Problems in measuring the JTC-bias in patients with psychotic disorders with the fish task: a secondary analysis of a baseline assessment of a randomized controlled trial.

BACKGROUND: The jumping to conclusions bias (JTC) is considered to be an important causal factor in theoretical models for the formation and maintenance of delusions. However, recent meta-analytic findings show a rather equivocal pattern of results regarding associations between JTC and delusions. Thus, the present study aims to investigate in a large sample whether the JTC-bias is more pronounced in patients with psychotic disorders in comparison to controls and whether the JTC bias is associated with a more severe delusional conviction, persecutory delusions, and positive symptoms in general. METHODS: Patients with psychotic disorders (n = 300) enrolled in a therapy trial and healthy controls (n = 51) conducted a variant of the beads task (fish task) as a measure for the JTC-bias at the start of the trial. Further, clinical interviews were used to assess patients' delusional severity and delusional conviction. RESULTS: There were no statistically significant differences between patients with psychotic disorders (with 53% displaying the JTC-bias) and controls (41%). Furthermore, there were no statistically significant correlations between JTC measures and persecutory delusions, delusional conviction, and positive symptoms. CONCLUSIONS: We found no differences in JTC between patients with psychotic disorders and healthy controls, which is in part in line with meta-analytic findings using a wide range of JTC task variants. Interestingly, patients with psychotic disorders displayed JTC rates commonly found in the literature, while healthy control subjects showed an unexpectedly high level of JTC. The task variant we used in the present study (fish task) is discussed as a potential reason for our results, as it may induce a more deliberative reasoning style in controls as compared to the traditional beads task. Furthermore, possible implications for the measurement of the JTC-bias, in general, are discussed. TRIAL REGISTRATION: ISRCTN29242879 ( isrctn.com ), date of registration: April 12th 2006, retrospectively registered.

Theory of mind, emotion recognition, delusions and the quality of the therapeutic relationship in patients with psychosis - a secondary analysis of a randomized-controlled therapy trial.

BACKGROUND: Cognitive models of psychosis postulate an important role of Theory of mind (ToM) in the formation and maintenance of delusions, but research on this plausible conjecture has gathered conflicting findings. In addition, it is still an open question whether problems in emotion recognition (ER) are associated with delusions. We examined the association of problems in ToM and ER with different aspects of delusions in a large sample of patients with psychosis enrolled in a therapy trial. This also enabled us to explore the possible impact of ToM and ER on one part of patients' social life: the quality of their therapeutic relationship. METHODS: Patients with psychotic disorders and delusions and/or hallucinations (n = 185) and healthy controls (n = 48) completed a ToM picture sequencing task and an ER task. Subsequently, patients were enrolled in a randomized-controlled Cognitive Behavior Therapy (CBT) trial (ISRCTN29242879). Patients and therapists rated the quality of the therapeutic relationship during the first five sessions of therapy. RESULTS: In comparison to controls, patients were impaired in both ToM and ER. Patients with deficits in ER experienced more severe delusional distress, whereas ToM problems were not related to delusions. In addition, deficits in ER predicted a less favorable therapeutic relationship and interactional problems viewed by the therapist. Impaired ER also moderated (increased) the negative influence of delusions on the therapeutic relationship and interactional difficulties viewed by the therapist. CONCLUSIONS: Cognitive models on the formation and maintenance of delusions should consider ER as a potential candidate that might be related to the formation and maintenance of delusional distress, whereas problems in ToM might not be directly related to delusions and secondary dimensions of delusions. In addition, problems in ER in patients with psychosis might have an impact on the quality of the therapeutic relationship and patients with problems in ER are more likely to be viewed as problematic by their therapists. Nevertheless, training ER might be a way to improve the quality of the therapeutic relationship and potentially the effectiveness of CBT or other interventions for patients with psychosis.

Negative schemata about the self and others and paranoid ideation in at-risk states and those with persisting positive symptoms.

BACKGROUND: The objective of this study is to test the conflicting theories concerning the association of negative self and other schemata and paranoid ideation. METHODS: A risk-based approach, including risk stratification, is used to gain insight into the association of the negative self and other schemata that may be shared by individuals or differentiate between individuals at clinical high risk (CHR) for a first-episode psychosis and those with full-blown psychosis. The dataset includes a sample of individuals at CHR (n = 137) and a sample of individuals with persisting positive symptoms (PPS, n = 211). The CHR sample was subdivided according to a prognostic index yielding 4 CHR sub-classes with increasing risk for transition to psychosis. RESULTS: Negative beliefs about the self were associated with paranoid ideation in CHR and a lower risk state. In the highest risk state and full-blown psychosis, there is an association with negative beliefs about others. CONCLUSION: These findings are in line with theories suggesting a switch from a predominantly activated negative self-schema to a malevolent others-schema in association with paranoid ideation along the risk-continuum. However, due to methodological limitations these results should be replicated by future studies.

The therapeutic alliance in different mental disorders: A comparison of patients with depression, somatoform, and eating disorders.

OBJECTIVE: The therapeutic alliance is intensively investigated in psychotherapy research. However, there is scarce research on the role of the specific diagnosis of the patient in the formation of the therapeutic alliance. Hence, the aim of this study was to address this research gap by comparing the alliance in different mental disorders. DESIGN: Our sample comprised 348 patients (mean age = 40 years; 68% female; 133 patients with depression, 122 patients with somatoform disorders, and 93 patients with eating disorders). METHODS: Patients completed the Working Alliance Inventory and measures of therapeutic outcome in early, middle, and late stages of inpatient psychotherapy. We applied multivariate multilevel models to address the nested data structure. RESULTS: All three disorder groups experienced positive alliances that increased across the course of therapy and showed similar alliance-outcome relations that were of comparable strengths as in current meta-analyses. However, we found perspective incongruence of alliance ratings from patient and therapist in the three disorder groups. CONCLUSIONS: Our results generally indicate that the working alliance is of importance irrespective of the specific mental disorder. Perspective incongruence feedback of working alliance experiences could help to strengthen coordination between patient and therapist and thereby improve the therapeutic process. Further implications of these findings are discussed. PRACTITIONER POINTS: We found no differences in the strengths of alliance ratings and alliance-outcome associations in depressive, somatoform, and eating disorder patients. This indicates that the working alliance is of general clinical importance irrespective of the disorder group and should be a central target in all therapies. We found perspective incongruence in alliance ratings between patient and therapist in all three disorder groups. Perspective incongruence feedback of working alliance experiences could help to strengthen coordination between patient and therapist and thereby improve the therapeutic process.

Longitudinal relations between symptoms, neurocognition, and self-concept in schizophrenia.

OBJECTIVE: Cognitive models suggest that the self-concept of persons with psychosis can be fundamentally affected. Self-concepts were found to be related to different symptom domains when measured concurrently. Longitudinal investigations to disentangle the possible causal associations are rare. METHOD: We examined a sample of 160 people with a diagnosis of schizophrenia who took part in a psychotherapy study. All participants had the DSM-IV diagnosis of a schizophrenia and pronounced negative symptoms. Neurocognition, symptoms, and self-concepts were assessed at two time points 12 months apart. Structural equation modeling was used to test whether symptoms influence self-concepts (scar-model) or self-concepts affect symptoms (vulnerability model). RESULTS: Negative symptoms correlated concurrently with self-concepts. Neurocognitive deficits are associated with more negative self-concepts 12 months later. Interpersonal self-concepts were found to be relevant for paranoia. CONCLUSION: The findings implicate that if deficits in neurocognition are present, fostering a positive self-concept should be an issue in therapy. Negative interpersonal self-concept indicates an increased risk for paranoid delusions in the course of 1 year. New aspects for cognitive models in schizophrenia and clinical implications are discussed.

The Vicious Cycle of Family Atmosphere, Interpersonal Self-concepts, and Paranoia in Schizophrenia-A Longitudinal Study.

Recent cognitive models of paranoid delusions highlight the role of self-concepts in the development and maintenance of paranoia. Evidence is growing that especially interpersonal self-concepts are relevant in the genesis of paranoia. In addition, negative interpersonal life-experiences are supposed to influence the course of paranoia. As dysfunctional family atmosphere corresponds with multiple distressing dyadic experiences, it could be a risk factor for the development and maintenance of paranoia. A total of 160 patients with a diagnosis of schizophrenia were assessed twice within 12 months. Standardized questionnaires and symptom rating scales were used to measure interpersonal self-concepts, perceived family atmosphere, and paranoia. Data were analyzed using longitudinal cross-lagged structural equation models. Perceived negative family atmosphere was associated with the development of more pronounced negative interpersonal self-concepts 12 months later. Moreover, paranoia was related to negative family atmosphere after 12 months as well. As tests revealed that reversed associations were not able to explain the data, we found evidence for a vicious cycle between paranoia, family atmosphere, and interpersonal self-concepts as suggested by theoretical/cognitive model of paranoid delusions. Results suggest that broader interventions for patients and their caretakers that aim at improving family atmosphere might also be able to improve negative self-concepts and paranoia.

Why do bad things happen to me? Attributional style, depressed mood, and persecutory delusions in patients with schizophrenia.

Theoretical models postulate an important role of attributional style (AS) in the formation and maintenance of persecutory delusions and other positive symptoms of schizophrenia. However, current research has gathered conflicting findings. In a cross-sectional design, patients with persistent positive symptoms of schizophrenia (n = 258) and healthy controls (n = 51) completed a revised version of the Internal, Personal and Situational Attributions Questionnaire (IPSAQ-R) and assessments of psychopathology. In comparison to controls, neither patients with schizophrenia in general nor patients with persecutory delusions (n = 142) in particular presented an externalizing and personalizing AS. Rather, both groups showed a "self-blaming" AS and attributed negative events more toward themselves. Persecutory delusions were independently predicted by a personalizing bias for negative events (beta = 0.197, P = .001) and by depression (beta = 0.152, P = .013), but only 5% of the variance in persecutory delusions could be explained. Cluster analysis of IPSAQ-R scores identified a "personalizing" (n = 70) and a "self-blaming" subgroup (n = 188), with the former showing slightly more pronounced persecutory delusions (P = .021). Results indicate that patients with schizophrenia and patients with persecutory delusions both mostly blamed themselves for negative events. Nevertheless, still a subgroup of patients could be identified who presented a more pronounced personalizing bias and more severe persecutory delusions. Thus, AS in patients with schizophrenia might be less stable but more determined by individual and situational characteristics that need further elucidation.

[Determinants of direct cost in schizophrenia patients with persistent positive symptoms]. / Determinanten direkter Kosten bei persistierender Positivsymptomatik psychotischer Erkrankungen.

OBJECTIVE: To analyze direct costs and cost determinants in psychotic patients with persistent positive symptoms (PPS). METHODS: A total of 330 patients with PPS were recruited via 6 university clinics and interviewed about service utilization in the previous 3 months. After monetary valuation, costs were analyzed via generalized linear mixed models with gamma distribution and log-link function to identify determinants of direct costs. RESULTS: The mean costs were 7,065 € and resulted predominantly from psychiatric hospital care (63 %), assisted living (17 %) and complementary services (8 %). We found statistically significant associations between direct costs and an increasing score of the negative subscale of the Positive and Negative Syndrome Scale (+ 2,484 € per point, p < 0.001) and experiencing less than one social contact per week (- 2,272 €, p = 0.003). CONCLUSION: PPS incurred substantial direct costs which primarily resulted from hospital treatment, and were strongly associated with symptom severity.

[Multiple-choice vocabulary intelligence test MWT in schizophrenia: valid measure of premorbid intelligence?]. / Mehrfachwahl-Wortschatz-Intelligenztest MWT bei Schizophrenie: Valides Maß der prämorbiden Intelligenz?

OBJECTIVE: The multiple-choice vocabulary intelligence test MWT (Mehrfachwahl-Wortschatz-Intelligenztest) as a measure of premorbid IQ is widely used in clinical practice and research in Germany. The study examined whether the MWT is actually insensitive to brain dysfunction and psychopathology in patients with schizophrenia. METHOD: 81 post-acute patients with schizophrenia and 27 matched healthy controls completed the MWT at two points in time. At baseline, we further applied a neuropsychological test battery and a psychopathology rating. RESULTS: The multiple linear regression analysis showed that the MWT-IQ of patients is significantly confounded by neuropsychological dysfunctions and psychopathology. The repeated measurement ANOVA pointed to a significant recovery effect of the MWT-IQ during clinical remission in the patient group. CONCLUSION: The results question the validity of the MWT as a measure of premorbid IQ in schizophrenia.

Associations between therapy skills and patient experiences of change processes in cognitive behavioral therapy for psychosis.

Despite the promising findings in relation to the efficacy of cognitive behavioral therapy for psychosis (CBTp), little attention has been paid to the therapy skills necessary to deliver CBTp and to the influence of such skills on processes underlying therapeutic change. Our study investigated the associations between general and technical therapy skills and patient experiences of change processes in CBTp. The study sample consisted of 79 patients with psychotic disorders who had undergone CBTp. We randomly selected one tape-recorded therapy session from each of the cases. General and technical therapy skills were assessed by the Cognitive Therapy Scale for Psychosis. The Bern Post Session Report for Patients was applied to measure patient experiences of general change processes in the sense of Grawe's psychological therapy. General skills, such as feedback and understanding, explained 23% of the variance of patients' self-esteem experience, but up to 10% of the variance of mastery, clarification, and contentment experiences. The technical skill of guided discovery consistently showed negative associations with patients' alliance, contentment, and control experiences. The study points to the importance of general therapy skills for patient experiences of change processes in CBTp. Some technical skills, however, could detrimentally affect the therapeutic relationship.

Change mechanisms in psychotherapy: multiperspective assessment and relation to outcome.

The study aimed at constructing a reliable and valid post-session questionnaire measuring general change mechanisms of psychotherapy with correspondent versions for patient and therapist perspectives. Therefore, 253 inpatients in early, middle, and late stages of psychotherapy completed the newly developed Scale for the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (SACiP) and diverse outcome measures. The psychometric qualities of the SACiP were excellent as shown by (a) exploratory factor analyses on patient and therapist ratings, (b) confirmatory factor analyses on later measuring times, and (c) high internal consistencies. Supporting construct validity, the SACiP predicted outcome, as shown by correlational analyses and mixed effects modeling. Patient evaluations of change mechanisms were better predictors of outcome than the corresponding therapist evaluations.

Patients with depression, somatoform disorders, and eating disorders on the stages of change: validation of a short version of the URICA.

The study aimed at constructing a time-efficient short version of the University of Rhode Island Change Assessment (URICA), and at exploring differences in the stages of change between patients with depression, somatoform disorders, and eating disorders across the course of therapy. The URICA and diverse outcome measures were administered to 253 patients in early-, middle-, and late stages of inpatient therapy. The factor structure of the short form of the URICA (URICA-S) was excellent as shown by (1) an exploratory factor analysis on a randomized one-half of the sample, (2) a confirmatory factor analysis on the other half of the sample, and (3) a stable factor structure over a 6-week interval. The resulting factors of the URICA-S were called precontemplation, contemplation, action, and maintenance. The internal consistencies of the URICA-S factors were sufficient to excellent. Supporting the criterion-related validity, the URICA-S predicted relevant outcome measures. Analyses of variance showed that the ratings on the action and the maintenance factors were differentially associated with outcome in patients with depression, somatoform disorders, and eating disorders. These findings implicate that a disorder-specific combination of action and relapse-prevention-oriented interventions might optimize outcome in inpatients with different psychiatric disorders.

Is impaired set-shifting a feature of "pure" anorexia nervosa? Investigating the role of depression in set-shifting ability in anorexia nervosa and unipolar depression.

Impaired set-shifting has been reported in patients with anorexia nervosa (AN) and in patients with affective disorders, including major depression. Due to the prevalent comorbidity of major depression in AN, this study aimed to examine the role of depression in set-shifting ability. Fifteen patients with AN without a current comorbid depression, 20 patients with unipolar depression (UD) and 35 healthy control participants were assessed using the Trail Making Test (TMT), the Wisconsin Card Sorting Test (WCST) and a Parametric Go/No-Go Test (PGNG). Set-shifting ability was intact in patients with AN without a comorbid depression. However, patients with UD performed significantly poorer in all three tasks compared to AN patients and in the TMT compared to healthy control participants. In both patient groups, set-shifting ability was moderately negatively correlated with severity of depressive symptoms, but was unrelated to BMI and severity of eating disorder symptoms in AN patients. Our results suggest a pivotal role of comorbidity for neuropsychological functioning in AN. Impairments of set-shifting ability in AN patients may have been overrated and may partly be due to comorbid depressive disorders in investigated patients.

Adverse effects of cognitive behavioral therapy and cognitive remediation in schizophrenia: results of the treatment of negative symptoms study.

This study examined the frequency and extent of detrimental effects of cognitive behavioral therapy (CBT) for psychosis. In a randomized clinical trial, we investigated the efficacy of CBT for the reduction of negative symptoms as compared with cognitive remediation (CR) in schizophrenia patients (n = 198). Safety was addressed through assessment of severe adverse events (SAEs), which were defined as suicides, suicide attempts, suicidal crises, and severe symptom exacerbations over a period of 12 months after inclusion in the study. Monthly assessments with Positive and Negative Syndrome Scale and Scale for the Assessment of Negative Symptoms allowed for the analysis of symptom increases during the treatment. There were no suicides in the trial. SAEs were observed in 10 CBT and 5 CR patients. Increases in negative symptoms occurred in 64 CBT and 58 CR patients. These differences were not significant. The maximum increase in negative symptoms under treatment, as compared with the baseline, was equal to an effect size of -0.66 in CBT patients and -0.77 in CR patients. Thus, the SAE rate was comparable between both interventions and was relatively low, given the severity of the psychotic disorder. Therapists should be aware of a subgroup of patients who show symptom increases with large effect sizes and might require more intensive care.

Specificity of jumping to conclusions and attributional biases: a comparison between patients with schizophrenia, depression, and anorexia nervosa.

INTRODUCTION: The knowledge of the specificity of cognitive biases in psychiatric disorders is important in order to develop disorder-specific cognitive models and therapies. This cross-sectional study aimed to investigate the specificity of jumping to conclusions (JTC) and attributional biases (AB) for patients with schizophrenia. METHODS: Twenty patients with paranoid schizophrenia were compared with patients with depression (n=20) and with anorexia nervosa (n=15) and nonclinical controls (n=55). All participants were administered a modified version of the beads task (JTC), a revised German version of the Internal, Personal, and Situational Attributions Questionnaire (AB), and several symptom and neurocognitive measures. RESULTS: The proportion of patients with JTC bias in the schizophrenia group was, at the descriptive level, higher than in the depression and the anorexia groups. Regarding AB, the schizophrenia group showed a significantly stronger externalising but not personalising bias than the clinical control groups. Neither JTC nor attributional biases were significantly associated with delusions in general or persecutory delusion. CONCLUSIONS: We found evidence for the specificity of an externalising bias for paranoid schizophrenia. Concerning JTC bias the evidence was less clear. Whether the modification of those biases through psychological interventions would have an effect on psychopathology should be investigated in the context of clinical trials.

Negative symptoms of schizophrenia as primary target of cognitive behavioral therapy: results of the randomized clinical TONES study.

Clinical studies on cognitive behavioral therapy (CBT) that include schizophrenia patients primarily on the basis of negative symptoms are uncommon. However, those studies are necessary to assess the efficacy of CBT on negative symptoms. This article first gives an overview of CBT on negative symptoms and discusses the methodological problems of selecting an adequate control group. Furthermore, the article describes a clinical study (the TONES-Study, ISRCTN 25455020), which aims to investigate whether CBT is specifically efficacious for the reduction of negative symptoms. This multicenter randomized clinical trial comparing CBT with cognitive remediation (CR) for control of nonspecific effects is depicted in detail. In our trial, schizophrenia patients (n = 198) participated in manualized individual outpatient treatments. Primary outcome is the negative syndrome assessed with the positive and negative syndrome scale, analyzed with multilevel linear mixed models. Patients in both groups moderately improved regarding the primary endpoint. However, against expectation, there was no difference between the groups after treatment in the intention to treat as well as in the per-protocol analysis. In conclusion, psychotherapeutic intervention may be useful for the reduction of negative symptoms. However, there is no indication for specific effects of CBT compared with CR.

Cognitive behavioural therapy versus supportive therapy for persistent positive symptoms in psychotic disorders: the POSITIVE Study, a multicenter, prospective, single-blind, randomised controlled clinical trial.

BACKGROUND: It has been demonstrated that cognitive behavioural therapy (CBT) has a moderate effect on symptom reduction and on general well being of patients suffering from psychosis. However, questions regarding the specific efficacy of CBT, the treatment safety, the cost-effectiveness, and the moderators and mediators of treatment effects are still a major issue. The major objective of this trial is to investigate whether CBT is specifically efficacious in reducing positive symptoms when compared with non-specific supportive therapy (ST) which does not implement CBT-techniques but provides comparable therapeutic attention. METHODS/DESIGN: The POSITIVE study is a multicenter, prospective, single-blind, parallel group, randomised clinical trial, comparing CBT and ST with respect to the efficacy in reducing positive symptoms in psychotic disorders. CBT as well as ST consist of 20 sessions altogether, 165 participants receiving CBT and 165 participants receiving ST. Major methodological aspects of the study are systematic recruitment, explicit inclusion criteria, reliability checks of assessments with control for rater shift, analysis by intention to treat, data management using remote data entry, measures of quality assurance (e.g. on-site monitoring with source data verification, regular query process), advanced statistical analysis, manualized treatment, checks of adherence and competence of therapists. Research relating the psychotherapy process with outcome, neurobiological research addressing basic questions of delusion formation using fMRI and neuropsychological assessment and treatment research investigating adaptations of CBT for adolescents is combined in this network. Problems of transfer into routine clinical care will be identified and addressed by a project focusing on cost efficiency. DISCUSSION: This clinical trial is part of efforts to intensify psychotherapy research in the field of psychosis in Germany, to contribute to the international discussion on psychotherapy in psychotic disorders, and to help implement psychotherapy in routine care. Furthermore, the study will allow drawing conclusions about the mediators of treatment effects of CBT of psychotic disorders.

Does the cognitive dispute of psychotic symptoms do harm to the therapeutic alliance?

We examined whether the cognitive dispute of psychotic symptoms has a negative impact on the course of the therapeutic alliance. Sixty-seven patients with persistent psychotic symptoms received either cognitive behavioral therapy (CBT) or supportive therapy. Questionnaire-based alliance ratings were repeatedly obtained throughout the course of therapy. Patient and therapist alliance ratings were examined separately. Data analyses comprised repeated measurement analyses of variance and cluster analytic procedures. Neither patient nor therapist alliance ratings showed a differential course throughout the treatments. This was despite the implementation of disputing strategies in later stages of CBT. Irrespective of the treatment condition a cluster with a positive alliance rating and a cluster with a poorer rating were found for therapist and patient ratings, respectively. Baseline symptoms and insight differentiated between the types of clusters. In conclusion, CBT-specific interventions that challenge psychotic symptoms do not necessarily negatively influence the course of the alliance.

Quality and correlates of specific self-esteem at the beginning stabilisation phase of schizophrenia.

In view of the potential importance of self-esteem in schizophrenia, there is a considerable lack of knowledge about the characteristics of specific self-esteem. The literature suggests that the experience of the self might be particularly destabilised in the transition phase between acute and remission points of the illness. Thus, the present study aims at examining the quality and correlates of different self-concepts at the beginning stabilisation phase of schizophrenia. In this study, 135 patients with schizophrenia were assessed 3 weeks after admission to inpatient treatment. Four central self-concepts were measured by the Frankfurt Self-Concept Scales (FSKN; Deusinger, I.M., 1986, Die Frankfurter Selbstkonzeptskalen (FSKN), Göttingen, Hogrefe). Clinical psychopathologic, neuropsychological and sociodemographic factors were analysed in two-step exploratory correlation and regression analyses to determine their relative contribution to self-concepts. The median of the four self-concepts ranged between -0.9 and -1.4 standard deviations below normative level. The relationship between negative symptoms and self-concepts was consistently significant, even when the contribution of depression was partialed out. In the multivariate analyses, these two symptom clusters explained up to 39% of the variances in our patients' self-evaluation. Neuropsychological dysfunctions were of relatively subordinate relevance for the patients' self-concepts. Thus, our results suggest that specific self-esteem at the point of beginning stabilisation of schizophrenia is significantly confounded not only by depression but also by negative symptoms.

Cognitive behavioural treatment of negative symptoms in schizophrenia patients: study design of the TONES study, feasibility and safety of treatment.

Currently, there are no convincing treatment strategies for negative symptoms of schizophrenia. On this background, we are conducting the treatment of negative symptoms (TONES) study which addresses the question whether cognitive behavioural therapy (CBT) is efficacious for the reduction of negative symptoms in schizophrenia. The present paper aims at presenting the design of the clinical trial of the study as well as the treatment concept. Further, we investigate the feasibility and the safety of our study treatment. The TONES study is a multicentric, prospective, single-blind, randomised, and controlled trial (RCT). The clinical trial compares CBT (test condition) and cognitive remediation (CR; control condition) with respect to the efficacy in reducing negative symptoms. In order to systematically assess aspects of adherence and feasibility therapists filled in session reports after each session. The safety analysis is performed using the sequential method of Whitehead (The design and analysis of sequential clinical trials, Ellis Horwood, Chichester, 1983). We were able to conduct a systematic recruitment and to include a sample of N = 198 patients which is characterised by negative symptoms of medium severity. The majority of patients accepted the format of a 50-min treatment session. The manualised treatment content seemed to be adequate and the cooperation between patients and therapists was excellent or adequate in approximately 80% of the treatment sessions. Of the 15 severe adverse events 10 occurred in the CBT and 5 in the CR. This difference between the groups was not significant. The study presented here is presumably the first high quality RCT which evaluates CBT with negative symptoms as primary endpoint. On the background of the data presented we conclude that CBT for the reduction of negative symptoms is feasible and can be conducted safely.