Lessening Homelessness Among Persons with Mental Illness: A Comparison of Five Randomized Treatment Trials.
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SUBMITTER: Schutt RK
PROVIDER: S-EPMC2788308 | biostudies-other | 2009 Oct
REPOSITORIES: biostudies-other
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Project description:It has been argued that persons with severe mental illness (SMI) receive poorer treatment for somatic comorbidities. This study assesses the treatment rates of glucose-lowering and cardiovascular medications among persons with incident type 2 diabetes (T2D) and SMI compared to persons with T2D without SMI. We identified persons ≥30 years old with incident diabetes (HbA1c ≥ 48 mmol/mol and/or glucose ≥ 11.0 mmol/L) from 2001 through 2015 in the Copenhagen Primary Care Laboratory (CopLab) Database. The SMI group included persons with psychotic, affective, or personality disorders within five years preceding the T2D diagnosis. Using a Poisson regression model, we calculated the adjusted rate ratios (aRR) for the redemption of various glucose-lowering and cardiovascular medications up to ten years after T2D diagnosis. We identified 1,316 persons with T2D and SMI and 41,538 persons with T2D but no SMI. Despite similar glycemic control at diagnosis, persons with SMI redeemed a glucose-lowering medication more often than persons without SMI in the period 0.5-2 years after the T2D diagnosis; for example, the aRR was 1.05 (95% CI 1.00-1.11) in the period 1.5-2 years after the T2D diagnosis. This difference was mainly driven by metformin. In contrast, persons with SMI were less often treated with cardiovascular medications during the first 3 years after T2D diagnosis, e.g., in the period 1.5-2 years after T2D diagnosis, the aRR was 0.96 (95% CI 0.92-0.99). For people with SMI in addition to T2D, metformin is more likely to be used in the initial years after T2D diagnosis, while our results suggest potential room for improvement regarding the use of cardiovascular medications.
| S-EPMC10263345 | biostudies-literature
Project description:ObjectiveTo evaluate the effectiveness of a composite oral health promotion program designed to reduce dental plaque among persons with severe mental illness in a psychiatric institution.MethodsA cluster randomized controlled study was carried out in chronic psychiatric wards of a general hospital in central Taiwan. Sixty-eight eligible male individuals admitted to 2 wards were randomly assigned to an experimental and a control group. Participants in the experimental group underwent an oral health promotion program that consisted of biweekly group education sessions, and a 12-week individual behavioral modification for oral hygiene course. The participants in the control group received usual care only. Dental plaque (measured by the Plaque Control Index) was examined by a single dentist before and after the experiment. Each participant responded to a questionnaire regarding oral health knowledge, attitude and behavior before and after the experiment.ResultsFifty-eight individuals completed the study. Before the experiment, the plaque index was similar between the intervention group (68.9; N = 27) and the control group (69.8; N = 31). After the experiment, the plaque index was significantly better in the intervention group than in the control group (42.6 vs. 61.8; P < 0.001). Participants in the intervention group also demonstrated better oral health knowledge, attitude and behavior than those in the control group after the experiment.ConclusionsA composite oral health promotion program using both group education and individual behavioral methods over a 12-week period was effective in both reducing dental plaque and improving the oral health knowledge of persons with severe mental illness in the institution.Trial registrationThis study was retrospectively registered in Clinicaltrials.gov, with number NCT04464941, dated 7/7/2020. https://register.clinicaltrials.gov/RD103035018 .
| S-EPMC7590455 | biostudies-literature
Project description:BackgroundPersons with severe, persistent mental illness (SPMI) are at high risk for poor health and premature mortality. Integrating primary care in a mental health center may improve health outcomes in a population with SPMI in a socioeconomically distressed region of the USA.ObjectiveTo examine the effects of reverse colocated integrated care on persons with SPMI and co-morbid chronic disease receiving behavioral health services at a local mental health authority located at the US-Mexico border.DesignRandomized trial evaluating the effect of a reverse colocated integrated care intervention among chronically ill adults.ParticipantsParticipants were recruited at a clinic between November 24, 2015, and June 30, 2016.InterventionsReceipt of at least two visits with a primary care provider and at least one visit with a chronic care nurse or dietician, compared with usual care (behavioral health only).Main measuresThe primary outcome was blood pressure. Secondary outcomes included HbA1c, BMI, total cholesterol, and depressive symptoms. Sociodemographic data were collected at baseline, and outcomes were measured at baseline and 6- and 12-month follow-ups.Key resultsA total of 416 participants were randomized to the intervention (n = 249) or usual care (n = 167). Groups were well balanced on almost all baseline characteristics. At 12 months, intent-to-treat analysis showed intervention participants improved their systolic blood pressure (β = - 3.86, p = 0.04) and HbA1c (β = - 0.36, p = 0.001) compared with usual care participants when controlling for age, sex, and other baseline characteristics. No participants withdrew from the study due to adverse effects. Per-protocol analyses yielded similar results to intent-to-treat analyses and found a significantly protective effect on diastolic blood pressure. Older and diabetic populations differentially benefited from this intervention.ConclusionsColocation and integration of behavioral health and primary care improved blood pressure and HbA1c after 1-year follow-up for persons with SPMI and co-morbid chronic disease in a US-Mexico border community.Trial registrationclinicaltrials.gov , Identifier: NCT03881657.
| S-EPMC7351885 | biostudies-literature
Project description:ImportancePersons with serious mental illness have a cardiovascular disease mortality rate more than twice that of the overall population. Meaningful cardiovascular risk reduction requires targeted efforts in this population, who often have psychiatric symptoms and cognitive impairment.ObjectiveTo determine the effectiveness of an 18-month multifaceted intervention incorporating behavioral counseling, care coordination, and care management for overall cardiovascular risk reduction in adults with serious mental illness.Design, setting, and participantsThis randomized clinical trial was conducted from December 2013 to November 2018 at 4 community mental health outpatient programs in Maryland. The study recruited adults with at least 1 cardiovascular disease risk factor (hypertension, diabetes, dyslipidemia, current tobacco smoking, and/or overweight or obesity) attending the mental health programs. Of 398 participants screened, 269 were randomized to intervention (132 participants) or control (137 participants). Data collection staff were blinded to group assignment. Data were analyzed on the principle of intention to treat, and data analysis was performed from November 2018 to March 2019.InterventionsA health coach and nurse provided individually tailored cardiovascular disease risk reduction behavioral counseling, collaborated with physicians to implement appropriate risk factor management, and coordinated with mental health staff to encourage attainment of health goals. Programs offered physical activity classes and received consultation on serving healthier meals; intervention and control participants were exposed to these environmental changes.Main outcomes and measuresThe primary outcome was the change in the risk of cardiovascular disease from the global Framingham Risk Score (FRS), which estimates the 10-year probability of a cardiovascular disease event, from baseline to 18 months, expressed as percentage change for intervention compared with control.ResultsOf 269 participants randomized (mean [SD] age, 48.8 [11.9] years; 128 men [47.6%]), 159 (59.1%) had a diagnosis of schizophrenia or schizoaffective disorder, 67 (24.9%) had bipolar disorder, and 38 (14.1%) had major depressive disorder. At 18 months, the primary outcome, FRS, was obtained for 256 participants (95.2%). The mean (SD) baseline FRS was 11.5% (11.5%) (median, 8.6%; interquartile range, 3.9%-16.0%) in the intervention group and 12.7% (12.7%) (median, 9.1%; interquartile range, 4.0%-16.7%) in the control group. At 18 months, the mean (SD) FRS was 9.9% (10.2%) (median, 7.7%; interquartile range, 3.1%-12.0%) in the intervention group and 12.3% (12.0%) (median, 9.7%; interquartile range, 4.0%-15.9%) in the control group. Compared with the control group, the intervention group experienced a 12.7% (95% CI, 2.5%-22.9%; P = .02) relative reduction in FRS at 18 months.Conclusions and relevanceAn 18-month behavioral counseling, care coordination, and care management intervention statistically significantly reduced overall cardiovascular disease risk in adults with serious mental illness. This intervention provides the means to substantially reduce health disparities in this high-risk population.Trial registrationClinicalTrials.gov Identifier: NCT02127671.
| S-EPMC7293000 | biostudies-literature
Project description:Overweight and obesity are epidemic among persons with serious mental illness, yet weight-loss trials systematically exclude this vulnerable population. Lifestyle interventions require adaptation in this group because psychiatric symptoms and cognitive impairment are highly prevalent. Our objective was to determine the effectiveness of an 18-month tailored behavioral weight-loss intervention in adults with serious mental illness.We recruited overweight or obese adults from 10 community psychiatric rehabilitation outpatient programs and randomly assigned them to an intervention or a control group. Participants in the intervention group received tailored group and individual weight-management sessions and group exercise sessions. Weight change was assessed at 6, 12, and 18 months.Of 291 participants who underwent randomization, 58.1% had schizophrenia or a schizoaffective disorder, 22.0% had bipolar disorder, and 12.0% had major depression. At baseline, the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 36.3, and the mean weight was 102.7 kg (225.9 lb). Data on weight at 18 months were obtained from 279 participants. Weight loss in the intervention group increased progressively over the 18-month study period and differed significantly from the control group at each follow-up visit. At 18 months, the mean between-group difference in weight (change in intervention group minus change in control group) was -3.2 kg (-7.0 lb, P=0.002); 37.8% of the participants in the intervention group lost 5% or more of their initial weight, as compared with 22.7% of those in the control group (P=0.009). There were no significant between-group differences in adverse events.A behavioral weight-loss intervention significantly reduced weight over a period of 18 months in overweight and obese adults with serious mental illness. Given the epidemic of obesity and weight-related disease among persons with serious mental illness, our findings support implementation of targeted behavioral weight-loss interventions in this high-risk population. (Funded by the National Institute of Mental Health; ACHIEVE ClinicalTrials.gov number, NCT00902694.).
| S-EPMC3743095 | biostudies-literature
Project description:As one of the areas of greatest concern for people with serious mental illness (SMI) are unmet social needs, psychosocial interventions have been developed to address them. The current study utilized a randomized controlled trial to examine the effectiveness of social cognition and interaction training (SCIT) versus a therapeutic alliance focused theraphy (TAFT) versus a treatment-as-usual (TAU) control group on social functioning and quality of life as primary outcomes and social cognition variables as secondary outcomes. Sixty-three persons between the ages of 24 and 69 years with SMI (41 men and 22 women), completers of the trial (23 in SCIT, 20 in TAFT, and 20 in TAU), were assessed at baseline, completion, and at a 3-month follow-up with measurements assessing social cognition (The Facial Emotion Identification Task, The Faux pas test, The Ambiguous Intentions Hostility Questionnaire) social functioning, (The Social Skills Performance Assessment, The Wisconsin Social Quality of Life Scale), and therapeutic alliance (adapted version for group of system for observing family therapy alliance). Results reveal that the two interventions were more effective than the control condition (TAU) in reducing attribution bias anger scores, SCIT was also effective in improving theory of mind (as can be seen in Faux pas test scores), and the TAFT in improving emotion recognition and reducing intentionality attribution bias scores. Improvement was related to therapeutic alliance which did not differ between the two intervention groups. Considering the role of alliance, it is recommended to consider the integration of the two studied interventions with other approaches that emphasize alliance and reflection. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02380885.
| S-EPMC6580150 | biostudies-literature
Project description:ObjectivesRecurring issues in clinical trial design may bias results toward the null, yielding findings inconclusive for treatment effects. This study evaluated for powering bias among high-impact critical care trials and the associated risk of masking clinically important treatment effects.Design, setting, and patientsSecondary analysis of multicenter randomized trials of critically ill adults in which mortality was the main endpoint. Trials were eligible for inclusion if published between 2008 and 2018 in leading journals. Analyses evaluated for accuracy of estimated control group mortality, adaptive sample size strategy, plausibility of predicted treatment effect, and results relative to the minimal clinically important difference. The main outcome was the mortality risk difference at the study-specific follow-up interval.InterventionsNone.Measurements and main resultsOf 101 included trials, 12 met statistical significance for their main endpoint, five for increased intervention-associated mortality. Most trials (77.3%) overestimated control group mortality in power calculations (observed minus predicted difference, -6.7% ± 9.8%; p < 0.01). Due to this misestimation of control group mortality, in 14 trials, the intervention would have had to prevent at least half of all deaths to achieve the hypothesized treatment effect. Seven trials prespecified adaptive sample size strategies that might have mitigated this issue. The observed risk difference for mortality fell within 5% of predicted in 20 trials, of which 16 did not reach statistical significance. Half of trials (47.0%) were powered for an absolute risk reduction greater than or equal to 10%, but this effect size was observed in only three trials with a statistically significant treatment benefit. Most trials (67.3%) could not exclude clinically important treatment benefit or harm.ConclusionsThe design of most high-impact critical care trials biased results toward the null by overestimating control group mortality and powering for unrealistic treatment effects. Clinically important treatment effects often cannot be excluded.
| S-EPMC7708428 | biostudies-literature
Project description:BackgroundMental illness stigma is a fundamental barrier to improving mental health worldwide, but little is known about how to durably reduce it. Understanding of mental illness as a treatable medical condition may influence stigmatizing beliefs, but available evidence to inform this hypothesis has been derived solely from high-income countries. We embedded a randomized survey experiment within a whole-population cohort study in rural southwestern Uganda to assess the extent to which portrayals of mental illness treatment effectiveness influence personal beliefs and perceived norms about mental illness and about persons with mental illness.Methods and findingsStudy participants were randomly assigned to receive a vignette describing a typical woman (control condition) or one of nine variants describing a different symptom presentation (suggestive of schizophrenia, bipolar, or major depression) and treatment course (no treatment, treatment with remission, or treatment with remission followed by subsequent relapse). Participants then answered questions about personal beliefs and perceived norms in three domains of stigma: willingness to have the woman marry into their family, belief that she is receiving divine punishment, and belief that she brings shame on her family. We used multivariable Poisson and ordered logit regression models to estimate the causal effect of vignette treatment assignment on each stigma-related outcome. Of the participants randomized, 1,355 were successfully interviewed (76%) from November 2016 to June 2018. Roughly half of respondents were women (56%), half had completed primary school (57%), and two-thirds were married or cohabiting (64%). The mean age was 42 years. Across all types of mental illness and treatment scenarios, relative to the control vignette (22%-30%), substantially more study participants believed the woman in the vignette was receiving divine punishment (31%-54%) or believed she brought shame on her family (51%-73%), and most were unwilling to have her marry into their families (80%-88%). In multivariable Poisson regression models, vignette portrayals of untreated mental illness, relative to the control condition, increased the risk that study participants endorsed stigmatizing personal beliefs about mental illness and about persons with mental illness, irrespective of mental illness type (adjusted risk ratios [ARRs] varied from 1.7-3.1, all p < 0.001). Portrayals of effectively treated mental illness or treatment followed by subsequent relapse also increased the risk of responses indicating stigmatizing personal beliefs relative to control (ARRs varied from 1.5-3.0, all p < 0.001). The magnitudes of the estimates suggested that portrayals of initially effective treatment (whether followed by relapse or not) had little moderating influence on stigmatizing responses relative to vignettes portraying untreated mental illness. Responses to questions about perceived norms followed similar patterns. The primary limitations of this study are that the vignettes may have omitted context that could have influenced stigma and that generalizability beyond rural Uganda may be limited.ConclusionsIn a population-based, randomized survey experiment conducted in rural southwestern Uganda, portrayals of effectively treated mental illness did not appear to reduce endorsement of stigmatizing beliefs about mental illness or about persons with mental illness. These findings run counter to evidence from the United States. Further research is necessary to understand the relationship between mental illness treatment and stigmatizing attitudes in Uganda and other countries worldwide.Trial registrationThe experimental procedures for this study were registered with ClinicalTrials.gov as "Measuring Beliefs and Norms About Persons With Mental Illness" (NCT03656770).
| S-EPMC6754129 | biostudies-literature
Project description:This study examined variation in the implementation of California's Full Service Partnerships (FSPs), which are supported housing programs that do "whatever it takes" to improve outcomes among persons with serious mental illness who are homeless or at risk of homelessness.Ninety-three FSPs in California.A mixed methods approach was selected to develop a better understanding of the complexity of the FSP programs. The design structure was a combined explanatory and exploratory sequential design (qual?QUAN?qual) where a qualitative focus group was used to develop a quantitative survey that was followed by qualitative site visits. The survey was used to describe the breadth of variation based on fidelity to the Housing First model, while the site visits were used to provide a depth of information on high- versus low-fidelity programs.We found substantial variation in implementation among FSPs. Fidelity was particularly low along domains related with housing and service philosophy, indicating that many FSPs implemented a rich array of services but applied housing readiness requirements and did not adhere to consumer choice in housing.There remains room for improvement in the recovery-orientation of FSPs. Fortunately, we have identified several processes by which program managers and counties can increase the fidelity of their programs.
| S-EPMC4097835 | biostudies-other
Project description:Purpose:To determine baseline predictors of visual acuity (VA) outcomes at 5 years after initiating treatment with ranibizumab or bevacizumab for neovascular age-related macular degeneration (AMD). Design:Secondary analysis of data from a cohort study. Participants:Patients enrolled in the Comparison of AMD Treatments Trials (CATT) who completed a 5-year follow-up visit. Methods:Participants were randomly assigned to ranibizumab or bevacizumab and to 1 of 3 dosing regimens. After two years, patients were released from the clinical trial protocol, and were recalled for examination at 5 years. Trained readers evaluated baseline lesion features, fluid and thickness. Baseline predictors were determined using univariate and multivariate regression analysis. Main Outcome Measures:VA score and change from baseline, ?3-line gain, and VA 20/200 or worse at 5 years. Results:Among 647 patients with VA measured at 5 years, mean VA score in the study eye was 58.9 letters (?20/63), mean decrease from baseline was 3.3 letters, 17.6% eyes gained ?3 lines, and 19.9% had VA of 20/200 or worse. In multivariate analysis, worse baseline VA was associated with worse VA, more VA gain, higher percentage with ?3-line gain, and higher percentage with 20/200 or worse at 5 years (all p<0.001). Larger baseline CNV lesion area was associated with worse VA, greater VA loss, and higher percentage with 20/200 or worse at 5 years (all p<0.05). Absence of baseline subretinal fluid was associated with worse VA (p=0.03) and more VA loss (p=0.03). Female gender, bevacizumab treatment in the first 2 years, and absence of RPE elevation were associated with higher percentage with ?3-line gain. Cigarette smoking was associated with a higher percentage with 20/200 or worse. None of the 21 SNPs evaluated were associated with VA outcomes. Conclusions:Five years after initiating treatment with ranibizumab or bevacizumab in CATT participants, worse baseline VA, larger baseline CNV lesion area, and presence of baseline RPE elevation remained independently associated with worse VA at 5 years. In addition, male gender, cigarette smoking, absence of subretinal fluid and treatment with ranibizumab in the first 2 years were independently associated with worse vision outcomes at 5 years.
| S-EPMC6009839 | biostudies-literature