Different perspectives in psychiatry: how family-oriented are professionals in Germany?

ΒACKGROUND: Children of parents with a mental illness have up to 50% chance of developing a mental illness themselves. Numerous studies have shown that preventive family-oriented interventions can decrease the risk by 40% and that professionals are a decisive factor influencing family-oriented practice. There are also substantial differences between professions in terms of their family-oriented practices. This study examines the level of family-oriented practice for different professional groups in Germany. METHODS: Data were used from the baseline assessment of the two-group randomized controlled multicenter trial ci-chimps as a subproject of CHIMPS-NET, which took place from January 2020 to May 2021 in 18 clinical centers in Germany. Child and adolescent mental health systems as well as adult mental health systems took part and every professional involved in the treatment was invited to participate. Data was used from 475 mental health professionals including physicians, psychologists, psychotherapists for adults and for children and adolescents, occupational/ music/ physio/ art therapists/ (social) education workers and nursing/ education service. Family-oriented mental health practice was examined using the translated version of the Family-Focused Mental Health Practice Questionnaire (FFMHPQ) with means and standard deviations calculated for each of the 18 FFMHPQ-GV subscales. ANOVAs were computed to compare professions and significant differences were examined via post hoc analyses (Scheffé). Additionally, effect sizes were calculated (Omega squared). RESULTS: Differences were seen between the professions in all aspects of family-oriented practice: Both regarding organizational policy and support aspects, issues concerning working with parent-clients, as well as professional skills and knowledge aspects. Psychotherapists for children and adolescents scored the highest family-oriented practices compared to all other professional groups on almost all subscales. CONCLUSION: This study examines the level of family-oriented practice for different professional groups in Germany. Apart from skills and knowledge about the impact of mental illness and parenting, psychotherapists for children and adolescents had the highest scores and engaged most in family-oriented practice. Psychotherapists for adults got the least workplace support for family-oriented practice but were competent providing resources and referral information to the concerned families and feel confidence working with them. Due to these results, a training need exists to improve skills and knowledge about the impact of mental illness and parenting. Additionally, there is still potential for institutional support in promoting family-oriented work. TRIAL REGISTRATION: The CHIMPS-NET-study was registered with the German Clinical Trials Register on 2019-12-19 (DRKS00020380) and with Clinical Trials on 2020-4-30 (NCT04369625), the ci-chimps-study was registered with the German Clinical Trials Register (DRKS00026217) on 2021-08-27 and with Clinical Trials on 2021-11-04 (NCT05106673).

Mind it! A mindfulness-based group psychotherapy for substance use disorders in adolescent inpatients.

Cannabis use disorder (CUD) is the most frequent reason for psychiatric inpatient substance use disorder (SUD) treatment among 15-19-year-olds in Germany. Despite effective treatment programs, relapse rates remain high. Thus, existing multi-component programs (TAU) need to be enhanced with SUD-specific elements. Mindfulness-based interventions (MBI) seem promising as they can positively influence SUD-related behaviors (e. g. craving). Given limited research in adolescents, this randomized controlled trial investigated the extent to which MBI-based group therapy (Mind it!) as an add-on treatment to TAU led to fewer cannabis use days after 6 months in 84 adolescent inpatients with CUD. Additionally, craving, severity of CUD, and changes in mindfulness were monitored (pre-, post-, and follow-up (FU) assessments). The results revealed a significant reduction in cannabis use days in both groups at 6-month FU (d = - 0.72 and = - 0.75). Although minor additional benefits of Mind it! were evident post-treatment, specifically reduction of craving and SUD severity, by the 6-month mark, TAU exhibited a more substantial decrease in SUD severity (d = 0.78), and reward craving (d = 0.28) compared to Mind it!. Regarding self-regulation skills (mindfulness), Mind it! demonstrated superiority over TAU after 6-month FU (d = 0.27). Therapists judged the MBI as feasible. (Serious) adverse events were unrelated to Mind it!. There was a systematic dropout among Mind it! participants. Primarily, the results emphasize the effectiveness of TAU in reducing cannabis use. MBI also seem feasible for youth, but results remain inconsistent and unstable over time. Importantly, enhanced adherence to reduce dropouts is needed.Trial registration: German Clinical Trials Register, DRKS00014041. Registered on 17 April 2018.

Associations between therapists' verbal techniques and patient-rated therapeutic alliance, insight, and problem solving.

OBJECTIVE: To investigate associations between common factors (alliance, insight, problem solving) and therapists' techniques. We expected a positive association between (1) supportive techniques and the alliance, (2) interpretative techniques and insight, and (3) a stronger association between interpretative techniques and insight for patients with more severe baseline symptoms. Other associations were analyzed in an exploratory way. METHOD: Sixty sessions from 15 adult female patients diagnosed with personality disorder were analyzed using the Psychodynamic Interventions List (verbal techniques, observer-rated transcripts), and the Session Questionnaire for General and Differential Individual Psychotherapy (common factors, patient-rated after each session). Multilevel modeling was applied. RESULTS: A greater use of supportive techniques was related to a higher therapeutic alliance (b = .28, 95% CI: .01-.55, p = .042). Neither the positive association between interpretative techniques and insight nor the moderating effect of baseline symptom severity could be confirmed. Exploratory analyses revealed associations between problem-solving and different verbal techniques. CONCLUSION: Therapists' use of supportive techniques seems to influence the therapeutic alliance positively in patients with personality disorders. The effect of interpretative techniques might depend on other factors like patient characteristics. In general, there seem to be differential and specific associations between different therapists' verbal techniques and common factors.

Temperature Control After In-Hospital Cardiac Arrest: A Randomized Clinical Trial.

BACKGROUND: This study was conducted to determine the effect of hypothermic temperature control after in-hospital cardiac arrest (IHCA) on mortality and functional outcome as compared with normothermia. METHODS: An investigator initiated, open-label, blinded-outcome-assessor, multicenter, randomized controlled trial comparing hypothermic temperature control (32-34°C) for 24 h with normothermia after IHCA in 11 hospitals in Germany. The primary endpoint was all-cause mortality after 180 days. Secondary end points included in-hospital mortality and favorable functional outcome using the Cerebral Performance Category scale after 180 days. A Cerebral Performance Category score of 1 or 2 was defined as a favorable functional outcome. RESULTS: A total of 1055 patients were screened for eligibility and 249 patients were randomized: 126 were assigned to hypothermic temperature control and 123 to normothermia. The mean age of the cohort was 72.6±10.4 years, 64% (152 of 236) were male, 73% (166 of 227) of cardiac arrests were witnessed, 25% (57 of 231) had an initial shockable rhythm, and time to return of spontaneous circulation was 16.4±10.5 minutes. Target temperature was reached within 4.2±2.8 hours after randomization in the hypothermic group and temperature was controlled for 48 hours at 37.0°±0.9°C in the normothermia group. Mortality by day 180 was 72.5% (87 of 120) in hypothermic temperature control arm, compared with 71.2% (84 of 118) in the normothermia group (relative risk, 1.03 [95% CI, 0.79-1.40]; P=0.822). In-hospital mortality was 62.5% (75 of 120) in the hypothermic temperature control as compared with 57.6% (68 of 118) in the normothermia group (relative risk, 1.11 [95% CI, 0.86-1.46, P=0.443). Favorable functional outcome (Cerebral Performance Category 1 or 2) by day 180 was 22.5% (27 of 120) in the hypothermic temperature control, compared with 23.7% (28 of 118) in the normothermia group (relative risk, 1.04 [95% CI, 0.78-1.44]; P=0.822). The study was prematurely terminated because of futility. CONCLUSIONS: Hypothermic temperature control as compared with normothermia did not improve survival nor functional outcome at day 180 in patients presenting with coma after IHCA. The HACA in-hospital trial (Hypothermia After Cardiac Arrest in-hospital) was underpowered and may have failed to detect clinically important differences between hypothermic temperature control and normothermia. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique Identifier: NCT00457431.

Obsessive-Compulsive Symptom Dimensions and Their Relationships with Obsessive Beliefs: A Structural Equation Modeling Analysis.

Dysfunctional beliefs are central in the development and maintenance of obsessive-compulsive disorder (OCD) as well as its treatment. Yet, research suggests that not all dysfunctional beliefs are equally important for each of the symptom dimensions of OCD. However, results are inconsistent in that studies contradict each other regarding the associations between specific symptom dimensions and belief domains. The aim of the present study was to clarify which belief domain is specifically associated with which OCD symptom dimension. Results could help to tailor treatments more specifically to the patient's OCD symptom dimension. In- and outpatients with OCD (N = 328; 43.6% male and 56.4% female) filled out questionnaires on symptom dimensions of OCD (Obsessive-Compulsive Inventory Revised) and dysfunctional beliefs (Obsessive Beliefs Questionnaire). A structural equation model analysis was conducted to identify the associations between dysfunctional beliefs and symptom dimensions. Our results showed that perfectionism/intolerance of uncertainty was associated with hoarding and symmetry/ordering, (2) overestimation of threat/inflated responsibility was associated with checking compulsions, and (3) importance of thoughts/control of thoughts was associated with obsessing. These results were largely supported by a backward selection. Our results demonstrated associations of specific dysfunctional beliefs and specific OCD symptom dimensions. However, future studies are necessary to replicate these findings with other measures (e.g., clinician ratings).

Health-related quality of life in severe psychotic disorders during integrated care: 5-year course, prediction and treatment implications (ACCESS II).

PURPOSE: Studies on outcomes mapping Quality of Life (QoL) as patient-reported outcome over a longer period in severe psychotic disorders are scarce. However, such data would be particularly important for structuring, implementing and operating effective and efficient care models and for promoting satisfaction with care, service engagement and adherence. METHODS: The ACCESS II study is a prospective long-term study of an integrated care model for people with severe psychotic disorders. The model includes Therapeutic Assertive Community Treatment within a cross-sectoral and interdisciplinary network. This publication analyses the course of QoL assessed with the Q-LES-Q-18 using a mixed model for repeated measures. RESULTS: Mapping the course of QoL in N = 329 participants, there is a significant increase in the first 6 weeks of treatment (early course). Comparison to a published norm show significant lower QoL for severe psychotic disorders. The variable having a traumatic event before the age of 18 was significantly negatively associated with QoL. A decrease in the severity of depressive as well as in positive symptomatology in the first six weeks after admission was associated with increase of QoL. CONCLUSION: Results indicate that the overall symptom burden at time of inclusion is not decisive for the perceived QoL in the long-term course while the reduction in the severity of depressive and positive symptoms is important. This means focusing even more on the treatment of depressive symptoms and include traumatherapeutic aspects in the long-term treatment of severe psychotic disorders if needed. TRAIL REGISTRATION: ClinicalTrials.gov (identifier: NCT01888627).

Health-Related Quality of Life and mental health of families with children and adolescents affected by rare diseases and high disease burden: the perspective of affected children and their siblings.

BACKGROUND: Advances in genetic and pharmaceutical technology and pediatric care have enabled treatment options for an increasing number of rare diseases in affected children. However, as current treatment options are primarily of palliative nature, the Health-Related Quality of Life (HRQoL) and mental health of this impaired population and their siblings are of increasing importance. Among children and adolescents with rare diseases, those who are technology-dependent carry a high disease burden and are selected as the target population in our study. In a cross-sectional observational design, the children's HRQoL was assessed with the DISABKIDS (DCGM-37) as well as KIDSCREEN-27, while mental health was assessed with the Strengths and Difficulties Questionnaire (SDQ) by both the affected children, their parents, and siblings. RESULTS: Results of the study sample were compared to normative data. Affected children scored significantly lower than the norm on almost all HRQoL subscales as reported by parent and child. From the parental perspective, more mental health subscales were significantly impaired compared to the child's perspective. Siblings showed no impairment in HRQoL as well as significantly fewer behavioral problems and higher prosocial behavior regarding their mental health compared to the norm. CONCLUSION: Children and adolescents with rare diseases seem particularly impaired in social and emotional aspects of HRQoL and mental health. Interventions may focus primarily on promoting social skills, fostering prosocial behavior and peer relationships.

Evaluation of putative CSF biomarkers in paediatric spinal muscular atrophy (SMA) patients before and during treatment with nusinersen.

Spinal muscular atrophy (SMA) is a genetic neurodegenerative disorder leading to immobilization and premature death. Currently, three alternative therapeutic options are available. Therefore, biomarkers that might reflect or predict the clinical course of the individual patient with treatment are of great potential use. Currently, the antisense oligonucleotide nusinersen is the prevalent and longest validated therapy for SMA. We analysed CSF candidate biomarkers for degenerative CNS processes (namely phosphorylated heavy chain (pNf-H), light-chain neurofilaments (NfL), total tau protein (T-Tau), neurogranin, ß-secretase BACE-1 and alpha-synuclein) in 193 CSF samples of 44 paediatric SMA types 1, 2 and 3 patients before and under nusinersen treatment and related them to standardized clinical outcome scores in a single-centre pilot study. pNf-H and NfL correlated with disease severity and activity, emphasizing their relevance as marker of neuronal loss and clinical outcome. T-Tau was significantly correlated with motor function scores in SMA type 1 making it an interesting marker for treatment response. Additionally, baseline T-Tau levels were elevated in most SMA patients possibly reflecting the extension of neuronal degeneration in paediatric-onset SMA. Further investigations of these CSF proteins might be beneficial for paediatric SMA subtypes and treatment modalities as an indicator for clinical outcome and should be analysed in larger cohorts.

IL22BP Mediates the Antitumor Effects of Lymphotoxin Against Colorectal Tumors in Mice and Humans.

BACKGROUND & AIMS: Unregulated activity of interleukin (IL) 22 promotes intestinal tumorigenesis in mice. IL22 binds the antagonist IL22 subunit alpha 2 (IL22RA2, also called IL22BP). We studied whether alterations in IL22BP contribute to colorectal carcinogenesis in humans and mice. METHODS: We obtained tumor and nontumor tissues from patients with colorectal cancer (CRC) and measured levels of cytokines by quantitative polymerase chain reaction, flow cytometry, and immunohistochemistry. We measured levels of Il22bp messenger RNA in colon tissues from wild-type, Tnf-/-, Lta-/-, and Ltb-/- mice. Mice were given azoxymethane and dextran sodium sulfate to induce colitis and associated cancer or intracecal injections of MC38 tumor cells. Some mice were given inhibitors of lymphotoxin beta receptor (LTBR). Intestine tissues were analyzed by single-cell sequencing to identify cell sources of lymphotoxin. We performed immunohistochemistry analysis of colon tissue microarrays from patients with CRC (1475 tissue cores, contained tumor and nontumor tissues) and correlated levels of IL22BP with patient survival times. RESULTS: Levels of IL22BP were decreased in human colorectal tumors, compared with nontumor tissues, and correlated with levels of lymphotoxin. LTBR signaling was required for expression of IL22BP in colon tissues of mice. Wild-type mice given LTBR inhibitors had an increased tumor burden in both models, but LTBR inhibitors did not increase tumor growth in Il22bp-/- mice. Lymphotoxin directly induced expression of IL22BP in cultured human monocyte-derived dendritic cells via activation of nuclear factor κB. Reduced levels of IL22BP in colorectal tumor tissues were associated with shorter survival times of patients with CRC. CONCLUSIONS: Lymphotoxin signaling regulates expression of IL22BP in colon; levels of IL22BP are reduced in human colorectal tumors, associated with shorter survival times. LTBR signaling regulates expression of IL22BP in colon tumors in mice and cultured human dendritic cells. Patients with colorectal tumors that express low levels of IL22BP might benefit from treatment with an IL22 antagonist.

Do Children With Functional Abdominal Pain Benefit More From a Pain-Specific Cognitive-Behavioral Intervention Than From an Unspecific Attention Control Intervention? Results of a Randomized Controlled Trial.

INTRODUCTION: We aimed to compare the efficacy of cognitive-behavioral therapy (CBT) among children with functional abdominal pain with an attention control (AC), hypothesizing the superiority of CBT group intervention regarding pain intensity (primary outcome), pain duration and frequency (further primary outcomes), functional disability, and quality of life and coping strategies (key secondary outcomes). METHODS: We conducted a prospective, multicenter, randomized controlled efficacy trial (RCT) with 4 time points (before intervention, after intervention, 3-month follow-up, and 12-month follow-up). One hundred twenty-seven children aged 7-12 years were randomized to either the CBT (n = 63; 55.6% girls) or the AC (n = 64; 57.8% girls). RESULTS: Primary endpoint analysis of the logarithmized area under the pain intensity curve showed no significant difference between groups (mean reduction = 49.04%, 95% confidence interval [CI] -19.98%-78.36%). Treatment success rates were comparable (adjusted odds ratio = 0.53, 95% CI 0.21-1.34, number needed to treat = 16). However, time trend analyses over the course of 1 year revealed a significantly greater reduction in pain intensity (40.9%, 95% CI 2.7%-64.1%) and pain duration (43.6%, 95% CI 6.2%-66.1%) in the CBT compared with the AC, but not in pain frequency per day (1.2, 95% CI -2.7 to 5.2). In the long term, children in the CBT benefitted slightly more than those in the AC with respect to functional disability, quality of life, and coping strategies. DISCUSSION: Both interventions were effective, which underlines the role of time and attention for treatment efficacy. However, in the longer term, CBT yielded more favorable results.

Shared decision making and patient-centeredness for patients with poorly controlled type 2 diabetes mellitus in primary care-results of the cluster-randomised controlled DEBATE trial.

BACKGROUND: We investigate whether an educational intervention of GPs increases patient-centeredness and perceived shared decision making in the treatment of patients with poorly controlled type 2 diabetes mellitus? METHODS: We performed a cluster-randomized controlled trial in German primary care. Patients with type 2 diabetes mellitus defined as HbA1c levels ≥ 8.0% (64 mmol/mol) at the time of recruitment (n = 833) from general practitioners (n = 108) were included. Outcome measures included subjective shared decision making (SDM-Q-9; scale from 0 to 45 (high)) and patient-centeredness (PACIC-D; scale from 1 to 5 (high)) as secondary outcomes. Data collection was performed before intervention (baseline, T0), at 6 months (T1), at 12 months (T2), at 18 months (T3), and at 24 months (T4) after baseline. RESULTS: Subjective shared decision making decreased in both groups during the course of the study (intervention group: -3.17 between T0 and T4 (95% CI: -4.66, -1.69; p < 0.0001) control group: -2.80 (95% CI: -4.30, -1.30; p = 0.0003)). There were no significant differences between the two groups (-0.37; 95% CI: -2.20, 1.45; p = 0.6847). The intervention's impact on patient-centeredness was minor. Values increased in both groups, but the increase was not statistically significant, nor was the difference between the groups. CONCLUSIONS: The intervention did not increase patient perceived subjective shared decision making and patient-centeredness in the intervention group as compared to the control group. Effects in both groups might be partially attributed to the Hawthorne-effect. Future trials should focus on patient-based intervention elements to investigate effects on shared decision making and patient-centeredness. TRIAL REGISTRATION: The trial was registered on March 10th, 2011 at ISRCTN registry under the reference ISRCTN70713571 .

Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual disabilities: study protocol for a randomised controlled trial.

BACKGROUND: Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11-17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. METHODS: In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11-17 year old boys with MBID without any alcohol experience. DISCUSSION: This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00014042 . Registered on March 19th 2018.

Implementation of Basic Life Support training in schools: a randomised controlled trial evaluating self-regulated learning as alternative training concept.

BACKGROUND: The Kids save lives statement recommends annual Basic Life Support (BLS) training for school children but the implementation is challenging. Trainings should be easy to realise and every BLS training should be as effective as possible to prepare learners for lifesaving actions. Preparedness implies skills and positive beliefs in the own capability (high self-efficacy). METHODS: This randomized controlled cluster study investigates, if self-regulated learning promotes self-efficacy and long-term retention of practical BLS skills. Students in the age of 12 years participated in a practical training in BLS and a scenario testing of skills. In the control group the practical training was instructor-led. In the intervention group the students self-regulated their learning processes and feedback was provided by the peer-group. The primary outcome self-efficacy for helping in cardiac arrest after the training and 9 months later was analysed using a multilevel mixed model. Means and pass-rates for BLS skills were secondary outcomes. RESULTS: Contrary to the assumptions, this study could not measure a higher self-efficacy for helping in cardiac arrest of the students participating in the intervention (n = 307 students) compared to the control group (n = 293 students) after training and at the follow-up (mean difference: 0.11 points, 95% CI: - 0.26 to 0.04, P = 0.135). The odds to pass all items of the BLS exam was not significantly different between the groups (OR 1.11, 95% CI: 0.81 to 1.52, p = 0.533). Self-regulated learning was associated with a higher performance of male students in the BLS exam (mean score: 7.35) compared to females of the intervention (female: 7.05) and compared to males of the control (7.06). CONCLUSION: This study could not resolve the question, if self-regulated learning in peer-groups improves self-efficacy for helping in cardiac arrest. Self-regulated learning is an effective alternative to instructor-led training in BLS skills training and may be feasible to realise for lay-persons. For male students self-regulated learning seems to be beneficial to support long-term retention of skills. TRIAL REGISTRATION: ISRCTN17334920, retrospectively registered 07.03.2019.

Evaluation of two family-based intervention programs for children affected by rare disease and their families - research network (CARE-FAM-NET): study protocol for a rater-blinded, randomized, controlled, multicenter trial in a 2x2 factorial design.

BACKGROUND: Families of children with rare diseases (i.e., not more than 5 out of 10,000 people are affected) are often highly burdened with fears, insecurities and concerns regarding the affected child and its siblings. Although families caring for children with rare diseases are known to be at risk for mental disorders, the evaluation of special programs under high methodological standards has not been conducted so far. Moreover, the implementation of interventions for this group into regular care has not yet been accomplished in Germany. The efficacy and cost-effectiveness of a family-based intervention will be assessed. METHODS/DESIGN: The study is a 2x2 factorial randomized controlled multicenter trial conducted at 17 study centers throughout Germany. Participants are families with children and adolescents affected by a rare disease aged 0 to 21 years. Families in the face-to-face intervention CARE-FAM, online intervention WEP-CARE or the combination of both will be treated over a period of roughly 6 months. Topics discussed in the interventions include coping, family relations, and social support. Families in the control condition will receive treatment as usual. The primary efficacy outcome is parental mental health, measured by the Structured Clinical Interview for DSM-IV (SCID-I) by blinded external raters. Further outcomes will be assessed from the parents' as well as the children's perspective. Participants are investigated at baseline, 6, 12 and 18 months after randomization. In addition to the assessment of various psychosocial outcomes, a comprehensive health-economic evaluation will be performed. DISCUSSION: This paper describes the implementation and evaluation of two family-based intervention programs for Children Affected by Rare Disease and their Family's Network (CARE-FAM-NET) in German standard care. A methodologically challenging study design is used to reflect the complexity of the actual medical care situation. This trial could be an important contribution to the improvement of care for this highly burdened group. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00015859 (registered 18 December 2018) and ClinicalTrials.gov : NCT04339465 (registered 8 April 2020). Protocol Version: 15 August 2020 (Version 6.1). Trial status: Recruitment started on 1 January 2019 and will be completed on 31 March 2021.

Effectiveness of Telephone-Administered Cognitive-Behavioral Psychotherapy for Depression With Versus Without Additional Letters: A Randomized Controlled Trial.

Background: Telephone-administered cognitive-behavioral psychotherapy (T-CBT) can effectively treat patients with depressive symptoms. Introduction: We investigated whether adding letters (via postal mail) to T-CBT reduces depressive symptoms and increases response and remission. Additionally, we assessed whether T-CBT reduced all patients' symptoms in the first depression-specific T-CBT sample in German healthcare. Materials and Methods: Primary care patients were randomized to T-CBT with versus without letters. All received 1 face-to-face and 8-12 telephone-administered sessions. An intention-to-treat sample was analyzed. Between-groups differences in symptom change and the total sample's symptom change were computed using linear mixed models with group as fixed effect, referring general practice as random effect and several covariates. Differences in response and remission were assessed using logistic regressions. Results: Fifty-nine patients were referred to T-CBT and randomized. Twenty-six patients actually participated in T-CBT with letters and 21 without letters. The groups did not differ significantly regarding symptom change (Patient Health Questionnaire [PHQ-9]) from baseline to end: T-CBT without letters showed 1.05 points greater reduction (95% confidence interval: -4.72 to 2.62; p = 0.56; Cohen's d = -0.12) (adjusted mean change). The groups did not differ significantly regarding symptom change from baseline to 6-month follow-up nor odds of response or remission. The total sample's PHQ-9 showed significant adjusted mean reduction from baseline to end of T-CBT and to 6-month follow-up. Discussion: Additional letters did not lead to greater symptom reduction. Overall results for the first German T-CBT intervention for depression appear promising but require further assessment using a control condition. Conclusions: Additional letters do not appear to enhance the effectiveness of T-CBT.

Emotions towards magnetic resonance imaging in people with multiple sclerosis.

OBJECTIVES: People with multiple sclerosis (pwMS) often have magnetic resonance imaging (MRI) examinations. While MRI can help guide MS management, it may be a source of anxiety for pwMS. We aimed to develop and validate a questionnaire on the "EMotions and Attitudes towards MRI" (MRI-EMA). MATERIAL AND METHODS: The questionnaire was developed, tested in two samples of pwMS and validated in a sample of n = 457 pwMS using exploratory (EFA) and confirmatory factor analysis (CFA). RESULTS: EFA revealed four factors underlying the questionnaire: fear of MRI scan, fear of MRI results, feeling of control over the disease and feeling of competence in the patient-physician encounter. CFA confirmed the model fit. Receiving the MRI results, but not undergoing the procedure was associated with anxiety. Seeing MRI results gave participants a feeling of control over the disease. Only 50% felt competent to discuss MRI findings with their physician. Fear of MRI results was especially high and feeling of competence low in participants with a short disease duration and little MRI experience. CONCLUSION: PwMS do not feel competent when discussing the role, MRI plays in their care. Receiving MRI results caused anxiety and provides some pwMS with a-perhaps false-feeling of control over the disease. The MRI-EMA constitutes a new tool for the assessments of pwMS' feelings towards MRI, that can be applied in future research and clinical settings.

Quality of life assessment in patients with heart failure: validity of the German version of the generic EQ-5D-5L™.

BACKGROUND: Chronic heart failure patients typically suffer from tremendous strain and are managed mainly in primary care. New care concepts adapted to the severity of heart failure are a challenge and need to consider health-related quality of life aspects. This is the first psychometric validation of the German EQ-5D-5L™ as a generic instrument for assessing health-related quality of life (HRQOL) in a primary care heart failure patient sample. METHODS: Confirmatory factor analysis (CFA) was performed on the baseline EQ-5D-5L™ data from the RECODE-HF study (responses to all items from n = 3225 of 3778 patients). Basic CFA models for HRQOL were calculated based on the EQ-5D-5L™ items using the maximum likelihood (ML) and the asymptotic distribution-free method. In an extended CFA, physical activity and depression were added. The basic CFA ML model was verified for the reduced number of cases of the extended CFA model (n = 3064). In analyses of variance the association of the EQ-5D-5L™ visual analogue scale (VAS) and both the German and the British EQ-5D-5L™ crosswalk index with the SF-36 measure of general health were examined. The discriminant validity was analysed using Pearson's chi-squared tests applying the New York Heart Association classification, for the VAS and indices analyses of variance were calculated. RESULTS: In the basic CFA models the root mean square error of approximation was 0.095 with the ML method, and 0.081 with the asymptotic distribution-free method (Comparative Fit Index > 0.90 for both). Physical activity and depression were confirmed as influential factors in the extended model. The VAS and indices were strongly associated with the SF-36 measure of general health (partial eta-squared 0.525/0.454/0.481; all p <  0.001; n = 3155/3210/3210, respectively), also for physical activity and depression when included together (partial eta-squared 0.050, 0.200/0.047, 0.213/0.051 and 0.270; all p <  0.001; n = 3015/n = 3064/n = 3064, respectively). The discriminant validity analyses showed p-values < 0.001 and small to moderate effect sizes for all EQ-5D-5L™ items. Analyses of variance demonstrated moderate effect sizes for the VAS and indices (0.067/0.087/0.084; all p <  0.001; n = 3110/3171/3171). CONCLUSION: The German EQ-5D-5L™ is a suitable method for assessing HRQOL in heart failure patients.

Patient-centered communication and shared decision making to reduce HbA1c levels of patients with poorly controlled type 2 diabetes mellitus - results of the cluster-randomized controlled DEBATE trial.

BACKGROUND: Does an intervention designed to foster patient-centered communication and shared decision making among GPs and their patients with poorly controlled type 2 diabetes mellitus reduce the level of HbA1c. METHODS: The DEBATE trial is a cluster-randomized controlled trial conducted in German primary care and including patients with type 2 diabetes mellitus having an HbA1c level of 8.0% (64 mmol/mol) or above at the time of recruitment. Data was measured before intervention (baseline, T0), 6-8 months (T1), 12-14 months (T2), 18-20 months (T3), and 24-26 months (T4) after baseline. Main outcome measure is the level of HbA1c. RESULTS: In both, the intervention and the control group the decline of the HbA1c level from T0 to T4 was statistically significant (- 0.67% (95% CI: - 0.80,-0.54%; p < 0.0001) and - 0.64% (95% CI: - 0.78, - 0.51%; p < 0.0001), respectively). However, there was no statistically significant difference between both groups. CONCLUSIONS: Although the DEBATE trial was not able to confirm effectiveness of the intervention tested compared to care as usual, the results suggest that patients with poorly controlled type 2 diabetes are able to improve their blood glucose levels. This finding may encourage physicians to stay on task to regularly approach this cohort of patients. TRIAL REGISTRATION: The trial was registered at ISRCTN registry under the reference ISRCTN70713571 .

[Clinical trial of a stepped and collaborative care model for mental illnesses and comorbidities in the Hamburg Network for Health Services Research]. / Erprobung eines integrierten und gestuften Behandlungsmodells für psychische Störungen und Komorbiditäten im Hamburger Netzwerk für Versorgungsforschung.

Healthcare for mental disorders is a big challenge for the German healthcare system. In cases of comorbid mental diseases, patients suffer from an especially high burden of disease. So far, innovative care models for collaborative and stepped care have only been investigated with respect to their effectiveness for single mental disorders.The project "Collaborative and Stepped Care in Mental Health by Overcoming Treatment Sector Barriers" (COMET), which is being carried out by the Hamburg Network for Health Services Research (HAM-NET) from 2017 until 2020, examines an innovative, guideline-based healthcare model for the improvement of healthcare for patients with mental illnesses and their potential comorbidities. In this article this new stepped and collaborative care model for patients in primary care that integrates general practitioners, psychiatrists, psychotherapists, and hospitals is presented. For the implementation and facilitation of the model, guideline-based treatment pathways, a tablet-based computer program for screening, diagnostic and guideline-based treatment recommendations, as well as a web-based transferal platform were developed.The results of this project on the effectiveness and efficacy of the model can help determine if the model can be implemented in routine healthcare. This could represent a major step towards more integrated and cross-sectoral healthcare for patients with mental illnesses.

[Effectiveness of Psychoanalytic Psychotherapy for Children and Adolescents with Severe Anxiety Psychopathology in a Naturalistic Treatment Setting]. / Wirksamkeit analytischer Psychotherapie bei Kindern und Jugendlichen mit klinischen Angstsyndromen im naturalistischen Behandlungssetting.

Effectiveness of Psychoanalytic Psychotherapy for Children and Adolescents with Severe Anxiety Psychopathology in a Naturalistic Treatment Setting The aim of the study was to evaluate naturalistic out-patient psychoanalytic youth psychotherapy in Germany. The study was a partly controlled effectiveness trial. While the first treatment interval (25 sessions, 6.13 months) was compared with a wait-list control group (5 supportive sessions, 2.94 months), the effects of long-term psychoanalytical treatment were analyzed using a time-series design. 86 children and adolescents (aged 4 to 21 years) and their parents who entered psychoanalytic therapy in private practices participated in this study. The wait-list control group comprised 35 patients. Questionnaires were administered at the beginning and the end of treatment, as well as 6 and 12 month follow-up (FU). Patients received on average 94.04 therapy sessions (range 8 to 300) over 25.70 months. Data analyses were carried out with multilevel mixed linear models on the intention-to-treat (ITT) sample. The patients in the intervention group reported moderate symptom improvements at the end of therapy (d = .57), these effects are stable at the 1-year follow-up and increase from the patient perspective (d = .80). When comparing the first therapy interval with the (minimal treatment) wait-list control group, both groups improved significantly with small effect sizes and no significant group differences. The results suggest that long-term psychoanalytic therapy is successful in alleviating anxiety pathology and improving quality of life for youth with anxiety disorders, and that improvements remain stable across a 1-year follow-up period.