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1.  Relapse Prevention in Major Depressive Disorder: Mindfulness-Based Cognitive Therapy Versus an Active Control Condition 
We evaluated the comparative effectiveness of Mindfulness-based cognitive therapy (MBCT) versus an active control condition (ACC) for depression relapse prevention, depressive symptom reduction, and improvement in life satisfaction.
Ninety-two participants in remission from Major Depressive Disorder with residual depressive symptoms were randomized to either an 8-week MBCT or a validated ACC that is structurally equivalent to MBCT and controls for non-specific effects (e.g., interaction with a facilitator, perceived social support, treatment outcome expectations). Both interventions were delivered according to their published manuals.
Intention-to-treat analyses indicated no differences between MBCT and ACC in depression relapse rates or time to relapse over a 60-week follow-up. Both groups experienced significant and equal reductions in depressive symptoms and improvements in life satisfaction. A significant quadratic interaction (group x time) indicated that the pattern of depressive symptom reduction differed between groups. The ACC experienced immediate symptom reduction post-intervention and then a gradual increase over the 60-week follow-up. The MBCT group experienced a gradual linear symptom reduction. The pattern for life satisfaction was identical but only marginally significant.
MBCT did not differ from an ACC on rates of depression relapse, symptom reduction, or life satisfaction, suggesting that MBCT is no more effective for preventing depression relapse and reducing depressive symptoms than the active components of the ACC. Differences in trajectory of depressive symptom improvement suggest that the intervention-specific skills acquired may be associated with differential rates of therapeutic benefit. This study demonstrates the importance of comparing psychotherapeutic interventions to active control conditions.
PMCID: PMC4571290  PMID: 26371618
mindfulness-based cognitive therapy; major depression; relapse prevention; depressive symptoms; active control condition
3.  Depression and clinical inertia in patients with uncontrolled hypertension 
JAMA internal medicine  2014;174(5):818-819.
PMCID: PMC4013232  PMID: 24615061
Depression; clinical inertia; hypertension
5.  Teacher Burnout: A Comparison of Two Cultures Using Confirmatory Factor and Item Response Models 
The present study addresses teacher burnout and in particular cultural differences and similarities in burnout. We used the Maslach Burnout Inventory Education Survey (MBI-ES) as the starting point for developing a latent model of burnout in two cultures; Jamaica W.I. teachers (N= 150) and New York City teachers (N= 150). We confirm a latent 3 factor structure, using a subset of the items from the MBI-ES that adequately fit both samples. We tested different degrees of measurement invariance (model fit statistics, scale reliabilities, residual variances, item thresholds, and total variance) to describe and compare cultural differences. Results indicate some differences between the samples at the structure and item levels. We found that factor variances were slightly higher in the New York City teacher sample. Emotional Exhaustion (EE) was a more informative construct for differentiating among teachers at moderate levels of burnout, as opposed to extreme high or low levels of burnout, in both cultures. In contrast, Depersonalization in the Workplace (DW) was more informative at the more extreme levels of burnout among both teacher samples. By studying the influence of culture on the experience of burnout we can further our understanding of burnout and potentially discover factors that might prevent burnout among primary and secondary school teachers.
PMCID: PMC4342052  PMID: 25729572
burnout; teacher; New York City; Jamaica W.I; culture; MBI-ES
6.  Probable Posttraumatic Stress Disorder and Psychiatric Co-morbidity among Latino Primary Care Patients in Puerto Rico 
The present investigation was designed to study PTSD among inner city primary care patients in Puerto Rico. Specifically, we examined the rate of probable PTSD, PTSD co-morbidity with MDD and GAD, and the association of probable PTSD and co-occurring disorders with demographic, treatment, and alcohol related factors.
We screened 3,568 patients at primary care practices serving primarily low-income patients. The presence of probable PTSD was assessed with the Primary Care PTSD screen, major depression with the PHQ-9, and generalized anxiety disorder with the GAD Q-IV.
Fourteen percent of our sample screened positive for probable PTSD. Among this group, 12% met criteria for co-morbid GAD without MDD and 15.9% for co-morbid MDD with/without GAD, whereas 72% of the patients with probable PTSD did not meet criteria for co-morbidity. Over 80% of the patients with probable PTSD indicated they were not receiving mental health treatment. Multiple logistic regression findings show that there were no significant differences in demographic and alcohol related factors by PTSD status. Multinomial logistic regression analysis revealed significant differences in the use of mental health treatment among the subgroups of patients with probable PTSD. As compared to patients with only probable PTSD, the use of mental health services was 4 times higher among patients with probable PTSD and MDD and over 2 1/2 times higher among patients with probable PTSD and GAD.
The prevalence rate of probable PTSD in our sample was similar to the rates reported for soldiers after returning from deployment and for Latinos after the September 11 attacks. The high prevalence of probable PTSD and low use of mental health treatment among inner city primary care patients in our study, highlight the need of future research to obtain information on how to effectively target and treat Latino primary care patients in need of treatment for PTSD.
PMCID: PMC4307810  PMID: 25635240
Posttraumatic stress disorder; Latinos; Puerto Ricans; Primary care; Depression; Generalized anxiety disorder; Psychiatric co-morbidity
7.  Food Insecurity and Effectiveness of Behavioral Interventions to Reduce Blood Pressure, New York City, 2012–2013 
Food insecurity is associated with diet-sensitive diseases and may be a barrier to successful chronic disease self-management. To evaluate the impact of food insecurity on blood pressure reduction in a pilot clinical trial, we tested the effectiveness of 2 behavioral interventions for hypertension in people with and without food security.
A group of 28 men and women with type 2 diabetes and uncontrolled hypertension were randomized to either 1) home blood pressure telemonitoring alone or 2) home blood pressure telemonitoring plus telephone-based nurse case management. The primary outcome was 6-month change in systolic blood pressure.
The 2 interventions resulted in modest, nonsignificant blood pressure reductions. Food-secure patients experienced clinically and statistically significant reductions in blood pressure, whereas no significant change was seen among food-insecure patients.
Screening for food insecurity may help identify patients in need of tailored disease management interventions.
PMCID: PMC4329953  PMID: 25674675
8.  A pilot controlled trial of insulin-like growth factor-1 in children with Phelan-McDermid syndrome 
Molecular Autism  2014;5:54.
Autism spectrum disorder (ASD) is now understood to have multiple genetic risk genes and one example is SHANK3. SHANK3 deletions and mutations disrupt synaptic function and result in Phelan-McDermid syndrome (PMS), which causes a monogenic form of ASD with a frequency of at least 0.5% of ASD cases. Recent evidence from preclinical studies with mouse and human neuronal models of SHANK3 deficiency suggest that insulin-like growth factor-1 (IGF-1) can reverse synaptic plasticity and motor learning deficits. The objective of this study was to pilot IGF-1 treatment in children with PMS to evaluate safety, tolerability, and efficacy for core deficits of ASD, including social impairment and restricted and repetitive behaviors.
Nine children with PMS aged 5 to 15 were enrolled in a placebo-controlled, double-blind, crossover design study, with 3 months of treatment with IGF-1 and 3 months of placebo in random order, separated by a 4-week wash-out period.
Compared to the placebo phase, the IGF-1 phase was associated with significant improvement in both social impairment and restrictive behaviors, as measured by the Aberrant Behavior Checklist and the Repetitive Behavior Scale, respectively. IGF-1 was found to be well tolerated and there were no serious adverse events in any participants.
This study establishes the feasibility of IGF-1 treatment in PMS and contributes pilot data from the first controlled treatment trial in the syndrome. Results also provide proof of concept to advance knowledge about developing targeted treatments for additional causes of ASD associated with impaired synaptic development and function.
PMCID: PMC4326443  PMID: 25685306
9.  Trait anxiety and trait anger measured by ecological momentary assessment and their correspondence with traditional trait questionnaires 
Journal of research in personality  2013;47(6):10.1016/j.jrp.2013.08.005.
Ecological momentary assessments (EMA) of anxiety and anger/hostility were obtained every 25–30 minutes over two 24-hour periods, separated by a median of 6 months, from 165 employees at a university in the Northeast. We used a multilevel trait-state-error structural equation model to estimate: (1) the proportion of variance in EMA anxiety and anger/hostility attributable to stable trait-like individual differences; (2) the correspondence between these trait-like components of EMA anxiety and anger/hostility and traditional questionnaire measures of each construct; and (3) the test-retest correlation between two 24-hour averages obtained several months apart. After adjustment for measurement error, more than half the total variance in EMA reports of anxiety and anger/hostility is attributable to stable trait-like individual differences; however, the trait-like component of each construct is only modestly correlated with questionnaire measures of that construct. The 6-month “test-retest” correlations of latent variables representing the true 24-hour EMA average anxiety and average anger are quite high (r ≥ 0.83). This study represents the longest follow-up period over which EMA-based estimates of traits have been examined. The results suggest that although the trait component (individual differences) of EMA momentary ratings of anxiety and anger is larger than the state component, traditional self-report questionnaires of trait anxiety and anger correspond only weakly with EMA-defined traits.
PMCID: PMC3815708  PMID: 24198441
Ecological momentary assessment; multilevel modeling; trait versus state measurement; assessment methods; anger; anxiety
11.  Correlates of Isolated Nocturnal Hypertension and Target Organ Damage in a Population-Based Cohort of African Americans: The Jackson Heart Study 
American Journal of Hypertension  2013;26(8):1011-1016.
African Americans have higher rates of nocturnal hypertension and less nocturnal blood pressure (BP) dipping compared with whites. Although nocturnal hypertension is associated with increased cardiovascular morbidity and mortality, its clinical significance among those with normal daytime BP is unclear. This paper reports the prevalence and correlates of isolated nocturnal hypertension (INH) in a population-based cohort of African Americans enrolled in the Jackson Heart Study (JHS).
The study sample included 425 untreated, normotensive and hypertensive JHS participants who underwent 24-hour ambulatory BP monitoring (ABPM), echocardiography, and 24-hour urine collection. Multiple logistic regression and 1-way analysis of variance models were used to test the hypothesis that those with INH have worse target organ damage reflected by greater left ventricular (LV) mass and proteinuria compared with normotensive participants.
Based on 24-hour ABP profiles, 19.1% of participants had INH. In age and sex-adjusted models, participants with INH had greater LV mass compared with those who were normotensive (P = 0.02), as well as about 3 times the odds of LV hypertrophy and proteinuria (Ps < 0.10). However, multivariable adjustment reduced the magnitude and statistical significance of each of these differences.
INH was associated with increased LV mass compared with normo tension in a population-based cohort of African Americans enrolled in the JHS. There were trends toward a greater likelihood of LV hyper trophy and proteinuria among participants with INH vs. those who were normotensive. The clinical significance of the noted target organ damage should be explored in this population.
PMCID: PMC3879438  PMID: 23676475
ambulatory blood pressure monitoring; blood pressure; hypertension; Jackson Heart Study; nocturnal blood pressure; target organ damage.
12.  A cluster-randomized trial of task shifting and blood pressure control in Ghana: study protocol 
Countries in sub-Saharan Africa (SSA) are experiencing an epidemic of cardiovascular disease (CVD) propelled by rapidly increasing rates of hypertension. Barriers to hypertension control in SSA include poor access to care and high out-of-pocket costs. Although SSA bears 24% of the global disease burden, it has only 3% of the global health workforce. Given such limited resources, cost-effective strategies, such as task shifting, are needed to mitigate the rising CVD epidemic in SSA. Ghana, a country in SSA with an established community health worker program integrated within a national health insurance scheme provides an ideal platform to evaluate implementation of the World Health Organization (WHO) task-shifting strategy. This study will evaluate the comparative effectiveness of the implementation of the WHO Package targeted at CV risk assessment versus provision of health insurance coverage, on blood pressure (BP) reduction.
Using a cluster randomized design, 32 community health centers (CHCs) and district hospitals in Ghana will be randomized to either the intervention group (16 CHCs) or the control group (16 CHCs). A total of 640 patients with uncomplicated hypertension (BP 140–179/90–99 mm Hg and absence of target organ damage) will be enrolled in this study (20 patients per CHC). The intervention consists of WHO Package of CV risk assessment, patient education, initiation and titration of antihypertensive medications, behavioral counseling on lifestyle behaviors, and medication adherence every three months for 12 months. The primary outcome is the mean change in systolic BP from baseline to 12 months. The secondary outcomes are rates of BP control at 12 months; levels of physical activity, percent change in weight, and dietary intake of fruits and vegetables at 12 months; and sustainability of intervention effects at 24 months. All outcomes will be assessed at baseline, six months and 12 months. Trained community health nurses will deliver the intervention as part of Ghana’s community-based health planning and services (CHPS) program.
Findings from this study will provide policy makers and other stakeholders needed information to recommend scalable and cost-effective policy with respect to comprehensive CV risk reduction and hypertension control in resource-poor settings.
Trial registration
PMCID: PMC4063247  PMID: 24923300
Hypertension; Cluster randomized controlled trial; Task shifting; Blood pressure control; Community health centers; Community health nurses; Ghana
13.  Centralized, Stepped, Patient Preference–Based Treatment for Patients With Post–Acute Coronary Syndrome Depression: CODIACS Vanguard Randomized Controlled Trial 
JAMA internal medicine  2013;173(11):997-1004.
Controversy remains about whether depression can be successfully managed after acute coronary syndrome (ACS) and the costs and benefits of doing so.
To determine the effects of providing post-ACS depression care on depressive symptoms and health care costs.
Design, Setting, and Participants
We performed a multicenter randomized controlled trial with 150 patients with elevated depressive symptoms (Beck Depression Inventory [BDI] score ≥10) 2 to 6 months after an ACS. Patients were recruited from 2 private and 5 academic ambulatory centers across the United States between March 18, 2010, and January 9, 2012.
Patients were randomized to 6 months of centralized depression care (patient preference for problem-solving treatment given via telephone or the Internet, pharmacotherapy, both, or neither), stepped every 6 to 8 weeks, (active treatment group; n=73) or to locally determined depression care after physician notification about the patient’s depressive symptoms (usual care group; n=77).
Main Outcome Measure(s)
Change in depressive symptoms during 6 months and total health care costs.
Depressive symptoms decreased significantly more in the active treatment group than in the usual care group (differential change between groups, −3.5 BDI points; 95% CI, −6.1 to −0.7; P = .01). Although mental health care estimated costs were higher for active treatment than for usual care, overall health care estimated costs were not significantly different (difference adjusting for confounding, −$325; 95% CI, −$2639 to $1989; P=.78).
For patients with post-ACS depression, active treatment had a substantial beneficial effect on depressive symptoms. This kind of depression care is feasible, effective, and may be cost-neutral within 6 months; therefore, it should be tested in a large phase 3 pragmatic trial.
Trial Registration Identifier: NCT01032018
PMCID: PMC3681929  PMID: 23471421
14.  Men’s and women’s health beliefs differentially predict coronary heart disease incidence in a population-based sample 
To examine gender differences in the association between beliefs in heart disease preventability and 10-year incidence of coronary heart disease (CHD) in a population-based sample.
2,688 non-institutionalized Nova Scotians without prior CHD enrolled in the Nova Scotia Health Study (NSHS95) and were followed for 10 years. Risk factors, health behaviors and incident CHD were assessed. Participants responded “yes” or “no” to a question about heart disease preventability.Survival models, adjusted for age, income,total and high density lipoprotein (HDL) cholesterol, and systolic blood pressure, were used to estimate the relation between health belief and incident CHD. Gender differences in the relation between health beliefs and health behaviors were assessed.
Gender was a significant moderator of the relation between belief and CHD incidence;specifically,women who believed heart disease could be prevented were less likely to have incident CHD events compared to women who believed heart disease could be not prevented (HR=0.36, 95% CI0.24-0.55, p <.001). This relation was not found for men. Belief was also related to smoking behavior for women (β = −0.70, OR= 0.50, 95% CI = 0.33-0.74, p =.001), but not men. Smoking significantly mediated the relation between health beliefs and incident CHD for women (z = −1.96, p =.05), but not for men.
Health belief in prevention and subsequent smokingwas an important independent predictor of incident coronary heart disease in women, but not men.
PMCID: PMC3676270  PMID: 22991050
health beliefs; gender differences; cardiovascular disease
15.  Revision and Validation of the Medication Adherence Self-Efficacy Scale (MASES) in Hypertensive African Americans 
Journal of behavioral medicine  2008;31(6):453-462.
To date, no studies have validated the Medication Adherence Self-Efficacy Scale (MASES) in an independent sample of hypertensive African Americans.
The purpose of this study was to revise and assess the validity of the MASES.
Study sample included 168 African Americans followed in primary care practices. Mean age was 54 (SD = 12.36); 86% was female; and 76% reported high school education or greater. Participants provided demographic information; completed the MASES, self-report and electronic measures of medication adherence for prescribed antihypertensive medications at baseline and three months.
Confirmatory (CFA), exploratory (EFA) factor analyses, and classical test theory (CTT) analyses, suggested that MASES is a unidimensional and internally reliable measure with relatively stable scores over 3 months. Results of item response theory (IRT) analyses led to revision of the scale to a 13-item version: the MASES-R. EFA, CTT, and IRT results for the MASES-R supported its reliability and validity.
Findings suggest that the MASES-R is a brief scale that is quick to administer and can capture useful data on adherence self-efficacy for African Americans. Research examining its psychometric properties in other ethnic groups will improve generalizability of findings and utility of the scale in diverse groups.
PMCID: PMC3763496  PMID: 18784996
16.  A Practice-based Trial of Motivational Interviewing and Adherence in Hypertensive 065African Americans1 
American journal of hypertension  2008;21(10):1137-1143.
Poor medication adherence is a significant problem in hypertensive African Americans. Although motivational interviewing (MINT) is effective for adoption and maintenance of health behaviors in patients with chronic diseases, its effect on medication adherence remains untested in this population.
This randomized controlled trial tested the effect of a practice-based MINT counseling versus usual care (UC) on medication adherence and blood pressure (BP) in 190 hypertensive African Americans (88% women; mean age 54 years). Patients were recruited from two community-based primary care practices in New York City. The primary outcome was adherence measured by electronic pill monitors; the secondary outcome was within-patient change in office BP from baseline to 12 months.
Baseline adherence was similar in both groups (56.2% and 56.6% for MINT and UC respectively, p = 0.94). Based on intent-to-treat analysis using mixed effects regression, a significant time X group interaction with model-predicted post-treatment adherence rates of 43% and 57% were found in the UC and MINT groups, respectively (p = 0.027), with a between-group difference of 14% (95% CI, −0.2% to −27%). The between-group difference in systolic and diastolic BP was −6.1 mm Hg (p = .065) and −1.4 mm Hg (p = .465), respectively, in favor of the MINT group.
A practice-based MINT counseling led to steady maintenance of medication adherence over time, compared to significant decline in adherence for UC patients. This effect was associated with a clinically meaningful net reduction in systolic BP in favor of the MINT group.
PMCID: PMC3747638  PMID: 18654123
Motivational Interviewing; Medication Adherence; African American; Hypertension
17.  Prospective investigation of autism and genotype-phenotype correlations in 22q13 deletion syndrome and SHANK3 deficiency 
Molecular Autism  2013;4:18.
22q13 deletion syndrome, also known as Phelan-McDermid syndrome, is a neurodevelopmental disorder characterized by intellectual disability, hypotonia, delayed or absent speech, and autistic features. SHANK3 has been identified as the critical gene in the neurological and behavioral aspects of this syndrome. The phenotype of SHANK3 deficiency has been described primarily from case studies, with limited evaluation of behavioral and cognitive deficits. The present study used a prospective design and inter-disciplinary clinical evaluations to assess patients with SHANK3 deficiency, with the goal of providing a comprehensive picture of the medical and behavioral profile of the syndrome.
A serially ascertained sample of patients with SHANK3 deficiency (n = 32) was evaluated by a team of child psychiatrists, neurologists, clinical geneticists, molecular geneticists and psychologists. Patients were evaluated for autism spectrum disorder using the Autism Diagnostic Interview-Revised and the Autism Diagnostic Observation Schedule-G.
Thirty participants with 22q13.3 deletions ranging in size from 101 kb to 8.45 Mb and two participants with de novo SHANK3 mutations were included. The sample was characterized by high rates of autism spectrum disorder: 27 (84%) met criteria for autism spectrum disorder and 24 (75%) for autistic disorder. Most patients (77%) exhibited severe to profound intellectual disability and only five (19%) used some words spontaneously to communicate. Dysmorphic features, hypotonia, gait disturbance, recurring upper respiratory tract infections, gastroesophageal reflux and seizures were also common. Analysis of genotype-phenotype correlations indicated that larger deletions were associated with increased levels of dysmorphic features, medical comorbidities and social communication impairments related to autism. Analyses of individuals with small deletions or point mutations identified features related to SHANK3 haploinsufficiency, including ASD, seizures and abnormal EEG, hypotonia, sleep disturbances, abnormal brain MRI, gastroesophageal reflux, and certain dysmorphic features.
This study supports findings from previous research on the severity of intellectual, motor, and speech impairments seen in SHANK3 deficiency, and highlights the prominence of autism spectrum disorder in the syndrome. Limitations of existing evaluation tools are discussed, along with the need for natural history studies to inform clinical monitoring and treatment development in SHANK3 deficiency.
PMCID: PMC3707861  PMID: 23758760
22q13 deletion syndrome; Autism; Microarrays; Mutation; Phelan-McDermid syndrome; SHANK3
18.  The Effect of Enhanced Depression Care on Anxiety Symptoms in Acute Coronary Syndrome Patients: Findings from the COPES Trial 
Psychotherapy and psychosomatics  2012;81(4):245-247.
PMCID: PMC3640416  PMID: 22678227
anxiety; depression; acute coronary syndrome; randomized controlled trial; problem solving therapy; antidepressant
19.  The Effect of Patient-Provider Communication on Medication Adherence in Hypertensive Black Patients: Does Race Concordance Matter? 
Despite evidence of a positive effect of collaborative patient-provider communication on patient outcomes, our understanding of this relationship is unclear.
To determine whether racial composition of the relationship modified the association between ratings of provider communication and medication adherence.
Effect modification of the communication-adherence association, by racial composition of the relationship, was evaluated using general linear mixed models while adjusting for selected covariates.
390 patients were in race-concordant (black patient, black provider) relationships, while 207 were in race-discordant (black patient, white provider) relationships. The communication-adherence association was significantly modified in race-discordant relationships (p=0.04). Communication rated as more collaborative in race-discordant relationships was associated with better adherence, while communication rated as less collaborative was associated with poor adherence. There was no significant association between adherence and communication in race-concordant relationships (p=0.24).
Collaborative patient-provider communication may play an influential role in black patients’ adherence behaviors when receiving care from white providers.
PMCID: PMC3665951  PMID: 22270266
hypertension; medication adherence; communication; race concordance
21.  Development and evaluation of a novel, real time mobile telesonography system in management of patients with abdominal trauma: study protocol 
Despite the use of e-FAST in management of patients with abdominal trauma, its utility in prehospital setting is not widely adopted. The goal of this study is to develop a novel portable telesonography (TS) system and evaluate the comparability of the quality of images obtained via this system among healthy volunteers who undergo e-FAST abdominal examination in a moving ambulance and at the ED. We hypothesize that: (1) real-time ultrasound images of acute trauma patients in the pre-hospital setting can be obtained and transmitted to the ED via the novel TS system; and (2) Ultrasound images transmitted to the hospital from the real-time TS system will be comparable in quality to those obtained in the ED.
Study participants are three healthy volunteers (one each with normal, overweight and obese BMI category). The ultrasound images will be obtained by two ultrasound-trained physicians The TS is a portable sonogram (by Sonosite) interfaced with a portable broadcast unit (by Live-U). Two UTPs will conduct e-FAST examinations on healthy volunteers in moving ambulances and transmit the images via cellular network to the hospital server, where they are stored. Upon arrival in the ED, the same UTPs will obtain another set of images from the volunteers, which are then compared to those obtained in the moving ambulances by another set of blinded UTPs (evaluators) using a validated image quality scale, the Questionnaire for User Interaction Satisfaction (QUIS).
Findings from this study will provide needed data on the validity of the novel TS in transmitting live images from moving ambulances to images obtained in the ED thus providing opportunity to facilitate medical care of a patient located in a remote or austere setting.
PMCID: PMC3546944  PMID: 23249290
Telesonography; Abdominal trauma; Patients; Pre-hospital; Novel; Real-time; Mobile
22.  Intranasal oxytocin versus placebo in the treatment of adults with autism spectrum disorders: a randomized controlled trial 
Molecular Autism  2012;3:16.
There are no effective medications for the treatment of social cognition/function deficits in autism spectrum disorder (ASD), and adult intervention literature in this area is sparse. Emerging data from animal models and genetic association studies as well as early, single-dose intervention studies suggest that the oxytocin system may be a potential therapeutic target for social cognition/function deficits in ASD. The primary aim of this study was to examine the safety/therapeutic effects of intranasal oxytocin versus placebo in adults with ASD, with respect to the two core symptom domains of social cognition/functioning and repetitive behaviors.
This was a pilot, randomized, double-blind, placebo-controlled, parallel design trial of intranasal oxytocin versus placebo in 19 adults with ASD (16 males; 33.20 ± 13.29 years). Subjects were randomized to 24 IU intranasal oxytocin or placebo in the morning and afternoon for 6 weeks. Measures of social function/cognition (the Diagnostic Analysis of Nonverbal Accuracy) and repetitive behaviors (Repetitive Behavior Scale Revised) were administered. Secondary measures included the Social Responsiveness Scale, Reading-the-Mind-in-the-Eyes Test and the Yale Brown Obsessive Compulsive Scale – compulsion subscale and quality of life (World Health Organization Quality of Life Questionnaire – emotional/social subscales). Full-information maximum-likelihood parameter estimates were obtained and tested using mixed-effects regression analyses.
Although no significant changes were detected in the primary outcome measures after correcting for baseline differences, results suggested improvements after 6 weeks in measures of social cognition (Reading-the-Mind-in-the-Eyes Test, p = 0.002, d = 1.2), and quality of life (World Health Organization Quality of Life Questionnaire – emotion, p = 0.031, d = 0.84), both secondary measures. Oxytocin was well tolerated and no serious adverse effects were reported.
This pilot study suggests that there is therapeutic potential to daily administration of intranasal oxytocin in adults with ASD and that larger and longer studies are warranted.
Trial registration
PMCID: PMC3539865  PMID: 23216716
Autism; Adults; Oxytocin; Clinical trial; Social cognition
23.  Observed Hostility and the Risk of Incident Ischemic Heart Disease: A Prospective Population Study from the 1995 Canadian Nova Scotia Health Survey 
To examine the relation between hostility and incident ischemic heart disease (IHD) and to determine whether observed hostility is superior to patient-reported hostility for the prediction of IHD in a large, prospective observational study.
Some studies have found that hostile patients have an increased risk of incident IHD. However, no studies have compared methods of hostility assessment, nor considered important psychosocial and cardiovascular risk factors as confounders. Further, it is unknown whether all expressions of hostility carry equal risk, or whether certain manifestations are more cardiotoxic.
We assessed the independent relationship between baseline observed hostility and 10-year incident IHD in 1,749 adults of the population-based Canadian Nova Scotia Health Survey.
There were 149 (8.5%) incident IHD events (140 non-fatal, 9 fatal) during the 15,295 person-years of observation (9.74 events/1000 person-years). Participants with any observed hostility had a greater risk of incident IHD than those without (p=0.02); no such relation was found for patient-reported hostility. After adjusting for cardiovascular (age, sex, Framingham Risk Score) and psychosocial (depression, positive affect, patient-reported hostility, and anger) risk factors, those with any observed hostility had a significantly greater risk of incident IHD (HR 2.06, 95% CI 1.04–4.08, P=0.04).
The presence of any observed hostility at baseline was associated with a two-fold increased risk of incident IHD over 10 years of follow-up. Compared to patient-reported measures, observed hostility is a superior predictor of IHD.
PMCID: PMC3188395  PMID: 21903054
Observed hostility; patient-reported hostility; ischemic heart disease; depression; positive affect
24.  Psychosocial Vulnerabilities to Depression after Acute Coronary Syndrome: The Pivotal Role of Rumination in Predicting and Maintaining Depression 
Psychosocial vulnerabilities may predispose individuals to develop depression after a significant life stressor, such as an acute coronary syndrome (ACS). The aims are (1) to examine the interrelations among vulnerabilities, and their relation with changes in depressive symptoms 3 months after ACS, (2) to prospectively assess whether rumination interacts with other vulnerabilities as a predictor of later depressive symptoms, and (3) to examine how these relations differ between post-ACS patients who meet diagnostic criteria for depression at baseline versus patients who do not. Within 1 week after hospitalization for ACS, and again after 3 months, 387 patients (41% female, 79.6% white, mean age 61) completed the Beck Depression Inventory (BDI) and measures of vulnerabilities (lack of pleasant events, dysfunctional attitudes, role transitions, poor dyadic adjustment). Exclusion criteria were a BDI score of 5–9, terminal illness, active substance abuse, cognitive impairment, and unavailability for follow-up visits. We used hierarchical regression modeling cross-sectionally and longitudinally. Controlling for baseline (in-hospital) depression and cardiovascular disease severity, vulnerabilities significantly predicted 3 month depression severity. Rumination independently predicted increased depression severity, above other vulnerabilities (β = 0.75, p < 0.001), and also interacted with poor dyadic adjustment (β = 0.32, p < 0.001) to amplify depression severity. Among initially non-depressed patients, the effects of vulnerabilities were amplified by rumination. In contrast, in patients who were already depressed at baseline, there was a direct effect of rumination above vulnerabilities on depression severity. Although all vulnerabilities predict depression 3 months after an ACS event has occurred rumination plays a key role to amplify the impact of vulnerabilities on depression among the initially non-depressed, and maintains depression among those who are already depressed.
PMCID: PMC3417406  PMID: 22905030
psychosocial vulnerabilities; post-ACS; depression; rumination; cardiovascular disease

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