WITHIN‐TRIAL CONTRAST: WHEN IS A FAILURE TO REPLICATE NOT A TYPE I ERROR?

Vasconcelos, Urcuioli, and Lionello-DeNolf (2007) report the results of five experiments that fail to replicate the results of our within-trial contrast study (Clement, Feltus, Kaiser, & Zentall, 2000) and suggest that our results may represent a Type I Error. We believe that this conclusion is not warranted because (a) there is considerable evidence in support of the effect and (b) the amount of training that they gave to their pigeons prior to test may not have been sufficient to observe the effect reliably. We suggest that when sufficient training is provided, reliable contrast can be found.     

The Effective Treatment of Juveniles Who Sexually Offend: An Ethical Imperative

This article raises serious concerns regarding the widespread use of unproven interventions with juveniles who sexually offend and suggests innovative methods for addressing these concerns. Dominant interventions (i.e., cognitive-behavioral group treatments with an emphasis on relapse prevention) typically fail to address the multiple determinants of juvenile sexual offending and could result in iatrogenic outcomes. Methodologically sophisticated research studies (i.e., randomized clinical trials) are needed to examine the clinical and cost-effectiveness of cognitive-behavioral group interventions, especially those delivered in residential settings. The moral and ethical mandate for such research is evident when considering the alternative, in which clinicians and society are willing to live in ignorance regarding the etiology and treatment of juvenile sexual offending and to consign offending youths to the potential harm of untested interventions. Encouraging signs of a changing ethical climate include recent federal funding of a randomized clinical trial examining treatment effectiveness with sexually offending youths and the introduction of separate (i.e., developmentally informed) clinical and legal interventions for juvenile versus adult sexual offenders.     

Internet-Based Therapy for Mild to Moderate Depression in Swedish Primary Care: Short Term Results from the PRIM-NET Randomized Controlled Trial

Depression presents a serious condition for the individual and a major challenge to health care and society. Internet-based cognitive behavior therapy (ICBT) is a treatment option supported in several trials, but there is as yet a lack of effective studies of ICBT in “real world” primary care settings. We examined whether ICBT differed from treatment-as-usual (TAU) in reducing depressive symptoms after 3 months. TAU comprised of visits to general practitioner, registered nurse, antidepressant drugs, waiting list for, or psychotherapy, or combinations of these alternatives. Patients, aged ≥ 18 years, who tentatively met criteria for mild to moderate depression at 16 primary care centers in the south-western region of Sweden were recruited and then assessed in a diagnostic interview. A total of 90 patients were randomized to either TAU or ICBT. The ICBT treatment included interactive elements online, a workbook, a CD with mindfulness and acceptance exercises, and minimal therapist contact. The treatment period lasted for 12 weeks after which both groups were assessed. The main outcome measure was Beck Depression Inventory-II (BDI-II). Additional measures were Montgomery Åsberg Depression Rating Scale – self rating version (MADRS-S) and Beck Anxiety Inventory (BAI). The analyses revealed no significant difference between the two groups at post treatment, neither on BDI-II, MADRS-S, nor BAI. Twenty patients (56%) in the ICBT treatment completed all seven modules. Our findings suggest that ICBT may be successfully delivered in primary care and that the effectiveness, after 3 months, is at par with TAU.     

Öst's (2008) methodological comparison of clinical trials of acceptance and commitment therapy versus cognitive behavior therapy: Matching Apples with Oranges?

Öst (2008) recently compared the methodological rigor of studies of acceptance and commitment therapy (ACT) and traditional cognitive behavior therapy (CBT). He concluded that the ACT studies had more methodological deficiencies, and thus the treatment did not qualify as an “empirically supported treatment.” Although Öst noted several important limitations that should be carefully considered when evaluating early ACT research, his attempt to devise an empirical matching strategy by creating a comparison sample of CBT studies to bolster his conclusions was itself problematic. The samples were clearly mismatched in terms of the populations being treated, leading to differences in study design and methodology. Furthermore, reanalysis showed clear differences in grant support favoring CBT compared with ACT studies that were not reported in the original article. Given the actual mismatch between the samples, Öst's methodological ratings are difficult to interpret and provide little useful information beyond what could already be gathered by a qualitative review of ACT study limitations. Such limitations are characteristic of the earlier randomized controlled trials of any emerging psychotherapeutic approach.     

Intelligence and persisting with medication for two years: Analysis in a randomised controlled trial

The study examined whether verbal intelligence is associated with persisting to take medication for up to two years. The design is a prospective follow-up of compliance with taking medication in high-risk individuals participating in a randomised, placebo-controlled trial set in Central Scotland. Participants were 1993 people aged between 50 and 77 years with an ankle brachial index ≤ 0.95. The medication was 100 mg aspirin or placebo daily.The principal outcome measure was continuing with taking medication or stopping it due to having ‘changed one's mind’. Higher verbal intelligence was associated with a greater likelihood of continuing to take medication up to two years after randomisation. For a standard deviation increase in Mill Hill Vocabulary Scale score, risk of stopping medication in the first two years of the study was 0.75 (95% CI 0.64 to 0.87, p < 0.001). Comparing the highest and lowest quartiles of IQ, the lowest IQ group's relative rate of stopping medication was 2.51 (95% CI 1.52 to 4.22). The effect was not attenuated after adjustment for sex, smoking, or level of deprivation. Verbal intelligence is associated with continuing, medium-to-long term engagement with health self-care, even in the face of uncertainty about whether active treatment is being received, whether the treatment is known to be effective in general, and whether it will be helpful to the individual taking it. Such persisting with potentially helpful health behaviours in the face of uncertainty might partly explain why people with higher intelligence live longer and suffer less morbidity from chronic diseases.     

An effectiveness trial of a new enhanced dissonance eating disorder prevention program among female college students

Objective

Efficacy trials indicate that a dissonance-based prevention program in which female high school and college students with body image concerns critique the thin-ideal reduced risk factors, eating disorder symptoms, and future eating disorder onset, but weaker effects emerged from an effectiveness trial wherein high school clinicians recruited students and delivered the program under real-world conditions. The present effectiveness trial tested whether a new enhanced dissonance version of this program produced larger effects when college clinicians recruited students and delivered the intervention using improved procedures to select, train, and supervise clinicians.

Method

Young women recruited from seven universities across the US (N = 408, M age = 21.6, SD = 5.64) were randomized to the dissonance intervention or an educational brochure control condition.

Results

Dissonance participants showed significantly greater decreases in risk factors (thin-ideal internalization, body dissatisfaction, dieting, negative affect) and eating disorder symptoms versus controls at posttest and 1-year follow-up, resulting in medium average effect size (d = .60). Dissonance participants also reported significant improvements in psychosocial functioning, but not reduced health care utilization or unhealthy weight gain.

Conclusions

This novel multisite effectiveness trial with college clinicians found that the enhanced dissonance version of this program and the improved facilitator selection/training procedures produced average effects that were 83% larger than effects observed in the high school effectiveness trial.     

由新药临床试验中的依从性问题引发的思考

本文就如何看待新药临床试验中的依从性问题提出了自己的看法：应用整体观、认识论的方法辩证地分析、处理依从性问题,以保证临床试验的顺利进行和质量可靠;文中通过实例并结合当前的医改背景,对临床医疗工作中的医患关系提出一些启发和看法,建议医务人员从自身出发重视患者的依从性。