Lessons Learned From a Randomized Controlled Pilot Trial Testing an Inhibitory Learning Approach to Exposure in Anxious Youth

Accumulating evidence from basic and translational research indicates that fear extinction may be best explained by principles of “inhibitory learning,” by which prefrontal cortical structures inhibit activity in the amygdala. New guidelines for the clinical practice of exposure therapy have arisen from research on inhibitory learning, but these guidelines have received little empirical testing in clinical samples of youth receiving treatment for anxiety disorders. We investigated the acceptability, feasibility, and initial efficacy of conducting exposure therapy for anxiety disorders in youth according to clinical guidelines developed from basic research on inhibitory learning principles, using a pilot randomized controlled trial design. Thirteen youths (ages 7 to 16) were recruited from a university hospital-based pediatric outpatient clinic to participate in a 9-week treatment study and were randomized to either an inhibitory learning-based exposure condition or a standard exposure condition. Results supported the feasibility and acceptability of an inhibitory learning-based approach to exposure therapy in youth and, despite the small sample size, effect sizes were in favor of the inhibitory learning approach on several measures. Differences between the standard exposure and inhibitory learning conditions are discussed using two case examples. Discussion of results and lessons learned may contribute to changes in clinical guidelines for optimally effective practice of exposure.     

Participatory work place intervention for stress prevention in primary health care. A randomized controlled trial

The aim of this study is to explore whether a participatory, organizational intervention can reduce work-related risk factors, and thereby prevent stress-related ill health. We build on the job demand-control and effort-reward imbalance models of stress. It is a two-armed randomized trial, with one primary health care unit receiving the intervention and a two-unit control group. Validated questionnaires for the assessment of psychosocial work environment and health were administered, at the baseline and at 6 and 12-month follow up. The primary outcome was job strain. Secondary outcomes were effort–reward imbalance, exhaustion, sleep, and recovery. Group-level objective data on workload and data about relevant processes during the study were continuously collected. The changes in the intervention group with regard to job strain, effort-reward imbalance, exhaustion, sleep and recovery were not statistically different from changes in the control group. For the non-exhausted employees though, reward was significantly higher at follow up compared to baseline, but only in the intervention group. An important piece of information is that the objective workload was statistically significantly higher in the intervention group throughout the study. Not all the components of the intervention were implemented as intended. Context and process information, such as objective data and implementation fidelity are necessary for a valid interpretation of the results.     

A randomized controlled pilot trial of acceptance and commitment training (ACT) for preventing stress-related ill health among future nurses

Background: Levels of stress and burnout increase during nursing education. This development has consequences for nursing students' health, learning, competence, and interest in quality issues in health care. Design: In a randomized controlled pilot trial with a sample of 113 nursing students the effect of an intervention using techniques from acceptance and commitment training (ACT) to prevent the development of stress and burnout was evaluated. Method: The 6 × 2-hour program was compared to standard treatment (reflection seminars) post-intervention and at a three-month follow-up using longitudinal analysis of mean response profiles. Mechanisms of change were investigated using a baseline-post intervention two-mediator model. Results: The intervention resulted in increased mindful awareness and decreased experiential avoidance, as well as decreased perceived stress and burnout. Levels of mindful awareness and perceived stress were sustained at follow-up. The proposed mechanisms of change were partly supported by the data. Conclusion: This study shows that techniques from ACT might have the potential to contribute to preventing the development of stress and burnout during nursing education. However, additional studies are needed to validate these results.     

The Effects of Modafinil on Convergent and Divergent Thinking of Creativity: A Randomized Controlled Trial

Modafinil is a drug licensed for the treatment of narcolepsy and sleep apnea. Recently, modafinil has been reported to be used as a pharmacological cognitive enhancer by healthy individuals with no psychiatric disorders. This paper reports on a study that investigated the effects of modafinil on divergent and convergent thinking tasks of creativity. Sixty‐four healthy male (n = 31) and female (n = 33) volunteers participated in a randomized double‐blind placebo‐controlled parallel group design study. For the convergent thinking tasks, modafinil had no significant main effect on the Group Embedded Figures Task and the Remote Associates Task (RAT). However, a median split analysis showed that modafinil participants low in creativity personality trait had significantly higher RAT scores (Mean [M] = 6.85, SD = 3.39; 95% confidence interval [95% CI]: 5.53–8.2) than those high in creativity personality trait (M = 4.27, SD = 3.0; 95% CI: 2.4–6.0). For the divergent thinking tasks, relative to placebo (M = 1.195, SD = 0.28; 95% CI: 1.0–1.3), modafinil (M = 0.77, SD = 0.37; 95% CI: 0.63–0.92) significantly reduced the performance of flexibility scores and marginally reduced the elaboration scores as measured by the Abbreviated Torrance Test for Adults (ATTA). Overall, participants on modafinil (M = 6.3, SD = 2.6; 95% CI: 5.3–7.4) had significantly lower ATTA scores relative to participants on placebo (M = 9.5, SD = 2.3; 95% CI: 8.6–10.4). These results indicate that modafinil might reduce divergent thinking of creativity in healthy individuals. They suggest that, rather than being a more general cognitive enhancer, modafinil might have negative and subtle effects on creativity. However, the results are from a small‐scale trial, which tested a small number of participants. Therefore, the results need to be interpreted with caution. A replication with a large sample of participants is recommended.     

1980年-2005年我国中西医结合临床研究的方法学评价

为了了解我国1980年～2005年以来关于中西医结合临床研究文献的质量,从中国生物医学文献数据库及维普全文库和中国期刊网全文库中查阅了相关文献,发现国内近年来开展中西医结合临床研究的RCT文献在不断增多,但研究方法学质量偏低,说明有关文献的RCT质量有待进一步提高,研究方法仍需要不断改进。     

Item Randomized-Response Models for Measuring Noncompliance: Risk-Return Perceptions,Social Influences,and Self-Protective Responses

Randomized response (RR) is a well-known method for measuring sensitive behavior. Yet this method is not often applied because: (i) of its lower efficiency and the resulting need for larger sample sizes which make applications of RR costly; (ii) despite its privacy-protection mechanism the RR design may not be followed by every respondent; and (iii) the incorrect belief that RR yields estimates only of aggregate-level behavior but that these estimates cannot be linked to individual-level covariates. This paper addresses the efficiency problem by applying item randomized-response (IRR) models for the analysis of multivariate RR data. In these models, a person parameter is estimated based on multiple measures of a sensitive behavior under study which allow for more powerful analyses of individual differences than available from univariate RR data. Response behavior that does not follow the RR design is approached by introducing mixture components in the IRR models with one component consisting of respondents who answer truthfully and another component consisting of respondents who do not provide truthful responses. An analysis of data from two large-scale Dutch surveys conducted among recipients of invalidity insurance benefits shows that the willingness of a respondent to answer truthfully is related to the educational level of the respondents and the perceived clarity of the instructions. A person is more willing to comply when the expected benefits of noncompliance are minor and social control is strong. The authors are grateful to the reviewers whose suggestions helped to improve the clarity of the paper substantially. The authors also wish to thank the Dutch Ministry of Social Affairs and Employment for making the reported data available. This research was supported in parts by grants from the Social Sciences and Humanities Research Council of Canada and the Canadian Foundation of Innovation.     

Does Evidence-Based Medicine Apply to Psychiatry?

Evidence-based psychiatry (EBP) has arisen through the application of evidence-based medicine (EBM) to psychiatry. However, there may be aspects of psychiatric disorders and treatments that do not conform well to the assumptions of EBM. This paper reviews the ongoing debate about evidence-based psychiatry and investigates the applicability, to psychiatry, of two basic methodological features of EBM: prognostic homogeneity of clinical trial groups and quantification of trial outcomes. This paper argues that EBM may not be the best way to pursue psychiatric knowledge given the particular features of psychiatric disorders and their treatments. As a result, psychiatry may have to develop its own standards for rigour and validity. This paper concludes that EBM has had a powerful influence on how psychiatry investigates and understands mental disorders. Psychiatry could influence EBM in return, reshaping it in ways that are more clinically useful and congruent with patients’ needs.     

循证医学在ICU中的应用

循证医学(Evidence-Based Medicine,EBM)是指慎重、准确而明智地应用当前所能获得的最佳的研究证据,同时结合医生个人的专业技能和临床经验,并考虑患者的价值和愿望,将三者完美地结合起来制定出对患者最有利的临床决策。然而,ICU中的各项治疗措施常缺乏大规模随机对照试验(RCT)的证据;对于已经实施的RCT同样存在着概念方面的错误,尤其是很多被认为已经RCT验证过的措施实际上并无RCT的证据。尽管如此,但近年来我们终于在临床试验结果方面有了更多积极的进步,一些干预措施已被证明可改善患者的预后。     

A THERAPEUTIC PLAYGROUP FOR DEPRESSED MOTHERS AND THEIR INFANTS: FEASIBILITY STUDY AND PILOT RANDOMIZED TRIAL OF COMMUNITY HUGS

Symptoms of depression negatively impact on mother?infant relationships and child outcomes. We evaluated a novel, 10‐session mother?infant therapeutic playgroup—Community HUGS (CHUGS)—which combines cognitive and experiential components through psychoeducation, play, music, and movement. Participants were mothers experiencing a range of postnatal mental health difficulties, including depression, with infants ≤12 months of age. However, the aim was not to treat maternal depression but to ameliorate associated problems in the mother?infant interaction. In the feasibility study, all participants received CHUGS. In the pilot randomized controlled trial (RCT), participants were randomized between intervention and a wait‐list. Outcomes were the Parenting Stress Index (PSI; R.R. Abidin, 1995), Parenting Sense of Competency Scale (Self‐Efficacy subscale; J. Gibaud‐Wallston & L.P. Wandersman, 1978), and the Depression, Anxiety, Stress Scales (P.F. Lovibond & S.H. Lovibond, 1995). In the feasibility study (n = 74), PSI scores dropped on all subscales, all ps < .01. Depression, p < .001, anxiety, p = .01, stress, p = .01, and self‐efficacy, p < .001, all showed improvements, as did observer‐rated mother?infant interactions, p < .001. In the RCT, depression, p < .001, anxiety, p = .005, and stress, p < .001, symptoms were significantly reduced for intervention participants (n = 16), as compared to wait‐list participants (n = 15). The CHUGS program had high participant satisfaction and produced improvements in self‐efficacy, depression, anxiety, stress, and mother?infant interactions that supported the program's acceptability and the utility of further rollout.     

Does the Method of Content Delivery Matter? Randomized Controlled Comparison of an Internet-Based Intervention for Eating Disorder Symptoms With and Without Interactive Functionality

Despite their potential as a scalable, cost-effective intervention format, self-guided Internet-based interventions for eating disorder (ED) symptoms continue to be associated with suboptimal rates of adherence and retention. Improving this may depend on the design of an Internet intervention and its method of content delivery, with interactive programs expected to be more engaging than static, text-based programs. However, causal evidence for the added benefits of interactive functionality is lacking. We conducted a randomized controlled comparison of an Internet-based intervention for ED symptoms with and without interactive functionality. Participants were randomized to a 4-week interactive (n = 148) or static (n = 145) version of an Internet-based, cognitive-behavioral program. The interactive version included diverse multimedia content delivery channels (video tutorials, graphics, written text), a smartphone app allowing users to complete the required homework exercises digitally (quizzes, symptom tracking, self-assessments), and progress monitoring features. The static version delivered identical intervention content but only via written text, and contained none of those interactive features. Dropout rates were high overall (58%), but were significantly—yet slightly—lower for the interactive (51%) compared to the static intervention (65%). There were no significant differences in adherence rates and symptom-level improvements between the two conditions. Adding basic interactive functionality to a digital intervention may help with study retention. However, present findings challenge prior speculations that interactive features are crucial for enhancing user engagement and symptom improvement.