Abstract Background Progress feedback provides therapists with progress notes on a regular basis through the continuous assessment of participants throughout their treatment (e.g., symptoms, therapeutic alliance). While for adults the evidence base has increased over the years, progress feedback in the therapy of children and adolescents has not been sufficiently investigated. This manuscript describes the trial protocol of the OPTIE study: a randomized trial that tests the efficacy of a progress feedback system in children and adolescents under conditions of routine care. Methods The study is based on a randomized parallel-group trial with two treatment groups (routine, feedback) at an outpatient unit of a university hospital. The target sample size is 439 families consisting of children and adolescents aged 6 to17 years old with internalizing and/or externalizing symptoms. Both the patients and the therapists are independently assigned to the treatment groups by stratified block randomization. In both treatment groups patients receive routine care behavioral therapy for a study-related 12 months; additionally, in the feedback group, a progress feedback system with three components is applied (monitoring, report, and supervision). For three informants (caregiver, child [≥ 11 years], therapist) surveys are conducted every 6 weeks (e.g., symptoms, goals, motivation). For both treatment groups, comparison data is collected at baseline and at six and 12 months after the beginning of the intervention (pre, inter, post), and includes five informants (blinded clinician, therapist, caregiver, child [≥ 11 years], teacher). Discussion The OPTIE study will contribute to the evidence base of progress feedback in children and adolescents and has the potential to uncover treatments’ effects in the small to medium range. Noteworthy features are the inclusion of children younger than 10 years old and the consideration of a blinded clinician rating. Trial registration German Clinical Trials Register (DRKS) DRKS00016737 ( https://www.drks.de/DRKS00016737 ). Registered 17 September, 2019.
Importance Physical diseases co-occur with late-life depression (LLD). The influence of physical diseases and the subjective perception of physical health (PPH) on treatment outcome in LLD, however, is not well understood. Objective To assess the association of physical diseases and PPH with the outcomes of 2 different types of psychotherapy in LLD. Design, Setting, and Participants This post hoc secondary analysis of a multicenter, observer-blinded, controlled, parallel-group randomized clinical trial assessed participants 60 years or older with moderate to severe depression recruited at 7 psychiatric-psychotherapeutic outpatient trial sites in Germany from October 1, 2018, to November 11, 2020. Data analysis was performed from April 1 to October 31, 2023. Interventions Patients received LLD-specific cognitive behavioral therapy (LLD-CBT) or supportive unspecific intervention (SUI). Main Outcomes and Measures Depression severity, response, and remission were measured during treatment and at 6-month follow-up by the change in the 30-item Geriatric Depression Scale (GDS) score. Physical health and PPH were assessed by the number of physical diseases, Charlson Comorbidity Index (CCI), and the World Health Organization Quality of Life Brief Version physical health subscale. Results A total of 251 patients were randomized to LLD-CBT (n = 126) or SUI (n = 125), of whom 229 (mean [SD] age, 70.2 [7.1] years; 151 [66%] female) were included in the intention-to-treat analysis. Patients with low and moderate PPH at baseline had significantly less reduction in the GDS score across both treatment groups than patients with high PPH (estimated marginal mean difference [EMMD], 2.67; 95% CI, 0.37-4.97; P = .02 for low PPH and EMMD, 1.82; 95% CI, 0.22-3.42; P = .03 for moderate vs high PPH). Higher PPH at baseline was associated with higher likelihood of response (odds ratio [OR], 1.04; 95% CI, 1.00-1.06; P = .009) and remission at the end of treatment (OR, 1.04; 95% CI, 1.02-1.08; P = .002) and response (OR, 1.05; 95% CI, 1.02-1.08; P < .001) and remission at follow-up (OR, 1.06; 95% CI, 1.03-1.10; P < .001) across both treatment groups. However, a significant interaction of PPH with treatment group was observed with low PPH at baseline being associated with significantly larger reduction in GDS scores in SUI compared with LLD-CBT at the end of treatment (EMMD, −6.48; 95% CI, −11.31 to −1.64; P = .009) and follow-up (EMMD, −6.49; 95% CI, −11.51 to −1.47; P = .01). In contrast, patients with high PPH at baseline had a significantly greater reduction in GDS scores in LLD-CBT compared with SUI at all time points (week 5: EMMD, −4.08; 95% CI, −6.49 to −1.67; P = .001; end-of-treatment: EMMD, −3.67; 95% CI, −6.72 to −0.61; P = .02; and follow-up: EMMD, −3.57; 95% CI, −6.63 to −0.51; P = .02). The number of physical diseases or CCI at baseline did not have an effect on the change in GDS score, response, or remission, neither across both groups nor within either group. Conclusions and Relevance In this secondary analysis of a randomized clinical trial, subjective PPH was associated with treatment outcome, response, and remission in psychotherapy of LLD. Patients with LLD responded differently to LLD-CBT and SUI, depending on their baseline PPH score. Treatment approaches for patients with LLD should address PPH in personalized interventions. Trial Registration ClinicalTrials.gov Identifier: NCT03735576 ; Deutsches Register Klinischer Studien Identifier: DRKS00013769
The stability and effectiveness of the Treatment Program for Children with Aggressive Behavior (THAV) in terms of reducing behavioral problems in children with oppositional defiant disorder (ODD) and conduct disorder (CD) were examined at a 10-month follow-up (FU). A total of 76 families and their children (boys aged 6-12 years), who previously participated in a randomized controlled trial comparing THAV with an active control group, took part in the 10-month FU assessment. Outcome measures were rated by parents and included the evaluation of child aggressive behavior, prosocial behavior, problem-maintaining and problem-moderating factors, and comorbid symptoms. Linear mixed models for repeated measures (MMRM) were conducted. The results revealed that THAV effects remained stable (problem-maintaining and problem-moderating factors; comorbid symptoms) and even partially improved (aggressive behavior; ADHD symptoms) over the FU period. Additionally, the differences between the THAV intervention group and the control group, which were apparent at the end of the treatment (post), mainly also remained at the FU assessment. It can be concluded that THAV is an effective and stable intervention for boys aged 6-12 years with ODD/CD.
Introduction: Tuberculosis (TB) remains a widespread and life-threatening global infectious disease. Extrapulmonary tuberculosis poses unique challenges in both diagnosis and treatment. This study's goal was to investigate cases of extrapulmonary TB, with a particular focus on epidemiology, diagnostic methods, and treatment practices, within a major German city over a ten-year period. The study aimed to ascertain the incidence rate and identify patient groups at higher risk, comparing them to cases of pulmonary TB.
Background: To comply with the World Health Organization (WHO) recommendations, our institution's administrative directives were adopted to advocate the provision of palliative care (PC) early in the disease trajectory of breast cancer (BC). To assess the outcome of this recommendation, this study evaluated the effects of this approach. Methods: A retrospective systematic chart analysis of a 2year period was performed. The first PC consultation of patients was analyzed according to (a) physical condition, (b) symptom burden of the patients, and (c) reasons for PC consultation. Results: Many patients were already in a reduced physical state and experienced burdening symptoms when first counselled by PC. After a 1year experience with PC consultations, the number of burdening symptoms identified at first PC consultation decreased and senologists increasingly requested PC support also for nonsomatic issues. Conclusions: A development towards a better understanding of PC competencies after a 1year initiation period could be demonstrated, but BC patients continued to be in late stages of the disease at the time of first PC contact. Diseasespecific guidelines may facilitate and optimize the integration of PC into breast cancer therapy.
Patients with type 2 diabetes are at a high risk for acute cardiovascular events, which usually arise from the rupture of a vulnerable coronary lesion characterized by specific morphological plaque features. Thus, the identification of vulnerable plaques is of utmost clinical importance in patients with type 2 diabetes. However, there is currently no scoring system available to identify vulnerable lesions based on plaque characteristics. Thus, we aimed to characterize the diagnostic value of optical coherence tomography (OCT) - derived lesion characteristics to quantify plaque vulnerability both as individual parameters and when combined to a score in patients with type 2 diabetes.OCT was performed in the coronary culprit lesions of 112 patients with type 2 diabetes. The score, which quantifies plaque vulnerability, was defined as the predicted probability that a lesion is the cause for an acute coronary syndrome (ACS) (vs. stable angina (SAP)) based on its specific plaque morphology.Multivariable logistic regression analysis demonstrated that plaque vulnerability was independently predicted by the minimal fibrous cap thickness overlying a lesion's lipid core (odds ratio (OR) per 10 μm 0.478, p = 0.002), the medium lipid arc (OR per 90° 13.997, p < 0.001), the presence of macrophages (OR 4.797, p = 0.015) and the lipid plaque length (OR 1.290, p = 0.098).This is the first study to present a score to quantify lesion vulnerability in patients with type 2 diabetes. This score may be a valuable adjunct in decision-making and useful in guiding coronary interventions.
Current treatment methods do not achieve recovery for most individuals with schizophrenia, and symptoms such as negative symptoms and cognitive deficits often persist. Aerobic endurance training has been suggested as a potential add-on treatment targeting both physical and mental health. We performed a large-scale multicenter, rater-blind, parallel-group randomized controlled clinical trial in individuals with stable schizophrenia. Participants underwent a professionally supervised six-month training comprising either aerobic endurance training (AET) or flexibility, strengthening, and balance training (FSBT, control group), follow-up was another six months. The primary endpoint was all-cause discontinuation (ACD); secondary endpoints included effects on psychopathology, cognition, functioning, and cardiovascular risk. In total, 180 participants were randomized. AET was not superior to FSBT in ACD and most secondary outcomes, with dropout rates of 59.55% and 57.14% in the six-month active phase, respectively. However, both groups showed significant improvements in positive, general, and total symptoms, levels of functioning and in cognitive performance. A higher training frequency additionally promoted further memory domains. Participants with higher baseline cognitive abilities were more likely to respond to the interventions. Our results support integrating exercise into schizophrenia treatment, while future studies should aim to develop personalized training recommendations to maximize exercise-induced benefits.
The safety of prolonged high-altitude stays and exercise for physically fit post-myocardial infarction (MI) patients is unclear. Myocardial tissue hypoxia and pulmonary hypertension can affect cardiac function and electrophysiology, possibly contributing to arrhythmias. We included four non-professional male athletes, clinically stable after left ventricular MI (three with ST-segment elevation MI and one with non-ST-segment elevation MI) treated with drug-eluting stents for single-vessel coronary artery disease. Oxygen levels were reduced to a minimum of 11.8%, then restored to 20.9%. We conducted electrocardiography (ECG), ergometry, and echocardiography assessments in normoxic and hypoxic conditions. With an average age of 57.8 ± 3.3 years and MI history 37 to 104 months prior, participants experienced a significant increase in QTc intervals during hypoxia using Bazett's (from 402 ± 13 to 417 ± 25 ms), Fridericia's (from 409 ± 12 to 419 ± 19 ms), and Holzmann's formulas (from 103 ± 4 to 107 ± 6%) compared to normoxia. This effect partially reversed during recovery. Echocardiographic signs of pulmonary hypertension during normobaric hypoxia correlated significantly with altered QTc intervals (p < 0.001). Despite good health and complete revascularization following MI, susceptibility to hypoxia-induced QTc prolongation and ventricular ectopic beats persists, especially during physical activity. MI survivors planning high-altitude activities should consult cardiovascular specialists with high-altitude medicine expertise.
