Self-harm is a potentially lethal symptom of borderline personality disorder (BPD) that often improves with dialectical behavior therapy (DBT). While DBT is effective for reducing self-harm in many patients with BPD, a small but significant number of patients either does not improve in treatment or ends treatment prematurely. Accordingly, it is crucial to identify factors that may prospectively predict which patients are most likely to benefit from and remain in treatment. In the present preliminary study, twenty-nine actively (...) self-harming patients with BPD completed brain-imaging procedures probing activation of the prefrontal cortex during impulse control prior to beginning DBT and after seven months of treatment. Patients that reduced their frequency of self-harm the most over treatment displayed lower levels of neural activation in the bilateral dorsolateral prefrontal cortex prior to beginning treatment, and they showed the greatest increases in activity within this region after seven months of treatment. Prior to starting DBT, treatment non-completers demonstrated greater activation than treatment-completers in the medial prefrontal cortex and right inferior frontal gyrus. Reductions in self-harm over the treatment period were associated with increases in activity in right dorsolateral prefrontal cortex even after accounting for improvements in depression, mania, and BPD symptom severity. These findings suggest that pre-treatment patterns of activation in the prefrontal cortex underlying impulse control may be prospectively associated with improvements in self-harm and treatment attrition for patients with BPD treated with DBT. (shrink)

This article addresses ethical issues in conducting randomized clinical trials with youth. Ethical considerations that occur prior to treatment, during treatment, and following treatment are reviewed. Recommendations, based on empirical evidence and clinical experience, are offered for conducting ethical treatment research with youth and future directions for carrying out research on the ethics of conducting RCTs with youth are offered.

Background: Post-traumatic stress disorder is a prevalent, debilitating, and costly psychiatric disorder. Evidenced-based psychotherapies, including Cognitive Processing Therapy, are effective in treating PTSD, although a fair proportion of individuals show limited benefit from such treatments. CPT requires cognitive demands such as encoding, recalling, and implementing new information, resulting in behavioral change that may improve PTSD symptoms. Individuals with PTSD show worse cognitive functioning than those without PTSD, particularly in acquisition of verbal memory. Therefore, memory dysfunction may limit treatment gains (...) in CPT in some individuals with PTSD. Methods and Analysis: Here, we present a protocol describing the Cognition and PsychoTherapy in PTSD study, a prospective, observational study examining how cognitive functioning affects treatment response in CPT for PTSD. The study aims to recruit 105 outpatient veterans with PTSD between the ages of 18 and 70 years. Prior to beginning 12 sessions of CPT, Veteran participants will have standardized assessments of mood and functioning and complete a comprehensive neurocognitive battery assessing episodic learning, attention and speed of processing, language ability, executive control, and emotional functioning. This study aims to fill gaps in the current literature by: examining the specificity of memory effects on treatment response; exploring how baseline cognitive functioning impacts functional outcomes; and examining potential mechanisms, such as memory for treatment content, that might explain the effects of baseline memory functioning on PTSD symptom trajectory. Discussion: If successful, this research could identify clinically relevant neurocognitive mechanisms that may impact PTSD psychotherapy and guide the development of individualized treatments for PTSD. (shrink)

Background and PurposeTranscranial direct current stimulation is an emerging non-invasive neuromodulation technique for focal epilepsy. Because epilepsy is a disease affecting the brain network, our study was aimed to evaluate and predict the treatment outcome of cathodal tDCS by analyzing the ctDCS-induced functional network alterations.MethodsEither the active 5-day, −1.0 mA, 20-min ctDCS or sham ctDCS targeting at the most active interictal epileptiform discharge regions was applied to 27 subjects suffering from focal epilepsy. The functional networks before and after (...) ctDCS were compared employing graph theoretical analysis based on the functional magnetic resonance imaging data. A support vector machine prediction model was built to predict the treatment outcome of ctDCS using the graph theoretical measures as markers.ResultsOur results revealed that the mean clustering coefficient and the global efficiency decreased significantly, as well as the characteristic path length and the mean shortest path length at the stimulation sites in the fMRI functional networks increased significantly after ctDCS only for the patients with response to the active ctDCS. Our prediction model achieved the mean prediction accuracy of 68.3% after the nested cross validation. The mean area under the receiver operating curve was 0.75, which showed good prediction performance.ConclusionThe study demonstrated that the response to ctDCS was related to the topological alterations in the functional networks of epilepsy patients detected by fMRI. The graph theoretical measures were promising for clinical prediction of ctDCS treatment outcome. (shrink)

BackgroundOther Specified Feeding and Eating Disorders are characterized by less frequent symptoms or symptoms that do not meet full criteria for another eating disorder. Despite its high prevalence, limited research has examined differences in severity and treatment outcome among patients with OSFED compared to threshold EDs [Anorexia Nervosa, Bulimia Nervosa, and Binge Eating Disorder ]. The purpose of the current study was to examine differences in clinical presentation and treatment outcome between a heterogenous group of patients (...) with OSFED or threshold EDs.MethodPatients with threshold EDs or OSFED presenting for eating disorder treatment completed self-report questionnaires at intake and discharge to assess eating disorder symptoms, depression symptoms, impairment, and self-esteem.ResultsAt intake, OSFED patients showed lower eating concerns compared to patients with BN, but similar levels compared to AN and BED. The OSFED group showed higher restraint symptoms compared to BED, and similar restraint to AN and BN. Global symptoms as well as shape and weight concerns were similar between OSFED and threshold ED groups. There were no differences between diagnostic groups in self-esteem, depression scores, or symptom change from intake to discharge.DiscussionOur findings suggest that individuals with OSFED showed largely similar ED psychopathology and similar decreases in symptoms across treatment as individuals diagnosed with threshold EDs. Taken together, findings challenge the idea that OSFED is less severe and more resistant to treatment than threshold EDs. (shrink)

Mothers with prenatal substance use disorder often show broad deficits in their reflective functioning, implying severe risk for the relationship with their baby. Two different types of prenatal maternal RF may be important for parenting: adult attachment-focused-RF, regarding parent's own childhood experiences, and parenting-focused RF regarding their own current process of becoming a parent. However, their inter-relations and potentially different roles for parenting intervention outcomes are not clear. This study examined the associations between mothers' prenatal AAI-RF and pre- and post-natal (...) PRF, and their role in mother-infant interaction and substance use as treatment outcomes. The participants were 57 treatment-enrolled pregnant mothers with SUD and 50 low-risk comparison mothers. AAI-RF was measured with the Adult Attachment Interview. For a subsample of 30 mothers with SUD, PRF was measured with Pregnancy Interview, and with Parent Development Interview at 4 months. Mother-infant interaction was measured with Emotional Availability Scales at 4 and 12 months, and maternal substance use by post-natal substance relapses. Prenatal AAI-RF and pre- and post-natal PRF were highly associated with each other. Only higher prenatal PRF predicted better mother-infant interaction quality at 4 months and less substance use during the child's first year. Interestingly, prenatal PRF and AAI-RF predicted opposite changes in mother-infant interaction: lower prenatal PRF, but higher AAI-RF predicting more positive change. AAI-RF was especially associated with a change in maternal intrusiveness and hostility, indicating that it represents a more general regulatory tendency. Further studies are needed in larger and lower-risk samples. Our results suggest, however, that AAI-RF and PRF are partially distinct and should be uniquely targeted in perinatal interventions. (shrink)

The literature on critical thinking (CT) in counselling and therapy generally posits higher quality outcomes when CT is applied in therapeutic treatment. We critically examine support for the claim that CT improves clinical outcomes. The purported effects of CT are first identified by arguments in favour of using CT in therapeutic treatment, both in terms of its general efficacy and with regard to its applicability in professional counselling. We then underscore limitations in the current literature, highlighting mainly a (...) gap between theory and practice. Overall, our results suggest that available evidence provides primarily inferential, rather than direct, support for the claim that CT positively influences therapy outcomes. We close the paper by proposing research questions to guide further empirical investigation. (shrink)

Principal Component Analysis is one of the data mining methods that can be used to analyze multidimensional datasets. The main objective of this method is a reduction of the number of studied variables with the mainte- nance of as much information as possible, uncovering the structure of the data, its visualization as well as classification of the objects within the space defined by the newly created components. PCA is very often used as a preliminary step in data preparation through the (...) creation of independent components for further analysis. We used the PCA method as a first step in analyzing data from IVF (in vitro fertilization). The next step and main purpose of the analysis was to create models that predict pregnancy. Therefore, 805 different types of IVF cy- cles were analyzed and pregnancy was correctly classified in 61-80% of cases for different analyzed groups in obtained models. (shrink)

Infertility is a serious social problem. Very often the only treatment possibility are IVF methods. This study explores the possibility of outcome prediction in the early stages of treatment. The data, collected from the previous treatment cycles, were divided into four subsets, which corresponded to the selected stages of treatment. On each such subset, sophisticated data mining analysis was carried out, with appropriate imputations and classification procedures. The obtained results indicate that there is a possibility (...) of predicting the final outcome at the beginning of treatment. (shrink)

Many patients experience aspects of treatment and care as dehumanizing because the body is considered separate from the self and its life context. An attempt to transcend viewing persons in dualistic terms is posed by phenomenologists who focus not on “the body” as such but on what it means to be “embodied.” In this paper, we review the relevance of the phenomenology of the body for health care and report the results of comparing Sally Gadow’s phenomenological insights about body-self (...) unity with a qualitative analysis of patients’ accounts of satisfaction with the outcome of hand surgery. We illustrate the ways in which our findings were and were not congruent with Gadow’s conceptualization of embodiment and highlight aspects that are ambiguous. We conclude that the body-self dialectical relationship should be recast as a body-self-society trialectic and discuss the implications of this new conceptualization for clinical practices. (shrink)

Intrauterine insemination is one of many treatments provided to infertility patients. Many factors such as, but not limited to, quality of semen, the age of a woman, and reproductive hormone levels contribute to infertility. Therefore, the aim of our study is to establish a statistical probability concerning the prediction of which groups of patients have a very good or poor prognosis for pregnancy after IUI insemination. For that purpose, we compare the results of two analyses: Cluster Analysis and Kohonen Neural (...) Networks. The k-means algorithm from the clustering methods was the best to use for selecting patients with a good prognosis but the Kohonen Neural Networks was better for selecting groups of patients with the lowest chances for pregnancy. (shrink)

Comparative effectiveness research (CER) is one of the Patient Protection and Affordable Care Act's significant initiatives that aims to improve treatment outcomes and lower health care costs. This article takes CER a step further and suggests a novel clinical application for it. The article proposes the development of a national framework to enable physicians to rapidly perform, through a computerized service, medically sound personalized comparisons of the effectiveness of possible treatments for patients' conditions. A treatment comparison for a (...) given patient would be based on data from electronic health records of a cohort of clinically similar patients who received the treatments previously and whose outcomes were recorded. This framework has unique potential to simultaneously improve the quality of health care, reduce its cost, and alleviate public concerns about rationing and “one size fits all” medicine. (shrink)

Substance use disorders (SUDs) constitute a growing global health crisis, yet many limitations and challenges exist in SUD treatment research, including the lack of objective brain-based markers for tracking treatment outcomes. Electroencephalography (EEG) is a neurophysiological technique for measuring brain activity, and although much is known about EEG activity in acute and chronic substance use, knowledge regarding EEG in relation to abstinence and treatment outcomes is sparse. We performed a scoping review of longitudinal and pre-post treatment (...) EEG studies that explored putative changes in brain function associated with abstinence and/or treatment in individuals with SUD. Following PRISMA guidelines, we identified studies published between January 2000 and March 2022 from online databases. Search keywords included EEG, addictive substances (e.g., alcohol, cocaine, methamphetamine), and treatment related terms (e.g., abstinence, relapse). Selected studies used EEG at least at one time point as a predictor of abstinence or other treatment-related outcomes; or examined pre- vs. post-SUD intervention (brain stimulation, pharmacological, behavioral) EEG effects. Studies were also rated on the risk of bias and quality using validated instruments. Forty-four studies met the inclusion criteria. More consistent findings included lower oddball P3 and higher resting beta at baseline predicting negative outcomes, and abstinence-mediated longitudinal decrease in cue-elicited P3 amplitude and resting beta power. Other findings included abstinence or treatment-related changes in late positive potential (LPP) and N2 amplitudes, as well as in delta and theta power. Existing studies were heterogeneous and limited in terms of specific substances of interest, brief times for follow-ups, and inconsistent or sparse results. Encouragingly, in this limited but maturing literature, many studies demonstrated partial associations of EEG markers with abstinence, treatment outcomes, or pre-post treatment-effects. Studies were generally of good quality in terms of risk of bias. More EEG studies are warranted to better understand abstinence- or treatment-mediated neural changes or to predict SUD treatment outcomes. Future research can benefit from prospective large-sample cohorts and the use of standardized methods such as task batteries. EEG markers elucidating the temporal dynamics of changes in brain function related to abstinence and/or treatment may enable evidence-based planning for more effective and targeted treatments, potentially pre-empting relapse or minimizing negative lifespan effects of SUD. (shrink)

Patients have a right to refuse medical treatment. But what should happen after a patient has refused recommended treatment? In many cases, patients receive alternative forms of treatment. These forms of care may be less cost-effective. Does respect for autonomy extend to providing these alternatives? How for does justice constrain autonomy? I begin by providing three arguments that such alternatives should not be offered to those who refuse treatment. I argue that the best argument which refusers (...) can appeal to is based on the egalitarian principle of equality of outcome. However, this principle does not ultimately support a right to less cost-effective alternatives. I focus on Jehovah's Witnesses refusing blood and requesting alternative treatments. However, the point applies to many patients who refuse cost-effective medical care. (shrink)

The unsustainable growth in U.S. health care costs is in large part attributable to the rising costs of pharmaceuticals and medical devices and to unnecessary medical procedures. This fact has led health reform advocates and policymakers to place considerable hope in the idea that increased government support for research on the comparative effectiveness of medical treatments will eventually help to reduce health care expenses by informing patients, health care providers, and payers about which treatments for common conditions are effective and (...) which are not. Comparative effectiveness research has shown in some cases that expensive but commonly used treatments are significantly less effective than relatively inexpensive alternatives. Critics warn, however, that CER will homogenize patient care, limit patient choices, and lead to improper health care rationing and even to the denial of lifesaving treatments. (shrink)

Background: No studies have examined the underlying structure or predictive validity of the Cognitive Therapy Adherence and Competence Scale. Examining the structure of the CTACS is of great relevance because it could provide information on what constitutes competence in CBT, and whether some underlying factors are more important for predicting treatment outcomes than others. This study investigates the psychometric properties of the Norwegian version of CTACS and its associations with treatment outcomes in a sample of primary care clients (...) who received CBT for anxiety and/or depression.Method: Independent assessors rated audiotaped therapy sessions in a sample of 132 primary care clients, participating in the Prompt Mental Health Care trial. Outcomes were symptoms of anxiety and depression assessed by patient self-report questionnaires. Structural validity was examined by means of confirmatory and exploratory factor analyses, whereas longitudinal associations with treatment outcome were explored by adopting multilevel modeling.Results: No evidence was found for the divergent validity of the constructs competence and adherence as indicated by a very high correlation between these two subscales in CTACS. Regarding reliability, ICCs for the mean score of the full competence scale and its associated subscales were generally good to excellent, although the subscale measuring the quality of the therapeutic relationship was relatively low. Internal consistency was overall acceptable, but our CFA models did not provide an acceptable fit for the pre-specified one-factor and four-factor solutions. EFA results were difficult to interpret, with a sub-optimal three-factor solution providing best model fit and only two meaningful factors [CBT specific skills and session structure ]. Overall, the results indicated no evidence for the scales' predictive validity.Conclusion: Our findings point to several psychometric problems of the CTACS that may limit both its research and clinical utility. The importance of providing empirical evidence for both reliability and validity aspects of scales are discussed and suggestions for future research are provided. (shrink)

We know from the research literature that psychotherapy is effective, but we also know that hundreds of diverse therapies are being practiced that have not been subjected to scientific scrutiny; thus, in some circumstances iatrogenic effects do occur. Therefore, it is crucial that we recognize and implement therapeutic interventions that are evidence based rather than succumb to ethical dilemma, frustration, and complacency. Recommendations for family therapists are discussed, including the need to (a) keep abreast of research findings, (b) translate research (...) findings and developments as they apply to clinical practice, (c) prioritize techniques and intervention models, and (d) reexamine funding priorities and research foci. (shrink)

Opioid treatment agreements are written agreements between physicians and patients enumerating the risks associated with opioid medications along with the requirements that patients must meet to receive these medications on an ongoing basis. The choice to use such agreements goes beyond the standard informed consent process, and has a distinctive symbolic significance. Specifically, it suggests that physicians regard it as important to hold their patients accountable for adhering to various protocols regarding the use of their opioid medications. After laying (...) out a taxonomy of accountability relationships between physicians and patients, I argue that opioid treatment agreements are only justifiable for physicians to use in their provision of care if they improve public health outcomes, which has yet to be demonstrated. (shrink)

Objectives Prompt Mental Health Care (PMHC) is the Norwegian version of the England’s Improving Access to Psychological Therapies (IAPT). Both programs have been associated with substantial symptom reductions from pre- to post-treatment. The present study extends these findings by investigating symptom levels at 12 months post-treatment, as well as treatment outcome in relation to low- vs. high-intensity treatment forms. Design and Outcome Measures A prospective cohort design was used. All participants ( n = 1530) (...) were asked to complete the Patient Health Questionnaire-9 (PHQ-9) and the Generalized Anxiety Disorder-7 questionnaire (GAD-7) at baseline, before each session during treatment, at final treatment, and at 12 months post-treatment. Cohen’s d was used as effect size measure. Sensitivity analyses were conducted to examine the impact of the high missing data rates at post-treatment (≈44%) and 12 months post-treatment (≈58%). Results A large symptom reduction was seen from baseline to 12 months post-treatment for both PHQ ( d = −0.98) and GAD ( d = −0.94). Improvements observed at post-treatment were largely maintained at 12 months post-treatment (PHQ (Δ d = 0.10) and GAD (Δ d = 0.09). Recovery rates decreased only slightly from 49.5% at post-treatment to 45.0% at follow-up. Both low- and high-intensity treatment forms were associated with substantial and lasting symptoms reductions (−1.26 ≤ d ≤ −0.73). Sensitivity analyses did not substantially alter the main results. Conclusion The findings suggest long-lasting effects of the PMHC program and encourage the use of low-intensity treatment forms in PMHC like settings. (shrink)

In the presence of heterogeneity between the randomized controlled trial (RCT) participants and the target population, evaluating the treatment effect solely based on the RCT often leads to biased quantification of the real-world treatment effect. To address the problem of lack of generalizability for the treatment effect estimated by the RCT sample, we leverage observational studies with large samples that are representative of the target population. This article concerns evaluating treatment effects on survival outcomes for a (...) target population and considers a broad class of estimands that are functionals of treatment-specific survival functions, including differences in survival probability and restricted mean survival times. Motivated by two intuitive but distinct approaches, i.e., imputation based on survival outcome regression and weighting based on inverse probability of sampling, censoring, and treatment assignment, we propose a semiparametric estimator through the guidance of the efficient influence function. The proposed estimator is doubly robust in the sense that it is consistent for the target population estimands if either the survival model or the weighting model is correctly specified and is locally efficient when both are correct. In addition, as an alternative to parametric estimation, we employ the nonparametric method of sieves for flexible and robust estimation of the nuisance functions and show that the resulting estimator retains the root- n n consistency and efficiency, the so-called rate-double robustness. Simulation studies confirm the theoretical properties of the proposed estimator and show that it outperforms competitors. We apply the proposed method to estimate the effect of adjuvant chemotherapy on survival in patients with early-stage resected non-small cell lung cancer. (shrink)

In a typical comparative clinical trial the randomization scheme is fixed at the beginning of the study, and maintained throughout the course of the trial. A number of researchers have championed a randomized trial design referred to as ‘outcome-adaptive randomization.’ In this type of trial, the likelihood of a patient being enrolled to a particular arm of the study increases or decreases as preliminary information becomes available suggesting that treatment may be superior or inferior. While the design merits (...) of outcome-adaptive trials have been debated, little attention has been paid to significant ethical concerns that arise in the conduct of such studies. These include loss of equipoise, lack of processes for adequate informed consent, and inequalities inherent in the research design which could lead to perceptions of injustice that may have negative implications for patients and the research enterprise. This article examines the ethical difficulties inherent in outcome-adaptive trials. (shrink)

BackgroundThe aim of this study was to investigate the effectiveness of psychotherapeutic interventions for clinically referred adolescents, as well as to examine whether sociodemographic, clinical, or treatment-related variables and patients’ role expectations predict treatment outcome or are possible predictors of treatment dropout.MethodThe study comprised 58 adolescents suffering from diverse psychiatric disorders referred to psychotherapeutic interventions conducted in outpatient care. The outcome measures, The Beck Depression Inventory, and the Clinical Outcomes in Routine Evaluation – Outcome (...) Measure were filled in at baseline and at 3-, 6-, and 12-month follow-ups. Possible predictors were assessed at baseline.ResultsThe results indicate that the mean level of symptoms and psychological distress decreased during the treatment, most reduction occurring in the first 6 months. The frequency of treatment sessions was the strongest predictor of good outcome. Adolescents with a higher level of externalizing problems or lower level of expectations for their own active role in treatment seem to have a higher risk of dropping out.ConclusionOffering intensive treatment for a shorter period might be the most efficient way to gain symptom reduction and decrease psychological distress in psychotherapeutic interventions with adolescents. Being aware of externalizing behavior and increasing the adolescents’ own agency during the assessment could strengthen commitment and result in the adolescent benefiting more from treatment. (shrink)

The outcomes of psychoanalysis, as with other psychotherapies, vary considerably. _Psychoanalytic Treatment in Adults _examines the results of a longitudinal study of change during psychoanalysis, illuminating the characteristics of patients, analysts and analyses which can help to predict outcomes of treatment. Written by experienced psychologists and psychoanalysts, chapters in the book draw upon sixty case studies to consider how patients with very different analytic outcomes respond at both the beginning and end of their analysis. Psychoanalysts used a clinician (...) report measure, the Shedler-Westen Assessment Procedure, to describe a patient at the beginning of psychoanalysis and every six months until the analysis ended. This allowed the authors to learn about changes over analysis and, in turn, improved treatment planning and practice for the well-being of other patients. Chapters explore five outcomes: a negative therapeutic reaction; attrition when the patient drops out; attrition due to external events; mutual agreement between patient and analyst without maximum benefits; and mutual agreement between patient and analyst with maximum benefits. The findings from these chapters will be of interest to researchers and academics in the fields of psychoanalysis, psychotherapy, psychodynamic therapy, psychoanalytic education, psychiatry and psychology. The results should also help clinicians recognize potential problems early in analytic treatments so that they can work more effectively with patients. (shrink)

Outcome-adaptive randomization has been proposed as a corrective to certain ethical difficulties inherent in the traditional randomized clinical trial using fixed-ratio randomization. In particular, it has been suggested that OAR redresses the balance between individual and collective ethics in favour of the former. In this paper, I examine issues of welfare and autonomy arising in relation to OAR. A central issue in discussions of welfare in OAR is equipoise, and the moral status of OAR is crucially influenced by the (...) way in which this concept is construed. If OAR is based on a model of equipoise that demands strict indifference between competing interventions throughout the trial, such equipoise is disturbed by accruing data favouring one treatment over another; OAR seeks to redress this by weighting randomization to the seemingly superior treatment. However, this is a partial response, as patients continue to be allocated to the inferior therapy. Moreover, it rests upon considerations of aggregate harms and benefits, and does not therefore uphold individual ethics. Issues of fairness also arise, as early and late enrollees are randomized on a different basis. Fixed-ratio randomization represents a fuller and more consistent response to a loss of equipoise, as so construed. With regard to consent, the complexity of OAR poses challenges to adequate disclosure and comprehension. Additionally, OAR does not offer a remedy to the therapeutic misconception—participants’ tendency to attribute treatment allocation in an RCT to individual clinical judgments, rather than to scientific considerations—and, if anything, accentuates rather than alleviates this misconception. In relation to these issues, OAR fails to offer ethical advantages over fixed-ratio randomization. More broadly, the ethical basis of OAR can be seen to lie more in collective than in individual ethics, and overall it fares worse in this territory than fixed-ratio randomization. (shrink)

Data from medical research are typically summarized with various types of outcome measures. We present three arguments in favor of absolute over relative outcome measures. The first argument is from cognitive bias: relative measures promote the reference class fallacy and the overestimation of treatment effectiveness. The second argument is decision-theoretic: absolute measures are superior to relative measures for making a decision between interventions. The third argument is causal: interpreted as measures of causal strength, absolute measures satisfy a (...) set of desirable properties, but relative measures do not. Absolute outcome measures outperform relative measures on all counts. (shrink)

Contemporary social-scientific research seeks to identify specific causal mechanisms for outcomes of theoretical interest. Experiments that randomize populations to treatment and control conditions are the “gold standard” for causal inference. We identify, describe, and analyze the problem posed by transformative treatments. Such treatments radically change treated individuals in a way that creates a mismatch in populations, but this mismatch is not empirically detectable at the level of counterfactual dependence. In such cases, the identification of causal pathways is underdetermined in (...) a previously unrecognized way. Moreover, if the treatment is indeed transformative it breaks the inferential structure of the experimental design. Transformative treatments are not curiosities or “corner cases,” but are plausible mechanisms in a large class of events of theoretical interest, particularly ones where deliberate randomization is impractical and quasi-experimental designs are sought instead. They cast long-running debates about treatment and selection effects in a new light, and raise new methodological challenges. (shrink)

Psychological assessment has long been reported as a key component of clinical psychology. This paper examined and shed light on the complexities surrounding the clinical significance of therapeutic approach to treatment Planning. To achieve this objective, the paper searched and used the PsycINFO and PubMed databases and the reference sections of chapters and journal articles to analysed the underlying themes: 1) a strong basis for the usage of therapeutic approach to psychological assessment in treatment plans, 2) explained the (...) conceptual meaning of clinical significant change in therapeutic assessment, 3) used initial theory to explain the therapeutic mechanisms of change in clinical practice, 4) analysed the empirically documenting clinically significant change in therapeutic assessment. Finally, the study suggested that though therapeutic assessment is not sufficient for the systematic study of psychotherapy outcome and process, it is still consistent with both the lay-man and professional expectations regarding treatment outcome and also provides a precise method for classifying clients as “changed” or “unchanged” on the basis of clinical significance criteria. (shrink)

Research on the predictors of outcome for early, community-based, and time-limited interventions targeted for clinical depression in adolescents is still scarce. We examined the role of demographic, psychosocial, and clinical variables as predictors of outcome in a trial conducted in Finnish school health and welfare services to identify factors associating to symptom reduction and remission after a brief depression treatment. A total of 55 12–16-year-olds with mild to moderate depression received six sessions of either interpersonal counseling for (...) adolescents or brief psychosocial support. Both interventions resulted in clinical improvement at end of treatment and 3- and 6-month follow-ups. Main outcome measures were self-rated BDI-21 and clinician-rated Adolescent Depression Rating Scale. Latent change score models were used to identify predictors of change in depressive symptom scores and clinical remission at end of treatment and 3- and 6-month follow-ups over the combined brief intervention group. Symptom improvement was predicted by younger age and having a close relationship with parents. Both symptom improvement and clinical remission were predicted by male gender, not having comorbid anxiety disorder, and not having sleep difficulties. Our results add to knowledge on factors associating with good treatment outcome after a brief community intervention for adolescent depression. Brief depression interventions may be useful and feasible especially for treatment of mild and moderate depression among younger adolescents and boys, on the other hand clinicians may need to cautiously examine sleep problems and anxiety comorbidity as markers of the need for longer treatment. (shrink)

The placebo drug reactions from controlled trials were studied for the first time systematically for efficacy and the safety in drug data pooled from randomized, placebo-controlled, multicentre studies. Results: The efficacy of placebo on clinical symptoms and outcome varied between the therapeutic indications. However, no placebo effects on laboratory values, as e.g. blood glucose or Hb1c in diabetics, were noted. The frequency and type of placebo-induced adverse reactions also varied between indication groups. The placebo side effect profile was largely (...) similar to the side effect profile of the active treatment. The mechanisms of placebo effects are manyfold and varied (e.g. endorphin release, conditioning), much lacks explanation. Conclusion: Since the prescription of non-evidence based medicines (= pseudoplacebos) may clearly also result in serious adverse effects, such practice may not only be non-beneficial but may even be harmful. In clinical research, the judicious use of placebo remains essential to establish the efficacy and safety, safeguarding that patients receiving placebo will not be subject to harm and are fully informed. (shrink)

ABSTRACT In this paper, I support the claim that placing certain restrictions on public access to possible new treatments is morally problematic under some exceptional circumstances. Very ill patients may find that all available standard treatments are unacceptable, either because they are ineffective or have serious adverse effects, and these patients may understandably be desperate to try something new even if this means stepping into the unknown. Faced with certain death, it is rational to want to try something new and (...) to chance a dire outcome. Restricting possible new treatments to research trials may put these treatments scientifically, geographically or economically out of reach of these patients. For those who can get access, research restrictions could weaken, though not necessarily eliminate, the value of consent participants of such trials are able to give. Some participants may therefore be exploited for scientific purposes in the name of public interest. There are nonetheless compelling reasons for keeping some restrictive regulation in this area. (shrink)