Reduced P300 amplitude in children and adolescents with autism is associated with slowed processing speed, executive difficulties, and social-communication problems.

LAY ABSTRACT: Selective attention to auditory input is reflected in the brain by an electric amplitude called the P3b amplitude, which is measured using electroencephalography. Previous research has shown that children and adolescents with autism have an attenuated P3b amplitude when they have to attend specific sounds while ignoring other sounds. However, it is unknown whether a reduced P3b amplitude in autistic children and adolescents is associated with their autism features, daily functioning and/or cognitive functions. This study aimed to examine these questions. Therefore, we assessed selective attention to auditory input in 57 children with autism aged 7-14 years and 57 neurotypically developing controls while measuring their brain activity with electroencephalography. Participants further underwent cognitive assessment, and parents reported on autistic traits and daily functioning. As expected, children with autism had lower P3b amplitude compared to their neurotypical peers. Importantly, an attenuated P3b amplitude was associated with more parent-reported social-communication problems and difficulties with daily functioning. Children with autism further had reduced processing speed of visual input, which also was coupled to a lower P3b amplitude. In conclusion, we found attenuated P3b amplitude in children with autism performing an auditory selective attention task, which was related to difficulties with processing visual input and allocating attentional resources critical for social and daily functioning. The results suggest that autistic children are more vulnerable to being disturbed when the environment is filled with conflicting sensory input.

Validation of the Danish Version of the Overall Depression Severity and Impairment Scale (ODSIS): A Reliable Instrument for Assessing Depression Symptoms and Functional Impairment.

INTRODUCTION: In psychotherapy, having a reliable tracking tool is vital for effective treatment. We have validated the Danish version of the 'Overall Depression Severity and Impairment Scale' (ODSIS), which is used in the Unified Protocol for Emotional Disorders (UP) and other cognitive behavioural therapies. This five-item self-rating scale is expected to correspond closely to the gold-standard Beck Depression Inventory-II (BDI-II), but also to self-rating scales addressing daily functioning and well-being. METHODS: Internal consistency is assessed using Cronbach's alpha and McDonald's omega. Criterion validity is explored through Pearson's correlation coefficient with BDI-II, the Work and Social Adjustment Scale (WSAS), the Five-Item World Health Organization Well-Being Index (WHO-5) and scatter plots, and an optimal cut-off score is determined using a receiver operating characteristic curve. The study included 340 respondents: 234 from a recent clinical trial, 56 psychiatric patients from inpatient/outpatient units and 50 healthy volunteers. RESULTS: ODSIS demonstrates strong internal consistency (Cronbach's alpha: 0.887-0.956, McDonald's omega: 0.888-0.957). Correlations with BDI-II, WSAS and WHO-5 highlight its strong criterion validity (BDI-II: 0.847, WSAS: 0.751, WHO-5: 0.771). The optimal cut-off score (> 7.5) for detecting depression shows great sensitivity (0.862) and specificity (0.731). CONCLUSION: The Danish version of ODSIS proves to be a reliable instrument for quantification of a combination of depression level and functional impairment from the symptoms. Its high correlation with established BDI-II makes it a brief and handy tool for repeated measurement in clinical and research settings.

Collaborative assessment as an intervention in the treatment of mental Illness: a systematic review.

BACKGROUND: Three meta-analyses suggested that the psychological assessment as a therapeutic intervention approach might have therapeutic effects but had unspecific inclusion criteria. METHODS: We searched four databases for RCTs that reported on the use of psychological assessment as an intervention. Two reviewers independently selected papers, extracted data, and assessed study quality.We conducted and reported the systematic review following the PRISMA statement. We assessed the Risk of bias in included studies using the Risk of Bias tool and graded the strength of the evidence with GRADE. RESULTS: We included two RCTs: The first study investigated Therapeutic Assessment (TA) combined with Manual-Assisted Cognitive Behavior Therapy (MACT) compared with MACT only in 16 outpatients with personality disorders. The trial found among completers (n = 7) no difference in borderline symptomatology but a possible difference regarding suicidality favoring MACT + TA. The trial did not provide any outcomes relating to readiness for treatment. The other trial investigated TA compared with a Goal-focused Pretreatment Intervention in a sample of 74 outpatients with personality disorders. The results found no intervention effects on symptomatology but suggested that TA might improve patient expectancy for future treatment among completers of the intervention. Both trials were judged at a high risk of bias and with very low certainty of evidence. DISCUSSION: We found no support for the clinical effect of psychological assessment as a therapeutic intervention due to the high risk of bias and low certainty of the evidence.

Emotion Regulation and Mentalization in Patients With Depression and Anxiety.

OBJECTIVE: Theoretical conceptualizations of emotion and affect regulation have a considerable common ground. However, mentalization theory considers the ability to regulate affects as being contingent on the ability to mentalize. The aim of the present study is to examine the association between emotion regulation and mentalization, operationalized as reflective functioning, in a sample of patients with depression and/or anxiety. METHODS: The study used data from the TRAns-diagnostic Cognitive behavioural Therapy versus standard cognitive behavioural therapy (TRACT-RCT) trial. Patients with depression and/or anxiety (N = 291; 64.4% female; Mage = 32.2; SD = 11.0) completed the Emotion Regulation Strategies Questionnaire (ERSQ) and the Reflective Functioning Questionnaire (RFQ-6). Correlation and regression analyses were performed to determine associations of the measures of ERSQ and RFQ-6 in relation to the outcome variables, global well-being (World Health Organization Well-being Index; WHO-5) and social functioning (Work and Social Adjustment Scale; WSAS). RESULTS: Overall, the patients had a reduced level of emotion regulation (MERSQ_Total = 1.77; SD = 0.59). However, only mildly impaired reflective functioning was found (MRFQ-6 = 3.57; SD = 1.26). ERSQ correlated significantly with RFQ-6 (r = -0.31), that is, more frequent use of emotion regulation strategies was associated with less hypomentalization. ERSQ was a stronger predictor of well-being and social function than RFQ-6. CONCLUSION: In patients with anxiety and/or depression, hypomentalization as measured by the RFQ-6 is not a major problem, but emotion regulation is. It seems that these two, theoretically related constructs, do not necessarily co-occur. Alternatively, the RFQ-6 scale might not capture the mentalization construct in a valid way. Emotion regulation strategies are highly related to symptomatology; therefore, they are likely to be an important target for psychotherapy.

Home-based Intervention with Semaglutide Treatment of Neuroleptic-Related Prediabetes (HISTORI): protocol describing a prospective, randomised, placebo controlled and double-blinded multicentre trial.

INTRODUCTION: Subjects with schizophrenia have a 2-3 fold higher mortality rate than the general population and a reduced life expectancy of 10-20 years. Approximately one-third of this excess mortality has been attributed to obesity-related type 2 diabetes (T2D) and to cardiovascular disease. Glucagon-like peptide-1 (GLP-1) analogues increase satiety and delay gastric emptying, thereby reducing food intake and weight. GLP-1 analogues also exert beneficial effects on cardiovascular outcomes in high-risk patients with T2D.Our aim is to investigate whether 30 weeks add-on treatment with the GLP-1 analogue semaglutide can reduce HbA1c sufficiently to reverse pre-diabetes and the metabolic syndrome in overweight schizophrenic patients. METHODS AND ANALYSIS: We will perform a 30 week, two-armed, multicentre, superiority, double-blinded, randomised trial investigating the effect of weekly injections of semaglutide versus placebo in mental health facilities in Region of Southern Denmark and Region of Zealand, Denmark. In total, 154 adults with schizophrenia spectrum disease, aged 18-60 years treated with second generation antipsychotic treatment, HbA1c 39-47 mmol/mol and body mass index >27 kg/m2 will be randomised to injections of 1.0 mg semaglutide or placebo. The primary outcome is changes in HbA1c. Secondary outcomes encompass metabolic measures, psychotic symptoms and quality of life. Exploratory outcomes encompass insulin sensitivity, cardiovascular risk profile, medication adherence, general well-being and physical activity. ETHICS AND DISSEMINATION: This study will be carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. This research has obtained approval from both the Danish Medicines Agency and The Regional Committees on Health Research Ethics for Southern Denmark. TRIAL REGISTRATION NUMBER: NCT05193578 European Clinical Trials Database Number (EudraCT) 2020-004374-22, Regional Ethical Committee number S-20200182.

Transdiagnostic psychopathology in the light of robust single-trial event-related potentials.

Recent evidence indicates that event-related potentials (ERPs) as measured on the electroencephalogram (EEG) are more closely related to transdiagnostic, dimensional measures of psychopathology (TDP) than to diagnostic categories. A comprehensive examination of correlations between well-studied ERPs and measures of TDP is called for. In this study, we recruited 50 patients with emotional disorders undergoing 14 weeks of transdiagnostic group psychotherapy as well as 37 healthy comparison subjects (HC) matched in age and sex. HCs were assessed once and patients three times throughout treatment (N = 172 data sets) with a battery of well-studied ERPs and psychopathology measures consistent with the TDP framework The Hierarchical Taxonomy of Psychopathology (HiTOP). ERPs were quantified using robust single-trial analysis (RSTA) methods and TDP correlations with linear regression models as implemented in the EEGLAB toolbox LIMO EEG. We found correlations at several levels of the HiTOP hierarchy. Among these, a reduced P3b was associated with the general p-factor. A reduced error-related negativity correlated strongly with worse symptomatology across the Internalizing spectrum. Increases in the correct-related negativity correlated with symptoms loading unto the Distress subfactor in the HiTOP. The Flanker N2 was related to specific symptoms of Intrusive Cognitions and Traumatic Re-experiencing and the mismatch negativity to maladaptive personality traits at the lowest levels of the HiTOP hierarchy. Our study highlights the advantages of RSTA methods and of using validated TDP constructs within a consistent framework. Future studies could utilize machine learning methods to predict TDP from a set of ERP features at the subject level.

Assessment of the acute subjective psychedelic experience: A review of patient-reported outcome measures in clinical research on classical psychedelics.

BACKGROUND: The classical psychedelics psilocybin, peyote, ayahuasca/ N, N-dimethyltryptamine, and lysergic acid diethylamide can temporarily produce altered states of consciousness, characterized by changes in sensory perception, thought, mood, and the sense of self-reality and meaning. It is important to have reliable instruments for quantifying these altered states in trials, due to a plausible link between the acute subjective experience and treatment outcome. METHODS: We conducted a review of outcome measures applied in research on classical psychedelics to assess one or more dimensions of the acute subjective psychedelic experience. Three relevant databases were searched electronically. Two reviewers independently conducted article selection and data extraction regarding the instruments, dimensions, geography, population, and psychedelic substance investigated in the included studies. We identified the five most utilized instruments for the most recent 6 years, as well as the five most utilized instruments for each psychedelic. RESULTS: We included 93 papers, which reported on 93 unique trials and utilized 17 different rating scales. Of these, the most utilized were the Five-Dimensional Altered States of Consciousness Questionnaire, visual analog or Likert scales specially developed for the trials, the Hallucinogen Rating Scale, the States of Consciousness Questionnaire, and the Abnormer Psychischer Zustand. DISCUSSION: Considerable variability was found in the instruments utilized in clinical trials on classical psychedelics. We advise and encourage the development of a core outcome set for psychedelic research to enable altered state comparisons across compounds, participants, and settings. We further advise that instruments be designed to assess the "setting" of a psychedelic experience.

Robust single-trial event-related potentials differentiate between distress and fear disorders.

Recent evidence indicates that measures of brain functioning as indexed by event-related potentials (ERPs) on the electroencephalogram align more closely to transdiagnostic measures of psychopathology than to categorical taxonomies. The Hierarchical Taxonomy of Psychopathology (HiTOP) is a transdiagnostic, dimensional framework aiming to solve issues of comorbidity, symptom heterogeneity, and arbitrary diagnostic boundaries. Based on shared features, the emotional disorders are allocated into subfactors Distress and Fear. Evidence indicates that disorders that are close in the HiTOP hierarchy share etiology, symptom profiles, and treatment outcomes. However, further studies testing the biological underpinnings of the HiTOP are called for. In this study, we assessed differences between Distress and Fear in a range of well-studied ERP components. In total, 50 patients with emotional disorders were divided into two groups (Distress, N = 25; Fear, N = 25) according to HiTOP criteria and compared against 37 healthy comparison (HC) subjects. Addressing issues in traditional ERP preprocessing and analysis methods, we applied robust single-trial analysis as implemented in the EEGLAB toolbox LIMO EEG. Several ERP components were found to differ between the groups. Surprisingly, we found no difference between Fear and HC for any of the ERPs. This suggests that some well-established results from the literature, e.g., increased error-related negativity in OCD, are not a shared neurobiological correlate of the Fear subfactor. Conversely, for Distress, we found reductions compared to Fear and HC in several ERP components across paradigms. Future studies could utilize HiTOP-validated psychopathology measures to more precisely define subfactor groups.

Utility of the Work and Social Adjustment Scale (WSAS) in predicting long-term sick-leave in Danish patients with emotional disorders.

BACKGROUND: The Work and Social Adjustment Scale (WSAS) is a self-administered measure designed to assess the level of inability to function socially as a consequence of a defined problem or disorder. METHODS: A total of 230 patients with emotional disorders completed the Danish translation of the WSAS, measures of anxiety and depression, the Level of Personality Functioning Brief Form, the Personality Inventory for DSM-5 Short Form, and the World Health Organization Five-Item Well-Being Index (WHO-5). We conducted a confirmatory factor analysis of the previously suggested factor structure of the instrument. We furthermore evaluated the construct validity of the WSAS by means of its relationship with depression, anxiety, personality functioning, and overall well-being. Finally, we evaluated the utility of the WSAS to identify those on long-term sick-leave by conducting receiver operating characteristic (ROC) curves. RESULTS: The instrument had a poor to average fit with the previously reported single-factor structure, but a better fit to a modified single-factor structure. Cronbach's alpha and McDonald's omega showed good internal scale reliability (α = .79, ωtotal = .85). WSAS was positively correlated with measures of anxiety (r = .33), depression (r = .44), and personality functioning (r = .23 and r = .20), and negatively correlated with WHO-5 wellbeing (r = -.57). The optimal cut-off point in the ROC-analyses was 23, which yielded a sensitivity of 74% and a specificity of 55% in the prediction of sick-leave status. DISCUSSION: The Danish WSAS shows promising psychometric properties, but has limited external validity insofar as predicting long-term sick leave in psychiatric patients with emotional disorders.

Affectivity in danish patients with emotional disorders: assessing the validity of the Positive and Negative Affect Schedule (PANAS).

BACKGROUND: The Positive and Negative Affect Schedule (PANAS) was designed to measure trait positive affect (PA) and trait negative affect (NA). METHODS: The Danish PANAS was administered to outpatients with depression and anxiety disorders. Internal consistency was assessed using Cronbach's alpha and McDonald's omega and factorial structure was evaluated using confirmatory factor analysis (CFA). Convergent validity was evaluated by means of correlations with the negative affectivity and the detachment domain of the Personality Inventory for DSM-5 Short Form (PID-5-SF), the Hamilton Anxiety Rating Scale 6 (HARS-6) and the Hamilton Depression Rating Scale 6 (HDRS-6). RESULTS: PANAS Scores of 256 patients were analyzed. Cronbach's alpha and McDonald's omega showed good internal consistency for both the PA score (alpha = .84 and omega = .89) and the NA score (alpha = .86 and omega = .90). CFA analysis confirmed a structure with two factors corresponding to the PA and NA factors. PA was negatively correlated with the detachment domain of PID-5 (r = -.47), HARS-6 (r = -.15) and HDRS-6 (r = -.37). NA was positively correlated with PID-5-SF negative affectivity domain (r = .43), HARS-6 (r = .51) and HDRS-6 (r = .52). DISCUSSION: The Danish PANAS has promising internal consistency and construct validity, which are comparable to other studies of the instrument.

Patients' and Therapists' Experiences of Standardized Group Cognitive Behavioral Therapy: Needs for a Personalized Approach.

Personalizing psychotherapy can be challenging within standardized group Cognitive Behavioral Therapy (CBT), in which sessions are structured according to a protocol and must accommodate the needs and preferences of multiple patients. In the current study, we aimed to examine patients' and therapists' experiences of standardized group CBT and identify their perceptions of different patient needs. Furthermore, we explored how these needs can inform possible content of add-on interventions for patients who are not improving as expected during group CBT.We conducted 21 individual in-depth interviews with patients with depression and their therapists about their experiences during group CBT with Routine Outcome Monitoring (ROM) and feedback. Interviews were analyzed by using a hermeneutic-phenomenological thematic analysis. Five themes, representing different patient needs, were identified: (1) Individual attention, (2) Psychological exploration, (3) A focus on the patient's life outside of therapy, (4) Extended assessment, and (5) Agreement on therapeutic tasks.The study supports that "one size does not fit all" when it comes to psychotherapy. Patients have varying needs when they are not making progress in therapy, and these needs, when unmet, can negatively impact the overall experience of group CBT. By acknowledging the unique needs of each patient and providing additional individual sessions as necessary, we can move towards a more personalized approach that maximizes the benefits of group psychotherapy.

Psychotherapy for patients with schizotypal personality disorder: A scoping review.

BACKGROUND: Treatment of schizotypal personality disorder is complex. Currently, there are no clear evidence-based recommendations for use of psychotherapy for individuals suffering from this mental illness, and studies are sparse. Our aim in this review is to map and describe the existing research and to answer the research question: What do we know about the use of psychotherapy for people with schizotypal personality disorder? METHODS: We conducted a scoping review using systematic searches in the Embase, MEDLINE and PsycINFO databases. Two reviewers screened possible studies and extracted data on subject samples, type of psychotherapy, outcomes and suggested mechanisms of change. The review is based on the PRISMA checklist for scoping reviews. RESULTS: Twenty-three papers were included, and we found a wide variety of study types, psychotherapeutic orientations and outcomes. Few studies emerged that focused solely on schizotypal personality disorder. CONCLUSION: Psychotherapy as a treatment for schizotypal personality disorder is understudied compared with diagnoses such as schizophrenia and borderline personality disorder. Our results included two randomized controlled studies, as well as mainly smaller studies with different approaches to diagnostic criteria, psychotherapeutic orientation and outcome measures. The findings are too sparse and too diverse to make any evidence-based recommendations. We found some indications that psychotherapy may support and assist individuals with schizotypal personality disorder.

Risk of bias in randomized clinical trials on psychedelic medicine: A systematic review.

BACKGROUND: The classical psychedelics, psilocybin, peyote, ayahuasca/N,N-dimethyltryptamine, and lysergic acid diethylamide are considered promising new treatments for psychiatric illnesses, such as depression, anxiety, addiction, and obsessive-compulsive disorders. However, their profound and characteristic subjective effects raise concern for distinctive biases in randomized clinical trials. METHODS: We performed a systematic literature search to identify all clinical trials on classical psychedelics with patient populations to examine descriptive data and determine the risk of bias. Two independent reviewers searched three databases (PubMed, Embase, and APA PsycNet) and extracted information on study design, study population, use of active or inactive placebo, dropouts, evaluation of blinding of intervention, and reporting of expectancy and therapeutic alliance. RESULTS: We included 10 papers reporting on 10 unique trials. The trials generally included populations that were predominantly white and highly educated. The trials had small samples and considerable dropout. Blinding was either unsuccessful or not reported regardless of type of placebo. Few trials published protocols, statistical analysis plans (SAPs), and outcomes relating to psychotherapy fidelity. All trials but one were rated as high risk of bias. CONCLUSION: Successful blinding of intervention is a significant challenge in this field. To better accommodate this, we suggest that future trials use a parallel-group design and utilize an active placebo on a psychedelic-naïve population. Future trials should publish trial protocol and SAPs, use clinician-rated outcomes accessed by a blinded rater, evaluate blinding of intervention, and consider measuring expectancy and therapeutic fidelity.

Social phobia and evasiveness: trial protocol for a randomized controlled feasibility and superiority trial of the effect of Modified Collaborative Assessment vs. standard assessment on patients' readiness for psychotherapy (CO-ASSM-RCT).

BACKGROUND: Evasive personality disorder (AvPD) and social phobia (SP) have substantial costs for patients and their families and great economic costs to the society. While psychotherapy can be an efficacious treatment, many patients drop out during treatment. Increased knowledge on how to decrease dropout from psychotherapy is warranted, including how to increase a patient's readiness for psychotherapy. METHODS: We describe a randomized controlled feasibility and superiority trial of 42 individuals with a clinical diagnosis of either SP or AvPD, who are to initiate psychotherapeutic treatment in Danish outpatient mental health services. They will be randomized in a 1:1 ratio to either assessment-as-usual and receive no further assessment or to a Modified Collaborative Assessment (MCA) provided as a pre-treatment intervention before psychotherapy initiation. MCA will include a battery of psychological tests designed to thoroughly assess the patients' psychopathology. The tests are administered in collaboration with the patient, including detailed oral and written feedback. We hypothesize that the intervention is feasible regarding patient's acceptance and adherence. We further hypothesize that patients randomized to MCA will reach higher levels of readiness for psychotherapy as assessed with the University of Rhode Island Change Assessment Scale (URICA). DISCUSSION: This protocol assesses the feasibility, efficacy, acceptability, and safety of an intervention aimed at changing the readiness for participation in psychotherapy of patients with SP and AvPD. Results from this feasibility study could guide the development of future large-scale trials of MCA and procedures for MCA treatment fidelity assessment. TRIAL REGISTRATION: NCT2021001.

"The Depressed" and "People with Anxiety" therapists' discursive representations of patients with depression and anxiety in Danish Psychiatry.

Stigmatization within mental health care has previously been identified, and some diagnoses have been shown to be particularly exposed to negative attitudes and stigma. However, no previous studies have explored practitioners' discursive construction of patients with different diagnoses within a transdiagnostic group context. We performed discourse analysis on 12 interviews with Danish mental health practitioners, who had been conducting either transdiagnostic psychotherapy (The Unified Protocol) or standard group cognitive behavioral therapy (CBT) with patients treated for anxiety disorders or major depressive disorder. The purpose of this study was to identify how patients with anxiety and depression were represented by therapists. We identified a "training discourse," within which patients were evaluated through perceived motivation, responsibility, active participation, and progression. We argue that this training discourse can be related to a broader neoliberal order of discourse valuing efficiency and agency. The analysis indicated that patients with anxiety were sometimes "favorized" over patients with depression, and it is argued that the neoliberal order of discourse and pre-assumptions related to the diagnoses are contributing to this. The interviews indicate that multiple discourses were applied when describing patients, and ambivalence was often detectable. We discuss the findings of the analysis in relation to therapists' general critical attitudes toward the psychiatric system and in relation to broader societal tendencies.

Combining diabetes and mental health care: An ethnographic exploration of user involvement in combined care.

PURPOSE: To explore and describe the enactment of user involvement and combined care in a Danish clinic that aimed at providing integrated diabetes and mental health care. DESIGN: An ethnographic study. DATA SOURCES AND METHODS: Data consisted of field notes from 96 hours of participant observations and field notes from 32 informal conversations with healthcare providers, users and relatives as well as 12 semistructured interviews with users. Data were analysed using a thematic analysis. This study reports to the SRQR guidelines. RESULTS: Treatment was not combined as intended if only one healthcare provider handled the consultations. Here, the healthcare providers' focus was often on their own area of expertise-either mental health or diabetes. If more than one healthcare provider handled consultations, the consultations were often divided between them, focussing on one condition at the time. Healthcare providers noted, that learning from peer colleagues was a way to increase the possibility for combined care. Furthermore, combined care was highly dependent on the healthcare providers' ability to involve users' illness experiences in their own care planning. Here, a high level of user involvement increased the levels of combined care during consultations. CONCLUSION: This study set out to explore and describe user involvement and combined care in a specialised diabetes and mental health outpatient clinic. Combined care is complexed and requires that healthcare providers are well-equipped to manage the complexity of delivering care for people with both conditions. The degree of combined care was linked with the healthcare providers' ability to involve users and their knowledge on the condition outside there are of expertise. RELEVANCE TO CLINICAL PRACTICE: A peer-learning environment in combination with clinical guidelines and joint display could support healthcare providers in involving users in own care and when delivering care outside their area of expertise. PUBLIC CONTRIBUTION: No patient or public contribution. Due to the COVID-19 pandemic, the original user council withdraw their consent to participate due to health-related worries and anxiety concerning the pandemic. The user council consisted of three members diagnosed with diabetes and severe mental illness. They were invited to participate in physical meetings, phone or online meetings. Presenting findings from the study to the study participants were also hindered by the second lockdown. This influenced the possibility for data triangulation.

Trait and symptom change in group cognitive behaviour therapy for anxiety and depression.

Personality traits underlying both anxiety disorders and depression are more malleable than previously presumed. This study examined associations between changes in personality traits (i.e. negative affectivity and detachment) and alleviation of anxiety and depression symptoms following cognitive behaviour therapy (CBT). We hypothesized that decreases in negative affectivity would predict alleviation of depression and anxiety symptoms and decreases in detachment would predict decreases in depression and, to a lesser degree, anxiety symptoms. Data (N = 156) were collected in a randomized controlled trial comparing transdiagnostic and diagnosis-specific group CBT for patients with major depressive disorder, social anxiety disorder, panic disorder or agoraphobia. We assessed personality traits using the Personality Inventory for DSM-5 (PID-5) and symptoms with the Hopkins Symptom Checklist 25-item scale (SCL). Prediction was based on regression analyses. We found that decreases in negative affectivity predicted lower levels of depression and anxiety symptoms while decreases in detachment only predicted lower levels of depression symptoms. The findings substantiate current efforts to explicate the dynamic interplay between personality traits and symptoms and support the existing focus on targeting negative affectivity and detachment in therapy for anxiety disorders and depression. The trial is registered at clinicaltrials.gov (ID NCT02954731).

Schizophrenia and type 2 diabetes: Perceptions and understandings of illness management in everyday life.

People with schizophrenia and type 2 diabetes face complex challenges in daily life and the management of both illnesses is burdensome. This qualitative interview study aimed to explore perceptions and understandings of the day-to-day management of schizophrenia and type 2 diabetes. Fourteen semi-structured interviews were conducted between January 2020 and October 2021 in the participants' respective mental health clinics, in their homes or by phone. Thematic analysis led to four themes representing participants' self-management strategies and perceived challenges. The first theme showed that participants use self-learned strategies for managing schizophrenia. In contrast, they perceived type 2 diabetes self-management as governed by a set of rules and guidelines given by health professionals. The second theme showed that both psychotic and negative symptoms present challenges to diabetes management. Theme 3 illustrated that participants consider their type 2 diabetes to be a very serious illness. They worried about potential long-term consequences and expressed wishes and motivation to improve their lifestyle. The final theme showed that participants discuss challenges related to their schizophrenia with family and friends but not type 2 diabetes. In conclusion, this study highlights the importance of considering individual challenges and everyday routines when supporting this population. It underlines the need for future research to further explore the complexity of managing the illnesses and to understand the needs for treatment and support.

Study protocol for a multicenter randomized controlled trial of personalized exercise therapy and self-management support for people with multimorbidity: The MOBILIZE study.

Background: Despite the great individual and societal burden associated with multimorbidity, little is known about how to effectively manage it. Objective: The aim of this multicenter randomized controlled trial (RCT) is to investigate the 12-month effects of a personalized exercise therapy and self-management support program in addition to usual care in people with multimorbidity. Design: This is a protocol for a pragmatic, parallel-group (1:1 ratio), superiority RCT conducted at five intervention sites (two hospitals, a private practice physiotherapy clinic and two municipal rehabilitation centers) in Region Zealand, Denmark. A total of 228 persons with multimorbidity aged 18 years or older, will be randomly allocated to one of two groups. Both groups will receive usual care, defined as routine care for multimorbidity at the discretion of the treating doctor, while the intervention group will also participate in a 12-week exercise therapy and self-management support program tailored to people with multimorbidity at one of the intervention sites. The primary outcome will be the between-group difference in change in EQ-5D-5L from baseline to the follow-up at 12 months. Secondary outcomes include objectively-measured physical function and physical activity, inflammatory markers, disease and treatment burden, anxiety, depression, stress, sleep, pain and other self-reported parameters. In parallel with the RCT, an observational cohort will follow persons aged ≥18 years with multimorbidity not adhering to all eligibility criteria, as well as people fulfilling all eligibility criteria, but unwilling to participate in the RCT. This study was approved by the Regional Committee on Health Research Ethics for Region Zealand (SJ-857) and results will be communicated in scientific papers, at relevant conferences and to a broader audience. Discussion: Exercise therapy and self-management support is safe and effective in people with single conditions. However, it is still unclear whether this holds true for individuals with multimorbidity. This pragmatic, multicenter RCT will provide high-quality evidence on the benefits and harms of exercise therapy and self-management support and, if the results support it, lead to the development of a plan for implementation in clinical practice.

Patient-reported outcome measures in depression.

AIM: Patient-reported outcome measures (PROMs) are increasingly important as a mean for quality assurance. Feasible estimates of recovery can be achieved through the application of Jacobson plots, which is a simple demonstration of the outcome of each case, recommended for clinical use. We applied this approach with PROMs collected regarding group psychotherapy in a mental health service (MHS) setting. We hypothesized a recovery rate of above 50% of all cases, expecting a lower recovery rate amongst patients with severe depression. METHODS: We made a secondary sub-sample analysis of data from patients with unipolar depression (N = 171) within a pragmatic, non-inferiority, randomized controlled clinical trial comparing two cognitive behavior therapy (CBT) group interventions. The treatment consisted of 14 2-hours weekly group CBT sessions. We collected depression PROMs with the Becks Depression Inventory-II and functional levels PROMs with the Work and Social Adjustment Scale at baseline, end-of-treatment, and at a 6-months follow-up. RESULTS: At follow-up, 35% (N = 43/123) of cases with moderate or severe depression (BDI > 19) at baseline reached scores below the cut-off for moderate depression. Recovery rates in severe cases were significantly lower (26.5 vs 52.5%; p = 0.0004). We observed severe functional impairment in 36% of the patients at baseline (52/144) and observed no changes or worsening in scores at a 6-months follow-up in 44% of the patients (64/144). CONCLUSION: We achieved satisfactory remission rates for patients with moderate depression. Patients with severe depression and patients with functional impairment reached recovery rates below the standard of comparable MHSs. Improved MHSs for these patients are needed.