The Process-Outcome Mindfulness Effects in Trainees (PrOMET) study: protocol of a pragmatic randomized controlled trial

Background: Mindfulness has its origins in an Eastern Buddhist tradition that is over 2500 years old and can be defined as a specific form of attention that is non-judgmental, purposeful, and focused on the present moment. It has been well established in cognitive-behavior therapy in the last decades, while it has been investigated in manualized group settings such as mindfulness-based stress reduction and mindfulness-based cognitive therapy. However, there is scarce research evidence on the effects of mindfulness as a treatment element in individual therapy. Consequently, the demand to investigate mindfulness under effectiveness conditions in trainee therapists has been highlighted. Methods/Design: To fill in this research gap, we designed the PrOMET Study. In our study, we will investigate the effects of brief, audiotape-presented, session-introducing interventions with mindfulness elements conducted by trainee therapists and their patients at the beginning of individual therapy sessions in a prospective, randomized, controlled design under naturalistic conditions with a total of 30 trainee therapists and 150 patients with depression and anxiety disorders in a large outpatient training center. We hypothesize that the primary outcomes of the session-introducing intervention with mindfulness elements will be positive effects on therapeutic alliance (Working Alliance Inventory) and general clinical symptomatology (Brief Symptom Checklist) in contrast to the session-introducing progressive muscle relaxation and treatment-as-usual control conditions. Treatment duration is 25 therapy sessions. Therapeutic alliance will be assessed on a session-to-session basis. Clinical symptomatology will be assessed at baseline, session 5, 15 and 25. We will conduct multilevel modeling to address the nested data structure. The secondary outcome measures include depression, anxiety, interpersonal functioning, mindful awareness, and mindfulness during the sessions. Discussion: The study results could provide important practical implications because they could inform ideas on how to improve the clinical training of psychotherapists that could be implemented very easily; this is because there is no need for complex infrastructures or additional time concerning these brief session-introducing interventions with mindfulness elements that are directly implemented in the treatment sessions. Trial registration: From ClinicalTrials.gov, Identifier: NCT02270073 (registered October 6, 2014

Low frequency of TERT promoter mutations in gastrointestinal stromal tumors (GISTs).

Somatic mutations in the promoter region of telomerase reverse transcriptase (TERT) gene, mainly at positions c. − 124 and c. − 146 bp, are frequent in several human cancers; yet its presence in gastrointestinal stromal tumor (GIST) has not been reported to date. Herein, we searched for the presence and clinicopathological association of TERT promoter mutations in genomic DNA from 130 bona fide GISTs. We found TERT promoter mutations in 3.8% (5/130) of GISTs. The c. − 124C4T mutation was the most common event, present in 2.3% (3/130), and the c. − 146C4T mutation in 1.5% (2/130) of GISTs. No significant association was observed between TERT promoter mutation and patient’s clinicopathological features. The present study establishes the low frequency (4%) of TERT promoter mutations in GISTs. Further studies are required to confirm our findings and to elucidate the hypothetical biological and clinical impact of TERT promoter mutation in GIST pathogenesis.This project was partially supported by Barretos Cancer Hospital internal research funds (PAIP) and CNPq Universal Grant (476192/2013-7) to RMR. NCC is a recipient of an FAPESP Doctoral Fellowship (2013/25787-3). Further funding from the project ‘Microenvironment, metabolism and cancer’ that was partially supported by Programa Operacional Regional do Norte (ON.2—O Novo Norte) under the Quadro de Referência Estratégico Nacional (QREN) and the Fundo Europeu de Desenvolvimento Regional (FEDER). IPATIMUP is an Associate Laboratory of the Portuguese Ministry of Science, Technology and Higher Education that is partially supported by the FCT

Telomerase promoter mutations in cancer: an emerging molecular biomarker?

João Vinagre, Vasco Pinto and Ricardo Celestino contributed equally to the manuscript.Cell immortalization has been considered for a long time as a classic hallmark of cancer cells. Besides telomerase reactivation, such immortalization could be due to telomere maintenance through the “alternative mechanism of telomere lengthening” (ALT) but the mechanisms underlying both forms of reactivation remained elusive. Mutations in the coding region of telomerase gene are very rare in the cancer setting, despite being associated with some degenerative diseases. Recently, mutations in telomerase (TERT) gene promoter were found in sporadic and familial melanoma and subsequently in several cancer models, notably in gliomas, thyroid cancer and bladder cancer. The importance of these findings has been reinforced by the association of TERT mutations in some cancer types with tumour aggressiveness and patient survival. In the first part of this review, we summarize the data on the biology of telomeres and telomerase, available methodological approaches and non-neoplastic diseases associated with telomere dysfunction. In the second part, we review the information on telomerase expression and genetic alterations in the most relevant types of cancer (skin, thyroid, bladder and central nervous system) on record, and discuss the value of telomerase as a new biomarker with impact on the prognosis and survival of the patients and as a putative therapeutic target

Mindfulness and progressive muscle relaxation as standardized session-introduction in individual therapy. A randomized controlled trial

Objective: There is scarce research on the effects of mindfulness in individual therapy. As many practitioners integrate mindfulness exercises into individual therapy, empirical evidence is of high clinical relevance. Method: We investigated the effects of a session?introducing intervention with mindfulness elements (SIIME) in a randomized, controlled design. The effects of SIIME on therapeutic alliance and symptomatic outcome were compared with progressive muscle relaxation (PMR) and treatment?as?usual (TAU) control conditions. The sample comprised 162 patients with anxiety and depression. Results: Multilevel modeling revealed a significant symptom reduction and significant increase of alliance over the course of therapy. There were no significant time-condition interactions on outcome and alliance, indicating the comparable efficiency of all three treatment conditions. Conclusions: We found no advantage of SIIME versus PMR and TAU. Add?on mindfulness might not improve individual therapy related to alliance and outcome. (DIPF/Orig.

Achtsamkeitsinterventionen in Ausbildungspsychotherapien: die "Process-Outcome Mindfulness Effects in Trainees (PROMET)-Studie"

Achtsamkeit hat seine Ursprünge in einer über 2500 Jahre alten, östlich-buddhistischen Tradition und kann konzeptualisiert werden als eine spezifische Form der Aufmerksamkeit, die nicht-bewertend, absichtsvoll und auf den aktuellen Moment fokussiert ist. Zentrale Ziel dieser Studie zu identifizieren, ob Übungen mit Achtsamkeitselementen, die zu Beginn von Therapiesitzungen durchgeführt werden, helfen können, den therapeutischen Prozess zu verbessern. Spezifischer werden die Effekte einer kurzen Übung mit Achtsamkeitselementen auf den therapeutischen Prozess und Behandlungserfolg unter Effectiveness-Bedingungen untersucht, die von ambulanten Patienten und Therapeuten gemeinsam zu Beginn jeder Therapiestunde durchgeführt wird. Dabei werden 150 Patienten vor dem Start ihrer therapeutischen Behandlung und nach Abschluss einer sechs Sitzungen andauernden diagnostischen Phase randomisiert auf entweder eine Achtsamkeitsinterventionsgruppe (AIG), eine Kontrollgruppe (KG), die eine Kurzversion von Progressiver Muskelrelaxation (PMR) durchführt, oder auf eine Treatment As Usual (TAU)-Gruppe. Das Studiendesign und erste Ergebnisse einer Vorstudie werden skizziert

Mindfulness and progressive muscle relaxation as standardized session-introduction in individual therapy: a randomized controlled trial

OBJECTIVE: There is scarce research on the effects of mindfulness in individual therapy. As many practitioners integrate mindfulness exercises into individual therapy, empirical evidence is of high clinical relevance. METHOD: We investigated the effects of a session-introducing intervention with mindfulness elements (SIIME) in a randomized, controlled design. The effects of SIIME on therapeutic alliance and symptomatic outcome were compared with progressive muscle relaxation (PMR) and treatment-as-usual (TAU) control conditions. The sample comprised 162 patients with anxiety and depression. RESULTS: Multilevel modeling revealed a significant symptom reduction and significant increase of alliance over the course of therapy. There were no significant time-condition interactions on outcome and alliance, indicating the comparable efficiency of all three treatment conditions. CONCLUSIONS: We found no advantage of SIIME versus PMR and TAU. Add-on mindfulness might not improve individual therapy related to alliance and outcome

Mindfulness and progressive muscle relaxation as standardized session-introduction in individual therapy: A randomized controlled trial

Objective: There is scarce research on the effects of mindfulness in individual therapy. As many practitioners integrate mindfulness exercises into individual therapy, empirical evidence is of high clinical relevance. Method: We investigated the effects of a session-introducing intervention with mindfulness elements (SIIME) in a randomized, controlled design. The effects of SIIME on therapeutic alliance and symptomatic outcome were compared with progressive muscle relaxation (PMR) and treatment-as-usual (TAU) control conditions. The sample comprised 162 patients with anxiety and depression. Results: Multilevel modeling revealed a significant symptom reduction and significant increase of alliance over the course of therapy. There were no significant time-condition interactions on outcome and alliance, indicating the comparable efficiency of all three treatment conditions. Conclusion: We found no advantage of SIIME versus PMR and TAU. Add-on mindfulness might not improve individual therapy related to alliance and outcome

Health and economic benefits of increased β-blocker use following myocardial infarction

Context: β-Blockers are underused in patients who have myocardial infarction (MI), despite the proven efficacy of these agents. New evidence indicates that β-blockers can have benefit in patients with conditions that have been considered relative contraindications. Understanding the consequences of underuse of β-blockers is important because of the implications for current policy debates over quality-of-care measures and Medicare prescription drug coverage. Objective: To examine the potential health and economic impact of increased use of β-blockers in patients who have had MI. Design and Setting: We used the Coronary Heart Disease (CHD) Policy Model, a computer-simulation Markov model of CHD in the US population, to estimate the epidemiological impact and cost-effectiveness of increased β-blocker use from current to target levels among survivors of MI aged 35 to 84 years. Simulations included 1 cohort of MI survivors in 2000 followed up for 20 years and 20 successive annual cohorts of all first-MI survivors in 2000-2020. Mortality and morbidity from CHD were derived from published meta-analyses and recent studies. This analysis used a societal perspective. Main Outcome Measures: Prevented MIs, CHD mortality, life-years gained, and cost per quality-adjusted life-year (QALY) gained in 2000-2020. Results: Initiating β-blocker use for all MI survivors except those with absolute contraindications in 2000 and continuing treatment for 20 years would result in 4300 fewer CHD deaths, 3500 MIs prevented, and 45000 life-years gained compared with current use. The incremental cost per QALY gained would be $4500. If this increase in β-blocker use were implemented in all first-MI survivors annually over 20 years, β-blockers would save$18 million and result in 72000 fewer CHD deaths, 62000 MIs prevented, and 447000 life-years gained. Sensitivity analyses demonstrated that the cost-effectiveness of β-blocker therapy would always be less than $11000 per QALY gained, even under unfavorable-assumptions, and may even be cost saving. Restricting β-blockers only to ideal patients (those without absolute or relative contraindications) would reduce the epidemiological impact of β-blocker therapy by about 60%. Conclusions: Our simulation indicates that increased use of β-blockers after MI would lead to impressive gains in health and would be potentially cost saving.</p