Group hypnosis for stress reduction and improved stress coping: a multicenter randomized controlled trial

Background: The aim of the trial was to investigate the effect of a hypnotherapeutic group program in healthy persons with increased levels of perceived stress. Methods: In a randomized controlled multicenter trial participants with a self-assessed subjective stress level ≥ 40 mm on a visual analogue scale (0–100 mm; VAS) for the previous week and a stable state of health were randomized to either 5 weekly sessions of 120-min duration of a hypnotherapeutic group program for stress reduction and improved stress coping plus 5 hypnosis audiorecords for individual practice at home plus an educational booklet for stress coping (hypnosis group) versus an educational booklet only (control group). The primary outcome parameter was the VAS stress level for the previous week after 5 weeks. Secondary outcome parameters included the VAS stress level after 12 weeks, perceived stress (CPSS), depression (ADS-K), self efficacy (SWE) and quality of life (SF 36) after 5 weeks and 12 weeks. Analysis of covariance with a significance level of 5% using the full analysis set was used for analysis; the model included treatment (fixed effect), VAS baseline value (fixed covariate), and center (random effect). Results: A total of 95 participants were randomized; 47 (40 female, 45 ± 13.4 years of age) were allocated to the hypnosis group, and 48 (41 female, 46.9 ± 14.3 years) were allocated to the control group. Regarding VAS stress level after 5 weeks, the adjusted VAS mean in the hypnosis group was 41.8 mm [95% confidence interval (CI): 35.2; 48.4] compared to 62.9 mm [56.2; 69.7] in the control group, and the group difference was − 21.2 mm [− 30.1; − 12.2] (P < 0.001). After 12 weeks, the stress intensity on the VAS showed a between-group difference of − 14.7 mm [− 25.1; − 4.4] (P = 0.006), and the adjusted means were 41.1 mm [33.4; 48.8] in the hypnosis group and 55.9 mm [48.4; 63.5] in the control group. Improvements were also reported for CPSS, SF-36, SWE and ADS-K after 5 and 12 weeks. Conclusion: Compared to the control group, the hypnosis group showed reduced perceived stress after 5 and 12 weeks. Trial registration: ClinicalTrials.gov NCT03525093; date of registration: May 15, 2018

How effective is the early support program Babylotse-Plus for psychosocially burdened mothers and their infants? A comparative intervention study

Objectives: Our aim was to examine the effects of an early perinatal prevention program offered to mothers and families suffering from significant psychosocial burden. Methods: All mothers giving birth in a Berlin university hospital during Jan-Aug 2013 were screened with a standardized 27-item questionnaire by trained staff. Mothers with a screening-score ≥ 3, who were not enrolled in other public support programs, were defined as psychosocially burdened. They received a detailed needs assessment and were followed up with counseling. When necessary, affected mothers were voluntarily guided through to specialized 'early support' institutions during the 12-month-intervention period. The historical control group (care-as-usual) consisted of children born at the same hospital the year before.At 12 months postnatally, we interviewed mothers in both groups to assess their stress burden and coping skills by Parenting Stress Index and assessed the current childcare condition. Differences between the groups were compared by multivariable logistic regression analyses adjusting for potential confounders. Results: The intervention group and the control group included 225 and 157 families, respectively. After 12-months, mothers in the 'early support' intervention group had significantly less often depression (adjusted odds ratio 0.25, 95%-confidence interval 0.07-0.94), less often a disturbed relationship with the parenting partner (0.34, 0.10-1.14) and reported reduced stress due to the child's demands (0.40, 0.15-1.10) compared to the control group. Childcare indicators did not differ between the 2 groups. Conclusions: In mothers at high psychosocial risk, the 'early support' intervention program Babylotse-Plus seemed to reduce the occurrence of depression and several stress indicators in the first postnatal year

Development, feasibility and effectiveness of a hypnotherapeutic group program to improve stress coping

Hintergrund/Zielstellung: Stress und Stressfolgeerkrankungen nehmen weltweit zu. Als Verfahren zur Stressreduktion und Stressbewältigung werden vor allem kognitiv-verhaltenstherapeutische Programme und achtsamkeitsbasierte Methoden angewendet. Hypnose und Hypnotherapie, für die in definierten Bereichen der Medizin und Psychotherapie bereits Wirksamkeitsnachweise erbracht werden konnten, werden ebenfalls zur verbesserten Stressbewältigung angewendet, sind bislang aber nur unzureichend untersucht. Ziel dieses Projektes war die Entwicklung eines präventiven, hypnotherapeutischen Gruppenprogramms zur verbesserten Stressbewältigungsbewältigung sowie dessen Untersuchung auf Machbarkeit sowie Wirksamkeit und Sicherheit. Methodik: Auf der Basis eines systematischen Literaturreviews (Publikation 1) und von Experteninterviews wurde ein hypnotherapeutisches Gruppenprogramm zur Stressbewältigung entwickelt. In einer prospektiven, einarmigen Pilotstudie wurde die Durchführbarkeit des hypnotherapeutischen Gruppenprogramms auf Machbarkeit getestet (Publikation 2). In einer prospektiven, randomisierten, kontrollierten, multizentrischen Interventionsstudie (RCT) wurde das hypnotherapeutische Gruppenprogramms zur Stressbewältigung auf seine Wirksamkeit hin untersucht (Publikation 3). Teilnehmer waren in der Machbarkeitsstudie und im RCT Frauen und Männer von 18-70 Jahren mit einer selbsteingeschätzten Stressbelastung ≥ 40 mm auf einer Visuellen Analogskala (minimal 0 bis maximal100 mm, VAS) in der letzten Woche, einer subjektiv erhöhten Stressbelastung seit mindestens drei Monaten und einem ansonsten stabilen Gesundheitszustand. Zielparameter waren die subjektive Stressbelastung auf der VAS, das Stresserleben auf Cohens Perceived Stress Scale (CPSS), Depressivität (ADS-K), Selbstwirksamkeit (SWE), Lebensqualität (SF 36) sowie Selbsteinschätzungen u.a. zur Zielerreichung und Zufriedenheit mit dem Gruppenprogramm auf Likert-Skalen. Die Zielparameter wurden zur Baseline, nach 5 Wochen und im RCT auch nach 12 Wochen erhoben. Ergebnisse: Im Ergebnis zeigte der systematische Literaturreview eine unklare Evidenz von Hypnose zur Stressbewältigung (Publikation 1). In der Machbarkeitsstudie erwies sich das Gruppenprogramm als gut durchführbar und stieß auf eine gute Akzeptanz bei den Teilnehmern. Es fanden sich im explorativen Vorher-Nachher-Vergleich deutliche Unterschiede in Stressbelastung, Stresserleben, Depressivität und auf Subskalen des SF 36 (Publikation 2). Im RCT zeigte sich eine signifikante Überlegenheit der Hypnose gegenüber der Kontrollgruppe auf der Visuellen Analogskala, im Stresserleben (CPSS), in Depressivität und auf Subskalen des SF 36 nach 5 Wochen und nach 12 Wochen (Publikation 3). In beiden Studien zeigte sich die überwiegende Zahl von Teilnehmern der Hypnosegruppe zufrieden mit dem Gruppenprogramm und der persönlichen Zielerreichung. Diskussion: Die Ergebnisse weisen auf eine Wirksamkeit des hypnotherapeutischen Gruppenprogramms zur Stressbewältigung im Vergleich zur Kontrolle hin. Zudem wird eine hohe Teilnehmerzufriedenheit und –akzeptanz berichtet. In weiteren Studien sollte die Intervention im randomisierten Kontrollgruppendesign auf Äquivalenz zu bereits etablierten Stressbewältigungsprogrammen (z.B. Verhaltenstherapie, MBSR) untersucht werden.Background/Aim: Stress and stress-related illnesses are increasing worldwide. Hypnosis and hypnotherapy, for which efficacy has already been proven in defined areas of medicine and psychotherapy, are also used to improve stress management, but have so far been insufficiently investigated. The aim of this project was to develop a preventive, hypnotherapeutic group program for improved stress coping and to examine it for feasibility and effectiveness and safety. Methods: A hypnotherapeutic group program for stress coping was developed on the basis of a systematic literature review (publication 1) and expert interviews. The feasibility of the group program was tested in a prospective, one-arm, pilot study (publication 2). The effectiveness of the group program for improved stress coping was examined in a prospective, randomized, controlled, multicenter intervention study (RCT) (publication 3). Participants in the feasibility study and in the RCT were women and men aged 18-70 with a self-assessed stress level ≥ 40 mm on a visual analog scale (minimum 0 to maximum 100 mm, VAS) in the last week, a subjectively increased stress level for at least three months and an otherwise stable state of health. The target parameters were the subjective stress load on the VAS, perceived stress (CPSS), depression (ADS-K), self-efficacy (SWE), quality of life (SF-36) and self-assessments for goal achievement and satisfaction with the group program on Likert scales. The target parameters were assessed at baseline, after 5 weeks and in the RCT also after 12 weeks. Results: As a result, the systematic literature review showed unclear evidence of hypnosis for stress coping (publication 1). In the feasibility study, the group program proved to be easy to implement and was well received by the participants. In the exploratory pre-post-comparison, there were clear differences in VAS stress, perceived stress, depression and subscales of the SF-36 (publication 2). The RCT showed a significant superiority of the hypnosis compared to the control group on the stress level (VAS, CPSS), self-efficacy, depression and on subscales of the SF-36 after 5 and 12 weeks (publication 3). In both studies, the most participants in the hypnosis group were satisfied with the group program and goal achievement. Discussion: The results indicate the effectiveness of the hypnotherapeutic group program for stress coping compared to the control. In further studies, the intervention design should be examined for equivalence to already established stress management programs (e.g. behavioral therapy, MBSR) in the randomized control group design

Implementation of a psychosocial early prevention program in obstetric medicine – Babylotse Plus

Einleitung: Die Entwicklung von Kindern, die in Familien mit starken psychosozialen Belastungen geboren werden, ist bereits während der Schwangerschaft und zunehmend postnatal gefährdet. Zielsetzung der Arbeit war es, die diagnostische Genauigkeit des Screeningbogens des psychosozialen Frühwarnsystems Babylotse Plus zu untersuchen, um Risikofamilien den notwendigen Unterstützungsbedarf im Sinne Früher Hilfen im ersten Jahr nach der Geburt zukommen zu lassen. Methoden: Für alle Geburten von zwei Geburtskliniken der Charité - Universitätsmedizin Berlin im Zeitraum 01.01. - 31.08.2013 wurde der Babylotse Plus Screeningbogen zur Identifizierung psychosozialer Risikoindikatoren möglicher Kindeswohlgefährdung (Score: 0 = geringstes bis 65 = höchstes Risiko) eingesetzt. Der Referenzstandard war die Expertenmeinung von Sozialpädagogen, sogenannten Babylotsen, die kurz nach der Geburt das umfassende standardisierte Babylotse Plus Erstgespräch durchführten, um Ressourcen, mögliche Belastungen und Unterstützungsbedarf zu erfassen. Ergebnisse: Von 2344 Familien wurden 279 als Studienteilnehmer eingeschlossen, davon 215 Familien mit einem „auffälligen“ Score (≥ 3) und eine Zufallsauswahl von 64 Familien mit einem „unauffälligen“ Score (< 3). Spezifität (33,0 %; 95 %-Konfidenzintervall [95 %-KI]: 30,5 - 33,5), positive Likelihood Ratio (1,5; 95 %-KI: 1,3 - 1,5) und “area under curve“ (0,76; 95 %-KI: 0,72 - 0,82) des Babylotse Plus Screeningbogens waren schwach. Hervorragend fielen dagegen Sensitivität mit 98,9 % (95 %-KI: 93,4 - 99,9) und negative Likelihood Ratio mit 0,03 (95 %-KI: 0,00 - 0,22) aus. Risikoindikatoren für Unterstützungsbedarf waren insbesondere Partnerschaftsprobleme (Odds Ratio [OR] 9,3; 95 %-KI: 2,9 - 29,5; p = 0,001), wirtschaftliche Probleme (OR 3,5; 95 %-KI: 1,8 - 6,7; p < 0,001), Probleme bei der Alltagsbewältigung (OR 3,4; 95 %-KI: 1,5 - 7,6; p = 0,003), Einschätzung durch medizinisches Personal (OR 3,1; 95 %-KI: 1,6 - 6,2; p = 0,001), Alter der Mutter < 21 Jahre (OR 3,1; 95 %-KI: 1,5 - 6,7; p = 0,003), Frühgeburt / Geburtskomplikationen (OR 2,3; 95 %-KI: 1,1 - 4,8; p = 0,031) und Rauchen (OR 1,8; 95 %-KI: 1,0 - 3,2; p = 0,044). Schlussfolgerungen: Durch die hohe Sensitivität des Babylotse Plus Screeningbogens gelang es sehr gut, frühzeitig fast alle psychosozial belasteten Familien mit Unterstützungsbedarf zu identifizieren und deren Überleitung zu Frühen Hilfen zu ermöglichen. Durch die relativ geringe Spezifität wurden jedoch viele risikofreie Familien fälschlicherweise positiv getestet, was für den zukünftigen Einsatz akzeptiert werden kann, da ein falsch positives Ergebnis nur ein Gespräch mit einem Babylotsen ohne große Belastungen für die Familie zur Folge hätte. Zukünftige Studien zur Optimierung des Risikoscreenings sollten versuchen, bei gleichbleibend hoher Sensitivität den Anteil der falsch positiv getesteten Familien zu reduzieren.Introduction: The well-being and healthy development of newborns and toddlers can be hampered pre- and postnatally, when they are born in families with severe psychosocial stress. The aim of the current project was to analyze the diagnostic accuracy of the newly developed "Babylotse-Plus"-screening form to identify families at high risk soon after birth. Methods: Babylotse-Plus- screening (score: from 0 = no risk to 65 = high risk) was used for every mother giving birth in two Charité-affiliated maternity clinics between January 1, 2013 and August 31, 2013. The opinion of experts (social workers) based on a comprehensive standardized interview served as the reference standard. The experts explored burdens, resources and stress factors for each family, evaluating the need for support. If necessary, they provided access to early prevention programs (interdisciplinary support from pregnancy on into early childhood years). Results: From 2344 families 279 participants were included in the analyses, 215 with possible high risk (score ≥ 3) and 64 with no or low risk (score < 3). Results were poor regarding the specificity (33.0 %; 95 %-CI: 30.5 - 33.5), positive likelihood ratio (1.5; 95 %-CI: 1.3 - 1.5) and area under curve (0.76; 95 %-CI: 0.72 - 0.82), whereas the sensitivity at 98.9 % (95 %-CI: 93.4 -99.9) and negative likelihood ratio at 0.03 (95 %-CI: 0.00 - 0.22) of the screening instrument were excellent. The following risk factors seem to be reliable predictors for the need of support: relationship issues (OR 9.3; 95 %-CI: 2.9 - 29.5; p = 0.001), financial problems (OR 3.5; 95 %-CI: 1.8 - 6.7; p < 0.001), struggle with everyday life (OR 3.4; 95 %-CI: 1.5 - 7.6; p = 0.003), the staff’s intuition (OR 3.1; 95 %-CI: 1.6 - 6.2; p = 0.001), young mothers < 21 years (OR 3.1; 95 %-CI: 1.5 - 6.7; p = 0.003), prematurity / pediatric perinatal complications (OR 2.3; 95 %-CI: 1.1 - 4.8; p = 0.031) and smoking during pregnancy (OR 1.8; 95 %-CI: 1.0 - 3.2; p = 0.044). Conclusion: The high sensitivity showed that Babylotse-Plus-screening successfully identified families in need of support. Low specificity showed that many families without need for support were falsely identified as families at risk. Nevertheless the low specificity could be accepted, since false positive results would lead to an interview with a social worker without stigmatizing effects or placing great strain on the family. Future research should try to optimize the screening instrument, to reduce false positive results without compromising the sensitivity of the test

Os direitos autorais musicais dos ringtones e dos truetones : execução pública ou distribuição

Trata do uso das novas tecnologias de comunicação, destacando-se o grande avanço da área de telecomunicações que possibilitou, em um curto espaço de tempo que o telefone celular passasse também a ser um veículo de distribuição de música, foto, som, e imagens. Neste contexto surge a discussão no âmbito da legislação autoral vigente sobre a natureza dos toques de celulares, denominados de ringtones e truetones para fins de recolhimento de direitos autorais pelos titulares das obras, em especial quanto à caracterização de tais utilizações como sendo distribuição, reprodução ou execução pública

Evaluation of the Babylotse-Plus screening form. Evaluation of a simple instrument to systematically identify parents of newborns with severe psychosocial stress at Charite Berlin

Hintergrund. Die Entwicklung und das Wohl von Kindern aus Familien mit schweren psychosozialen Belastungen können schon in der Schwangerschaft und im Säuglingsalter gefährdet sein. In der Geburtsmedizin in Deutschland fehlen einfache, valide Frühwarnsysteme, um Risikofamilien rechtzeitig zu identifizieren. Zielsetzung. Unser Ziel war es, die diagnostische Genauigkeit eines perinatal eingesetzten, einfachen Screeningbogens zur Identifizierung psychosozial belasteter Familien zu evaluieren. Methoden. Für alle Geburten der Berliner Charité im Zeitraum 1.1.–31.8.2013 füllte medizinisches Personal im Rahmen des Projekts Babylotse-Plus einen 5-minütigen Screeningbogen mit 27 Items aus. Ein daraus resultierender Summenscore ≥3 wurde als „auffällig“ definiert. Anschließend erfolgte zur genauen Erfassung der familiären Ressourcen undmöglicher psychosozialer Belastungen ein einstündiges, standardisiertes Elterninterview, welches als Referenzstandard für die Evaluation des Screeningbogens verwendet wurde. Ergebnisse. In die vorliegende Analyse konnten 279 Familien eingeschlossen werden. Beim Vergleich der 215 Familien mit „auffälligem“ Score mit einer Zufallsauswahl von 64 Familien mit „unauffälligem“ Score <3, zeigte sich für den Screeningbogen eine hervorragende Sensitivität (98,9%; 95%- Konfidenzintervall 93,4–99,9%), jedoch nur eine geringe Spezifität (33,0%; 95%- Konfidenzintervall 30,5–33,5%). Die daraus resultierende positive Likelihood Ratio fiel mit 1,5 schwach, die negative Likelihood Ratio dagegen mit 0,03 sehr gut aus. Schlussfolgerungen. Mithilfe des Screeningbogens konnten psychosoziale Risikofamilien sehr gut identifiziert werden, jedoch wurden auch viele Familien ohne oder mit nur einem geringen Risiko fälschlicherweise als unterstützungsbedürftig eingestuft. Weitere Studien sollten in anderen Settings und zur Verbesserung der Spezifität bei möglichst gleichbleibender Sensitivität des Screeningbogens durchgeführt werden.Background. The well-being and healthy development of children are at risk in families with severe psychosocial stress. In Germany, simple and valid screening instruments are lacking to identify families in need of early support. Objectives. We aimed to examine the diagnostic accuracy of a simple perinatal screening form to identify families at high psychosocial risk. Methods. For every mother giving birth at Charite Berlin between January and August 2013 the short Babylotse-Plus screening form with 27 items was filled out by medical staff. Completing the form took about 5 min. After calculating a sum score, values of >= 3 were defined as "likely at risk". A one-hour comprehensive standardized interview with the parents after birth served as the reference standard for assessing family resources and stress factors. Results. Among the 279 participants included in the analyses, 215 were "likely at risk" and 64 had a low or no risk, the latter were randomly selected among all families with scores <3. The screening form had an excellent sensitivity (98.9%; 95% confidence interval 93.4-99.9%) to detect families likely at risk, whereas its specificity was only low (33.0%; 95% confidence interval 30.5-33.5%). This resulted in a rather poor positive likelihood ratio of 1.5 but a very good negative likelihood ratio of 0.03. Conclusions. The screening form identified families with psychosocial risks well, but many families with low or no risk were falsely defined as being at risk. Before recommending the screening instrument for clinical practice, further studies are needed in different settings to improve the specificity without reducing its high sensitivity

Laterality in persons with intellectual disability II. Hand, foot, ear, and eye laterality in persons with trisomy 21 and Williams-Reuren syndrome

International audienceLaterality (hand, foot, ear and eye) was assessed in participants with Trisomy 21 (62) and Williams-Beuren syndrome (WBS) (39). Handedness was also assessed in a card reaching task. The comparison group included 184 typically developing persons. Two independent age sub-groups were formed: 7 to 10 years old and 11 to 34 years old. We confirmed previous data: individuals with 7-21 were more frequently left- or mixed-handed than typically developing persons; individuals with WBS had intermediate scores. The two groups with genetic disorders had less right foot preference. Manual and foot inconsistencies characterized both groups with genetic disorders. Cross hand-foot preference was lower in the typically developing group. Differences in IQ levels did not correlate with differences in laterality scores. Overall laterality profiles were not the same in the two groups with genetic disorders: the greatest differences were observed between typically developing persons and persons with Trisomy 21. (c) 2006 Wiley Periodicals, Inc

Expansion of NKG2A−LIR1− Natural Killer Cells in HLA-Matched, Killer Cell Immunoglobulin-Like Receptors/HLA-Ligand Mismatched Patients following Hematopoietic Cell Transplantation

The prognosis after hematopoietic cell transplantation (HCT) for the treatment of leukemia or lymphoma in humans is influenced by donor-derived natural killer (NK) cells, which enhance the graft-versus-leukemia (GVL) effect. Such alloreactive killer cells can be generated in vivo after HCT if the donor expresses killer cell immunoglobulin-like receptors (KIRs), such as KIR2DL1, KIR2DL2/3, or KIR3DL1, for which the recipient lacks HLA class I ligands. We studied effector cells from 22 KIR/HLA-ligand mismatched and 14 KIR/HLA-ligand matched, primarily HLA-matched patient-donor pairs after allogeneic HCT. A novel 8-color flow cytometry panel allowed us to characterize effector-cell populations without “broadly reactive” inhibitory receptors such as CD94/NKG2A or LIR1. The numbers of such NKG2A– LIR1– NK cells increased following HCT in patients transplanted by KIR/HLA-ligand mismatched grafts, compared to KIR/HLA-ligand matched grafts, and in patients transplanted from donors of the A/B, compared to A/A, KIR haplotypes. NKG2A–LIR1– NK cells expressing only those inhibitory KIRs for which the patient had no HLA class I ligands could be stimulated by HLA class I-deficient cells to express CD107a. Thus, NKG2A–LIR1– NK cells may be important GVL effector cells following HCT, even in patients transplanted from HLA-matched donors