Article

Randomized trial of achieving healthy lifestyles in psychiatric rehabilitation: the ACHIEVE trial

Welch Center for Prevention, Epidemiology, Clinical Research, Johns Hopkins University, Baltimore, Maryland, USA.
BMC Psychiatry (Impact Factor: 2.24). 12/2010; 10:108. DOI: 10.1186/1471-244X-10-108
Source: DOAJ

ABSTRACT Overweight and obesity are highly prevalent among persons with serious mental illness. These conditions likely contribute to premature cardiovascular disease and a 20 to 30 percent shortened life expectancy in this vulnerable population. Persons with serious mental illness need effective, appropriately tailored behavioral interventions to achieve and maintain weight loss. Psychiatric rehabilitation day programs provide logical intervention settings because mental health consumers often attend regularly and exercise can take place on-site. This paper describes the Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE). The goal of the study is to determine the effectiveness of a behavioral weight loss intervention among persons with serious mental illness that attend psychiatric rehabilitation programs. Participants randomized to the intervention arm of the study are hypothesized to have greater weight loss than the control group.
A targeted 320 men and women with serious mental illness and overweight or obesity (body mass index ≥ 25.0 kg/m2) will be recruited from 10 psychiatric rehabilitation programs across Maryland. The core design is a randomized, two-arm, parallel, multi-site clinical trial to compare the effectiveness of an 18-month behavioral weight loss intervention to usual care. Active intervention participants receive weight management sessions and physical activity classes on-site led by study interventionists. The intervention incorporates cognitive adaptations for persons with serious mental illness attending psychiatric rehabilitation programs. The initial intensive intervention period is six months, followed by a twelve-month maintenance period in which trained rehabilitation program staff assume responsibility for delivering parts of the intervention. Primary outcomes are weight loss at six and 18 months.
Evidence-based approaches to the high burden of obesity and cardiovascular disease risk in person with serious mental illness are urgently needed. The ACHIEVE Trial is tailored to persons with serious mental illness in community settings. This multi-site randomized clinical trial will provide a rigorous evaluation of a practical behavioral intervention designed to accomplish and sustain weight loss in persons with serious mental illness.

0 Followers
 · 
281 Views
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: This pilot study examines the proof of concept of a consolidated Nutrition, Exercise, and Wellness Treatment (NEW Tx) for overweight individuals with bipolar disorder. Five participants completed NEW Tx, a 20-week individual cognitive behavioral therapy-based treatment comprising three modules: Nutrition teaches appropriate serving sizes and balanced diet; Exercise emphasizes increasing weekly physical activity; Wellness focuses on skills for healthy decision-making. Participants attended most sessions and reported high satisfaction with the treatment. Participants' weight, cholesterol and trigyclerides decreased over the study duration as well as number of daily calories and sugar intake. We found that weekly exercise duration more than tripled over the study duration and depressive symptoms and functioning have improved. These results offer proof of concept that consolidated NEW Tx is feasible and acceptable and has the potential to improve nutrition, exercise, wellness, and mood symptoms in bipolar disorder. Future iterations of NEW Tx will reflect the strengths and lessons learned from this study.
    10/2013; 1(1):24. DOI:10.1186/2194-7511-1-24
  • [Show abstract] [Hide abstract]
    ABSTRACT: There is currently much focus on provision of general physical health advice to people with serious mental illness and there has been increasing pressure for services to take responsibility for providing this. To review the effects of general physical healthcare advice for people with serious mental illness. We searched the Cochrane Schizophrenia Group's Trials Register (last update search October 2012) which is based on regular searches of CINAHL, BIOSIS, AMED, EMBASE, PubMed, MEDLINE, PsycINFO and registries of Clinical Trials. There is no language, date, document type, or publication status limitations for inclusion of records in the register. All randomised clinical trials focusing on general physical health advice for people with serious mental illness.. We extracted data independently. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For continuous data, we estimated the mean difference (MD) between groups and its 95% CI. We employed a fixed-effect model for analyses. We assessed risk of bias for included studies and created 'Summary of findings' tables using GRADE. Seven studies are now included in this review. For the comparison of physical healthcare advice versus standard care we identified six studies (total n = 964) of limited quality. For measures of quality of life one trial found no difference (n = 54, 1 RCT, MD Lehman scale 0.20, CI -0.47 to 0.87, very low quality of evidence) but another two did for the Quality of Life Medical Outcomes Scale - mental component (n = 487, 2 RCTs, MD 3.70, CI 1.76 to 5.64). There was no difference between groups for the outcome of death (n = 487, 2 RCTs, RR 0.98, CI 0.27 to 3.56, low quality of evidence). For service use two studies presented favourable results for health advice, uptake of ill-health prevention services was significantly greater in the advice group (n = 363, 1 RCT, MD 36.90, CI 33.07 to 40.73) and service use: one or more primary care visit was significantly higher in the advice group (n = 80, 1 RCT, RR 1.77, CI 1.09 to 2.85). Economic data were equivocal. Attrition was large (> 30%) but similar for both groups (n = 964, 6 RCTs, RR 1.11, CI 0.92 to 1.35). Comparisons of one type of physical healthcare advice with another were grossly underpowered and equivocal. General physical health could lead to people with serious mental illness accessing more health services which, in turn, could mean they see longer-term benefits such as reduced mortality or morbidity. On the other hand, it is possible clinicians are expending much effort, time and financial resources on giving ineffective advice. The main results in this review are based on low or very low quality data. There is some limited and poor quality evidence that the provision of general physical healthcare advice can improve health-related quality of life in the mental component but not the physical component, but this evidence is based on data from one study only. This is an important area for good research reporting outcome of interest to carers and people with serious illnesses as well as researchers and fundholders.
    Cochrane database of systematic reviews (Online) 03/2014; 3(3):CD008567. DOI:10.1002/14651858.CD008567.pub3 · 5.94 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: At more than 10 years after the paper by Hotopf and colleagues regarding pragmatic trials in psychiatry, the field has evolved and is evolving further. There have been many developments in our understanding of what pragmatism really means, and excellent examples of truly pragmatic trials in psychiatry are currently available. Funders have helped encourage more emphasis on the need for such studies, but 'local' and trans-national regulations could help more. Consumers of the evidence should have a greater voice in generating the research agenda and, as this happens, the questions generated are more likely to be answered by a pragmatic approach to trials.
    Psychological Medicine 06/2014; DOI:10.1017/S0033291714001275 · 5.43 Impact Factor

Full-text (3 Sources)

Download
66 Downloads
Available from
May 27, 2014