Michael G. Goldstein

Evidence-based behavioral medicine: What is it and how do we achieve it?

The goal of evidence-based medicine is ultimately to improve patient outcomes and quality of care. Systematic reviews of the available published evidence are required to identify interventions that lead to improvements in behavior, health, and well-being. Authoritative literature reviews depend on the quality of published research and research reports. The Consolidated Standards for Reporting Trials (CONSORT) Statement (www.consort-statement.org) was developed to improve the design and reporting of interventions involving randomized clinical trials (RCTs) in medical journals. We describe the 22 CONSORT guidelines and explain their application to behavioral medicine research and to evidence-based practice. Additional behavioral medicine-specific guidelines (e.g., treatment adherence) are also presented. Use of these guidelines by clinicians, educators, policymakers, and researchers who design, report, and evaluate or review RCTs will strengthen the research itself and accelerate efforts to apply behavioral medicine research to improve the processes and outcomes of behavioral medicine practice.

Integrating individual and public health perspectives for treatment of tobacco dependence under managed health care: a combined stepped-care and matching model.

There is an increasing momentum to integrate prevention into mainstream health care. Three decades of research on tobacco dependence can provide insights into the conceptual, clinical, economic, and service delivery challenges to such an integration. Biological sciences, cognitive-behavioral, clinical treatment outcome, and public health arenas are selectively reviewed. The key conceptual issues are explored relevant to the optimal delivery of quality smoking cessation treatments for the general population of adult smokers at reasonable cost. A comprehensive model for adult smoking cessation treatment is developed. The model consists of an overarching public health approach, focusing on enhancing motivational level from low motivation to quit to high motivation. A common outcome metric of overall impact is proposed to facilitate comparisons between clinical and public health interventions. Smokers are then assessed and triaged into one of three treatment steps of minimal, moderate, and maximal intensity and cost. Smoker individual differences at both the population and individual level are also taken into account as part of a tailoring or matching strategy within and across the stepped interventions. Smoker profiles include sociocultural, nicotine dependence, and comorbidity factors. The result is a hybrid stepped-care matching model. The model serves to illustrate some of the needs and challenges facing future tobacco dependence research and practice. Comparisons are made between tobacco control and other preventive medicine practices in terms of cost per quality adjusted life-year saved. The barriers and opportunities under managed care are explored. The conceptual principles identified here could be used as a guidepost for integrating other preventive medicine programs into the evolving managed health care system.

Physician-based activity counseling: intervention effects on mediators of motivational readiness for physical activity.

In theory-based interventions for behavior change, there is a need to examine the effects of interventions on the underlying theoretical constructs and the mediating role of such constructs. These two questions are addressed in the Physically Active for Life study, a randomized trial of physician-based exercise counseling for older adults. Three hundred fifty-five patients participated (intervention n = 181, control n = 174; mean age = 65.6 years). The underlying theories used were the Transtheoretical Model, Social Cognitive Theory and the constructs of decisional balance (benefits and barriers), self-efficacy, and behavioral and cognitive processes of change. Motivational readiness for physical activity and related constructs were assessed at baseline, 6 weeks, and 8 months. Linear or logistic mixed effects models were used to examine intervention effects on the constructs, and logistic mixed effects models were used for mediator analyses. At 6 weeks, the intervention had significant effects on decisional balance, self-efficacy, and behavioral processes, but these effects were not maintained at 8 months. At 6 weeks, only decisional balance and behavioral processes were identified as mediators of motivational readiness outcomes. Results suggest that interventions of greater intensity and duration may be needed for sustained changes in mediators and motivational readiness for physical activity among older adults.

Physician-based physical activity counseling for middle-aged and older adults: A randomized trial.

Sedentary behavior among older adults increases risk for chronic diseases. Physicians in a primary care setting can play an important role in promoting physical activity adoption among their older patients. The Physically Active for Life (PAL) project was a randomized, controlled trial comparing the efficacy of brief physician-delivered physical activity counseling to usual care on self-reported physical activity levels. The physical activity counseling was based on the Transtheoretical Model of Change and social learning theory. Twenty-four community-based primary care medical practices were recruited into the study; 12 were randomized to the Intervention condition and 12 to the Control condition. Physicians in the Intervention practices received training in the delivery of brief physical activity counseling. Subjects in the Intervention practices (n=181) received brief activity counseling matched to their stage of motivational readiness for physical activity, a patient manual, a follow-up appointment with their physician to discuss activity counseling, and newsletter mailings. Subjects in the Control practices (n=174) received standard care. Measures of motivational readiness for physical activity and the Physical Activity Scale for the Elderly (PASE) were administered to subjects in both conditions at baseline, 6 weeks following their initial appointment, and at 8 months. Results showed that at the 6-week follow-up, subjects in the Intervention condition were more likely to be in more advanced stages of motivational readiness for physical activity than subjects in the Control condition. This effect was not maintained at the 8 month follow-up and the intervention did not produce significant changes in PASE scores. Results suggest that more intensive, sustained interventions may be necessary to promote the adoption of physical activity among sedentary, middle-aged, and older adults in primary care medical practices.

Clinic-Based Support to Help Overweight Patients With Type 2 Diabetes Increase Physical Activity and Lose Weight

BACKGROUND Our objective was to test the effect of physicians providing brief health lifestyle counseling to patients with type 2 diabetes mellitus during usual care visits. METHODS We conducted a randomized controlled trial of a 12-month intervention at 2 large community health centers, enrolling 310 patients with a body mass index (calculated as weight in kilograms divided by height in meters squared) of 25 or greater. In the intervention group, self-management goals for nutrition and physical activity were set using a tailored computer program. Goals were then reviewed at each clinic visit by physicians. The control group received only printed health education materials. The main outcome measures included change in physical activity and body weight. RESULTS In the intervention group, recommended levels of physical activity increased from 26% at baseline to 53% at 12 months (P< .001) compared with controls (30% to 37%; P= .27), and 32% of patients in the intervention group lost 6 or more pounds at 12 months compared with 18.9% of controls (odds ratio, 2.2; P= .006). CONCLUSION A brief intervention to increase the dialogue between patients and health care providers about behavioral goals can lead to increased physical activity and weight loss.

Effects of motivational interviewing on smoking cessation in adolescents with psychiatric disorders

Objective:To test the hypothesis that among adolescent smokers hospitalised for psychiatric and substance use disorders, motivational interviewing (MI) would lead to more and longer quit attempts, reduced smoking, and more abstinence from smoking over a 12 month follow up. Design:Randomised control trial of MI versus brief advice (BA) for smoking cessation, with pre- and post-intervention assessment of self efficacy and intentions to change, and smoking outcome variables assessed at one, three, six, nine, and 12 month follow ups. Setting:A private, university affiliated psychiatric hospital in Providence, Rhode Island, USA. Patients or other participants:Consecutive sample (n = 191) of 13–17 year olds, admitted for psychiatric hospitalisation, who smoked at least one cigarette per week for the past four weeks, had access to a telephone, and did not meet DSM-IV criteria for current psychotic disorder. Interventions:MI versus BA. MI consisted of two, 45 minute individual sessions, while BA consisted of 5–10 minutes of advice and information on how to quit smoking. Eligible participants in both conditions were offered an eight week regimen of transdermal nicotine patch upon hospital discharge. Main outcome measures:Point prevalence abstinence, quit attempts, changes in smoking rate and longest quit attempt. Proximal outcomes included intent to change smoking behaviour (upon hospital discharge), and self efficacy for smoking cessation. Results:MI did not lead to better smoking outcomes compared to BA. MI was more effective than BA for increasing self efficacy regarding ability to quit smoking. A significant interaction of treatment with baseline intention to quit smoking was also found. MI was more effective than BA for adolescents with little or no intention to change their smoking, but was actually less effective for adolescents with pre-existing intention to cut down or quit smoking. However, the effects on these variables were relatively modest and only moderately related to outcome. Adolescents with comorbid substance use disorders smoked more during follow up while those with anxiety disorders smoked less and were more likely to be abstinent. Conclusions:The positive effect of MI on self efficacy for quitting and the increase in intention to change in those with initially low levels of intentions suggest the benefits of such an intervention. However, the effects on these variables were relatively modest and only moderately related to outcome. The lack of overall effect of MI on smoking cessation outcomes suggests the need to further enhance and intensify this type of treatment approach for adolescent smokers with psychiatric comorbidity.

History and symptoms of depression among smokers during a self-initiated quit attempt:

History of depression in smokers has been associated with an inability to quit smoking and with an increased likelihood of smoking relapse. This study prospectively tracked nicotine withdrawal symptoms, symptoms of depression, and ability to quit smoking between smokers with and without a probable history of major depression who were trying to quit smoking with minimal assistance. Results indicated that prior to quitting, smokers with a history of depression smoked to reduce negative affect, in response to craving, and in social situations. Additionally, positive history smokers scored higher on the Center for Epidemiological Studies Depression Scale (CES-D) than did smokers without such a history. Following a quit attempt, positive history smokers were somewhat more likely to experience greater symptoms of nicotine withdrawal than negative history smokers. However, among the positive history smokers, depressive symptoms as measured by the CES-D increased significantly 4 weeks after trying to quit, compared to a decline among negative history smokers. Positive and negative history smokers did not significantly differ on ability to quit smoking within the 30-day follow-up period. History of depression appears to be associated with a delayed increase in symptoms of depression following a quit attempt. However, it remains to be demonstrated whether such an increase in depressive symptoms may influence later probability of relapse.

Screening mammography and constructs from the transtheoretical model: Associations using two definitions of the stages-of-adoption

The two purposes of this investigation were: (a) to examine whether an association existed between stages of adopting regular mammography and decision-making constructs from the Transtheoretical Model (TTM) of behavior change, and (b) to determine whether any such associations would be found for each of the two ways of defining the stages-of-adoption. One method integrated past screening history with a report of future intention for screening; the other method used a single item with predetermined response categories. Data were from the baseline survey of 1,323 women aged 50–74 who were recruited as part of an intervention study through a local Health Maintenance Organization. Results showed that both ways of defining stages of adopting regular mammography were associated with decisional balance and processes-of-change. The method that integrated past history plus intention provided somewhat better discrimination among stages. Women who were labeled as being at “Risk of Relapse,” and those who said they waited for a “Provider’s Recommendation,” may be useful groups to add to the set of stages that have been employed so far by the TTM. In addition, a tendency to avoid the health care system in general was used as a process-of-change to complement the mammography-specific processes.

Home‐based physical activity intervention for colorectal cancer survivors

The efficacy of a home‐based physical activity (PA) intervention for colorectal cancer patients versus contact control was evaluated in a randomized controlled trial.

Multicenter Trial of Fluoxetine as an Adjunct to Behavioral Smoking Cessation Treatment

The authors evaluated the efficacy of fluoxetine hydrochloride (Prozac; Eli Lilly and Company, Indianapolis, IN) as an adjunct to behavioral treatment for smoking cessation. Sixteen sites randomized 989 smokers to 3 dose conditions: 10 weeks of placebo, 30 mg, or 60 mg fluoxetine per day. Smokers received 9 sessions of individualized cognitive-behavioral therapy, and biologically verified 7-day self-reported abstinence follow-ups were conducted at 1, 3, and 6 months posttreatment. Analyses assuming missing data counted as smoking observed no treatment difference in outcomes. Pattern-mixture analysis that estimates treatment effects in the presence of missing data observed enhanced quit rates associated with both the 60-mg and 30-mg doses. Results support a modest, short-term effect of fluoxetine on smoking cessation and consideration of alternative models for handling missing data.