Resting-state functional connectivity in anxiety disorders: a multicenter fMRI study.

Anxiety disorders (AD) are associated with altered connectivity in large-scale intrinsic brain networks. It remains uncertain how much these signatures overlap across different phenotypes due to a lack of well-powered cross-disorder comparisons. We used resting-state functional magnetic resonance imaging (rsfMRI) to investigate differences in functional connectivity (FC) in a cross-disorder sample of AD patients and healthy controls (HC). Before treatment, 439 patients from two German multicenter clinical trials at eight different sites fulfilling a primary diagnosis of panic disorder and/or agoraphobia (PD/AG, N = 154), social anxiety disorder (SAD, N = 95), or specific phobia (SP, N = 190) and 105 HC underwent an 8 min rsfMRI assessment. We performed categorical and dimensional regions of interest (ROI)-to-ROI analyses focusing on connectivity between regions of the defensive system and prefrontal regulation areas. AD patients showed increased connectivity between the insula and the thalamus compared to controls. This was mainly driven by PD/AG patients who showed increased (insula/hippocampus/amygdala-thalamus) and decreased (dorsomedial prefrontal cortex/periaqueductal gray-anterior cingulate cortex) positive connectivity between subcortical and cortical areas. In contrast, SAD patients showed decreased negative connectivity exclusively in cortical areas (insula-orbitofrontal cortex), whereas no differences were found in SP patients. State anxiety associated with the scanner environment did not explain the FC between these regions. Only PD/AG patients showed pronounced connectivity changes along a widespread subcortical-cortical network, including the midbrain. Dimensional analyses yielded no significant results. The results highlighting categorical differences between ADs at a systems neuroscience level are discussed within the context of personalized neuroscience-informed treatments. PROTECT-AD's registration at NIMH Protocol Registration System: 01EE1402A and German Register of Clinical Studies: DRKS00008743. SpiderVR's registration at ClinicalTrials.gov: NCT03208400.

Lack of evidence for predictive utility from resting state fMRI data for individual exposure-based cognitive behavioral therapy outcomes: A machine learning study in two large multi-site samples in anxiety disorders.

Data-based predictions of individual Cognitive Behavioral Therapy (CBT) treatment response are a fundamental step towards precision medicine. Past studies demonstrated only moderate prediction accuracy (i.e. ability to discriminate between responders and non-responders of a given treatment) when using clinical routine data such as demographic and questionnaire data, while neuroimaging data achieved superior prediction accuracy. However, these studies may be considerably biased due to very limited sample sizes and bias-prone methodology. Adequately powered and cross-validated samples are a prerequisite to evaluate predictive performance and to identify the most promising predictors. We therefore analyzed resting state functional magnet resonance imaging (rs-fMRI) data from two large clinical trials to test whether functional neuroimaging data continues to provide good prediction accuracy in much larger samples. Data came from two distinct German multicenter studies on exposure-based CBT for anxiety disorders, the Protect-AD and SpiderVR studies. We separately and independently preprocessed baseline rs-fMRI data from n = 220 patients (Protect-AD) and n = 190 patients (SpiderVR) and extracted a variety of features, including ROI-to-ROI and edge-functional connectivity, sliding-windows, and graph measures. Including these features in sophisticated machine learning pipelines, we found that predictions of individual outcomes never significantly differed from chance level, even when conducting a range of exploratory post-hoc analyses. Moreover, resting state data never provided prediction accuracy beyond the sociodemographic and clinical data. The analyses were independent of each other in terms of selecting methods to process resting state data for prediction input as well as in the used parameters of the machine learning pipelines, corroborating the external validity of the results. These similar findings in two independent studies, analyzed separately, urge caution regarding the interpretation of promising prediction results based on neuroimaging data from small samples and emphasizes that some of the prediction accuracies from previous studies may result from overestimation due to homogeneous data and weak cross-validation schemes. The promise of resting-state neuroimaging data to play an important role in the prediction of CBT treatment outcomes in patients with anxiety disorders remains yet to be delivered.

Screening and assessment for cancer patients' psychosocial support needs: Development and validation of the psychosocial risk questionnaire.

PURPOSE: Psychosocial factors can negatively influence the ability to cope with cancer-specific therapy. To identify high-risk patients and to offer need-based care concerning social issues, valid, reliable, and economic instruments are needed. This study aims to develop a tool assessing psychosocial support needs and analyze its psychometric properties. METHODS: Based on an extensive literature search, items for the scale of psychosocial risks (PSR) were developed to assess the need for psychosocial support. Overall, N = 343 participants with cancer took part in the study to investigate the psychometric properties of the PSR. The factor structure was examined by using a principal component analysis. Correlations with criteria-related constructs determined the convergent validity. Cut-off scores for the PSR were selected based on receiver-operating characteristics and the calculation of Youden indices. RESULTS: The principal component analysis suggests a two-factor structure: (1) Psychosocial support need to ensure medical and social care services, and (2) Support need for coping with problems. The predicted correlations confirm the convergent validity. Both scales showed excellent internal consistency (Ensure medical and social care services: Omega = 0.94) and (Coping with problems: Omega = 0.90). CONCLUSION: The newly developed scale can provide helpful information regarding psychosocial support needs to professionals (psychotherapists, psychologists, physicians, and social workers) in the psycho-oncological field. Based on this information, specific and personalized interventions for cancer patients can be offered. The PSR is appropriate for assessing specific psychosocial needs to support cancer patients.

Misclassification of Self-Directed Violence.

Background: Classification of acts of self-directed violence has been shown to be inadequate in past research. Furthermore, level of expertise have been shown to be unrelated to classification correctness. Aim: The aim of the present study was to investigate whether participants provided with a definition are more reliable in their judgment than participants without a definition. Method: Two hundred sixty-one participants (psychology students, psychotherapists-in-training) were presented with case vignettes describing different acts of self-directed violence and were asked to make a classification. On the basis of randomized allocation, half of the participants received a definition of the different acts of self-directed violence, whereas the others did not. Results: Overall, 24.9% of the cases were misclassified. The presentation of a definition was not accompanied by a higher classification accuracy. Limitations: There may be issues about the validity of the case vignettes. Conclusions: The results highlight the importance of more methodological training of psychologists regarding suicidal issues.

Psychometric evaluation of the Positive Mental Health (PMH) scale using item response theory.

BACKGROUND: The investigation of patient-reported outcomes and psycho-oncological interventions mainly focuses on psychological distress or psychopathology. However, the recognition of the equal importance of positive mental health (PMH) has increased lately. The PMH-scale is a brief questionnaire allowing to assess well-being in individuals in the general population and in patients. Previous studies evaluated the psychometric properties of the PMH-scale using classical test theory (CTT). This study is the first to investigate the PMH-scale in patients with cancer using item analysis according to the Rasch model. METHODS: In total, N = 357 cancer patients participated in the study. A Rasch analysis of the PMH-scale was conducted including testing of unidimensionality, local independence, homogeneity and differential item functioning (DIF) with regard to age, gender, type of cancer, the presence of metastases, psycho-oncological support, and duration of disease. Additionally, the ordering of the item thresholds as well as the targeting of the scale were investigated. RESULTS: After excluding one misfitting item and accounting for local dependence by forming superitems, a satisfactory overall fit to the Rasch model was established (χ2 = 30.34, p = 0.21). The new PMH-8 scale proved to be unidimensional, and homogeneity of the scale could be inferred. All items showed ordered thresholds, there was no further item misfit. DIF was found for age, but as the impact of DIF was not substantial, no adjustment related to the age-DIF had to be made. The Person Separation Index (PSI = 0.89) was excellent, indicating excellent discriminatory power between different levels of positive mental health. Overall, the targeting of the PMH-8 was good for the majority of the present sample. However, at both ends of the scale item thresholds are missing as indicated by a slight floor effect (1.4%) and a considerable ceiling effect (9.8%). CONCLUSIONS: Overall, the results of the analysis according to the Rasch model support the use of the revised PMH-scale in a psycho-oncological context.

Psychotherapists' Knowledge of Guideline Recommendations for the Treatment of Depressed Suicidal Patients.

Objective: Clinical practice guidelines present expert consensus on the treatment of mental disorders. Yet, studies have shown that knowledge of and adherence to recommendations are moderate. The aim of the present study was to investigate, whether and to what extent psychotherapists are aware of and follow the German guideline recommendations for the treatment of suicidal depressed patients. Methods: 174 participants (licensed psychotherapists, psychotherapists-in-training) were presented with five groups of guideline recommendations (referring to inpatient admission, psychotherapy, acute pharmacotherapy, pharmacologic relapse prevention, follow-up appointments) and were asked to identify the guideline recommendation and indicate whether they provided treatment according to the guideline. Results: Knowledge and adherence to the guidelines recommendations on psychotherapy and inpatient admission were well present. However, knowledge about pharmacological treatment recommendations was low; same as the knowledge on the necessity of immediate follow-up appointments after discharge of patients hospitalized due to suicidality. Discussion: The results highlight the importance of greater dissemination of various facts about the management of suicidal patients.

Integrated, cross-sectoral psycho-oncology (isPO): a new form of care for newly diagnosed cancer patients in Germany.

BACKGROUND: The annual incidence of new cancer cases has been increasing worldwide for many years, and is likely to continue to rise. In Germany, the number of new cancer cases is expected to increase by 20% until 2030. Half of all cancer patients experience significant emotional and psychosocial distress along the continuum of their disease, treatment, and aftercare, and also as long-term survivors. Consequently, in many countries, psycho-oncological programs have been developed to address this added burden at both the individual and population level. These programs promote the active engagement of patients in their cancer therapy, aftercare and survivorship planning and aim to improve the patients' quality of life. In Germany, the "new form of care isPO" ("nFC-isPO"; integrated, cross-sectoral psycho-oncology/integrierte, sektorenübergreifende Psycho-Onkologie) is currently being developed, implemented and evaluated. This approach strives to accomplish the goals devised in the National Cancer Plan by providing psycho-oncological care to all cancer patients according to their individual healthcare needs. The term "new form of care" is defined by the Innovation Fund (IF) of Germany's Federal Joint Committee as "a structured and legally binding cooperation between different professional groups and/or institutions in medical and non-medical care". The nFC-isPO is part of the isPO project funded by the IF. It is implemented in four local cancer centres and is currently undergoing a continuous quality improvement process. As part of the isPO project the nFC-isPO is being evaluated by an independent institution: the Institute for Medical Sociology, Health Services Research, and Rehabilitation Science (IMVR), University of Cologne, Germany. The four-year isPO project was selected by the IF to be eligible for funding because it meets the requirements of the federal government's National Cancer Plan (NCP), in particular, the "further development of the oncological care structures and quality assurance" in the psycho-oncological domain. An independent evaluation is required by the IF to verify if the new form of care leads to an improvement in cross-sectoral care and to explore its potential for permanent integration into the German health care system. METHODS: The nFC-isPO consists of six components: a concept of care (C1), care pathways (C2), a psycho-oncological care network (C3), a care process organization plan (C4), an IT-supported documentation and assistance system (C5) and a quality management system (C6). The two components concept of care (C1) and care pathways (C2) represent the isPO clinical care program, according to which the individual cancer patients are offered psycho-oncological services within a period of 12 months after program enrolment following the diagnosis of cancer. The remaining components (C3-C6) represent the formal-administrative aspects of the nFC-isPO that are intended to meet the legally binding requirements of patient care in the German health care system. With the aim of systematic development of the nFC-isPO while at the same time enabling the external evaluators to examine its quality, effectiveness and efficiency under conditions of routine care, the project partners took into consideration approaches from translational psycho-oncology, practice-based health care research and program theory. In order to develop a structured, population-based isPO care program, reference was made to a specific program theory, to the stepped-care approach, and also to evidence-based guideline recommendations. RESULTS: The basic version, nFC-isPO, was created over the first year after the start of the isPO project in October 2017, and has since been subject to a continuous quality improvement process. In 2019, the nFC-isPO was implemented at four local psycho-oncological care networks in the federal state North Rhine-Westphalia, in Germany. The legal basis of the implementation is a contract for "special care" with the German statutory health insurance funds according to state law (§ 140a SCB V; Social Code Book V for the statutory health insurance funds). Besides the accompanying external evaluation by the IMVR, the nFC-isPO is subjected to quarterly internal and cross-network quality assurance and improvement measures (internal evaluation) in order to ensure continuous quality improvement process. These quality management measures are developed and tested in the isPO project and are to be retained in order to ensure the sustainability of the quality of nFC-isPO for later dissemination into the German health care system. DISCUSSION: Demands on quality, effectiveness and cost-effectiveness of in the German health care system are increasing, whereas financial resources are declining, especially for psychosocial services. At the same time, knowledge about evidence-based screening, assessment and intervention in cancer patients and about the provision of psychosocial oncological services is growing continuously. Due to the legal framework of the statutory health insurance in Germany, it has taken years to put sound psycho-oncological findings from research into practice. Ensuring the adequate and sustainable financing of a needs-oriented, psycho-oncological care approach for all newly diagnosed cancer patients, as required by the NCP, may still require many additional years. The aim of the isPO project is to develop a new form of psycho-oncological care for the individual and the population suffering from cancer, and to provide those responsible for German health policy with a sound basis for decision-making on the timely dissemination of psycho-oncological services in the German health care system. TRIAL REGISTRATION: The study was pre-registered at the German Clinical Trials Register (https://www.drks.de/DRKS00015326) under the following trial registration number: DRKS00015326 ; Date of registration: October 30, 2018.

An item analysis according to the Rasch model of the German 12-item WHO Disability Assessment Schedule (WHODAS 2.0).

PURPOSE: The World Health Organization Disability Assessent Schedule 2.0 (WHODAS 2.0) assesses disability in individuals irrespective of their health condition. Previous studies validated the usefulness of the WHODAS 2.0 using classical test theory. This study is the first investigating the psychometric properties of the 12-items WHODAS 2.0 in patients with cancer using item analysis according to the Rasch model. METHODS: In total, 350 cancer patients participated in the study. Rasch analysis of the 12-items version of the WHODAS 2.0 was conducted and included testing unidimensionality, local independence, and testing for differential item functioning (DIF) with regard to age, gender, type of cancer, presence of metastases, psycho-oncological support, and duration of disease. RESULTS: After accounting for local dependence, which was mainly found across items of the same WHODAS domain, satisfactory overall fit to the Rasch model was established (χ2 = 36.14, p = 0.07) with good reliability (PSI = 0.82) and unidimensionality of the scale. DIF was found for gender (testlet 'Life activities') and age (testlet 'Getting around/Self-care'), but the size of DIF was not substantial. CONCLUSION: Overall, the analysis results according to the Rasch model support the use of the WHODAS 2.0 12-item version as a measure of disability in cancer patients.

The Effects of Modifying Dysfunctional Appraisals in Posttraumatic Stress Disorder Using a Form of Cognitive Bias Modification: Results of a Randomized Controlled Trial in an Inpatient Setting.

INTRODUCTION: Dysfunctional appraisals about traumatic events and their sequelae are a key mechanism in posttraumatic stress disorder (PTSD). Experimental studies have shown that a computerized cognitive training, cognitive bias modification for appraisals (CBM-APP), can modify dysfunctional appraisals and reduce analogue trauma symptoms amongst healthy and subclinical volunteers. OBJECTIVE: We aimed to test whether CBM-APP could reduce dysfunctional appraisals related to trauma reactions in PTSD patients, and whether this would lead to improvements in PTSD symptoms. METHODS: We compared CBM-APP to sham training in a parallel-arm proof-of-principle double-blind randomized controlled trial amongst 80 PTSD patients admitted to an inpatient clinic. Both arms comprised a training schedule of 8 sessions over a 2-week period and were completed as an adjunct to the standard treatment programme. RESULTS: In intention-to-treat analyses, participants receiving CBM-APP showed a greater reduction in dysfunctional appraisals on a scenario task from pre- to posttraining (primary outcome) assessments, compared to those receiving sham training (d = 1.30, 95% CI 0.82-1.80), with between-group differences also found on the Posttraumatic Cognitions Inventory (PTCI; d = 0.85, 95% CI 0.39-1.32) and the PTSD Checklist for DSM-5 (PCL-5; d = 0.68, 95% CI 0.23-1.14), but not for long-term cortisol concentrations (d = 0.25, 95% CI -0.28 to 0.78). Reductions in dysfunctional appraisals assessed via the scenario task correlated with reductions on the PTCI, PCL-5, and hair cortisol concentrations from pre- to posttraining time points. CONCLUSIONS: Results support dysfunctional appraisals as a modifiable cognitive mechanism, and that their proximal modification transfers to downstream PTSD symptoms. These findings could open new avenues for improving present therapeutic approaches.

The significance of the Interpersonal-Psychological Theory of Suicide in an oncological context-A scoping review.

OBJECTIVES: Since individuals afflicted with cancer are at an elevated risk of dying by suicide, understanding suicide-related ideation and behaviours is critical in identifying vulnerable patients. The interpersonal theory of suicide (IPTS) provides a framework to research risk factors for suicide and has been validated in different samples. The aim of this scoping review is to study literature related to IPTS and cancer patients. METHODS: This scoping review was registered with the OPEN Science Framework (osf.io/92465). The databases PsycINFO, Web of Science, PubMed and PubMed Central were searched. Eligible research needed to use a minimum of one psychometric element to measure at least one of the factors of the IPTS in individuals with cancer. RESULTS: Ninety-six studies were identified and screened. Eligible research included individuals with cancer and the use of at least one measurement of at least one of the factors of the IPTS. Overall, four articles met the inclusion criteria and three studies found significant associations of components of the IPTS and suicidal ideation/behaviour. CONCLUSION: While these initial findings support the notion that the IPTS is relevant for individuals with cancer as well, a direct validation of the IPTS in cancer patients is needed.

Associations Between Difficulties in Emotion Regulation and Post-Traumatic Stress Disorder in Deployed Service Members of the German Armed Forces.

BACKGROUND: Experiencing a traumatic event can lead to post-traumatic stress disorder (PTSD), but not every traumatized person develops PTSD. Several protective and risk factors have been identified in civilians and veterans to explain why some individuals develop PTSD and others do not. However, no research has confirmed the relationship between emotion regulation and PTSD in deployed German Armed Forces service members after a foreign assignment. Previous studies have identified some protective factors, such as social support, social acknowledgment, specific personal values, and posttraumatic growth, as well as risk factors, like moral injury and emotion regulation. Thus, the aim of the present study is to confirm the relationship between emotion regulation and PTSD and to test for factors that are associated with higher severity of PTSD symptoms in such a sample. METHODS: A post-hoc secondary analysis was conducted on data collected in a randomized controlled trial. Participants (N = 72) were male active and former military service members that have returned from deployment and were recruited from the German Armed Forces. These participants were separated into two groups according to PTSD diagnosis based on the results of a structured diagnostic interview. Data from evaluation questionnaires administered upon entry into the study were subjected to a cross-sectional analysis. The measures included the severity of PTSD symptoms, clusters of PTSD symptoms, clinical measures, and several measures assessing PTSD-related constructs. Analyses included the Spearman rank correlation coefficient, X2 tests for nominal data, Mann-Whitney U-tests for non-parametric data, and a mediation analysis. RESULTS: The results of the mediation analysis revealed that difficulties in emotion regulation were significantly associated with the severity of PTSD symptoms, which was mediated by social acknowledgment and experimental avoidance but not by moral injury. The analyses showed that the severity of PTSD symptoms and all clusters of PTSD symptoms were significantly associated with most of the measured constructs in expectable directions. Participants in the PTSD group showed significantly higher mean scores on questionnaires measuring constructs that have been associated with PTSD, like emotion regulation and moral injury. They also showed lower mean scores in questionnaires for social support and social acknowledgment as a victim or survivor than participants in the non-PTSD group. CONCLUSION: The present results show that difficulties in emotion regulation are directly associated with the severity of PTSD symptoms in service members of the German Armed Forces. This association is mediated by social acknowledgment and experimental avoidance, but not by moral injury. Thus, future studies should investigate these potentially crucial factors for better understanding of the development and maintenance of PTSD in service members of the German Armed Forces after deployment to create possible treatment adaptions. CLINICAL TRIAL REGISTRATION: Australian Clinical Trials Registry, identifier ACTRN 12616000956404 http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370924.

Validation of the German capability for suicide questionnaire (GCSQ) in a high-risk sample of suicidal inpatients.

BACKGROUND: The German Capability for Suicide Questionnaire (GCSQ) was developed to measure fearlessness of death and pain tolerance - two constructs central to the Interpersonal Theory of Suicide. Initial scale development, definition of the factor structure and confirmation of the two-dimensional factor structure was performed in samples suffering from relatively low levels of suicide ideation/behavior. The present study aimed to validate the German Capability for Suicide Questionnaire (GCSQ) in a high-risk sample of suicidal inpatients. METHODS: Factor structure, reliability and validity were investigated in a sample of inpatients (N = 296; 53.0% female; age in years: M = 36.81, SD = 14.27) admitted to a hospital due to a recent suicide attempt or an acute suicidal crisis (in immediate need of inpatient treatment). To establish convergent validity, interview-based assessments of lifetime suicide attempts and non-suicidal self-injury as well as questionnaire-based assessments of painful and provocative events were used. Finally, stability of GCSQ-scores over a follow-up period of 12 months was assessed. RESULTS: Results indicated good psychometric properties, and provided additional evidence for construct validity and stability of the subscales over a one-year period, and demonstrated adequate fit of the data with respect to the original factor structure. CONCLUSIONS: Results suggest that the GCSQ is a brief, reliable, and valid measure of capability for suicide that can be used in clinic assessment and research.

Psychometric properties of the German version of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) in clinical routine settings: study design and protocol of a multitrait-multimethod study.

INTRODUCTION: The aim of this study is to investigate the diagnostic accuracy, psychometric properties and clinical utility of the German version of the Clinician-Administered Post-Traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) (CAPS-5) in routine clinical settings. METHODS AND ANALYSIS: This study is a non-interventional, multitrait-multimethod design, multicentre study that will be carried out at German civil and military inpatient and outpatient clinics. A total sample size of n=219 participants who have experienced at least one traumatic event according to criteria as defined in the DSM-5 will be recruited. For the investigation of the diagnostic accuracy and clinical utility of the CAPS-5, participants will be categorised into one of three groups, depending on their traumatic experiences and post-traumatic symptomatology: (1) monotraumatisation with PTSD; (2) multiple traumatisation with PTSD and (3) traumatisation without PTSD. Interviews will be conducted face to face by interviewers in routine clinical settings. All participants will also be asked to complete a comprehensive set of questionnaires in order to investigate different facets of construct validity and clinical utility. First, differences between all three groups in CAPS-5 sum and subscale scores will be investigated. Test-retest reliability and inter-rater reliability will be determined. Internal consistency will be calculated using structural equation modeling (SEM) based internal consistency coefficients. Construct validity will be measured with Spearman's rank correlation analyses and multivariate analyses of variance with Holm-Bonferroni corrected post hoc analysis of variances. In order to test diagnostic accuracy, receiver operating characteristics and sensitivity and specificity analyses will be conducted. The model structure of the German CAPS-5 will be analysed using confirmatory factor analyses. ETHICS AND DISSEMINATION: The study received ethical approval by the Ethics Committees of the Faculty of Psychology at the Ruhr-Universität Bochum (reference numbers: 331 and 358). The results of the study will be presented nationally and internationally at scientific conferences and will be published in scientific journals. TRIAL REGISTRATION NUMBER: DRKS00015325.

Evaluation of a complex integrated, cross-sectoral psycho-oncological care program (isPO): a mixed-methods study protocol.

INTRODUCTION: International standards of care require the complete integration of psycho-oncological care into biomedical cancer treatment. The structured integrated, cross-sectoral psycho-oncological programme 'isPO' is aiming to ensure a provision of care in inpatient and outpatient settings according to a stepped-care approach. Up to now, psycho-oncological care is missing regulated and standardised processes to demonstrate the effectiveness. This study protocol describes the process and outcome evaluation that is conducted, along with the isPO study. The programme evaluation is aiming to proof effectiveness, explain potential discrepancies between expected and observed outcomes. Additionally, provide insight into the implementation process, as well as contextual factors that might promote or inhibit the dissemination and implementation of the stepped care programme will be gained. In addition to these measures, a cost-consequence analysis will provide further evidence aimed at integrating psycho-oncological care into primary healthcare. METHODS AND ANALYSIS: The evaluation concept is based on a tripartite strategy consisting of a prospective, formative and summative evaluation. To capture all determinants, a concurrent mixed-method design is applied comprising qualitative (interviews and focus groups) and quantitative (standardised questionnaires) surveys of patients and healthcare providers. In addition, analysis of the psycho-oncological care data (isPO care data) and statutory health insurance claims data will be conducted. Primary and secondary data will complement one another (data linkage) to obtain a more comprehensive picture of the effectiveness and implementation of the complex intervention within the isPO study. ETHICS AND DISSEMINATION: The study has been approved by the ethics committee of the Medical Faculty of the University of Cologne. For all collected data, the relevant national and European data protection regulations will be considered. All personal identifiers (eg, name, date of birth) will be pseudonymised. Dissemination strategies include annual reports as well as quality workshops for the organisations, the presentation of results in publications and on conferences, and public relations. TRIAL REGISTRATION NUMBER: DRKS00015326; Pre-results.

Short defeat and entrapment scale: A psychometric investigation in three German samples.

BACKGROUND: The present study aimed to validate the German version of the Short Defeat and Entrapment Scale (SDES). METHODS: Validity and reliability were established in an online (N = 480), an outpatient (N = 277) and an inpatient sample (N = 296). Statistical analyses included confirmatory factor analyses (CFA) and group differences in defeat and entrapment. RESULTS: For the online and the inpatient sample, the CFA indicated a two-factor solution, whereas for the outpatient sample both one- and two-factor solutions fitted the data equally well. Scale properties for the two-factor solution (defeat and entrapment subscale) were excellent. Thus, further analyses were based on this solution. For the online and the outpatient sample, suicidal ideators and suicide attempters scored significantly higher in defeat and entrapment than non-ideators and non-attempters. LIMITATIONS: Limiting factors of the study were the different measures across the samples and the cross-sectional design of the study. CONCLUSION: Though results were partly mixed, we found support for a two-factor solution of the instrument showing excellent psychometric properties in all three samples. The two-factor solution is further expected to have higher clinical utility than a one-factor solution. Suicidal ideators and suicide attempters in the online and outpatient sample showed higher scores in defeat and entrapment than non-ideators and non-attempters, emphasizing these two concepts as predictors for suicidal ideation. All in all, the present study supports the general validity and reliability of the SDES. However, future investigations based on prospective data are warranted.

Critical consideration of assessment methods for clinically significant changes of mental distress after psycho-oncological interventions.

OBJECTIVES: Considering the heterogeneity of cancer entities and the associated disease progression, personalized care of patients is increasingly emphasized in psycho-oncology. This individualization makes the use of measurements of individual clinically significant change important when studying the efficacy and effectiveness of psycho-oncological care. Two conceptualizations for the measurement of clinical significance are critically contrasted in this study: the Reliable Change Index (RCI) and the Minimal Important Difference (MID) method. METHODS: In total, 2,121 cancer patients participated in the study and a subsample of 708 patients was reassessed about 4 months later. Psychological distress was measured using the Hospital Anxiety and Depression Scale. We evaluated two measures of clinical significance (RCI, MID) by comparing the respective numbers of improved, unimproved, and deteriorated patients. RESULTS: Individually significant changes were observed with both methods; however, determined rates of improvement differed substantially: MID (66.67%) and RCI (48.23%). Most importantly, according to MID, 17.93% of patients were identified as being improved, although their respective improvements were not statistically significant and thus unreliable. CONCLUSIONS: The benefits of RCI outweigh MID, and therefore, the RCI is recommended as a measure to assess change.

Reduced gray matter volume in the left prefrontal, occipital, and temporal regions as predictors for posttraumatic stress disorder: a voxel-based morphometric study.

The concept of acute stress disorder (ASD) was introduced as a diagnostic entity to improve the identification of traumatized people who are likely to develop posttraumatic stress disorder (PTSD). Neuroanatomical models suggest that changes in the prefrontal cortex, amygdala, and hippocampus play a role in the development of PTSD. Using voxel-based morphometry, this study aimed to investigate the predictive power of gray matter volume (GMV) alterations for developing PTSD. The GMVs of ASD patients (n = 21) were compared to those of PTSD patients (n = 17) and healthy controls (n = 18) in whole-brain and region-of-interest analyses. The GMV alterations seen in ASD patients shortly after the traumatic event (T1) were also correlated with PTSD symptom severity and symptom clusters 4 weeks later (T2). Compared with healthy controls, the ASD patients had significantly reduced GMV in the left visual cortex shortly after the traumatic event (T1) and in the left occipital and prefrontal regions 4 weeks later (T2); no significant differences in GMV were seen between the ASD and PTSD patients. Furthermore, a significant negative association was found between the GMV reduction in the left lateral temporal regions seen after the traumatic event (T1) and PTSD hyperarousal symptoms 4 weeks later (T2). Neither amygdala nor hippocampus alterations were predictive for the development of PTSD. These data suggest that gray matter deficiencies in the left hemispheric occipital and temporal regions in ASD patients may predict a liability for developing PTSD.

Long-Term Effectiveness of Cognitive Behavioral Therapy in Routine Outpatient Care: A 5- to 20-Year Follow-Up Study.

OBJECTIVE: Long-term follow-ups several years after receiving cognitive behavioral therapy (CBT) are scarce and most of the existing literature describes follow-up data of randomized-controlled trials. Thus, very little is known about the long-term effects of CBT in routine care. METHODS: We investigated psychological functioning in a sample of 263 former outpatients who had received CBT for a variety of mental disorders such as depression, anxiety-, eating- or somatoform disorders 8.06 (SD 5.08) years after treatment termination. All participants completed a diagnostic interview as well as the Brief-Symptom Inventory (BSI) and the Beck Depression Inventory (BDI). Effect sizes and response rates according to Jacobson and Truax [J Consult Clin Psychol 1991;59:12-9] were calculated from pre- to posttreatment and from pretreatment to follow-up assessment. RESULTS: Pre- to posttreatment effect sizes ranged between 0.75 (BDI) and 0.63 (BSI) and pretreatment to follow-up effect sizes were 0.92 (BDI) and 0.75 (BSI). Of all patients, 29% (BDI) and 17% (BSI) experienced clinically significant change at posttreatment and 42% (BDI) and 24% (BSI) at follow-up. CONCLUSION: The results point to the long-term effectiveness of CBT under routine conditions for a wide array of problems, especially when compared to the long-term effects of medical treatment. It is noteworthy that the results at follow-up were even better than at posttreatment, indicating further improvement. However, about a quarter of the patients did not respond sufficiently to therapy, neither concerning short-term nor long-term effects.

Investigating the effect of proactive interference control training on intrusive memories.

Intrusive re-experiencing is a hallmark symptom of Posttraumatic Stress Disorder (PTSD). According to prominent models of intrusive phenomena, intrusive memories may result from impairments in the efficiency of working memory capacity (WMC), more specifically proactive interference control. Yet, experimental research is scarce. Therefore, the present study aimed to investigate experimentally the role of proactive interference control in intrusive memories. We randomly assigned 57 healthy participants to either receive a high interference control training or a low interference control training. Participants were then exposed to highly distressing film clips. WMC was assessed before and after the training. Intrusion symptoms were assessed directly post-training and after one week using an Intrusion Provocation Task (IPT), a one-week intrusions diary, and the retrospective intrusion subscale of the Impact of Event Sale - Revised (IES-R). Results indicated that both groups reported improvements in WMC and fewer intrusions on the second IPT post-training, with no differences between groups. Similarly, no group differences on intrusions were found at one-week follow-up (i.e., intrusion diary and IES-R). To conclude, these data are not consistent with the hypothesis that WMC plays a role in intrusive re-experiencing. Implications for future research are discussed.

La re-experiencia intrusiva es un síntoma distintivo del trastorno por estrés postraumático (TEPT). De acuerdo con los prominentes modelos de fenómenos intrusivos, las memorias intrusivas pueden resultar en deterioros en la eficiencia de la capacidad de memoria de trabajo (CMT), más específicamente del control proactivo de interferencias. Sin embargo, la investigación experimental a este respecto es escasa. Por lo tanto, el presente estudio tuvo como objetivo investigar experimentalmente el papel del control proactivo de interferencias en las memorias intrusivas. Asignamos aleatoriamente 57 participantes sanos a recibir, ya sea, un entrenamiento de control de alta interferencia o un entrenamiento de control de baja interferencia. Luego, los participantes fueron expuestos a videoclips de películas altamente angustiantes. La CMT fue evaluada antes y después del entrenamiento. Los síntomas de intrusión se evaluaron directamente después del entrenamiento y después de una semana utilizando una Tarea de Provocación de Intrusión (IPT), registro diario de intrusiones (por una semana), y la subescala de intrusión retrospectiva de la Escala del Impacto del Evento - Revisada (IES-R). Los resultados indicaron que ambos grupos experimentaron mejoras en la CMT y reducción de intrusiones en la segunda IPT posterior al entrenamiento, sin diferencias entre los grupos. De manera similar, no se encontraron diferencias de grupo en las intrusiones en el seguimiento de una semana (es decir, en el diario de intrusiones y la IES-R). Para concluir, estos datos no son consistentes con la hipótesis de que la CMT desempeña un papel en la re-experiencia intrusiva. Se discuten las implicaciones para futuras investigaciones.

HPA axis regulation in posttraumatic stress disorder: A meta-analysis focusing on potential moderators.

Posttraumatic stress disorder (PTSD) is often associated with alterations in the hypothalamic-pituitary-adrenal (HPA) axis. Previous findings are inconsistent, possibly due to trauma exposure of controls or different hormone measurement methods. We investigated cortisol, dehydroepiandrosterone (DHEA) and its sulfate (DHEA-S) in adults with clinical PTSD under basal or challenged conditions (Prospero registration no. CRD42016041690). A search of PubMed, Scopus, Medline, PsycINFO, Pilots/ProQuest, and Web of Science resulted in 108 included studies (N = 6484). Morning and 24 h cortisol were significantly lower in PTSD than in controls (g = -0.21; 95% CI: -0.42-(-0.01); g = -0.31; CI: -0.60-(-0.03)). Significant cortisol increases occurred after awakening in PTSD (g = 0.40; CI: 0.13-0.67) and in non-exposed controls (g = 0.96; CI: 0.59-1.33). Evening DHEA was significantly higher in PTSD than in non-exposed controls (g = 0.58; CI: 0.17-0.99). All groups showed large cortisol suppression effects after dexamethasone administration. Overall, the potential moderators investigated did not reveal a consistent pattern of HPA alterations.