, which could then be used for evidence based personalized treatment development. We present initial data collected via experience sampling (i.e., ecological momentary assessment) over the course of 15 days, 5 times a day (75 total measurement points) that were used to select treatment targets for a personalized treatment for EDs. RESULTS: Overall, we found that treatment targets were highly variable, with less than 50% of individuals endorsing central symptoms related to weight and shape, consistent with current treatment response rates for treatments designed to target those symptoms. We also found that different aspects of selection methods (e.g., number of items, type of centrality measure) impacted treatment target selection. CONCLUSIONS: We discuss implications of these data, how to use idiographic network analysis to personalize treatment, and identify areas that need future research. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04183894. Registered 3 December 2019-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04183894 . NCT04183894 (ClinicalTrials.gov identifier).


Eating disorders are severe psychiatric illnesses that carry high mortality, morbidity, and societal and personal burden. Treatments for eating disorders only work in 50% of patients, signifying a great need to improve treatments. One reason that treatments may not work, is because eating disorders vary substantially from one individual to the next, which existing treatments do not fully consider. The current study (N = 34 participants with an eating disorder diagnosis) uses a new modeling technique to identify which symptoms should be targeted in treatment in a personalized manner. As expected, we found that, using this modeling technique, symptoms that should be targeted in treatment vary considerably. We discuss how to use this modeling technique to identify individual treatment targets and ways in which the field can use this strategy to improve existing and create new treatments.

10.
Headache ; 61(9): 1411-1420, 2021 10.
Article in English | MEDLINE | ID: mdl-34591982

ABSTRACT

OBJECTIVE: To assess the risk of hypertension in patients with migraine who received erenumab in clinical trials and in the postmarketing setting. BACKGROUND: Erenumab is a monoclonal antibody for migraine prevention that targets the calcitonin gene-related peptide (CGRP) receptor. Hypertension is a theoretical risk for inhibitors of the CGRP pathway. Although no evidence of an association between erenumab treatment and hypertension was observed during the clinical development program, adverse events (AEs) of hypertension have been identified in the postmarketing setting. METHODS: Safety data from four phase 2 and phase 3 clinical trials were used to perform a pooled analysis of hypertension AEs in patients with migraine receiving erenumab. Postmarketing AEs of hypertension were identified from the Amgen Global Safety database from May 17, 2018, through January 31, 2020. RESULTS: In the pooled analysis of clinical trials, hypertension AEs (placebo, 9/1043 [0.9%]; erenumab 70 mg, 7/893 [0.8%]; erenumab 140 mg, 1/507 [0.2%]) and percentage of patients initiating medication to treat hypertension (12/1043 [1.2%], 7/893 [0.8%], 1/507 [0.2%], respectively) were similar across treatment groups. A total of 362 AEs of hypertension were identified from the postmarketing setting, 26.2% (95/362) of which were serious, >245,000 patient-years of exposure. The exposure-adjusted incidence of hypertension was 0.144 per 100 patient-years. CONCLUSIONS: Clinical trials did not demonstrate an increased risk of hypertension with erenumab compared with placebo, and AE rates of hypertension reported with erenumab in the postmarketing setting were generally low. Additional data are needed to fully characterize the extent to which hypertension is a risk associated with erenumab.


Subject(s)
Antibodies, Monoclonal, Humanized/adverse effects , Calcitonin Gene-Related Peptide Receptor Antagonists/adverse effects , Clinical Trials, Phase II as Topic/statistics & numerical data , Clinical Trials, Phase III as Topic/statistics & numerical data , Drug-Related Side Effects and Adverse Reactions , Hypertension/chemically induced , Migraine Disorders/drug therapy , Product Surveillance, Postmarketing/statistics & numerical data , Adult , Antibodies, Monoclonal, Humanized/administration & dosage , Calcitonin Gene-Related Peptide Receptor Antagonists/administration & dosage , Female , Humans , Male , Middle Aged
11.
Int J Eat Disord ; 54(9): 1672-1679, 2021 09.
Article in English | MEDLINE | ID: mdl-34245028

ABSTRACT

INTRODUCTION: Eating disorders (EDs) are serious mental illnesses with high rates of mortality, morbidity, and personal and societal costs. Onset of the Covid-19 pandemic led to increased ED diagnoses in the general public, as well as worsening of ED symptoms in those with an existing ED diagnosis. Heightened prevalence and severity of EDs during the pandemic is complicated by the fact that traditional modes of ED care (specialty intensive treatment provided by a multidisciplinary team) have been difficult to access during the pandemic. METHODS: The current between-groups study (N = 93 ED) tested a multidisciplinary intensive outpatient program (IOP) delivered via in-person (pre-pandemic; n = 60) and virtually via telehealth (during the pandemic; n = 33). RESULTS: We found no differences in outcomes via delivery mode, such that regardless of in-person versus telehealth programming, ED symptoms, depression, and perfectionism significantly decreased and body mass index significantly increased. CONCLUSIONS: Our findings suggest that a multi-disciplinary telehealth ED IOP program is feasible and has comparable outcomes to in-person IOP treatment. These findings have implications for treatment beyond the pandemic, suggesting that adoption of telehealth IOPs is warranted. Such delivery modes of intensive treatments for EDs could be expanded to reach underserved populations, especially in rural areas where treatment is often difficult to access.


Subject(s)
Ambulatory Care , COVID-19 , Feeding and Eating Disorders , Pandemics , Telemedicine , Ambulatory Care/methods , COVID-19/epidemiology , Feeding and Eating Disorders/therapy , Humans , Pilot Projects , Program Evaluation , Telemedicine/organization & administration , Treatment Outcome
12.
Early Interv Psychiatry ; 15(6): 1650-1658, 2021 12.
Article in English | MEDLINE | ID: mdl-33386707

ABSTRACT

AIM: Engagement in risky behaviours, including substance use, disordered eating, suicidal behaviour, and peer victimization/violence, during adolescence is becoming increasingly prevalent. These risky behaviours are highly comorbid and associated with long-term consequences for health, relationships, and socioeconomic status, representing an important public health concern. Past research has primarily investigated risky behaviours in adolescence using latent variable models, which are based on assumptions that may limit insight into the complex reality of these behaviours. METHODS: The current study uses network analysis to examine adolescent substance use, disordered eating, suicide risk, and peer victimization/violence in a national (N = 29 008) and state-level (Kentucky; N = 3455) epidemiological dataset. We calculated central and bridge symptoms and compared network structure based on demographic factors (race, sex, grade) and sample (state vs. nation). RESULTS: The most central symptoms were suicidal ideation and attempts, stimulant drug use, and prescription drug misuse. The most central bridge symptoms were depression, methamphetamine use, peer violence, and suicide attempts. There were no differences in network structure between samples or across demographic factors in the Kentucky sample. There were differences in network structure across sex and race in the national dataset. CONCLUSIONS: These findings suggest stimulant use, suicidal ideation, depression, and peer violence may contribute to the high rates and co-occurrence of risky behaviours in adolescence. Based on network theory, these symptoms may represent important targets for intervention. Due to network differences, special considerations may be necessary to adapt such interventions to meet the needs of students from different backgrounds.


Subject(s)
Adolescent Behavior , Crime Victims , Adolescent , Humans , Students , Suicidal Ideation , Suicide, Attempted
13.
J Trauma Stress ; 34(3): 665-674, 2021 06.
Article in English | MEDLINE | ID: mdl-33370465

ABSTRACT

Posttraumatic stress disorder (PTSD) and eating disorders (EDs) are individually debilitating and highly comorbid conditions. Childhood abuse is a prominent risk factor for PTSD and ED symptoms both individually and as a comorbid syndrome (PTSD-ED). There may be a functional association between comorbid PTSD-ED symptoms whereby disordered eating behaviors are used to avoid trauma-related thoughts and feelings. The current study used a network analytic approach to examine key associations between PTSD and ED symptom subscales (i.e., PCL-5 and EPSI, respectively) in a community sample of 120 adults who endorsed at least one experience of childhood abuse (i.e., physical, sexual, or emotional abuse; witnessing domestic violence). Participants completed an anonymous online survey using Amazon's Mechanical Turk Prime. We used three network analysis indices (i.e., strength centrality, key players, and bridge symptoms) to identify symptoms that may maintain the comorbid PTSD-ED network. The results indicated that reexperiencing symptoms had the highest strength centrality in the PTSD-ED network and bridged the PTSD and ED clusters. For ED, cognitive restraint was a bridge to all PTSD symptoms. Hyperarousal, negative alterations in cognitions and mood (NACM), and purging were key players, indicating they are integral to the network structure. If replicated in prospective studies, these results may indicate that reexperiencing and cognitive restraint are core drivers of PTSD-ED comorbidity, whereas hyperarousal, NACM, and purging may be downstream consequences maintaining the comorbid condition. Concurrent treatments that address PTSD and ED symptoms simultaneously may result in the best outcomes.


Subject(s)
Child Abuse , Feeding and Eating Disorders , Stress Disorders, Post-Traumatic , Adult , Child , Comorbidity , Feeding and Eating Disorders/epidemiology , Humans , Prospective Studies , Stress Disorders, Post-Traumatic/epidemiology
14.
Int J Eat Disord ; 53(12): 2086-2094, 2020 12.
Article in English | MEDLINE | ID: mdl-33179347

ABSTRACT

Enhanced cognitive-behavioral therapy (CBT-E) is one of the primary evidence-based treatments for adults with eating disorders (EDs). However, up to 50% of individuals do not respond to CBT-E, likely because of the high heterogeneity present even within similar diagnoses. This high heterogeneity, especially in regard to presenting pathology, makes it difficult to develop a treatment based "on averages" and for clinicians to accurately pinpoint which symptoms should be targeted in treatment. As such, new models based at both the group, and individual level, are needed to more accurately refine targets for personalized evidence-based treatments that can lead to full remission. The current study (Expected N = 120 anorexia nervosa, atypical anorexia nervosa, and bulimia nervosa) will build both group and individual longitudinal models of ED behaviors, cognitions, affect, and physiology. We will collect data for 30 days utilizing a mobile application to assess behaviors, cognition, and affect and a sensor wristband that assesses physiology (heart rate, acceleration). We will also collect outcome data at 1- and 6-month follow-ups to assess ED outcomes and remission status. These data will allow for identification of "on average" and "individual" targets that maintain ED pathology and test if these targets predict outcomes, including ED remission.


Subject(s)
Cognitive Behavioral Therapy/methods , Feeding and Eating Disorders/psychology , Precision Medicine/methods , Adolescent , Adult , Aged , Female , Humans , Longitudinal Studies , Male , Middle Aged , Treatment Outcome , Young Adult
15.
Mater Sci Eng C Mater Biol Appl ; 114: 110976, 2020 Sep.
Article in English | MEDLINE | ID: mdl-32994026

ABSTRACT

Hybrid composite nanofibers, with the potential to enhance cell adhesion while improving sustained drug release profiles, were fabricated by the blend electrospinning of poly(d,l-lactic-co-glycolic acid) (PLGA), gelatin, pluronic F127 and prodigiosin (PG). Scanning Electron Microscopy (SEM) images of the nanofibers revealed diameters of 1.031 ±â€¯0.851 µm and 1.349 ±â€¯1.264 µm, corresponding to PLGA/Ge-PG and PLGA/Ge-F127/Ge, respectively. The Young's moduli were also determined to be 1.446 ±â€¯0.496 kPa and 1.290 ±â€¯0.617 kPa, while the ultimate tensile strengths were 0.440 ±â€¯0.117 kPa and 0.185 ±â€¯0.480 kPa for PLGA/Ge-PG and PLGA/Ge-F127/Ge, respectively. In-vitro drug release profiles showed initial (burst) release for a period of 1 h to be 26.000 ±â€¯0.004% and 16.000 ±â€¯0.015% for PLGA/Ge and PLGA/Ge-F127 nanofibers, respectively. This was followed by 12 h of sustained release, and subsequent slow sustained release of PG from the composite nanofibers. The cumulative release of PG (for three days) was determined to be 82.0 ±â€¯0.1% for PLGA/Ge and 49.7 ±â€¯0.1% for PLGA/Ge-F127 nanofibers. The release exponents (n) show that both nanofibers exhibit diffusion-controlled release by non-Fickian (zeroth order) and quasi-Fickian diffusion in the initial and sustained release regimes, respectively. The suitability of the composite nanofibers for supporting cell proliferation and viability, as well as improving sustained release of the drug were explored. The in-vitro effects of cancer drug (PG) release were also studied on breast cancer cell lines (MCF-7 and MDA-MB-231 cells). The implications of the results are discussed for the potential applications of drug-nanofiber scaffolds as capsules for localized delivery of chemotherapeutic drugs for the treatment of triple negative breast cancer.


Subject(s)
Nanofibers , Triple Negative Breast Neoplasms , Humans , Polyglycolic Acid , Polylactic Acid-Polyglycolic Acid Copolymer , Prodigiosin
16.
Int J Eat Disord ; 53(10): 1636-1646, 2020 10.
Article in English | MEDLINE | ID: mdl-32776570

ABSTRACT

OBJECTIVE: Little is known about the optimal treatment of avoidant/restrictive food intake disorder (ARFID). The purpose of this study was to evaluate feasibility, acceptability, and proof-of-concept for cognitive-behavioral therapy for ARFID (CBT-AR) in children and adolescents. METHOD: Males and females (ages 10-17 years) were offered 20-30 sessions of CBT-AR delivered in a family-based or individual format. RESULTS: Of 25 eligible individuals, 20 initiated treatment, including 17 completers and 3 dropouts. Using intent-to-treat analyses, clinicians rated 17 patients (85%) as "much improved" or "very much improved." ARFID severity scores (on the Pica, ARFID, and Rumination Disorder Interview) significantly decreased per both patient and parent report. Patients incorporated a mean of 16.7 (SD = 12.1) new foods from pre- to post-treatment. The underweight subgroup showed a significant weight gain of 11.5 (SD = 6.0) pounds, moving from the 10th to the 20th percentile for body mass index. At post-treatment, 70% of patients no longer met criteria for ARFID. DISCUSSION: This is the first study of an outpatient manualized psychosocial treatment for ARFID in older adolescents. Findings provide evidence of feasibility, acceptability, and proof-of-concept for CBT-AR. Randomized controlled trials are needed.


Subject(s)
Avoidant Restrictive Food Intake Disorder , Cognitive Behavioral Therapy/methods , Patient Acceptance of Health Care/psychology , Adolescent , Child , Feasibility Studies , Feeding and Eating Disorders , Female , Humans , Male , Proof of Concept Study
17.
Int J Eat Disord ; 53(10): 1583-1604, 2020 10.
Article in English | MEDLINE | ID: mdl-32737999

ABSTRACT

OBJECTIVE: Although muscle dysmorphia (MD) is a new addition to DSM-5 as a specifier of body dysmorphic disorder (BDD), previous studies have treated MD as a stand-alone diagnosis. We aimed to assess the validity of MD as a stand-alone diagnosis via systematic and meta-analytic review of MD literature using both Robins and Guze criteria and additional criteria from Kendler. METHOD: We performed a systematic search of ProQuest, PsycInfo, and PubMed databases for the period of January 1993 to October 2019 resulting in 40 papers to examine Robins and Guze's criteria (clinical picture) as well as those added by Kendler (antecedent validators; concurrent validators; predictive validators). RESULTS: We identified two distinct symptomatic presentations of MD using cluster analysis, a behavioral type and cognitive/behavioral type. For examining the concurrent validators, quantitative meta-analyses differentiated MD populations from controls; however, results were inconclusive in delineating MD from existing disorders. For assessing antecedent and predictive validators, the symptomatic profiles, treatment response, and familial links for MD were similar to those for BDD and for eating disorders. DISCUSSION: We found preliminary support for MD as a clinically valid presentation, but insufficient evidence to determine whether it is best categorized as a specifier of BDD or unique psychiatric condition.


OBJECTIVO: Aunque la dismorfia muscular (MD, por sus siglas en inglés) es una nueva adición al DSM-5 como un especificador del trastorno dismórfico corporal (BDD, por sus siglas en inglés), los estudios previos han tratado la MD como un diagnóstico independiente. El objetivo fue evaluar la validez de la MD como un diagnóstico independiente a través de revisiones sistemáticas y metaanalíticas de la literatura de MD utilizando los criterios de Robin y Guze (1970) y los criterios adicionales de Kendler (1980). MÉTODO: Realizamos una búsqueda sistemática de las bases de datos ProQuest, PsycInfo y PubMed para el período de enero de 1993 a octubre de 2019, lo que resultó en 40 documentos para examinar los criterios de Robins y Guze (cuadro clínico), así como los agregados por Kendler (validadores antecedentes; validadores concurrentes; validadores predictivos). RESULTADOS: identificamos dos presentaciones sintomáticas distintas de MD mediante análisis de conglomerados, una de tipo conductual y una de tipo cognitivo / conductual. Para examinar los validadores concurrentes, los metaanálisis cuantitativos diferenciaron las poblaciones de MD de los controles; sin embargo, los resultados no fueron concluyentes para delinear la MD de los trastornos existentes. Para evaluar los validadores antecedente y predictivo, los perfiles sintomáticos, la respuesta al tratamiento y los vínculos familiares para la MD fueron similares a los de la BDD y los trastornos de la conducta alimentaria. DISCUSIÓN: Encontramos apoyo preliminar para la MD como una presentación clínicamente válida, pero evidencia insuficiente para determinar si se clasifica mejor como un especificador de BDD o una condición psiquiátrica única.


Subject(s)
Body Dysmorphic Disorders/psychology , Diagnostic and Statistical Manual of Mental Disorders , Muscle, Skeletal/abnormalities , Adult , Female , Humans , Male , Young Adult
18.
Int J Eat Disord ; 53(4): 625-630, 2020 04.
Article in English | MEDLINE | ID: mdl-32112594

ABSTRACT

OBJECTIVE: Eating disorders (EDs) are characterized by significant anxiety during mealtime that contributes to food avoidance and weight loss. Individuals with EDs commonly use avoidance coping (e.g., distraction) to tolerate meals and comply with meal plans. Although this strategy may be effective short term, a large body of anxiety literature suggests that avoidance can lead to worsening of psychological symptoms long term. METHOD: The current study (N = 66 individuals diagnosed with ED) used ecological momentary assessment (EMA) to examine the short-term and long-term associations of avoidance coping on ED symptoms. RESULTS: Distraction during meals predicted a reduction in anxiety in the short term, and both distraction and avoidance of emotions predicted increases in excessive exercise in the short term. Distraction and avoidance of emotions predicted increases in bulimic symptoms 1 month after completion of EMA. DISCUSSION: These results are consistent with prior literature on avoidance and suggest that avoidance coping during meals may contribute to the increase of ED behaviors in the long term. Coping strategies that encourage approach and tolerance of difficult thoughts and emotions (e.g., acceptance-based strategies) rather that avoidance coping may promote longer-term symptom reduction.


Subject(s)
Adaptation, Psychological/physiology , Anxiety/psychology , Emotions/physiology , Feeding and Eating Disorders/psychology , Meals/psychology , Female , Humans , Male
19.
Int J Eat Disord ; 53(3): 472-477, 2020 03.
Article in English | MEDLINE | ID: mdl-31886575

ABSTRACT

OBJECTIVE: This study examined the relationship between eating-disorder behaviors-including restrictive eating, binge eating, and purging-and suicidal ideation. We hypothesized that restrictive eating would significantly predict suicidal ideation, beyond the effects of binge eating/purging. METHODS: Participants were 82 adolescents and young adults with low-weight eating disorders. We conducted a hierarchical logistic regression, with binge eating and purging in Step 1 and restrictive eating in Step 2, to predict suicidal ideation. RESULTS: Step 1 was significant (p = .01) and explained 20% variance in suicidal ideation; neither binge eating nor purging significantly predicted suicidal ideation. Adding restrictive eating in Step 2 significantly improved the model (ΔR2 = .07, p = .009). This final model explained 27% of the variance, and restrictive eating (but not binge eating/purging) significantly predicted suicidal ideation (p = .02). DISCUSSION: Restrictive eating is associated with suicidal ideation in youth with low-weight eating disorders, beyond the effects of other eating-disorder behaviors. Although healthcare providers may be more likely to screen for suicidality in patients with binge eating and purging, our findings indicate clinicians should regularly assess suicide and self-injury in patients with restrictive eating. Future research examining how individuals progress from suicidal ideation to suicidal attempts can further enhance our understanding of suicide in eating disorders.


Subject(s)
Binge-Eating Disorder/complications , Feeding Behavior/psychology , Suicidal Ideation , Adolescent , Adult , Child , Female , Humans , Young Adult
20.
Int J Eat Disord ; 53(1): 143-148, 2020 01.
Article in English | MEDLINE | ID: mdl-31758819

ABSTRACT

OBJECTIVE: The cognitive-behavioral therapy (CBT) model of eating disorders suggests that compensatory purging behaviors (e.g., self-induced vomiting, inappropriate laxative use) are primarily driven by binge eating. However, many individuals endorse purging in the absence of binge eating (i.e., noncompensatory purging [NCP]). Research is needed to understand why some individuals purge in the absence of objective or subjective binge-eating episodes. METHOD: Given the importance of overvaluation of shape/weight in the CBT model, and the existing evidence linking temperamental characteristics like behavioral inhibition (i.e., the tendency to withdraw in response to threat cues) with purging in general, we tested whether behavioral inhibition moderated the relationship between overvaluation of shape/weight and NCP in a sample of individuals in a residential eating disorder treatment center (N = 143). RESULTS: Overvaluation was more strongly related to NCP in individuals with high (relative to low) levels of behavioral inhibition. Among individuals low in behavioral inhibition, overvaluation predicted engagement in NCP to a much weaker extent. DISCUSSION: For those high (relative to low) in behavioral inhibition, both emotional avoidance and overvaluation may be important targets in the treatment of NCP, particularly in the absence of binge eating.


Subject(s)
Cognitive Behavioral Therapy/methods , Feeding and Eating Disorders/psychology , Vomiting/psychology , Adolescent , Adult , Body Image/psychology , Female , Humans , Male , Young Adult
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