Worksite intervention effects on sleep quality: a randomized controlled trial

Employees with sleep disturbance are at increased risk of disease. Exercise is believed to be effective for improving sleep quality, but few studies have been conducted. This study investigated the effects of a 24-week worksite exercise/behavioral intervention on self-rated sleep quality, via the Pittsburgh Sleep Quality Index (PSQI), in 73 employees. Greater post-test improvements in the PSQI (-2.0 +/- 2.6 vs. -1.3 +/- 2.7 points, p = .006, and -16 +/- 61 vs. -1 +/- 76%, p = .02) were found in treatment versus controls, and in women versus men (by -2.7 points [-5.0 to -0.3 points, p = .03], and by -72% [-142 to -2%, p = .04]). Similar results were found in the shift worker subgroup. Changes in sleep scores were not significantly related to baseline characteristics, changes in psychological health or quality-of-life scores, or level of exercise compliance.     

Evaluation of a Web-based intervention to promote hand hygiene: exploratory randomized controlled trial

Background

Hand-washing is regarded as a potentially important behavior for preventing transmission of respiratory infection, particularly during a pandemic.

Objective

The objective of our study was to evaluate whether a Web-based intervention can encourage more frequent hand-washing in the home, and to examine potential mediators and moderators of outcomes, as a necessary first step before testing effects of the intervention on infection rates in the PRIMIT trial (PRimary care trial of a website based Infection control intervention to Modify Influenza-like illness and respiratory infection Transmission).

Methods

In a parallel-group pragmatic exploratory trial design, 517 nonblinded adults recruited through primary care were automatically randomly assigned to a fully automated intervention comprising 4 sessions of tailored motivational messages and self-regulation support (n = 324) or to a no-intervention control group (n = 179; ratio 2:1). Hand-washing frequency and theory of planned behavior cognitions relating to hand-washing were assessed by online questionnaires at baseline (in only half of the control participants, to permit evaluation of effects of baseline assessment on effect sizes), at 4 weeks (postintervention; all participants), and at 12 weeks.

Results

Hand-washing rates in the intervention group were higher at 4 weeks than in the control group (mean 4.40, n = 285 and mean 4.04, n = 157, respectively; P < .001, Cohen d = 0.42) and remained higher at 12 weeks (mean 4.45, n = 282 and mean 4.12, n = 154, respectively; P < .001, Cohen d = 0.34). Hand-washing intentions and positive attitudes toward hand-washing increased more from baseline to 4 weeks in the intervention group than in the control group. Mediation analyses revealed positive indirect effects of the intervention on change in hand-washing via intentions (coefficient = .15, 95% confidence interval [CI], .08–.26) and attitudes (coefficient = 0.16, 95% CI, .09–.26). Moderator analyses confirmed that the intervention was similarly effective for men and women, those of higher and lower socioeconomic status, and those with higher and lower levels of perceived risk.

Conclusions

This study provides promising evidence that Web-based interventions could potentially provide an effective method of promoting hand hygiene in the home. Data were collected during the 2010 influenza pandemic, when participants in both groups had already been exposed to extensive publicity about the need for hand hygiene, suggesting that our intervention could add to existing public health campaigns. However, further research is required to determine the effects of the intervention on actual infection rates.

Trial

International Standard Randomized Controlled Trial Number (ISRCTN): 75058295; http://www.controlled-trials.com/ISRCTN75058295 (Archived by WebCite at http://www.webcitation.org/62KSbkNmm)     

A randomized, controlled pilot trial of a school intervention for children with sickle cell anemia

OBJECTIVE: To investigate the feasibility and efficacy of a randomized clinical pilot trial comparing routine services (RS) with a school intervention program (SIP) for children with sickle cell anemia (SCA). METHOD: Twenty-four children (ages 8-12 years) with SCA were randomized to RS or SIP. General disease knowledge, consumer satisfaction, self-concept, and school absences were evaluated. RESULTS: Compared with children receiving RS, children and teachers receiving SIP evidenced more accurate information about their disease, and children with SCA had significantly fewer absences. Teachers receiving SIP reported higher consumer satisfaction. CONCLUSIONS: A modest educational curriculum can increase knowledge of SCA, is associated with lower absence rates, and yields high consumer satisfaction ratings.     

The evaluation of a brief motivational intervention to promote intention to participate in cardiac rehabilitation: A randomized controlled trial

Objectives

Cardiac rehabilitation (CR) is an effective treatment for cardiovascular disease, yet many referred patients do not participate. Motivational interviewing could be beneficial in this context, but efficacy with prospective CR patients has not been examined. This study investigated the impact of motivational interviewing on intention to participate in CR.

Feasibility,acceptability, and effectiveness of a decision aid versus an informational website to promote clinical trial decision-making among cancer patients: A pilot randomized controlled trial

ObjectiveTo assess intervention feasibility and acceptability, and compare the effectiveness of the CHOICES Decision Aid (DA) versus the National Cancer Institute (NCI) Cancer Clinical Trials (CCT) website to improve knowledge about CCTs and preparedness to make an informed decision.MethodsOncology patients (n = 101) with a scheduled clinic visit were enrolled and randomized. Decision-making variables were collected at two timepoints. Post-intervention scores were examined via paired t-tests and multivariate regression analyses. Predictors of the magnitudes of the change in scores were examined in multivariable regression analyses.ResultsThe interventions were feasible to implement and acceptable to participants. Both interventions increased objective and subjective knowledge, improved clarity of opinions, and reduced decisional conflict (p-values < 0.01). Improvements in the belief that one could find out about CCTs were observed in the CHOICES DA arm (p < 0.001). Multivariable analyses controlling for educational attainment showed no significant differences in the magnitude of change in outcome variables between intervention arms, but did find that improvements in some variables in the NCI arm – but not CHOICES DA arm – were associated with previous educational attainment.ConclusionsInterventions were feasible to implement and acceptable. Improvements in knowledge and decision-making outcomes were observed in both arms, supporting the view that interventions to improve CCT decision making are effective and feasible. Our results suggest that the CHOICES DA may be more effective than an informational website in improving decision-making outcomes regardless of participants’ educational attainment.Practice implicationsCCT resources should support informed decision-making among all cancer survivors, regardless of educational attainment.     

A text messaging intervention to promote medication adherence for patients with coronary heart disease: A randomized controlled trial

Objective

Pharmacologic treatment for secondary prevention of coronary heart disease (CHD) is critical to prevent adverse clinical outcomes. In a randomized controlled trial, we compared antiplatelet and statin adherence among patients with CHD who received: (1) text messages (TM) for medication reminders and education, (2) educational TM only, or (3) No TM.

Methods

A mobile health intervention delivered customized TM for 30 days. We assessed and analyzed medication adherence with electronic monitoring devices [Medication Event Monitoring System (MEMS)] by one-way ANOVA and Welch tests, two-way TM response rates by t-tests, and self-reported adherence (Morisky Medication Adherence Scale) by Repeated Measures ANOVA.

Results

Among 90 patients (76% male, mean age 59.2 years), MEMS revealed patients who received TM for antiplatelets had a higher percentage of correct doses taken (p = 0.02), percentage number of doses taken (p = 0.01), and percentage of prescribed doses taken on schedule (p = 0.01). TM response rates were higher for antiplatelets than statins (p = 0.005). Self-reported adherence revealed no significant differences among groups.

Conclusion

TM increased adherence to antiplatelet therapy demonstrated by MEMS and TM responses.

Practice implications

Feasibility and high satisfaction were established. Mobile health interventions show promise in promoting medication adherence.     

A pilot randomized, controlled trial of a longitudinal residents-as-teachers curriculum.

PURPOSE: To determine whether a longitudinal residents-as-teachers curriculum improves generalist residents' teaching skills. METHOD: From May 2001 to February 2002, 23 second-year generalist residents in four residencies affiliated with the University of California, Irvine, College of Medicine, completed a randomized, controlled trial of a longitudinal residents-as-teachers program. Thirteen intervention residents underwent a 13-hour curriculum during one-hour noon conferences twice monthly for six months, practicing teaching skills and receiving checklist-guided feedback. In a 3.5-hour, eight-station objective structured teaching examination (OSTE) enacted and rated by 15 senior medical students before and after the curriculum, two trained, blinded raters independently assessed each station with detailed, case-specific rating scales (rating scale reliability = 0.96, inter-rater reliability = 0.78). RESULTS: The intervention and control groups were similar in academic performance, specialty distribution, and gender (chi(2) = 0.434, p =.81). On a five-point Likert scale (5 = best teaching skills), intervention and control residents showed similar mean pretest OSTE scores (2.83 vs. 2.88, p =.736). The intervention group improved their mean overall OSTE scores 22.3% (more than two standard deviations) from 2.83 (pretest) to 3.46 (post-test; p <.0005; 95% CI 0.53 to 0.72). Intervention residents also improved significantly on six of eight OSTE stations. Within the control group, no pretest-to-post-test change achieved statistical significance. Mann-Whitney and Wilcoxon signed-rank tests confirmed these results. CONCLUSIONS: Generalist residents randomly assigned to receive a 13-hour longitudinal residents-as-teachers curriculum consistently showed improved OSTE scores. Future research should clarify which aspects of residents-as-teachers curricula most effectively improve educational outcomes.     

A Sleep Position Trainer for positional sleep apnea: a randomized,controlled trial

We tested the effect of the Sleep Position Trainer, a vibrational device, for positional sleep apnea in an open, randomized controlled trial with 101 patients, where 52 patients were allocated to Sleep Position Trainer and 49 patients to a non‐treatment control group for 2 months (Part 1). All patients were then followed as a cohort for a period of 6 months with use of the Sleep Position Trainer (Part 2). The participants were assessed with polygraphy at entry, and after 2 and 6 months. The mean apnea–hypopnea index supine was 35 per h (SD, 18) in the Sleep Position Trainer group and 38 per h (SD, 15) in the control group at entry. In a per protocol analysis, the mean total apnea–hypopnea index at entry and after 2 months in the Sleep Position Trainer group was 18 per h (SD, 10) and 10 per h (SD, 9; P < 0.001) versus 20 per h (SD, 9) and 18 per h (SD, 10; NS) in the control group. The mean supine sleep time decreased from 47% (SD, 22) to 17% (SD, 18; P < 0.001) in the Sleep Position Trainer group after 2 months. In the control group, the mean supine sleep time was 48% (SD, 20) at entry and 39% (SD, 21; NS) after 2 months. The positive effect of Sleep Position Trainer was maintained in all patients treated with Sleep Position Trainer after 6 months. Daytime sleepiness improved after 6 months. Compliance with the Sleep Position Trainer device during the first 2 months, defined as use of Sleep Position Trainer >4 h per night for all weekdays, was 75.5% (SD 21.2). The discontinuation rate was 28.8 and 49.4% after 2 and 6 months, respectively.     

An intervention to reduce postpartum depressive symptoms: a randomized controlled trial

Depressive symptoms and depression are a common complication of childbirth, and a growing body of literature suggests that there are modifiable factors associated with their occurrence. We developed a behavioral educational intervention targeting these factors and successfully reduced postpartum depressive symptoms in a randomized trial among low-income black and Latina women. We now report results of 540 predominantly white, high-income mothers in a second randomized trial. Mothers in the intervention arm received a two-step intervention that prepared and educated mothers about modifiable factors associated with postpartum depressive symptoms (e.g., physical symptoms, low self-efficacy), bolstered social support, and enhanced management skills. The control arm received enhanced usual care. Participants were surveyed prior to randomization, 3 weeks, 3 months, and 6 months postpartum. Depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS of 10 or greater). Prevalence of depressive symptoms postpartum was unexpectedly low precluding detection of difference in rates of depressive symptoms among intervention versus enhanced usual care posthospitalization: 3 weeks (6.0 vs. 5.6 %, p?=?0.83), 3 months (5.1 vs. 6.5 %, p?=?0.53), and 6 months (3.6 vs. 4.6 %, p?=?0.53).     

A culturally competent asthma management intervention: a randomized controlled pilot study.

BACKGROUND: Despite significant medical advances, many ethnic and racial minority children who live in inner cities continue to experience disproportionately high levels of asthma morbidity and mortality compared with white children. As a result, a growing number of psychosocial asthma management interventions are being developed to address their needs; however, only a few of these interventions have incorporated cultural variables into their treatments and have had their efficacy evaluated. OBJECTIVE: To examine the efficacy of the Multifamily Asthma Group Treatment (MFAGT), designed to enhance asthma management and reduce emergency department (ED) visits among African American and Hispanic families. METHODS: Twenty-four African American and Hispanic families who have children with asthma were randomly assigned to either the MFAGT or the Standard Psychoeducational Asthma Intervention. Differences in the number of ED visits and the level of asthma management in both groups were compared 1 year before and 1 year after the intervention. In addition, these groups were contrasted to a control group that did not receive any psychoeducational intervention. RESULTS: The MFAGT was significantly (P = .04) more effective than the Standard Psychoeducational Asthma Intervention and the control in decreasing ED visits and increasing parental asthma knowledge. CONCLUSIONS: These preliminary results suggest that the MFAGT is efficacious in enhancing asthma management and in reducing ED visits in inner-city African American and Hispanic children from a lower socioeconomic background.     

A dietary supplement to improve the quality of sleep: a randomized placebo controlled trial

Background  

To evaluate the effect of a dietary supplement containing polyunsaturated fatty acids, in association with Humulus lupulus extract, on the quality of sleep using the Leeds sleep evaluation questionnaire (LSEQ) in subjects with moderate to severe sleep disorders.     

A randomized,controlled pilot trial of hormone therapy for menopausal insomnia

Insomnia is a frequent climacteric symptom. This pilot, double-blind, randomized placebo-controlled trial compared estradiol associated with trimegestone or placebo in 12 women with perimenopausal insomnia. The Pittsburgh Sleep Quality Index (PSQI) was administered, and polysomnography was performed at baseline and after 28 days. Sleep efficiency and median score of the PSQI improved significantly in the hormone therapy group (HT) (p = 0.041 and p = 0.027, respectively) and not in placebo group. Perimenopausal insomnia improved after short-term HT.     

A multifaith spiritually based intervention for generalized anxiety disorder: a pilot randomized trial

This pilot trial evaluated the efficacy of a multifaith spiritually based intervention (SBI) for generalized anxiety disorder (GAD). Patients meeting DSM‐IV criteria for GAD of at least moderate severity were randomized to either 12 sessions of the SBI (n=11) delivered by a spiritual care counselor or 12 sessions of psychologist‐administered cognitive‐behavioral therapy (CBT; n=11). Outcome measures were completed at baseline, post‐treatment, and 3‐month and 6‐month follow‐ups. Primary efficacy measures included the Hamilton Anxiety Rating Scale, Beck Anxiety Inventory, and Penn State Worry Questionnaire. Data analysis was performed on the intent‐to‐treat sample using the Last Observation Carried Forward method. Eighteen patients (82%) completed the study. The SBI produced robust and clinically significant reductions from baseline in psychic and somatic symptoms of GAD and was comparable in efficacy to CBT. A reduction in depressive symptoms and improvement in social adjustment was also observed. Treatment response occurred in 63.6% of SBI‐treated and 72.3% of CBT‐treated patients. Gains were maintained at 3‐month and 6‐month follow‐ups. These preliminary findings are encouraging and suggest that a multifaith SBI may be an effective treatment option for GAD. Further randomized controlled trials are needed to establish the efficacy of this intervention. © 2010 Wiley Periodicals, Inc. J Clin Psychol: 66(4):1–12, 2010.     

A guided Internet-delivered intervention for adjustment disorders: A randomized controlled trial

Evidence of self-help interventions for adjustment disorder (AjD) is limited. This study aims at testing in a randomized controlled trial (RCT) the effectiveness of a disorder-specific, Internet-delivered cognitive–behavioural therapy (ICBT) intervention for AjD. Participants were randomly allocated to either an ICBT with brief weekly telephone support (n = 34) or a waiting list group (n = 34). Beck's inventories for depression and anxiety were used as primary outcomes. The secondary outcomes were AjD symptoms, post-traumatic growth, positive and negative affect, and quality of life. In all, 76.5% of the participants completed the intervention. Compared with the control group, participants in the intervention condition showed significantly greater improvement in all outcomes (Cohen's d ranged from 0.54 to 1.21) except in anxiety symptoms measured by Beck Anxiety Inventory (d = 0.27). Only ICBT group showed a significant improvement in post-traumatic growth, positive and negative affect, and quality of life. The number of cases that achieved clinically meaningful change in all outcome measures was also higher in the ICBT group. All therapeutic gains were maintained at 3-, 6- and 12-month follow-ups. The current study provides evidence on the effectiveness of ICBT interventions to reduce the impact of AjD. Results suggest that brief self-help intervention with minimal therapist support is more effective than the mere passage of time in reducing the distress symptoms associated to the disorder and also can confer additional benefits.     

Simulation-based childbirth education for Chinese primiparas: A pilot randomized controlled trial

ObjectiveTo evaluate the effectiveness and feasibility of simulation-based childbirth education (SBCE) on reducing fear of childbirth (FOC) of Chinese primiparas.MethodsA total of 56 primiparas completed the trial including 26 in the intervention group and 30 in the control group. The intervention group received four sessions of SBCE while the control group received routine prenatal care. Chinese versions of the Wijma Delivery Expectancy/Experience Questionnaire (WDEQ-A) and Childbirth Self-Efficacy Inventory (CBSEI) were used to evaluate FOC and childbirth self-efficacy. Birth outcomes including delivery method, labor duration and Apgar scores were collected.ResultsScores on the WDEQ-A of the intervention group were statistically lower than those of the control group (P < 0.05). The CBSEI scores of the intervention group were significantly higher than those of the control group (P < 0.05). The cesarean birth rate of the intervention group was lower than that of the control group (34.61% vs 46.67%, P > 0.05).ConclusionSimulation-based childbirth education alleviates FOC, increases childbirth self-efficacy and improves birth outcomes, providing a new perspective to alleviate FOC of primiparas in the future.Practice implicationsSimulation-based childbirth education is an effective and feasible method to educate women about childbirth. Its integration into routine prenatal care of Chinese primiparas should be encouraged to reduce FOC.     

Probiotics and the immunological response to infant vaccinations; a double-blind randomized controlled trial

Objectives

To examine the effect of a combination of probiotics on the antibody response to pneumococcal and pertussis vaccination in healthy Danish children, aged 8–14 months, at the time of starting day care. Moreover, the cytokine response to lipopolysaccharide of whole blood was assessed.

Posttraumatic sleep disturbances in veterans: A pilot randomized controlled trial of cognitive behavioral therapy for insomnia and imagery rehearsal therapy

Objectives

Posttraumatic stress disorder (PTSD) is associated with sleep disturbances including insomnia and nightmares. This study compared cognitive behavioral therapy for insomnia (CBT-I) with CBT-I combined with imagery rehearsal therapy (IRT) for nightmares to evaluate if the combined treatment led to greater reductions in trauma-related sleep disturbances in Australian veterans.

Methods

Veterans with diagnosed PTSD, high insomnia symptom severity, and nightmares (N = 31) were randomized to eight group CBT-I sessions or eight group CBT-I + IRT sessions. Self-reported sleep, nightmare, and psychological measures (primary outcome: Pittsburgh Sleep Quality Index), and objective actigraphy data were collected; the effect of obstructive sleep apnea (OSA) risk on treatment outcomes was also examined.

Results

No treatment condition effects were detected for the combined treatment compared to CBT-I alone, and no moderating effect of OSA risk was detected. On average, participants from both groups improved on various self-report measures over time (baseline to 3 months posttreatment). Despite the improvements, mean scores for sleep-specific measures remained indicative of poor sleep quality. There were also no significant differences between the groups on the actigraphy indices.

Conclusions

The findings indicate that there is potential to optimize both treatments for veterans with trauma-related sleep disturbances.     

Using self-determination theory to promote physical activity and weight control: a randomized controlled trial in women

Behavior change interventions are effective to the extent that they affect appropriately-measured outcomes, especially in experimental controlled trials. The primary goal of this study was to analyze the impact of a 1-year weight management intervention based on self-determination theory (SDT) on theory-based psychosocial mediators, physical activity/exercise, and body weight and composition. Participants were 239 women (37.6 ± 7.1 years; 31.5 ± 4.1 kg/m²) who received either an intervention focused on promoting autonomous forms of exercise regulation and intrinsic motivation, or a general health education program (controls). At 12 months, the intervention group showed increased weight loss (−7.29%,) and higher levels of physical activity/exercise (+138 ± 26 min/day of moderate plus vigorous exercise; +2,049 ± 571 steps/day), compared to controls (P < 0.001). Main intervention targets such as more autonomous self-regulation (for treatment and for exercise) and a more autonomous perceived treatment climate revealed large effect sizes (between 0.80 and .96), favoring intervention (P < 0.001). Results suggest that interventions grounded in SDT can be successfully implemented in the context of weight management, enhancing the internalization of more autonomous forms of behavioral regulation, and facilitating exercise adherence, while producing clinically-significant weight reduction, when compared to a control condition. Findings are fully consistent with previous studies conducted within this theoretical framework in other areas of health behavior change.