Control condition design and implementation features in controlled trials: a meta-analysis of trials evaluating psychotherapy for depression.

ABSTRACT: Control conditions are the primary methodology used to reduce threats to internal validity in randomized controlled trials (RCTs). This meta-analysis examined the effects of control arm design and implementation on outcomes in RCTs examining psychological treatments for depression. A search of MEDLINE, PsycINFO, and EMBASE identified all RCTs evaluating psychological treatments for depression published through June 2009. Data were analyzed using mixed-effects models. One hundred twenty-five trials were identified yielding 188 comparisons. Outcomes varied significantly depending control condition design (p < 0.0001). Significantly smaller effect sizes were seen when control arms used manualization (p = 0.006), therapist training (p = 0.002), therapist supervision (p = 0.009), and treatment fidelity monitoring (p = 0.003). There were no significant effects for differences in therapist experience, level of expertise in the treatment delivered, or nesting vs. crossing therapists in treatment arms. These findings demonstrate the substantial effect that decisions regarding control arm definition and implementation can have on RCT outcomes.

Telephone-based self-change modules help stabilize early natural recovery in problem drinkers.

OBJECTIVE: Self-guided attempts to resolve drinking problems are common, but little is known about the processes by which supportive interventions of lower intensity might promote resolution. This study investigated how brief supportive educational modules delivered as part of an interactive voice response self-monitoring (IVR SM) system helped stabilize initial resolution among otherwise untreated problem drinkers. METHOD: Recently resolved problem drinkers allocated to the intervention group of a randomized controlled trial were offered IVR access for 24 weeks to report daily drinking and hear weekly educational modules designed to support resolution. Using data from the 70 active IVR callers, hierarchical linear models evaluated whether module retrieval reduced subsequent alcohol consumption, including high-risk drinking, and whether module retrieval attenuated the effects on drinking of established proximal risk factors for relapse (e.g., urges, drug use, and weekends). The analyses controlled for initial resolution status (abstinence or low-risk drinking). RESULTS: Urges, drug use, and weekends were associated with increased drinking reports on the next IVR call (all ps < .01), whereas retrieving a module was associated with decreases in next-call drinking reports, including high-risk drinking episodes (p < .05). Module retrieval, however, did not reduce or buffer the effects of urges on drinking. Findings were similar across initially abstinent and low-risk drinkers. CONCLUSIONS: IVR-delivered supportive educational modules may help stabilize initial problem-drinking resolutions, but mechanisms of change deserve more study. The study adds to evidence of the co-occurring negative effects of multiple behavioral and environmental risk factors on the temporal patterning of post-recovery alcohol use.

High survival in young patients using a second generation uncemented total hip replacement.

PURPOSE: Whilst excellent long-term results with contemporary uncemented stems have been reported for total hip arthroplasty in young patients, the survival rates for the whole reconstruction are often compromised by high failure rates on the acetabular site due to peri-acetabular osteolysis and accelerated wear. METHODS: In patients 60 years old or younger, we retrospectively reviewed the results at a minimum of ten years of 89 consecutive uncemented total hip replacements in 88 patients using the press-fit Fitmore acetabular component in combination with the CLS Spotorno stem and a 28-mm Metasul metal-on-metal articulation or a 28-mm alumina ceramic on conventional polyethylene bearing. The mean age at the time of surgery was 49 years (range, 25-60). The mean clinical and radiological follow-up was 12 years (range, 10-15). RESULTS: Six patients (six hips) died and two patients (two hips) were lost to follow-up. Five hips were revised: one for deep infection, one for peri-prosthetic femoral fracture, and one for aseptic stem loosening. In two hips an isolated revision of the acetabular liner was performed (one for recurrent dislocation and one for unexplained pain). No revision was performed for accelerated wear, osteolysis or aseptic loosening of the acetabular shell. We could not detect peri-acetabular osteolysis visible on plain radiographs in those hips evaluated radiographically. The Kaplan-Meier survival with revision for any reason as the endpoint was 94% (95% confidence interval, 86-97) at 12 years. CONCLUSIONS: The survival rates and the radiological outcomes with this implant combination in this young and active patient group are encouraging when compared to the results reported for other uncemented cups in this age group.

Computer-assisted dieting: effects of a randomized nutrition intervention.

OBJECTIVES: To compare the effects of a computer-assisted dieting intervention (CAD) with and without self-management training on dieting among 55 overweight and obese adults. METHODS: Random assignment to a single-session nutrition intervention (CAD-only) or a combined CAD plus self-management group intervention (CAD+G). Dependent variables were the number of servings from various food groups and macronutrients related to body weight. RESULTS: Both intervention groups reduced the consumption of energy, fat, and carbohydrates. Relative to CAD-only, the CAD+G condition was more successful in reducing fat intake, increasing vegetable consumption, and maintaining fruit intake. CONCLUSIONS: Effects of computer-assisted self-monitoring can be augmented through self-management training.

Nanoparticle layer deposition for plasmonic tuning of microstructured optical fibers.

Plasmonic nanoparticles with spectral properties in the UV-to-near-IR range have a large potential for the development of innovative optical devices. Similarly, microstructured optical fibers (MOFs) represent a promising platform technology for fully integrated, next-generation plasmonic devices; therefore, the combination of MOFs and plasmonic nanoparticles would open the way for novel applications, especially in sensing applications. In this Full Paper, a cost-effective, innovative nanoparticle layer deposition (NLD) technique is demonstrated for the preparation of well-defined plasmonic layers of selected particles inside the channels of MOFs. This dynamic chemical deposition method utilizes a combination of microfluidics and self-assembled monolayer (SAM) techniques, leading to a longitudinal homogeneous particle density as long as several meters. By using particles with predefined plasmonic properties, such as the resonance wavelength, fibers with particle-adequate spectral characteristics can be prepared. The application of such fibers for refractive-index sensing yields a sensitivity of about 78 nm per refractive index unit (RIU). These novel, plasmonically tuned optical fibers with freely selected, application-tailored optical properties present extensive possibilities for applications in localized surface plasmon resonance (LSPR) sensing.

Computer-assisted dieting: effects of a randomised controlled intervention.

In this pilot study, the effects of two computer-assisted dieting (CAD) interventions on weight loss and blood chemistry were examined among overweight and obese adults. Participants (91 community members, average age 42.6 years) were randomly assigned to CAD-only (a single-session introduction and provision of a dieting software, n = 30), CAD plus an additional four-session self-management group training (CAD+G, n = 31) and a waitlist control group whose members were randomised into the two interventions at the 3-month follow-up (n = 30). A three (group)-by-two (time) repeated measures ANOVA revealed no significant group by time interaction during the initial 3-month period. However, the two intervention groups combined showed a significant, though moderate weight loss relative to the control group. Further, although a general improvement was found with regard to the lipid panel results during the first 3 months of the trial, the treatment by time interaction was not significant. A comparison of the developments in the two intervention groups during the 3- to 6-month follow-up time period revealed a tendency towards greater weight regain in the CAD-only condition. The evidence suggests that CAD supports initial weight loss; however, additional self-management training might be necessary to support maintenance.

Effects of fruit consumption on body mass index and weight loss in a sample of overweight and obese dieters enrolled in a weight-loss intervention trial.

OBJECTIVE: Fruit and vegetable consumption is an important part of a healthy diet and assumed to aid in the reduction of energy intake and body weight. Fruits and vegetables may display differential effects on weight and weight loss; however, the effects of the two food groups have rarely been investigated separately. METHODS: The present study focused on the effects of fruit consumption on body weight and weight loss in a sample of 77 overweight and obese dieters enrolled in an intervention program. Food consumption was assessed at baseline by food diaries and after the introduction of nutrition software through electronic food records. Body weight and additional physiologic outcomes were assessed three times, once before the intervention and again at the 3- and 6-mo follow-ups. RESULTS: Vegetable and fruit consumption differed in their associations with body weight and weight loss. Although vegetable consumption increased as a result of the intervention (P<0.01), fruit consumption did not. However, only fruit consumption was associated with body mass index, showing an inverse relation with body weight in cross-sectional and longitudinal analyses (r=-0.27 to -0.44). The relation between fruit consumption and body weight remained significant after controlling for age, gender, physical activity level, and daily macronutrient consumption (DeltaR(2)=0.06-0.13). Further, increases in fruit consumption were associated with subsequent weight loss, controlling for the same covariates (DeltaR(2)=0.05-0.07). CONCLUSION: The results indicate unique contributions of fruit consumption to the management of body weight and indicate that a separation of effects for fruit and vegetable food groups may be warranted.

Interactive voice response technology to measure HIV-related behavior.

Computerized telephone technology has garnered increasing interest as an assessment tool specifically for the collection of daily, near-contemporaneous self-reports of HIV risk behaviors. In this review, we discuss advantages and recent applications of interactive voice response technology (IVR) to HIV risk behavior research, including feasibility studies, assessment mode comparisons between IVR and alternative self-reporting methods, and unique findings derived from event-level data analyses illuminating risk factors for unprotected intercourse on within-person level. We also review reactivity effects of daily IVR self-reports and applications of IVR systems in risk behavior intervention research. We conclude that IVR is a feasible and highly promising tool for various research and health care applications that should be considered more frequently for use in HIV-risk populations.

An event-level analysis of condom use as a function of mood, alcohol use, and safer sex negotiations.

Daily self-reports of condom-protected intercourse were analyzed as a function of emotional states, alcohol consumption, and safer sex negotiations in a sample of single, low-income Hispanic students. The sample included 15 women and 17 men who reported a minimum of four sexual episodes as well as inconsistent condom use over a 3-month self-reporting period. The analyses focused on 829 days out of 2,586 daily self-reports on which sexual intercourse was reported. Hierarchical linear modeling was used to predict condom-protected intercourse as a function of mood states, substance use, and safer sex negotiations. Safer sex negotiation was the strongest positive predictor of condom use. Contrary to expectation, unprotected intercourse was less likely to occur in episodes characterized by greater negative affect and more likely in episodes in which greater positive mood was reported. No main effect of alcohol consumption on safer sex was observed; however, an interaction between alcohol consumption and positive mood emerged, indicating that unprotected intercourse was most likely to occur when positive mood was combined with alcohol consumption. The results contradict the assumption that emotional distress predicts engagement in more risky sexual behavior and indicate that safer sex negotiations are likely to outweigh any effects of mood or alcohol consumption on subsequent condom use.

Covariations of emotional states and alcohol consumption: evidence from 2 years of daily data collection.

We examined inter- and intra-individual covariations of mood and alcohol consumption in a sample of 171 light, medium, and heavy alcohol consumers aged 21 and over who reported daily about drinking and mood for a period of up to 2 years. The sample was recruited by advertisements in local newspapers and referral from former respondents in Northern Vermont, USA, between July 1997 and September 2000. Participants reported daily alcohol consumption and mood via interactive voice response (IVR) technology. Within-subject correlations were calculated for each individual separately and analyzed via cluster analysis. The cluster solution was subsequently used as a categorical Level-2 predictor in hierarchical linear modeling of daily alcohol consumption. Cluster analyses of the within-subject correlations revealed four clusters: (1) emotion-inhibited drinking (drinking combined with reduced emotional arousal, n=12); (2) "positive emotion drinking" (drinking in combination with positive mood, n=69); (3) "stress drinking" (drinking combined with negative mood, n=12); and (4) "non-emotional drinking" (no relationship between alcohol consumption and mood, n=78). Hierarchical linear modeling (HLM) analyses revealed that a significant amount of random variance of the Level-1 mood slopes (38% and 40%) was accounted for by the clusters, demonstrating the predictive power of cluster membership on individual drinking patterns. Although Cluster 3 members (stress drinking) did not report significantly higher levels of alcohol consumption, they were more likely to report current and lifetime dependence symptoms. The results point to the existence of stable, but diverse drinking patterns among non-clinical alcohol consumers with potentially different implications for development into alcohol abuse and dependence.

Interactive Voice Response Technology applied to sexual behavior self-reports: a comparison of three methods.

We tested the feasibility and performance of the Interactive Voice Response Technology (IVR) in the assessment of sexual behavior self-reports, relative to self-administered questionnaire (SAQ) and Timeline Followback (TLFB) methods. The sample consisted of 44 sexually active Hispanic students recruited at the University of Texas at El Paso who reported daily about sexual behaviors and substance use. Thirty-three participants (75%, 18 women, 15 men) were retained for at least 80 days of the 91-day IVR. At follow-up, sexual behaviors and substance use were assessed by questionnaire (summary) reports and by TLFB, referring to the same 3-month interval. ANOVAs with normalized variables indicated less reporting in the TLFB and over-reporting of substance use in the questionnaire relative to the daily IVR self-reports. Gender moderated the effects of assessment mode, which were observed among women only. HLM analyses indicated a significant decrease in self-reports over time, suggesting reactivity of self-monitoring via IVR on behavior.

Anger as a moderator of safer sex motivation among low-income urban women.

Theoretical models suggest that both HIV knowledge and HIV risk perception inform rational decision making and, thus, predict safer sex motivation and behavior. However, the amount of variance explained by knowledge and risk perception is typically small. In this cross-sectional study, we investigated whether the predictive power of HIV knowledge and HIV risk perception on safer sex motivation is affected by trait anger. We hypothesized that anger may disrupt rational decision making, distorting the effects of both HIV knowledge and risk perception on safer sex intentions. Data from 232 low-income, urban women at risk for HIV infection were used to test a path model with past sexual risk behavior, HIV knowledge, and HIV risk perception as predictors of safer sex intentions. Moderator effects of anger on safer sex intentions were tested by simultaneous group comparisons between high-anger and low-anger women (median split). The theoretically expected "rational pattern" was found among low-anger women only, including (a) a positive effect of knowledge on safer sex intentions, and (b) buffer (inhibitor) effects of HIV knowledge and HIV risk perception on the negative path leading from past risk behavior to safer sex intentions. Among high-anger women, an "irrational pattern" emerged, with no effects of HIV knowledge and negative effects of both past risk behavior and HIV risk perception on safer sex intentions. In sum, the results suggest that rational knowledge- and risk-based decisions regarding safer sex may be limited to low-anger women.

How many drinks did you have on September 11, 2001?

OBJECTIVE: This study tested the predictability of error in retrospective self-reports of alcohol consumption on September 11, 2001, among 80 Vermont light, medium and heavy drinkers. METHOD: Subjects were 52 men and 28 women participating in daily self-reports of alcohol consumption for a total of 2 years, collected via interactive voice response technology (IVR). In addition, retrospective self-reports of alcohol consumption on September 11, 2001, were collected by telephone interview 4-5 days following the terrorist attacks. Retrospective error was calculated as the difference between the IVR self-report of drinking behavior on September 11 and the retrospective self-report collected by telephone interview. Retrospective error was analyzed as a function of gender and baseline drinking behavior during the 365 days preceding September 11, 2001 (termed "the baseline"). RESULTS: The intraclass correlation (ICC) between daily IVR and retrospective self-reports of alcohol consumption on September 11 was .80. Women provided, on average, more accurate self-reports (ICC = .96) than men (ICC = .72) but displayed more underreporting bias in retrospective responses. Amount and individual variability of alcohol consumption during the 1-year baseline explained, on average, 11% of the variance in overreporting (r = .33), 9% of the variance in underreporting (r = .30) and 25% of the variance in the overall magnitude of error (r = .50), with correlations up to .62 (r2 = .38). CONCLUSIONS: The size and direction of error were clearly predictable from the amount and variation in drinking behavior during the 1-year baseline period. The results demonstrate the utility and detail of information that can be derived from daily IVR self-reports in the analysis of retrospective error.

Habitual self-control and the management of health behavior among heart patients.

This study examined the predictive power of habitual self-control on health behaviors among 381 heart surgery patients in Germany. Habitual self-control and other trait predictors (dispositional optimism, generalized self-efficacy beliefs, health locus of control beliefs) were assessed before and six months after surgery. Social-cognitive predictors of health behavior (behavior-specific self-efficacy and outcome beliefs, intentions) were assessed only before surgery. Outcomes were dieting, physical exercise, and smoker status before and after surgery. Compared to other trait variables, habitual self-control emerged as a superior predictor of the behavioral outcomes. Further, habitual self-control explained unique variance in dieting and physical exercise beyond proximal behavior-specific predictors (i.e., self-efficacy beliefs, intentions) that are supposed to display direct effects on behavior. Results of hierarchical linear regressions provided partial support for the assumption that habitual self-control strengthens the intention-behavior congruence. In prospective analyses predicting dieting at the 6-month follow-up an interaction between habitual self-control and dieting intentions emerged indicating that self-control supported dieting among patients with imperfect (moderate) dieting intentions only. In sum, the results suggest that habitual self-control may be a useful construct in research on health behavior management, in particular when long-term maintenance of health behavior is the target.

Vigilance to a persisting personal threat: unmasking cardiovascular consequences in adolescents with the Social Competence Interview.

We report the first systematic study of hemodynamic responses to the Social Competence Interview, using the original Ewart protocol, which focuses attention on a persisting personal threat. Physiologic changes in 212 African American and Caucasian urban adolescents during the Social Competence Interview, mirror tracing, and reaction time tasks showed that the Social Competence Interview elicits a pronounced vasoconstrictive response pattern, with diminished cardiac activity, that is more typical of alert mental vigilance than of active coping. This pattern was observed in all race and gender subgroups. Results suggest that the Social Competence Interview may be a broadly useful procedure for investigating the role of threat-induced vigilance in cardiovascular and other diseases.

Coping competence as predictor and moderator of depression among chronic disease patients.

This tested the utility of the "Coping Competence Questionnaire" (CCQ) in predicting depression among chronic disease patients. Coping competence is defined as a dispositional stress resistance factor based on helplessness and hopelessness theory. Predictive power and buffering effects of the CCQ were tested in three patient samples scheduled for Coronary Artery Bypass Surgery (N = 272), other heart surgeries (N = 109), or lung tumor surgery (N = 203). Coping competence, symptom stress, and depression were assessed before and 6-months following surgery. Hierarchical multiple regressions indicated moderator effects of coping competence in the relationship between symptom stress and depression, supporting the stress-buffer hypothesis. Symptom stress was strongly correlated with depression among patients who were low in coping competence only. Among patients high in coping competence, depression was low and unaffected by symptom stress. The results suggest that the 12-item coping competence scale may qualify as useful tool for the prediction of depression in chronic disease populations.

HIV risk behavior among psychiatric outpatients: association with psychiatric disorder, substance use disorder, and gender.

People living with a mental illness are disproportionately vulnerable to human immunodeficiency virus. The current study sought to examine the influence of psychiatric disorder, substance use disorder, and gender on risky sexual behavior in this vulnerable population. Participants were 228 female and 202 male outpatients (66% mood disorder, 34% schizophrenia), each of whom took part in a Structured Clinical Interview for the DSM-IV and a comprehensive assessment of sexual risk behavior. Univariate and multivariate analyses tested a priori hypotheses. The results indicated that risk behavior was more frequent among patients diagnosed with a mood disorder (compared with those diagnosed with schizophrenia) or a substance use disorder (compared with those without a comorbid disorder) or both. We recommend routine human immunodeficiency virus risk screening and risk reduction programs for this vulnerable population.

Reducing HIV-risk behavior among adults receiving outpatient psychiatric treatment: results from a randomized controlled trial.

This study investigated the efficacy of a 10-session, HIV-risk-reduction intervention with 221 women and 187 men receiving outpatient psychiatric care for a mental illness. Patients were randomly assigned to the HIV intervention, a structurally equivalent substance use reduction (SUR) intervention, or standard care; they were assessed pre- and postintervention and at 3- and 6-month follow-ups. Patients receiving the HIV-risk-reduction intervention reported less unprotected sex, fewer casual sex partners, fewer new sexually transmitted infections, more safer sex communications, improved HIV knowledge, more positive condom attitudes, stronger condom use intentions, and improved behavioral skills relative to patients in the SUR and control conditions. Patients receiving the SUR intervention reported fewer total and casual sex partners compared with control patients. Exploratory analyses suggested that female patients and patients diagnosed with a major depressive disorder were more likely to benefit from the HIV-risk-reduction intervention.

The impact of the September 11, 2001, terrorist attacks on alcohol consumption and distress: reactions to a national trauma 300 miles from Ground Zero.

OBJECTIVE: This study examined the short- and long-term effects of the September 11, 2001, terrorist attacks in a sample of light, medium and heavy drinkers who live 300+ miles north of the epicenters. METHOD: Participants in an ongoing longitudinal study submitted daily reports on alcohol consumption and mood via Interactive Voice Response technology. The daily self-reports of 86 subjects between September 11, 2000, and December 30, 2001, were used to analyze alcohol consumption and mood before, on and after September 11, 2001. Data were analyzed by statistical process control (SPC) analyses. RESULTS: Descriptive analyses revealed that by comparison with the average alcohol consumption on the previous 52 Tuesdays, women drank 33.9% more alcohol and men 13.9% more on Tuesday, September 11, 2001. Compared with the average alcohol consumption on the 365 days preceding September 11, however, no increase in alcohol consumption was found. SPC analyses did not indicate a significant increase of alcohol consumption in response to September 11 in terms of baseline standard error computed from the 365 days preceding the events. Marked increases, on the other hand, were found in self-reported levels of stress, anger and sadness, with elevations up to nine standard errors beyond average baseline ratings. Negative emotions remained elevated for up to 69 days following the attacks. CONCLUSIONS: Vicarious experience of terrorism affects emotions significantly but may not significantly affect alcohol consumption among drinkers remote from the events.

Methodological challenges in research on sexual risk behavior: II. Accuracy of self-reports.

Assessing sexual behavior with self-report is essential to research on a variety of health topics, including pregnancy and infertility, sexually transmitted infections, and sexual health and functioning. Recent methodological research has provided new insights regarding the accuracy of self-reports of sexual behavior. We review these studies, paying particular attention to a promising new development: the use of computer-assisted assessments. The collection of sexual risk behavior data with computers has increased dramatically in recent years, but little is known about the accuracy of such assessments. We summarize the evidence, discuss methodological issues that arise in studies evaluating the accuracy of self-reports, and offer recommendations for future research.