Brief interventions to reduce ecstasy use : a multi-site randomized controlled trial

Studies examining the ability of motivational enhancement therapy (MET) to augment education provision among ecstasy users have produced mixed results and none have examined whether treatment fidelity was related to ecstasy use outcomes. The primary objectives of this multi-site, parallel, two-group randomized controlled trial were to determine if a single-session of MET could instill greater commitment to change and reduce ecstasy use and related problems more so than an education-only intervention and whether MET sessions delivered with higher treatment fidelity are associated with better outcomes. The secondary objective was to assess participants’ satisfaction with their assigned interventions. Participants (N = 174; Mage = 23.62) at two Australian universities were allocated randomly to receive a 15-minute educational session on ecstasy use (n = 85) or a 50-minute session of MET that included an educational component (n = 89). Primary outcomes were assessed at baseline, and then at 4-, 16-, and 24-weeks post-baseline, while the secondary outcome measure was assessed 4-weeks post-baseline by researchers blind to treatment allocation. Overall, the treatment fidelity was acceptable to good in the MET condition. There were no statistical differences at follow-up between the groups on the primary outcomes of ecstasy use, ecstasy-related problems, and commitment to change. Both interventions groups reported a 50% reduction in their ecstasy use and a 20% reduction in the severity of their ecstasy-related problems at the 24-week follow up. Commitment to change slightly improved for both groups (9% - 17%). Despite the lack of between-group statistical differences on primary outcomes, participants who received a single session of MET were slightly more satisfied with their intervention than those who received education only. MI fidelity was not associated with ecstasy use outcomes. Given these findings, future research should focus on examining mechanisms of change. Such work may suggest new methods for enhancing outcomes.

Exercise and psychosocial interventions in breast cancer survivors: Preliminary results of a randomized controlled trial

Physical and psychological decline is common in the post-treatment breast cancer population, yet the efficacy of concurrent interventions to meet both physical- psychosocial needs in this population has not been extensively examined. PURPOSE: This study explores the effects of a combined exercise and psychosocial intervention model on selected physiological-psychological parameters in post-treated breast cancer. METHODS: Forty-one breast cancer survivors were randomly assigned to one of four groups for an 8-week intervention: exercise only [EX, n=13] (aerobic and resistance training), psychosocial therapy only [PS, n=11] (biofeedback), combined EX and PS [EX+PS, n=11], or to control conditions [CO, n=6]. Mean delta score (post-intervention - baseline) were calculated for each of the following: body weight, % body fat (skin folds), predicted VO2max (Modified Bruce Protocol), overall dynamic muscular endurance [OME] (RMCRI protocol), static balance (Single leg stance test), dynamic balance (360° turn and 4-square step test), fatigue (Revised Piper Scale), and quality of life (FACT-B). A one-way ANOVA was used to analyze the preliminary results of this on-going randomized trial. RESULTS: Overall, there were significant differences in the delta scores for predicted VO2max, OME, and dynamic balance among the 4 groups (p<0.05). The EX+PS group showed a significant improvement in VO2max compared with the PS group (4.2 ± 3.8 vs. -0.9 ± 4.2 mL/kg/min; p<0.05). Both the EX+PS and EX groups showed significant improvements in OME compared with the PS and CO groups (44.5 ± 23.5 and 43.4 ± 22.1 vs. -3.9 ± 15.2 and 2.7 ± 13.7 repetitions; p<0.05). All 3 intervention groups showed significant improvements in dynamic balance compared with the CO group (-0.8 ± 0.6, -0.6 ± 0.8, and -0.6 ±1.0 vs. 0.6 ± 0.6 seconds; p<0.05). Overall, changes in fatigue tended towards significance among the 4 groups (p = 0.08), with decreased fatigue in the intervention groups and increased fatigue in the CO group. CONCLUSIONS: Our preliminary findings suggest that EX and PS seem to produce greater positive changes in the outcome measures than CO. However, at this point no definite conclusions can be made on the additive effects of combining the EX and PS interventions.

A Randomized Controlled Trial of Interventions to Promote Adjustment in Children With Congenital Heart Disease Entering School and Their Families

Objective: To report on a randomized controlled trial of psychological interventions to promote adjustment in children with congenital heart disease and their families.
Method: Following baseline assessment, 90 children (aged 4–5 years) and their families were randomly assigned to an Intervention or Control group before entering school. 68 (76%) were retained at 10-month follow-up.
Results: Gains were observed on measures of maternal mental health and family functioning. Although no differences were found on measures of child behavior at home or school, children in the intervention group were perceived as “sick” less often by their mother and missed fewer days from school. A regression model, using baseline measures as predictors, highlighted the importance of maternal mental health, worry and child neurodevelopmental functioning for child behavioral outcomes almost a year later.
Conclusions: The intervention promoted clinically significant gains for the child and family. The program is of generalizable significance.

Evaluating three self-help smoking cessation interventions for post-secondary smokers : a randomized controlled trial on six Ontario campuses

Objective. Smoking prevalence is highest among the young adult cohort. Postsecondary students are no exception. Although many students intend to quit smoking, no research has established what methods best promote reductions in, or complete abstinence from smoking. This randomized controlled trial examined the effectiveness of three self-help smoking cessation interventions. Method. On six post-secondary campuses, 483 smokers who voluntarily accessed Leave The Pack Behind (a tobacco control initiative) were randomly assigned to one of three smoking cessation interventions: One Step At A Time (a 2-booklet, *gold standard' program for adults); Smoke|Quit (a newly-developed 2-booklet program for young adult students); and usual care (a 'Quit Kit' containing a booklet on stress management, information about pharmacological quitting aides and novelty items). All participants also received one proactive telephone support call from a peer counsellor. During the study, 85 participants withdrew. The final sample of 216 students who completed baseline questionnaires and 12-week follow-up telephone interviews was representative of the initial sample in terms of demographic characteristics, and smokingquitting- related variables. Results. Whether participants quit smoking depended upon treatment condition, ^(2, N=2\6) = 6.34, p = .04, with Smoke|Quit producing more successfijl quitters (18.4%) than One Step At A Time (4.5%) or the Quit Kit (1 1.4%). On average, participants had quit 53.46 days, with no significant difference across treatments. Selfefficacy also increased. Use of the intervention or other quitting aides was not associated with treatment condition. Among the 191 participants who did not quit smoking, treatment condition did not influence outcomes. Overall, 46.2% had made a quit attempt. Significant decreases in weekly tobacco consumption and increases in self-efficacy to resist smoking were observed from baseline to follow-up. Conclusion. Post-secondary institutions represent a potentially final opportunity for age-targeted interventions. Self-help resources tailored to students' social and contextual characteristics will have considerable more impact than stage-only tailored interventions. Both reduction and abstinence outcomes should be emphasized to positively support students to stop smoking.

Effects of percutaneous coronary interventions in silent ischemia after myocardial infarction: the SWISSI II randomized controlled trial

CONTEXT: The effect of a percutaneous coronary intervention (PCI) on the long-term prognosis of patients with silent ischemia after a myocardial infarction (MI) is not known. OBJECTIVE: To determine whether PCI compared with drug therapy improves long-term outcome of asymptomatic patients with silent ischemia after an MI. DESIGN, SETTING, AND PARTICIPANTS: Randomized, unblinded, controlled trial (Swiss Interventional Study on Silent Ischemia Type II [SWISSI II]) conducted from May 2, 1991, to February 25, 1997, at 3 public hospitals in Switzerland of 201 patients with a recent MI, silent myocardial ischemia verified by stress imaging, and 1- or 2-vessel coronary artery disease. Follow-up ended on May 23, 2006. INTERVENTIONS: Percutaneous coronary intervention aimed at full revascularization (n = 96) or intensive anti-ischemic drug therapy (n = 105). All patients received 100 mg/d of aspirin and a statin. MAIN OUTCOME MEASURES: Survival free of major adverse cardiac events defined as cardiac death, nonfatal MI, and/or symptom-driven revascularization. Secondary measures included exercise-induced ischemia and resting left ventricular ejection fraction during follow-up. RESULTS: During a mean (SD) follow-up of 10.2 (2.6) years, 27 major adverse cardiac events occurred in the PCI group and 67 events occurred in the anti-ischemic drug therapy group (adjusted hazard ratio, 0.33; 95% confidence interval, 0.20-0.55; P<.001), which corresponds to an absolute event reduction of 6.3% per year (95% confidence interval, 3.7%-8.9%; P<.001). Patients in the PCI group had lower rates of ischemia (11.6% vs 28.9% in patients in the drug therapy group at final follow-up; P = .03) despite fewer drugs. Left ventricular ejection fraction remained preserved in PCI patients (mean [SD] of 53.9% [9.9%] at baseline to 55.6% [8.1%] at final follow-up) and decreased significantly (P<.001) in drug therapy patients (mean [SD] of 59.7% [11.8%] at baseline to 48.8% [7.9%] at final follow-up). CONCLUSION: Among patients with recent MI, silent myocardial ischemia verified by stress imaging, and 1- or 2-vessel coronary artery disease, PCI compared with anti-ischemic drug therapy reduced the long-term risk of major cardiac events. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00387231.

Comparing different boosters of planning interventions on changes in fat consumption in overweight and obese individuals: A randomized controlled trial

Single planning interventions have been found to promote short-term dietary change. Repeated planning interventions may foster long-term effects on behavior change. It remains unknown whether there is a critical number of boosters to establish long-term maintenance of behavioral changes. This study aimed at investigating what social-cognitive variables mediate the effects of the interventions on dietary behavior change. Overall, 373 participants (n = 270 women, 72.4%; age M = 52.42, SD = 12.79) were randomly allocated to one of five groups: a control group, a single planning group, and three groups with 3, 6, or 9 weeks' repeated planning interventions. Follow-ups took place 4, 6, and 12 months after baseline. Change in fat consumption was not promoted by any of the interventions. In terms of social-cognitive variables, intentions, self-efficacy and coping planning displayed a time × group interaction, with the 9 weeks' planning group showing the most beneficial effects. Effect sizes, however, were very small. None of the tested planning interventions successfully promoted change in fat consumption across the 12 month period. This, however, could not be explained by problems with adherence to the intervention protocol. Potential explanations for this unexpected result are discussed.

A Comparison of Methodologies from Two Longitudinal Community-Based Randomized Controlled Trials of Similar Interventions in Palliative Care: What Worked and What Did Not

Background: Methodological challenges such as recruitment problems and participant burden make clinical trials in palliative care difficult. In 2001-2004, two community-based randomized controlled trials (RCTs) of case conferences in palliative care settings were independently conducted in Australia-the Queensland Case Conferences trial (QCC) and the Palliative Care Trial (PCT). Design: A structured comparative study of the QCC and PCT was conducted, organized by known practical and organizational barriers to clinical trials in palliative care. Results: Differences in funding dictated study designs and recruitment success; PCT had 6 times the budget of QCC. Sample size attainment. Only PCT achieved the sample size goal. QCC focused on reducing attrition through gatekeeping while PCT maximized participation through detailed recruitment strategies and planned for significant attrition. Testing sustainable interventions. QCC achieved a higher percentage of planned case conferences; the QCC strategy required minimal extra work for clinicians while PCT superimposed conferences on normal work schedules. Minimizing participant burden. Differing strategies of data collection were implemented to reduce participant burden. QCC had short survey instruments. PCT incorporated all data collection into normal clinical nursing encounters. Other. Both studies had acceptable withdrawal rates. Intention-to-treat analyses are planned. Both studies included substudies to validate new outcome measures. Conclusions: Health service interventions in palliative care can be studied using RCTs. Detailed comparative information of strategies, successes and challenges can inform the design of future trials. Key lessons include adequate funding, recruitment focus, sustainable interventions, and mechanisms to minimize participant burden.

Randomized controlled trial of cognitive-behavioural therapy for coexisting depression and alcohol problems : short-term outcome

AIMS: Alcohol use disorders and depression co-occur frequently and are associated with poorer outcomes than when either condition occurs alone. The present study (Depression and Alcohol Integrated and Single-focused Interventions; DAISI) aimed to compare the effectiveness of brief intervention, single-focused and integrated psychological interventions for treatment of coexisting depression and alcohol use problems. METHODS: Participants (n = 284) with current depressive symptoms and hazardous alcohol use were assessed and randomly allocated to one of four individually delivered interventions: (i) a brief intervention only (single 90-minute session) with an integrated focus on depression and alcohol, or followed by a further nine 1-hour sessions with (ii) an alcohol focus; (iii) a depression focus; or (iv) an integrated focus. Follow-up assessments occurred 18 weeks after baseline. RESULTS: Compared with the brief intervention, 10 sessions were associated with greater reductions in average drinks per week, average drinking days per week and maximum consumption on 1 day. No difference in duration of treatment was found for depression outcomes. Compared with single-focused interventions, integrated treatment was associated with a greater reduction in drinking days and level of depression. For men, the alcohol-focused rather than depression-focused intervention was associated with a greater reduction in average drinks per day and drinks per week and an increased level of general functioning. Women showed greater improvements on each of these variables when they received depression-focused rather than alcohol-focused treatment. CONCLUSIONS: Integrated treatment may be superior to single-focused treatment for coexisting depression and alcohol problems, at least in the short term. Gender differences between single-focused depression and alcohol treatments warrant further study.

Patient education to prevent falls among older hospital inpatients : a randomized controlled trial

Background Falls are a common adverse event during hospitalization of older adults, and few interventions have been shown to prevent then. Methods This study was a 3-group randomized trial to evaluate the efficacy of 2 forms of multimedia patient education compared with usual care for the prevention of in-hospital falls. Older hospital patients (n = 1206) admitted to a mixture of acute (orthopedic, respiratory, and medical) and subacute (geriatric and neurorehabilitation) hospital wards at 2 Australian hospitals were recruited between January 2008 and April 2009. The interventions were a multimedia patient education program based on the health-belief model combined with trained health professional follow-up (complete program), multi-media patient education materials alone (materials only), and usual care (control). Falls data were collected by blinded research assistants by reviewing hospital incident reports, hand searching medical records, and conducting weekly patient interviews. Results Rates of falls per 1000 patient-days did not differ significantly between groups (control, 9.27; materials only, 8.61; and complete program, 7.63). However, there was a significant interaction between the intervention and presence of cognitive impairment. Falls were less frequent among cognitively intact patients in the complete program group (4.01 per 1000 patient-days) than among cognitively intact patients in the materials-only group (8.18 per 1000 patient-days) (adjusted hazard ratio, 0.51; 95% confidence interval, 0.28-0.93]) and control group (8.72 per 1000 patient-days) (adjusted hazard ratio, 0.43; 95% confidence interval, 0.24-0.78). Conclusion Multimedia patient education with trained health professional follow-up reduced falls among patients with intact cognitive function admitted to a range of hospital wards.

Living well with diabetes: a randomized controlled trial of a telephone-delivered intervention for maintenance of weight loss, physical activity and glycaemic control in adults with type 2 diabetes

Background By 2025, it is estimated that approximately 1.8 million Australian adults (approximately 8.4% of the adult population) will have diabetes, with the majority having type 2 diabetes. Weight management via improved physical activity and diet is the cornerstone of type 2 diabetes management. However, the majority of weight loss trials in diabetes have evaluated short-term, intensive clinic-based interventions that, while producing short-term outcomes, have failed to address issues of maintenance and broad population reach. Telephone-delivered interventions have the potential to address these gaps. Methods/Design Using a two-arm randomised controlled design, this study will evaluate an 18-month, telephone-delivered, behavioural weight loss intervention focussing on physical activity, diet and behavioural therapy, versus usual care, with follow-up at 24 months. Three-hundred adult participants, aged 20-75 years, with type 2 diabetes, will be recruited from 10 general practices via electronic medical records search. The Social-Cognitive Theory driven intervention involves a six-month intensive phase (4 weekly calls and 11 fortnightly calls) and a 12-month maintenance phase (one call per month). Primary outcomes, assessed at 6, 18 and 24 months, are: weight loss, physical activity, and glycaemic control (HbA1c), with weight loss and physical activity also measured at 12 months. Incremental cost-effectiveness will also be examined. Study recruitment began in February 2009, with final data collection expected by February 2013. Discussion This is the first study to evaluate the telephone as the primary method of delivering a behavioural weight loss intervention in type 2 diabetes. The evaluation of maintenance outcomes (6 months following the end of intervention), the use of accelerometers to objectively measure physical activity, and the inclusion of a cost-effectiveness analysis will advance the science of broad reach approaches to weight control and health behaviour change, and will build the evidence base needed to advocate for the translation of this work into population health practice.

Cost effectiveness of patient education for the prevention of falls in hospital : economic evaluation from a randomized controlled trial

Background Falls are one of the most frequently occurring adverse events that impact upon the recovery of older hospital inpatients. Falls can threaten both immediate and longer-term health and independence. There is need to identify cost-effective means for preventing falls in hospitals. Hospital-based falls prevention interventions tested in randomized trials have not yet been subjected to economic evaluation. Methods Incremental cost-effectiveness analysis was undertaken from the health service provider perspective, over the period of hospitalization (time horizon) using the Australian Dollar (A$) at 2008 values. Analyses were based on data from a randomized trial among n = 1,206 acute and rehabilitation inpatients. Decision tree modeling with three-way sensitivity analyses were conducted using burden of disease estimates developed from trial data and previous research. The intervention was a multimedia patient education program provided with trained health professional follow-up shown to reduce falls among cognitively intact hospital patients. Results The short-term cost to a health service of one cognitively intact patient being a faller could be as high as A$14,591 (2008). The education program cost A$526 (2008) to prevent one cognitively intact patient becoming a faller and A$294 (2008) to prevent one fall based on primary trial data. These estimates were unstable due to high variability in the hospital costs accrued by individual patients involved in the trial. There was a 52% probability the complete program was both more effective and less costly (from the health service perspective) than providing usual care alone. Decision tree modeling sensitivity analyses identified that when provided in real life contexts, the program would be both more effective in preventing falls among cognitively intact inpatients and cost saving where the proportion of these patients who would otherwise fall under usual care conditions is at least 4.0%. Conclusions This economic evaluation was designed to assist health care providers decide in what circumstances this intervention should be provided. If the proportion of cognitively intact patients falling on a ward under usual care conditions is 4% or greater, then provision of the complete program in addition to usual care will likely both prevent falls and reduce costs for a health service.

Home-based activity program for older people with depressive symptoms: DeLLITE–A randomized controlled trial

PURPOSE We wanted to assess the effectiveness of a home-based physical activity program, the Depression in Late Life Intervention Trial of Exercise (DeLLITE), in improving function, quality of life, and mood in older people with depressive symptoms. METHODS We undertook a randomized controlled trial involving 193 people aged 75 years and older with depressive symptoms at enrollment who were recruited from primary health care practices in Auckland, New Zealand. Participants received either an individualized physical activity program or social visits to control for the contact time of the activity intervention delivered over 6 months. Primary outcome measures were function, a short physical performance battery comprising balance and mobility, and the Nottingham Extended Activities of Daily Living scale. Secondary outcome measures were quality of life, the Medical Outcomes Study 36-item short form, mood, Geriatric Depression Scale (GDS-15), physical activity, Auckland Heart Study Physical Activity Questionnaire, and self-report of falls. Repeated measures analyses tested the differential impact on outcomes over 12 months’ follow-up. RESULTS The mean age of the participants was 81 years, and 59% were women. All participants scored in the at–risk category on the depression screen, 53% had a Diagnostic and Statistical Manual of Mental Disorders or International Classification of Diseases, Tenth Revision diagnosis of major depression or scored more than 4 on the GDS-15 at baseline, indicating moderate or severe depression. Almost all participants, 187 (97%), completed the trial. Overall there were no differences in the impact of the 2 interventions on outcomes. Mood and mental health related quality of life improved for both groups. CONCLUSION he DeLLITE activity program improved mood and quality of life for older people with depressive symptoms as much as the effect of social visits. Future social and activity interventions should be tested against a true usual care control.

Moving MobileMums forward: protocol for a larger randomized controlled trial of an improved physical activity program for women with young children

Background: Women with young children (under 5 years) are a key population group for physical activity intervention. Previous evidence highlights the need for individually tailored programs with flexible delivery mechanisms for this group. Our previous pilot study suggested that an intervention primarily delivered via mobile phone text messaging (MobileMums) increased self-reported physical activity in women with young children. An improved version of the MobileMums program is being compared with a minimal contact control group in a large randomised controlled trial (RCT). Methods/design: This RCT will evaluate the efficacy, feasibility and acceptability, cost-effectiveness, mediators and moderators of the MobileMums program. Primary (moderate-vigorous physical activity) and secondary (intervention implementation data, health service use costs, intervention costs, health benefits, theoretical constructs) outcomes are assessed at baseline, 3-months (end of intervention) and 9-months (following 6-month no contact: maintenance period). The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12611000481976; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=336109).The intervention commences with a face-to-face session with a behavioural counsellor to initiate rapport and gather information for tailoring the 12-week text message program. During the program participants also have access to a: MobileMums Participant Handbook, MobileMums refrigerator magnet, MobileMums Facebook(C) group, and a MobileMums website with a searchable, on-line exercise directory. A nominated support person also receives text messages for 12-weeks encouraging them to offer their MobileMum social support for physical activity. Discussion: Results of this trial will determine the efficacy and cost-effectiveness of the MobileMums program, and the feasibility of delivering it in a community setting. It will inform the broader literature of physical activity interventions for women with young children and determine whether further investment in the translation of the program is warranted.