@article{GeisslerJansBanaschewskietal.2018, author = {Geissler, Julia and Jans, Thomas and Banaschewski, Tobias and Becker, Katja and Renner, Tobias and Brandeis, Daniel and D{\"o}pfner, Manfred and Dose, Christina and Hautmann, Christopher and Holtmann, Martin and Jenkner, Carolin and Millenet, Sabina and Romanos, Marcel}, title = {Individualised short-term therapy for adolescents impaired by attention-deficit/hyperactivity disorder despite previous routine care treatment (ESCAadol)-Study protocol of a randomised controlled trial within the consortium ESCAlife}, series = {Trials}, volume = {19}, journal = {Trials}, number = {254}, doi = {10.1186/s13063-018-2635-2}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-176061}, year = {2018}, abstract = {Background: Despite the high persistence rate of attention-deficit/hyperactivity disorder (ADHD) throughout the lifespan, there is a considerable gap in knowledge regarding effective treatment strategies for adolescents with ADHD. This group in particular often shows substantial psychosocial impairment, low compliance and insufficient response to psychopharmacological interventions. Effective and feasible treatments should further consider the developmental shift in ADHD symptoms, comorbidity and psychosocial adversity as well as family dysfunction. Thus, individualised interventions for adolescent ADHD should comprise a multimodal treatment strategy. The randomised controlled ESCAadol study addresses the needs of this patient group and compares the outcome of short-term cognitive behavioural therapy with parent-based telephone-assisted self-help. Methods/design: In step 1, 160 adolescents aged 12 to 17 years with a diagnosis of ADHD will undergo a treatment as usual (TAU) observation phase of 1 month. In step 2, those still severely affected are randomised to the intervention group with an Individualised Modular Treatment Programme (IMTP) or a telephone-assisted self-help programme for parents (TASH) as an active control condition. The IMTP was specifically designed for the needs of adolescent ADHD. It comprises 10 sessions of individual cognitive behavioural therapy with the adolescents and/or the parents, for which participants choose three out of 10 available focus modules (e.g. organisational skills and planning, emotion regulation, problem solving and stress management, dysfunctional family communication). TASH combines a bibliotherapeutic component with 10 counselling sessions for the parents via telephone. Primary outcome is the change in ADHD symptoms in a clinician-rated diagnostic interview. Outcomes are assessed at inclusion into the study, after the TAU phase, after the intervention phase and after a further 12-week follow-up period. The primary statistical analysis will be by intention-to-treat, using linear regression models. Additionally, we will analyse psychometric and biological predictors and moderators of treatment response. Discussion: ESCAadol compares two short-term non-pharmacological interventions as cost-efficient and feasible treatment options for adolescent ADHD, addressing the specific needs and obstacles to treatment success in this group. We aim to contribute to personalised medicine for adolescent ADHD intended to be implemented in routine clinical care.}, language = {en} } @article{LeopoldBauerBechdolfetal.2020, author = {Leopold, Karolina and Bauer, Michael and Bechdolf, Andreas and Correll, Christoph U. and Holtmann, Martin and Juckel, Georg and Lambert, Martin and Meyer, Thomas D. and Pfeiffer, Steffi and Kittel-Schneider, Sarah and Reif, Andreas and Stamm, Thomas J. and Rottmann-Wolf, Maren and Mathiebe, Josephine and Kellmann, Eva L. and Ritter, Philipp and Kr{\"u}ger-{\"O}zg{\"u}rdal, Seza and Karow, Anne and Sondergeld, Lene-Marie and Roessner, Veit and Sauer, Cathrin and Pfennig, Andrea}, title = {Efficacy of cognitive-behavioral group therapy in patients at risk for serious mental illness presenting with subthreshold bipolar symptoms: Results from a prespecified interim analysis of a multicenter, randomized, controlled study}, series = {Bipolar Disorders}, volume = {22}, journal = {Bipolar Disorders}, number = {5}, doi = {10.1111/bdi.12894}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-215469}, pages = {517 -- 529}, year = {2020}, abstract = {Objective Most patients with bipolar disorders (BD) exhibit prodromal symptoms before a first (hypo)manic episode. Patients with clinically significant symptoms fulfilling at-risk criteria for serious mental illness (SMI) require effective and safe treatment. Cognitive-behavioral psychotherapy (CBT) has shown promising results in early stages of BD and in patients at high risk for psychosis. We aimed to investigate whether group CBT can improve symptoms and functional deficits in young patients at risk for SMI presenting with subthreshold bipolar symptoms. Method In a multicenter, randomized, controlled trial, patients at clinical risk for SMI presenting with subthreshold bipolar symptoms aged 15-30 years were randomized to 14 weeks of at-risk for BD-specific group CBT or unstructured group meetings. Primary efficacy endpoints were differences in affective symptomatology and psychosocial functioning at 14 weeks. At-risk status was defined as a combination of subthreshold bipolar symptomatology, reduction of psychosocial functioning and a family history for (schizo)affective disorders. A prespecified interim analysis was conducted at 75\% of the targeted sample. Results Of 128 screened participants, 75 were randomized to group CBT (n = 38, completers = 65.8\%) vs unstructured group meetings (n = 37, completers = 78.4\%). Affective symptomatology and psychosocial functioning improved significantly at week 14 (P < .001) and during 6 months (P < .001) in both groups, without significant between-group differences. Findings are limited by the interim character of the analysis, the use of not fully validated early detection interviews, a newly adapted intervention manual, and the substantial drop-outs. Conclusions Results suggest that young patients at-risk for SMI presenting with subthreshold bipolar symptoms benefit from early group sessions. The degree of specificity and psychotherapeutic interaction needed requires clarification.}, language = {en} } @article{KaiserAggensteinerHoltmannetal.2021, author = {Kaiser, Anna and Aggensteiner, Pascal-M. and Holtmann, Martin and Fallgatter, Andreas and Romanos, Marcel and Abenova, Karina and Alm, Barbara and Becker, Katja and D{\"o}pfner, Manfred and Ethofer, Thomas and Freitag, Christine M. and Geissler, Julia and Hebebrand, Johannes and Huss, Michael and Jans, Thomas and Jendreizik, Lea Teresa and Ketter, Johanna and Legenbauer, Tanja and Philipsen, Alexandra and Poustka, Luise and Renner, Tobias and Retz, Wolfgang and R{\"o}sler, Michael and Thome, Johannes and Uebel-von Sandersleben, Henrik and von Wirth, Elena and Zinnow, Toivo and Hohmann, Sarah and Millenet, Sabina and Holz, Nathalie E. and Banaschewski, Tobias and Brandeis, Daniel}, title = {EEG data quality: determinants and impact in a multicenter study of children, adolescents, and adults with attention-deficit/hyperactivity disorder (ADHD)}, series = {Brain Sciences}, volume = {11}, journal = {Brain Sciences}, number = {2}, issn = {2076-3425}, doi = {10.3390/brainsci11020214}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-228788}, year = {2021}, abstract = {Electroencephalography (EEG) represents a widely established method for assessing altered and typically developing brain function. However, systematic studies on EEG data quality, its correlates, and consequences are scarce. To address this research gap, the current study focused on the percentage of artifact-free segments after standard EEG pre-processing as a data quality index. We analyzed participant-related and methodological influences, and validity by replicating landmark EEG effects. Further, effects of data quality on spectral power analyses beyond participant-related characteristics were explored. EEG data from a multicenter ADHD-cohort (age range 6 to 45 years), and a non-ADHD school-age control group were analyzed (n\(_{total}\) = 305). Resting-state data during eyes open, and eyes closed conditions, and task-related data during a cued Continuous Performance Task (CPT) were collected. After pre-processing, general linear models, and stepwise regression models were fitted to the data. We found that EEG data quality was strongly related to demographic characteristics, but not to methodological factors. We were able to replicate maturational, task, and ADHD effects reported in the EEG literature, establishing a link with EEG-landmark effects. Furthermore, we showed that poor data quality significantly increases spectral power beyond effects of maturation and symptom severity. Taken together, the current results indicate that with a careful design and systematic quality control, informative large-scale multicenter trials characterizing neurophysiological mechanisms in neurodevelopmental disorders across the lifespan are feasible. Nevertheless, results are restricted to the limitations reported. Future work will clarify predictive value.}, language = {en} } @article{PfennigLeopoldBechdolfetal.2014, author = {Pfennig, Andrea and Leopold, Karolina and Bechdolf, Andreas and Correll, Christoph U. and Holtmann, Martin and Lambert, Martin and Marx, Carolin and Meyer, Thomas D. and Pfeiffer, Steffi and Reif, Andreas and Rottmann-Wolf, Maren and Schmitt, Natalie M. and Stamm, Thomas and Juckel, Georg and Bauer, Michael}, title = {Early specific cognitive-behavioural psychotherapy in subjects at high risk for bipolar disorders: study protocol for a randomised controlled trial}, series = {TRIALS}, volume = {15}, journal = {TRIALS}, number = {161}, issn = {1468-6694}, doi = {10.1186/1745-6215-15-161}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-116279}, year = {2014}, abstract = {Background: Bipolar disorders (BD) are among the most severe mental disorders with first clinical signs and symptoms frequently appearing in adolescence and early adulthood. The long latency in clinical diagnosis (and subsequent adequate treatment) adversely affects the course of disease, effectiveness of interventions and health-related quality of life, and increases the economic burden of BD. Despite uncertainties about risk constellations and symptomatology in the early stages of potentially developing BD, many adolescents and young adults seek help, and most of them suffer substantially from symptoms already leading to impairments in psychosocial functioning in school, training, at work and in their social relationships. We aimed to identify subjects at risk of developing BD and investigate the efficacy and safety of early specific cognitive-behavioural psychotherapy (CBT) in this subpopulation. Methods/Design: EarlyCBT is a randomised controlled multi-centre clinical trial to evaluate the efficacy and safety of early specific CBT, including stress management and problem solving strategies, with elements of mindfulness-based therapy (MBT) versus unstructured group meetings for 14 weeks each and follow-up until week 78. Participants are recruited at seven university hospitals throughout Germany, which provide in-and outpatient care (including early recognition centres) for psychiatric patients. Subjects at high risk must be 15 to 30 years old and meet the combination of specified affective symptomatology, reduction of psychosocial functioning, and family history for (schizo) affective disorders. Primary efficacy endpoints are differences in psychosocial functioning and defined affective symptomatology at 14 weeks between groups. Secondary endpoints include the above mentioned endpoints at 7, 24, 52 and 78 weeks and the change within groups compared to baseline; perception of, reaction to and coping with stress; and conversion to full BD. Discussion: To our knowledge, this is the first study to evaluate early specific CBT in subjects at high risk for BD. Structured diagnostic interviews are used to map the risk status and development of disease. With our study, the level of evidence for the treatment of those young patients will be significantly raised.}, language = {en} }