TY - JOUR A1 - Warschburger, Petra A1 - Kröller, Katja A1 - Haerting, Johannes A1 - Unverzagt, Susanne A1 - van Egmond-Fröhlich, Andreas T1 - Empowering Parents of Obese Children (EPOC): A randomized controlled trial on additional long-term weight effects of parent training JF - Appetite : multidisciplinary research on eating and drinking N2 - Although inpatient lifestyle treatment for obese children and adolescents can be highly effective in the short term, long-term results are unconvincing. One possible explanation might be that the treatment takes place far from parents' homes, limiting the possibility to incorporate the parents, who play a major role in establishing and maintaining a healthy lifestyle in childhood and adolescence. The main goal was to develop a brief behaviorally oriented parent training program that enhances ‘obesity-specific’ parenting skills in order to prevent relapse. We hypothesized that the inclusion of additional parent training would lead to an improved long-term weight course of obese children. Parents of obese children (n = 686; 7–13 years old) either participated in complementary cognitive-behavioral group sessions (n = 336) or received written information only (n = 350) during the inpatient stay. Children of both groups attended multidisciplinary inpatient rehabilitation. BMI-SDS as a primary outcome was evaluated at baseline, post-intervention and at 6- and 12-month follow-up. Intention-to-treat (ITT) as well as per-protocol analyses (PPA) were performed. A significant within-group decrease of 0.24 (95% CI 0.18 to 0.30) BMI-SDS points from the beginning of the inpatient stay through the first year was found, but no group difference at the one-year follow-up (mean difference 0.02; 95% CI -0.04 to 0.07). We also observed an increase in quality of life scores, intake of healthy food and exercise for both groups, without differences between groups (ITT and PPA). Thus, while the inpatient treatment proved highly effective, additional parent training did not lead to better results in long-term weight maintenance or to better psychosocial well-being compared to written psycho-educational material. Further research should focus on subgroups to answer the question of differential treatment effects. KW - Obesity KW - Children KW - Randomized controlled trial KW - Weight KW - Parent training KW - Quality of life Y1 - 2016 U6 - https://doi.org/10.1016/j.appet.2016.04.007 SN - 0195-6663 SN - 1095-8304 VL - 103 SP - 148 EP - 156 PB - Elsevier CY - London ER - TY - JOUR A1 - Warschburger, Petra A1 - Calvano, Claudia A1 - Becker, Sebastian A1 - Friedt, Michael A1 - Hudert, Christian A1 - Posovszky, Carsten A1 - Schier, Maike A1 - Wegscheider, Karl T1 - Stop the pain: study protocol for a randomized-controlled trial JF - Trials N2 - Background: Functional abdominal pain (FAP) is not only a highly prevalent disease but also poses a considerable burden on children and their families. Untreated, FAP is highly persistent until adulthood, also leading to an increased risk of psychiatric disorders. Intervention studies underscore the efficacy of cognitive behavioral treatment approaches but are limited in terms of sample size, long-term follow-up data, controls and inclusion of psychosocial outcome data. Methods/Design: In a multicenter randomized controlled trial, 112 children aged 7 to 12 years who fulfill the Rome III criteria for FAP will be allocated to an established cognitive behavioral training program for children with FAP (n = 56) or to an active control group (focusing on age-appropriate information delivery; n = 56). Randomization occurs centrally, blockwise and is stratified by center. This study is performed in five pediatric gastroenterology outpatient departments. Observer-blind assessments of outcome variables take place four times: pre-, post-, 3- and 12-months post-treatment. Primary outcome is the course of pain intensity and frequency. Secondary endpoints are health-related quality of life, pain-related coping and cognitions, as well as selfefficacy. Discussion: This confirmatory randomized controlled clinical trial evaluates the efficacy of a cognitive behavioral intervention for children with FAP. By applying an active control group, time and attention processes can be controlled, and long-term follow-up data over the course of one year can be explored. KW - FAP KW - Randomized controlled trial KW - Cognitive behavioral intervention KW - Children KW - Pain Y1 - 2014 U6 - https://doi.org/10.1186/1745-6215-15-357 SN - 1745-6215 VL - 15 PB - BioMed Central CY - London ER - TY - JOUR A1 - Tjaden, Jasper Dag A1 - Dunsch, Felipe Alexander T1 - The effect of peer-to-peer risk information on potential migrants BT - evidence from a randomized controlled trial in Senegal JF - World development : the multi-disciplinary international journal devoted to the study and promotion of world development N2 - In response to mounting evidence on the dangers of irregular migration from Africa to Europe, the number of information campaigns which aim to raise awareness about the potential risks has rapidly increased. Governments, international organizations and civil society organizations implement a variety of campaigns to counter the spread of misinformation accelerated by smuggling and trafficking networks. The evidence on the effects of such information interventions on potential migrants remains limited and largely anecdotal. More generally, the role of risk perceptions in the decision-making process of potential irregular migrants is rarely explicitly tested, despite the fact that the concept of risk pervades conventional migration models, particularly in the field of economics. We address this gap by assessing the effects of a peer-to-peer information intervention on the perceptions, knowledge and intentions of potential migrants in Dakar, Senegal, using a randomized controlled trial design. The results show that - three months after the intervention - peer-to-peer information events increase potential migrants' subjective information levels, raise risk awareness, and reduce intentions to migrate irregularly. We find no substantial effects on factual migration knowledge. We discuss how the effects may be driven by the trust and identification-enhancing nature of peer-to-peer communication.
(c) 2021 Elsevier Ltd. All rights reserved. KW - Randomized controlled trial KW - Migration KW - Information KW - Decision-making KW - Communication for development KW - Peer-to-peer Y1 - 2021 U6 - https://doi.org/10.1016/j.worlddev.2021.105488 SN - 0305-750X VL - 145 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Raith, Anna-Marie A1 - Hämmerling, Marie A1 - Klein, Sabrina A1 - Peitz, Diana A1 - Knaevelsrud, Christine A1 - Zagorscak, Pavle T1 - Selbstwertförderung in der universellen Prävention von Essstörungen BT - Pilotierung einer internetbasierten Intervention an einer studentischen Stichprobe JF - Psychotherapeut N2 - Background Eating disorders are prevalent, often have chronic courses and relapses are frequent even after effective treatment approaches. Therefore, prevention is decisive; however, many of the current prevention programs are resource intensive. Internet-based interventions can represent cost-effective and low threshold alternatives but only few approaches have so far been investigated. Objective The aim of this study was to evaluate the efficacy of an internet-based unaccompanied preventive intervention. Material and methods The intervention was newly developed based on behavior therapeutic techniques and piloted in a group of 200 students using a randomized waiting list control group design. Data on eating disorder-specific pathology (eating disorder examination questionnaire, EDE-Q), self-esteem (Rosenberg self-esteem scale, RSES), and well-being (World Health Organization-five well-being index, WHO-5) were collected before and after the intervention or the waiting period. Data were evaluated based on variance analysis. Results A total of 43% of participants completed the intervention. Self-esteem increases were stronger in the intervention group in comparison to the waiting control group with large effect sizes (eta(2)(p) p = 0.33). There were no significant differences between the groups for the other variables. Conclusion Unaccompanied online self-help appears to provide a promising approach for improving self-esteem thus contributing to the prevention of eating disorders. Investigations in larger and more heterogeneous groups are necessary in the future to identify possibly present smaller preventive effects. N2 - Hintergrund Essstörungen sind prävalent, chronifizieren häufig und gehen trotz wirksamer Behandlungsansätze oft mit Rückfällen einher. Prävention ist daher entscheidend, jedoch sind viele aktuelle Präventionsprogramme ressourcenintensiv. Internetbasierte Interventionen können eine kostengünstige und niedrigschwellige Alternative darstellen, sind jedoch bislang nur wenig untersucht. Fragestellung Wie wirksam ist ein internetbasiertes, unbegleitetes Präventionsangebot? Material und Methode Die Intervention wurde auf Basis verhaltenstherapeutischer Techniken neu entwickelt und im Rahmen eines randomisierten Wartekontrollgruppendesigns an 200 Studierenden pilotiert. Vor und nach der Intervention bzw. Wartezeit wurden Daten zu essstörungsspezifischer Pathologie (Eating Disorder Examination-Questionnaire, EDE‑Q), Wohlbefinden (WHO-Five Well-Being Index, WHO-5) sowie Selbstwert (Rosenberg Self-Esteem Scale, RSES) erhoben und varianzanalytisch untersucht. Ergebnisse Die Intervention wurde von 43 % der Teilnehmenden vollständig durchlaufen. Der Selbstwert nahm in der Interventionsgruppe im Vergleich zur Wartekontrollgruppe stärker zu (η2p= 0,33). Auf den anderen Variablen ergaben sich keine signifikanten Unterschiede zwischen den Gruppen. Schlussfolgerung Unbegleitete Online-Selbsthilfe erscheint vielversprechend, um den Selbstwert zu verbessern und damit einen Beitrag zur Prävention von Essstörungen zu leisten. Untersuchungen in größeren, heterogenen Gruppen sind künftig nötig, um ggf. vorhandene, kleinere Präventionseffekte zu entdecken. T2 - Promotion of self-esteem in the universal prevention of eating disorders. Pilot study of an internet-based intervention in a sample of students KW - Internet-based Interventions KW - Self-care KW - Treatment adherence KW - Treatment KW - efficacy KW - Randomized controlled trial KW - Internetbasierte Interventionen KW - Selbsthilfe KW - Behandlungsadhärenz KW - Behandlungswirksamkeit KW - Randomisierte kontrollierte Studie Y1 - 2021 U6 - https://doi.org/10.1007/s00278-021-00515-4 SN - 0935-6185 SN - 1432-2080 VL - 66 IS - 4 SP - 275 EP - 281 PB - Springer CY - Berlin ; Heidelberg ER - TY - JOUR A1 - Puerto Valencia, Laura Maria A1 - Arampatzis, Adamantios A1 - Beck, Heidrun A1 - Dreinhöfer, Karsten E. A1 - Drießlein, Drießlein A1 - Mau, Wilfried A1 - Zimmer, Julia-Marie A1 - Schäfer, Michael A1 - Steinfeldt, Friedemann A1 - Wippert, Pia-Maria T1 - RENaBack: Low back pain patients in rehabilitation: Study Protocol for a Multicenter, Randomized Controlled Trial JF - Trials N2 - Background Millions of people in Germany suffer from chronic pain, in which course and intensity are multifactorial. Besides physical injuries, certain psychosocial risk factors are involved in the disease process. The national health care guidelines for the diagnosis and treatment of non-specific low back pain recommend the screening of psychosocial risk factors as early as possible, to be able to adapt the therapy to patient needs (e.g., unimodal or multimodal). However, such a procedure has been difficult to implement in practice and has not yet been integrated into the rehabilitation care structures across the country. Methods The aim of this study is to implement an individualized therapy and aftercare program within the rehabilitation offer of the German Pension Insurance in the area of orthopedics and to examine its success and sustainability in comparison to the previous standard aftercare program. The study is a multicenter randomized controlled trial including 1204 patients from six orthopedic rehabilitation clinics. A 2:1 allocation ratio to intervention (individualized and home-based rehabilitation aftercare) versus the control group (regular outpatient rehabilitation aftercare) is set. Upon admission to the rehabilitation clinic, participants in the intervention group will be screened according to their psychosocial risk profile. They could then receive either unimodal or multimodal, together with an individualized training program. The program is instructed in the clinic (approximately 3 weeks) and will continue independently at home afterwards for 3 months. The success of the program is examined by means of a total of four surveys. The co-primary outcomes are the Characteristic Pain Intensity and Disability Score assessed by the German version of the Chronic Pain Grade questionnaire (CPG). Discussion An improvement in terms of pain, work ability, patient compliance, and acceptance in our intervention program compared to the standard aftercare is expected. The study contributes to provide individualized care also to patients living far away from clinical centers. Trial registration DRKS, DRKS00020373. Registered on 15 April 2020 KW - Chronic low back pain KW - Aftercare KW - Individualized therapy KW - Randomized controlled trial KW - Rehabilitation Y1 - 2021 U6 - https://doi.org/10.1186/s13063-021-05823-3 SN - 1745-6215 SP - 1 EP - 18 PB - Springer Nature / BMC CY - Heidelberg ER - TY - JOUR A1 - Muckelbauer, Rebecca A1 - Englert, Heike A1 - Rieckmann, Nina A1 - Chen, Chih-Mei A1 - Wegscheider, Karl A1 - Völler, Heinz A1 - Katus, Hugo A. A1 - Willich, Stefan N. A1 - Müller-Nordhorn, Jacqueline T1 - Long-term effect of a low-intensity smoking intervention embedded in an adherence program for patients with hypercholesterolemia: Randomized controlled trial JF - Preventive medicine : an international journal devoted to practice and theory N2 - Objective. We evaluated the long-term effect of a smoking intervention embedded in an adherence program in patients with an increased risk for cardiovascular disease. Method. Secondary analysis of a randomized controlled trial: In 2002-2004,8108 patients with hypercholesterolemia were enrolled from general practices in Germany. Patients received a 12-month adherence program and statin medication (intervention) or statin medication only (control). The program aimed to improve adherence to medication and lifestyle by educational material, mailings, and phone calls. Smoking was self-reported at baseline and every 6 months during the 3-year follow-up. Results. In total, 7640 patients were analyzed. At baseline, smoking prevalence was 21.7% in the intervention and 21.5% in the control group. Prevalence decreased in both groups to 16.6% vs. 19.5%, 153% vs. 16.8%, and 14.2% vs. 15.6% at the 12-, 24-, and 36-month follow-up. The intervention had a beneficial effect on smoking differing over time (group x time: P = 0.005). The effect was largest after 6 and 12 months [odds ratios (95% confidence intervals): 0.67 (0.54-0.82) and 0.63 (0.51-0.78)]. The effect decreased until the 18-month follow-up [0.72 (0.58-0.90)] and was not significant after 24 months. Conclusion. A low-intensity smoking intervention embedded in an adherence program can contribute to smoking cessation although the intervention effect diminished over time. (C) 2015 Elsevier Inc. All rights reserved. KW - Smoking KW - Smoking cessation KW - Cardiovascular risk factors KW - Health promotion KW - Randomized controlled trial KW - Multiple risk factor intervention KW - Hypercholesterolemia Y1 - 2015 U6 - https://doi.org/10.1016/j.ypmed.2015.05.026 SN - 0091-7435 SN - 1096-0260 VL - 77 SP - 155 EP - 161 PB - Elsevier CY - San Diego ER - TY - JOUR A1 - Kühne, Franziska A1 - Heinze, Peter Eric A1 - Weck, Florian T1 - Standardized patients in psychotherapy training and clinical supervision BT - study protocol for a randomized controlled trial JF - Trials N2 - Background Psychotherapy is highly effective and widely acknowledged for treating various mental disorders. Nevertheless, in terms of methods for teaching effective psychotherapeutic approaches and competencies, there has been a lack of investigation. Training and supervision are the main strategies for teaching therapist competencies, and standardized role-plays with simulated patients (i.e., trained individuals playing someone with a mental disorder) seem useful for evaluating training approaches. In medical education, this procedure is now internationally established. However, so far, little use has been made of standardized role-playing to evaluate training and supervision in the area of clinical psychology and psychotherapy. Methods In this study, standardized role-plays are used to evaluate methods for training and supervision. Central cognitive behavioral approaches for treating depression are taught in the training. The first experiment compares an active training approach (i.e., model learning) with a passive one (i.e., reading manual-based instructions). The second experiment compares a direct supervision technique (i.e., supervision based on video analysis) with an indirect one (i.e., supervision based on verbal reporting). In each experiment, 68 bachelor’s and master’s students of psychology will be randomly assigned to the experimental and control groups. Each student takes part in three role-plays (baseline, post and 3-month follow-up), which are all videotaped. Two independent raters assess therapist competencies in each role-play on the basis of a standardized competence scale. Discussion The research project aims to contribute to the development of specific training and supervision methods in order to improve psychotherapy training and patient care. KW - Clinical psychology KW - Education KW - Psychotherapeutic competencies KW - Psychotherapy research KW - Role-playing KW - Simulated patients KW - Standardized patients KW - Randomized controlled trial Y1 - 2020 U6 - https://doi.org/10.1186/s13063-020-4172-z SN - 1745-6215 VL - 21 PB - BioMed Central CY - London ER -