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A 60-Week Prospective RCT of a Self-Management Intervention for Individuals With Serious Mental Illness and Diabetes Mellitus.

ABSTRACT: A 60-week randomized controlled trial assessed the effects of targeted training in illness management (TTIM) versus treatment as usual among 200 individuals with serious mental illness and diabetes mellitus.The study used the Clinical Global Impression (CGI), the Montgomery-Asberg Depression Rating Scale (MADRS), and the Brief Psychiatric Rating Scale (BPRS) to assess psychiatric symptoms; the Global Assessment of Functioning (GAF) and the Sheehan Disability Scale (SDS) to assess functioning; the 36-Item Short-Form Health Survey (SF-36) to assess general health, and serum glycosylated hemoglobin (HbA1c) to assess diabetes control.Participants' mean±SD age was 52.7±9.5 years, and 54% were African American. They were diagnosed as having depression (48%), schizophrenia (25%), and bipolar disorder (28%). At baseline, depression severity was substantial but psychosis severity was modest. At 60 weeks, there was greater improvement among TTIM participants versus treatment-as-usual recipients on the CGI (p<.001), the MADRS (p=.016), and the GAF (p=.003). Diabetes knowledge was significantly improved among TTIM participants but not in the treatment-as-usual group. In post hoc analyses among participants whose HbA1c levels at baseline met recommendations set by the American Diabetes Association for persons with high comorbidity (53%), TTIM participants had minimal change in HbA1c over the 60-week follow-up, whereas HbA1c levels worsened in the treatment-as-usual group.TTIM was associated with improved psychiatric symptoms, functioning, and diabetes knowledge compared with treatment as usual. Among participants with better diabetes control at baseline, TTIM participants had better diabetes control at 60 weeks compared with recipients of treatment as usual.

SUBMITTER: Sajatovic M

PROVIDER: S-EPMC5675044 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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A 60-Week Prospective RCT of a Self-Management Intervention for Individuals With Serious Mental Illness and Diabetes Mellitus.

Sajatovic Martha M Gunzler Douglas D DD Kanuch Stephanie W SW Cassidy Kristin A KA Tatsuoka Curtis C McCormick Richard R Blixen Carol E CE Perzynski Adam T AT Einstadter Douglas D Thomas Charles L CL Lawless Mary E ME Martin Siobhan S Falck-Ytter Corinna C Seeholzer Eileen L EL McKibben Christine L CL Bauer Mark S MS Dawson Neal V NV

Psychiatric services (Washington, D.C.) 20170515 9

<h4>Objectives</h4>A 60-week randomized controlled trial assessed the effects of targeted training in illness management (TTIM) versus treatment as usual among 200 individuals with serious mental illness and diabetes mellitus.<h4>Methods</h4>The study used the Clinical Global Impression (CGI), the Montgomery-Asberg Depression Rating Scale (MADRS), and the Brief Psychiatric Rating Scale (BPRS) to assess psychiatric symptoms; the Global Assessment of Functioning (GAF) and the Sheehan Disability Sc ...[more]

PMID: 28502243

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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.).

Project description:IntroductionThe US Food and Drug Administration is considering implementing a reduced-nicotine standard for cigarettes. Given the high rate of smoking among people with serious mental illness (SMI), it is important to examine the responses of these smokers to very low nicotine content (VLNC) cigarettes.MethodsThis trial compared the effects of VLNC (0.4 mg nicotine/g tobacco) and normal nicotine content cigarettes (15.8 mg/g) over a 6-week period in non-treatment-seeking smokers with schizophrenia, schizoaffective disorder, or bipolar disorder (n = 58). Linear regression was used to examine the effects of cigarette condition on cigarettes per day, subjective responses, nicotine and tobacco toxicant exposure, craving, withdrawal symptoms, and psychiatric symptoms.ResultsAt week 6, participants in the VLNC condition smoked fewer cigarettes per day, had lower breath carbon monoxide levels, lower craving scores, and rated their study cigarettes lower in satisfaction, reward, enjoyment, and craving reduction than those in the normal nicotine content condition (ps < .05). Week 6 psychiatric and extrapyramidal symptoms did not differ by condition, except for scores on a measure of parkinsonism, which were lower in the VLNC condition (p < .05). There were no differences across conditions on total nicotine exposure, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol, withdrawal symptoms, or responses to abstinence.ConclusionsThese results suggest that a reduced-nicotine standard for cigarettes would reduce smoking among smokers with SMI. However, the lack of effect on total nicotine exposure indicates VLNC noncompliance, suggesting that smokers with SMI may respond to a reduced-nicotine standard by substituting alternative forms of nicotine.ImplicationsResults from this trial suggest that a reduced-nicotine standard for cigarettes would reduce smoking rates and smoke exposure in smokers with SMI, without increasing psychiatric symptoms. However, noncompliance with VLNC cigarettes was observed, suggesting that these smokers might respond to a reduced-nicotine standard by substituting alternative forms of nicotine.

Project description:BackgroundExperiences of homelessness and serious mental illness (SMI) negatively impact health and receipt of healthcare. Interventions that promote the use of primary care services for people with both SMI and homelessness may improve health outcomes, but this literature has not been evaluated systematically. This evidence map examines the breadth of literature to describe what intervention strategies have been studied for this population, elements of primary care integration with other services used, and the level of intervention complexity to highlight gaps for future intervention research and program development.MethodsWe followed an a priori protocol developed in collaboration with clinical stakeholders. We systematically searched the published literature to identify interventions for adults with homelessness who also had SMI. We excluded case reports, editorials, letters, and conference abstracts. Data abstraction methods followed standard practice. Data were categorized into intervention strategies and primary care integration strategies. Then we applied the Complexity Assessment Tool for Systematic Reviews (iCAT_SR) to characterize intervention complexity.ResultsTwenty-two articles met our inclusion criteria evaluating 15 unique interventions to promote engagement in primary care for adults with experiences of homelessness and SMI. Study designs varied widely from randomized controlled trials and cohort studies to single-site program evaluations. Intervention strategies varied across studies but primarily targeted patients directly (e.g., health education, evidence-based interactions such as motivational interviewing) with fewer strategies employed at the clinic (e.g., employee training, multidisciplinary teams) or system levels (e.g., data sharing). We identified elements of primary care integration, including referral strategies, co-location, and interdisciplinary care planning. Interventions displayed notable complexity around the number of intervention components, interaction between intervention components, and extent to which interventions were tailored to specific patient populations.DiscussionWe identified and categorized elements used in various combinations to address the primary care needs of individuals with experiences of homeless and SMI.

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A 60-Week Prospective RCT of a Self-Management Intervention for Individuals With Serious Mental Illness and Diabetes Mellitus.

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A 60-Week Prospective RCT of a Self-Management Intervention for Individuals With Serious Mental Illness and Diabetes Mellitus.

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