Schema therapy versus treatment as usual for outpatients with difficult-to-treat depression: study protocol for a parallel group randomized clinical trial (DEPRE-ST).

BACKGROUND: About one third of patients with depression are in a condition that can be termed as "difficult-to-treat". Some evidence suggests that difficult-to-treat depression is associated with a higher frequency of childhood trauma and comorbid personality disorders or accentuated features. However, the condition is understudied, and the effects of psychotherapy for difficult-to-treat depression are currently uncertain. The aim of this trial is to investigate the beneficial and harmful effects of 30 sessions of individual schema therapy versus treatment as usual for difficult-to-treat depression in the Danish secondary, public mental health sector. METHODS: In this randomized, multi-centre, parallel-group, superiority clinical trial, 129 outpatients with difficult-to-treat depression will be randomized (1:1) to 30 sessions of individual schema therapy or treatment as usual; in this context mainly group-based, short-term cognitive behaviour or psychodynamic therapy. The primary outcome is the change from baseline in depressive symptoms 12 months after randomization, measured on the observer-rated 6-item Hamilton Rating Scale for Depression. The secondary outcomes are health-related quality of life assessed with the European Quality of Life 5 Dimensions 5 Level Version, functional impairment assessed with the Work and Social Adjustment Scale, psychological wellbeing assessed with the WHO-5 Well-being Index, and negative effects of treatment assessed with the Negative Effects Questionnaire. Exploratory outcomes are improvement on patient self-defined outcomes, personal recovery, anxiety symptoms, anger reactions, metacognitive beliefs about anger, and perseverative negative thinking. Outcomes will be assessed at 6, 12, and 24 months after randomization; the 12-month time-point being the primary time-point of interest. Outcome assessors performing the depression-rating, data managers, statisticians, the data safety and monitoring committee, and conclusion makers for the outcome article will be blinded to treatment allocation and results. To assess cost-effectiveness of the intervention, a health economic analysis will be performed. DISCUSSION: This trial will provide evidence on the beneficial and harmful effects, as well as the cost-effectiveness of schema therapy versus treatment as usual for outpatients with difficult-to-treat depression. The results can potentially improve treatment for a large and understudied patient group. TRIAL REGISTRATION: ClinicalTrials.gov NCT05833087. Registered on 15th April 2023 (approved without prompts for revision on 27th April 2023).

Sharing and Receiving Eye-Contact Predicts Mate Choice After a 5-Minute Conversation: Evidence from a Speed-Dating Study.

In popular narratives, the first date with a potential mate often centers on their gaze as embodiment of interest and attraction. However, evidence is still lacking on the role of eye-contact as a potent signal in human social interaction in the context of dating. In addition, behavioral mechanisms of mate selection are not well understood. In the present study, we therefore examined mutual eye-contact and its influence on mate choice by applying dual mobile eye-tracking during naturalistic speed-dates. A total of 30 male and 30 female subjects attended four speed-dates each (N = 240). Subjects were more likely to choose those dating partners with whom they shared more eye-contact with. In addition, perceived attractiveness played an important role for mate choice. Interestingly, receiving but not giving eye-contact also predicted individual mate choice. Eye-contact thus acts as an important signal of romantic attraction when encountering a dating partner.

National norms of mental health for Denmark.

INTRODUCTION: To facilitate interpretation and clinical utility of patient-reported outcomes, normative data provide a reference for a person's score on a particular outcome in relation to the general population. This study reports Danish general population norms for four mental health indicators, assessing social functioning (Sheehan Disability Scale, SDS) personal recovery (Brief INSPIRE-O), symptom burden (Symptom Check List-10, SCL-10) and subjective well-being (WHO-5). METHODS: The study was a cross-sectional survey study organized by the State's statistical authority among the general population of adult Danish residents in Denmark, ranging in age between 18 to 79 years. RESULTS: A total of 8003 citizens were contacted including reminders from 2 March 2019 to 11 April 2019 by electronic letters, resulting in 2819 (35%) citizens providing complete responses. Female gender, higher age, Danish origin and living with a partner were associated with increased participation, and decreased participation was observed in male immigrants. We found a mean score of subjective well-being slightly lower than the population norm typically found in Danish general population studies. Elderly persons, Danes, and persons living with a partner reported better subjective mental health. Subjective well-being and personal recovery were positively correlated with social contacts and self-reported general health rating, and negatively correlated with social functioning and symptoms of depression and anxiety. CONCLUSION: This normative data provides a reference for interpreting mental health status. Our findings indicate slightly poorer subjective mental health than previously found. There is a need for special attention to engaging male immigrants in studies on mental health in the general population.

Evaluation of a standardized posttraumatic stress disorder treatment framework in routine mental health care: Effectiveness and predictors of treatment outcome in a consecutive sample.

The primary aim of the present study was to evaluate the effectiveness of standardized care package (CP) treatment for posttraumatic stress disorder (PTSD) in a Danish sample of adult psychiatric outpatients (N = 948). Secondary aims were to identify baseline predictors of treatment outcomes and investigate between-group differences in outcomes with regard to sex and treatment modality (i.e., group vs. individual therapy). The naturalistic, nonrandomized study followed a pre-post design. Patient data from five psychiatric outpatient clinics were collected between March 2011 and November 2017. Data were drawn from self-report questionnaires (i.e., SCL-90-R, WHO-5, BHS) and therapist-reported measures (i.e., GAF-S, GAF-F) administered at baseline and posttreatment. Between-group effects for sex and therapy modality (group vs. individual) were analyzed using analyses of variance, and possible predictors of outcomes were selected through LASSO regression and analyzed via hierarchical regression. Pre-post effects were small to moderate, ds = 0.39-0.69. No differences emerged regarding treatment modality, but women had significantly better outcomes than men. Aside from sex, only baseline symptom severity predicted outcomes. The effectiveness of the CP treatment was generally limited, indicating the need to implement improved therapeutic practices, such as the use of evidence-based treatments, and to provide better training to mental health clinicians. The findings underscore the need for further comparisons of group and individual treatment modalities using evidence-based therapies as well as the need to investigate factors that may affect treatment outcome.

Comparing responses in repeated cross-sectional and panel studies: Results across eight weeks during the first COVID-19 lockdown in Denmark.

It is often important to study people's thoughts, feelings, and behaviors over time. To this end, researchers have relied on repeated cross-sectional (RCS) studies, in which different people from the same population participate on different measurement occasions. Also, researchers have relied on panel studies, in which the same group of people participate on different measurement occasions. However, few studies have directly tested whether participants' responses in RCS studies were similar to those found in panel studies. To address this gap, we compared the responses to 33 items, 28 of which were further grouped into four aggregates (Affections, Worries, States, Health concerns), over 8 weeks during the first COVID-19 lockdown in Denmark in a RCS study (overall N = 5,993, per measurement occasion 616 ≤ n ≤ 964) with the responses in a largely equivalent panel study (993 ≤ n ≤ 2,546 across measurement occasions). The study participants were randomly drawn from the same quota-representative participant pool and responded to the same items on the same measurement occasions. Results indicated a few differences between the study samples on the first measurement occasion (i.e., selection effects between studies). Further, we found statistical support for different trajectories in 21 aggregates/items. However, visual inspection of the trajectories suggested subtle differences between the studies at large. The results thus raise awareness that the trajectories of people's thoughts, feelings, and behaviors can differ between survey methods, especially when only a few measurement occasions are considered. Nevertheless, such differences might not be substantial over time. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Personality Functioning and Mentalizing in Patients With Subthreshold or Diagnosed Borderline Personality Disorder: Implications for ICD-11.

The 11th revision of the International Classification of Diseases for Mortality and Morbidity Statistics (ICD-11) defines personality disorder according to personality functioning, which relates to self- and interpersonal functioning. The aim of the present study was to assess the relationship between mentalizing and personality functioning in patients with subthreshold or diagnosed borderline personality disorder. A total of 116 eligible participants were included. Mentalizing was assessed using the Mentalization Questionnaire (MZQ), personality functioning (self- and interpersonal functioning) was assessed using the Level of Personality Functioning Scale-Brief Form 2.0 (LPFS-BF), and borderline severity was assessed using the Zanarini Rating Scale (ZAN-BPD). Mediation analysis was employed to test if mentalizing accounted for the relationship between borderline severity and self- and interpersonal functioning. We found a significant relationship between borderline severity and both subscales of the LPFS-BF. Mentalizing fully and significantly mediated the relationship between borderline severity and interpersonal functioning. However, mentalizing only partly mediated the relationship between borderline severity and self-functioning. Controlling for the covariates gender and age did not impact the results. Mentalizing is likely to be involved in the ICD-11 model of personality functioning, especially interpersonal functioning. This could emphasize the relevance of therapy aimed at strengthening mentalizing abilities when treating personality pathology in general and people with borderline personality disorder in particular. However, self-functioning may be more nuanced, as aspects other than mentalizing also influence self-functioning. The study is explorative in nature and has methodological limitations that require caution in the interpretation and generalizability.

Mentalization-based treatment in groups for adolescents with Borderline Personality Disorder: 3- and 12-month follow-up of a randomized controlled trial.

Mentalization-based treatment in groups (MBT-G) has never been tested in adolescents with Borderline Personality Disorder (BPD) in a randomized controlled trial. The current study aimed to test the long-term effectiveness of MBT-G in an adolescent sample with BPD or BPD features (≥ 4 DSM-5 BPD criteria). Hundred and eleven patients with BPD (n = 106) or BPD features (n = 5) were randomized to either (1) a 1-year modified MBT-G program comprising three MBT introductory sessions, five individual case formulation sessions, 37 weekly MBT group sessions, and six MBT-Parent sessions, or (2) treatment as usual (TAU), defined as at least 12 individual monthly treatment sessions with follow-up assessments at 3 and 12 months post treatment. The primary outcome was the score on the Borderline Personality Features Scale for Children (BPFS-C), and secondary outcomes included clinician-rated BPD symptoms and global level of functioning as well as self-reported self-harm, depression, externalizing and internalizing symptoms, and caregiver reports. There were no statistically significant differences between MBT-G and TAU on the primary outcome measure or any of the secondary outcomes. Both groups showed improvement on the majority of clinical and social outcomes at both follow-up points, although remission rates were modest with just 35% in MBT-G and 39% in TAU 2 years after inclusion into the study. MBT-G was not superior to TAU in improving borderline features in adolescents. Although improvement was observed equally in both interventions over time, the patients continued to exhibit prominent BPD features, general psychopathology and decreased functioning in the follow-up period, which points to a need for more research and better understanding of effective components in early intervention programs. The ClinicalTrials.gov identifier is NCT02068326.

Level of alexithymia as a measure of personality dysfunction in avoidant personality disorder.

BACKGROUND AND OBJECTIVES: Avoidant Personality Disorder (AvPD) is considered a mild to moderate personality disorder. However, few studies have focused on the heterogeneity of AvPD in terms of symptoms and severity. In the current study we set out to replicate and extend earlier findings showing that there is variation among patients with AvPD in terms of alexithymia and, further, that this variation is especially associated with specific facets of personality functioning and is not explained by measures of depression, symptom severity, or co-occurring personality disorder traits. METHOD: We used intake data from a sample of AvPD patients (n = 56) who had been treated in similar outpatient services. Alexithymia was measured using the Toronto Alexithymia Scale (TAS-20). Patients filled out questionnaires that were analysed using linear regression models. RESULTS AND CONCLUSIONS: Using well-established cut-off points for low, intermediate and high levels of alexithymia we found an almost equal distribution of alexithymia groups in our sample. Alexithymia was associated with higher personality dysfunction on twelve out of sixteen facets of personality functioning. For eight of these personality facets the alexithymia total score explained significant variance even after controlling for self-reported depression, symptom severity and clinician ratings of personality disorder. Results suggest that AvPD is heterogeneous and that alexithymia may be important as an indicator of severity of specific personality dysfunction.

The PTSD help app in a Danish PTSD population: research protocol of a randomized controlled feasibility trial.

BACKGROUND: Due to an increase in PTSD patients seeking help in the Danish mental health sector and the addition of Complex PTSD to the ICD-11, there is a need to increase efficiency of existing treatments for PTSD. mHealth interventions have been shown to reduce PTSD symptoms. Therefore, the implementation of a mHealth intervention designed for psychiatric PTSD patients as a therapy add-on may improve treatment outcome. No study to date has explored the effects of mHealth interventions for PTSD in the Danish mental health sector, the feasibility and effect of this type of intervention needs testing. METHODS: The study is an investigator-initiated randomized controlled feasibility trial investigating the clinical mHealth tool PTSD help combined with care as usual (CAU) compared to CAU for adults with PTSD. Seventy patients will be recruited and receive either the mHealth intervention combined with CAU or CAU alone. The primary feasibility outcome is the proportion of eligible patients that participate in the study until the end assessment. Secondary outcome data consists of the fraction of compliant patients in the experimental group and exploratory data on PTSD help on PTSD symptom severity, level of psychological distress, sleep quality, dissociation symptoms, therapy readiness, quality of life, disability levels, and recovery. DISCUSSION: This study may help increase our knowledge of possible benefits of, as well as potential barriers to, the implementation of mHealth tools in the psychiatric sector. It may also provide a cost-efficient means to increase therapy outcomes and decrease the duration of suffering for PTSD patients in the psychiatric sector. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov (ID: NCT03862703) https://clinicaltrials.gov/ct2/show/NCT03862703 on the 27 of February 2019 and has been approved by the Danish Data Protection Agency (journal number: VD-2018-200 ISuite number 6443). Referring to the committee law §2, the National Committee on Health Research Ethics (DNVK) [H-18024180] decided that the study could proceed without approval as the use of PTSD help did not constitute a health science intervention according to Danish health science legislation.

Group rumination-focused cognitive-behavioural therapy (CBT) v. group CBT for depression: phase II trial.

BACKGROUND: Although cognitive-behavioural therapy (CBT) is an effective treatment for depression, less than half of patients achieve satisfactory symptom reduction during treatment. Targeting known psychopathological processes such as rumination may increase treatment efficacy. The aim of this study was to test whether adding group rumination-focused CBT (RFCBT) that explicitly targets rumination to routine medical management is superior to adding group CBT to routine medical management in treating major depression. METHODS: A total of 131 outpatients with major depression were randomly allocated to 12 sessions group RFCBT v. group CBT, each in addition to routine medical management. The primary outcome was observer-rated symptoms of depression at the end of treatment measured on the Hamilton Rating Scale for Depression. Secondary outcomes were rumination at post-treatment and depressive symptoms at 6 months follow-up (Trial registered: NCT02278224). RESULTS: RFCBT significantly improved observer-rated depressive symptoms (Cohen's d 0.38; 95% CI 0.03-0.73) relative to group CBT at post-treatment on the primary outcome. No post-treatment differences were found in rumination or in depressive symptoms at 6 months follow-up, although these secondary analyses may have been underpowered. CONCLUSIONS: This is the first randomized controlled trial providing evidence of benefits of RFCBT in major depression compared with CBT. Group RFCBT may be a beneficial alternative to group CBT for major depression.

Mentalization-based treatment in groups for adolescents with borderline personality disorder: a randomized controlled trial.

BACKGROUND: Borderline personality disorder (BPD) typically onsets in adolescence and predicts later functional disability in adulthood. Highly structured evidence-based psychotherapeutic programs, including mentalization-based treatment (MBT), are first choice treatment. The efficacy of MBT for BPD has mainly been tested with adults, and no RCT has examined the effectiveness of MBT in groups (MBT-G) for adolescent BPD. METHOD: A total of 112 adolescents (111 females) with BPD (106) or BPD symptoms ≥4 DSM-5 criteria (5) referred to child and adolescent psychiatric outpatient clinics were randomized to a 1-year MBT-G, consisting of three introductory, psychoeducative sessions, 37 weekly group sessions, five individual case formulation sessions, and six group sessions for caregivers, or treatment as usual (TAU) with at least 12 monthly individual sessions. The primary outcome was the score on the borderline personality features scale for children (BPFS-C); secondary outcomes included self-harm, depression, externalizing and internalizing symptoms (all self-report), caregiver reports, social functioning, and borderline symptoms rated by blinded clinicians. Outcome assessments were made at baseline, after 10, 20, and 30 weeks, and at end of treatment (EOT). The ClinicalTrials.gov identifier is NCT02068326. RESULTS: At EOT, the primary outcome was 71.3 (SD = 15.0) in the MBT-G group and 71.3 (SD = 15.2) in the TAU group (adjusted mean difference 0.4 BPFS-C units in favor of MBT-G, 95% confidence interval -6.3 to 7.1, p = .91). No significant group differences were found in the secondary outcomes. 29% in both groups remitted. 29% of the MBT group completed less than half of the sessions compared with 7% of the control group. CONCLUSIONS: There is no indication for superiority of either therapy method. The low remission rate points to the importance of continued research into early intervention. Specifically, retention problems need to be addressed.

Audiovisual detection at different intensities and delays.

In the redundant signals task, two target stimuli are associated with the same response. If both targets are presented together, redundancy gains are observed, as compared with single-target presentation. Different models explain these redundancy gains, including race and coactivation models (e.g., the Wiener diffusion superposition model, Schwarz, 1994, Journal of Mathematical Psychology, and the Ornstein Uhlenbeck diffusion superposition model, Diederich, 1995, Journal of Mathematical Psychology). In the present study, two monkeys performed a simple detection task with auditory, visual and audiovisual stimuli of different intensities and onset asynchronies. In its basic form, a Wiener diffusion superposition model provided only a poor description of the observed data, especially of the detection rate (i.e., accuracy or hit rate) for low stimulus intensity. We expanded the model in two ways, by (A) adding a temporal deadline, that is, restricting the evidence accumulation process to a stopping time, and (B) adding a second "nogo" barrier representing target absence. We present closed-form solutions for the mean absorption times and absorption probabilities for a Wiener diffusion process with a drift towards a single barrier in the presence of a temporal deadline (A), and numerically improved solutions for the two-barrier model (B). The best description of the data was obtained from the deadline model and substantially outperformed the two-barrier approach.

Differential coactivation in a redundant signals task with weak and strong go/no-go stimuli.

When participants respond to stimuli of two sources, response times (RTs) are often faster when both stimuli are presented together relative to the RTs obtained when presented separately (redundant signals effect [RSE]). Race models and coactivation models can explain the RSE. In race models, separate channels process the two stimulus components, and the faster processing time determines the overall RT. In audiovisual experiments, the RSE is often higher than predicted by race models, and coactivation models have been proposed that assume integrated processing of the two stimuli. Where does coactivation occur? We implemented a go/no-go task with randomly intermixed weak and strong auditory, visual, and audiovisual stimuli. In one experimental session, participants had to respond to strong stimuli and withhold their response to weak stimuli. In the other session, these roles were reversed. Interestingly, coactivation was only observed in the experimental session in which participants had to respond to strong stimuli. If weak stimuli served as targets, results were widely consistent with the race model prediction. The pattern of results contradicts the inverse effectiveness law. We present two models that explain the result in terms of absolute and relative thresholds.

Mind the gap: In-session silences are associated with client attachment insecurity, therapeutic alliance, and treatment outcome.

OBJECTIVE: The association between in-session silences and client attachment, therapeutic alliance, and treatment outcome was investigated in two treatments for bulimia nervosa. METHOD: 69 women and one man were randomized to two years of psychoanalytic psychotherapy (PPT) or 20 sessions of cognitive behavioral therapy (CBT). Client attachment was assessed using the Adult Attachment Interview. Early, middle and late sessions (N = 175) were evaluated with the Vanderbilt Therapeutic Alliance Scales, and quality of in-session silences was coded with the Pausing Inventory Categorization System (PICS). Multilevel Poisson and linear regression analyses were performed. RESULTS: Coders identified 6236 pauses, which were more frequent in PPT than in CBT. Higher pausing frequency and higher relative frequency of obstructive pauses were associated with client insecure attachment as well as with poorer treatment alliance, and accounted for part of the relation between client attachment and therapeutic alliance. Good outcome clients had higher relative frequency of productive pauses, especially in mid-treatment, and lower relative frequency of obstructive pauses, especially in late treatment. CONCLUSION: The study further validates the PICS. Findings indicate that therapists may be able to use in-session silences as an indicator of client attachment insecurity and as a prognostic sign of eventual treatment outcome.

Premorbid adjustment in individuals at ultra-high risk for developing psychosis: a case-control study.

AIM: Deterioration in premorbid adjustment is related to ultra-high risk (UHR) individuals developing psychosis, but it has not been examined how UHR individuals' development differs compared to healthy controls. This study investigates differences in premorbid adjustment between UHR individuals and a healthy control group. METHOD: A total of 48 UHR individuals and 50 healthy controls matched on group level for age, gender and parents' socio-economic status were included in the study. Both groups were assessed with the Premorbid Adjustment Scale (PAS). Based on the PAS scores, composite social and academic scales were computed. RESULTS: Compared to the healthy controls the UHR individuals' social and academic premorbid adjustment declined across age periods. Social premorbid adjustment declined particularly between late adolescence and adulthood. Academic premorbid adjustment declined particularly between childhood and early adolescence. The UHR individuals had more premorbid adjustment difficulties on both the social and academic scale, and on the individual PAS scales. CONCLUSION: From childhood UHR individuals have lower levels of social and academic premorbid adjustment compared to healthy controls, and the difficulties increase with age. As such, social and academic premorbid adjustment could be an important focus for early intervention.

Therapist adherence is associated with outcome in cognitive-behavioral therapy for bulimia nervosa.

Studies of therapist adherence in relation to treatment outcome have produced mixed results. The aim of the present study was to investigate change in therapist adherence to cognitive-behavioral therapy (CBT) for bulimia nervosa over time, and to investigate the relationship between adherence and client outcome in early, middle, and late phases of treatment. Thirty-six clients received the focused form of "enhanced" CBT (CBT-E) for bulimia nervosa. Trained observers rated audiotapes of 92 full-length therapy sessions from early (Session 3), middle (Session 11), and late phases (Session 20) of treatment using the Cognitive-Behavioral Therapy Treatment Protocol Adherence Scale. Change in adherence across the 3 treatment phases was examined using multilevel analysis. The relationship between early, middle, and late adherence levels and end-of-treatment binging frequency was examined using multilevel Poisson regression analysis. Adherence decreased significantly over the course of treatment. Higher levels of therapist adherence in early and middle phases of treatment were associated with reduced binging frequency, whereas higher levels of adherence measured late in treatment was not. Results indicate that therapists' adherence to the CBT-E treatment protocol decreases over time and that high levels of protocol adherence in early and middle phases of treatment are more important for positive client outcomes than high levels of adherence in the end of treatment. (PsycINFO Database Record

Correction: Use of Mesh in Laparoscopic Paraesophageal Hernia Repair: A Meta-Analysis and Risk-Benefit Analysis.

[This corrects the article DOI: 10.1371/journal.pone.0139547.].

First empirical evaluation of outcomes for mentalization-based group therapy for adolescents with BPD.

Adolescent borderline personality disorder (BPD) is a devastating disorder, and it is essential to identify and treat the disorder in its early course. A total of 34 female Danish adolescents between 15 and 18 years old participated in 1 year of structured mentalization-based group therapy. Twenty-five adolescents completed the study, of which the majority (23) displayed improvement regarding borderline symptoms, depression, self-harm, peer-attachment, parent-attachment, mentalizing, and general psychopathology. Enhanced trust in peers and parents in combination with improved mentalizing capacity was associated with greater decline in borderline symptoms, thereby pointing to a candidate mechanism responsible for the efficacy of the treatment. The current study provides a promising rationale for the further development and evaluation of group-format mentalization-based treatment for adolescents with borderline traits. (PsycINFO Database Record

Mentalization-based treatment in groups for adolescents with borderline personality disorder (BPD) or subthreshold BPD versus treatment as usual (M-GAB): study protocol for a randomized controlled trial.

BACKGROUND: Evidence-based outpatient psychotherapeutic programs are first-line treatment of borderline personality disorder (BPD). Early and effective treatment of BPD is crucial to the prevention of its individual, psychosocial, and economic consequences. However, in spite of recent advantages in diagnosing adolescent BPD, there is a lack of cost-effective evidence-based treatment programs for adolescents. Mentalization-based treatment is an evidence-based program for BPD, originally developed for adults. AIMS/HYPOTHESES: We will investigate whether a specifically designed mentalization-based treatment in groups is an efficacious treatment for adolescents with BPD or subthreshold BPD compared to treatment as usual. The trial is a four-center, two-armed, parallel-group, assessor-blinded randomized clinical superiority trial. One hundred twelve patients aged 14 to 17 referred to Child and Adolescent Psychiatric Clinics in Region Zealand are randomized to 1 year of either mentalization-based treatment in groups or treatment as usual. Patients will be included if they meet at least four DSM-5 criteria for BPD. The primary outcome is self-reported borderline features at discharge. Secondary outcomes will include self-harm, depression, BPD criteria, externalizing and internalizing symptoms, and social functioning, together with parental reports on borderline features, externalizing and internalizing symptoms. Measures of attachment and mentalization will be included as mediational variables. Follow-up assessment will take place at 3 and 12 months after end of treatment. DISCUSSION: This is the first randomized controlled trial to test the efficacy of a group-based mentalization-based treatment for adolescents with BPD or subthreshold BPD. If the results confirm our hypothesis, this trial will add to the treatment options of cost-effective treatment of adolescent BPD. TRIAL REGISTRATION: Clinicaltrials.gov NCT02068326 , February 19, 2014.

Medical Assistant-Based Care Management for High-Risk Patients in Small Primary Care Practices: A Cluster Randomized Clinical Trial.

BACKGROUND: Patients with multiple chronic conditions are at high risk for potentially avoidable hospitalizations, which may be reduced by care coordination and self-management support. Medical assistants are an increasingly available resource for patient care in primary care practices. OBJECTIVE: To determine whether protocol-based care management delivered by medical assistants improves care in patients at high risk for future hospitalization in primary care. DESIGN: Two-year cluster randomized clinical trial. (Current Controlled Trials: ISRCTN56104508). SETTING: 115 primary care practices in Germany. PATIENTS: 2076 patients with type 2 diabetes, chronic obstructive pulmonary disease, or chronic heart failure and a likelihood of hospitalization in the upper quartile of the population, as predicted by an analysis of insurance data. INTERVENTION: Protocol-based care management, including structured assessment, action planning, and monitoring delivered by medical assistants, compared with usual care. MEASUREMENTS: All-cause hospitalizations at 12 months (primary outcome) and quality-of-life scores (12-Item Short Form Health Survey [SF-12] and EuroQol instrument [EQ-5D]). RESULTS: Included patients had an average of 4 co-occurring chronic conditions. All-cause hospitalizations did not differ between groups at 12 months (risk ratio [RR], 1.01 [95% CI, 0.87 to 1.18]) and 24 months (RR, 0.98 [CI, 0.85 to 1.12]). Quality of life (differences, 1.16 [CI, 0.24 to 2.08] on SF-12 physical component and 1.68 [CI, 0.60 to 2.77] on SF-12 mental component) and general health (difference on EQ-5D, 0.03 [CI, 0.00 to 0.05]) improved significantly at 24 months. Intervention costs totaled $10 per patient per month. LIMITATION: Small number of primary care practices and low intensity of intervention. CONCLUSION: This low-intensity intervention did not reduce all-cause hospitalizations but showed positive effects on quality of life at reasonable costs in high-risk multimorbid patients. PRIMARY FUNDING SOURCE: AOK Baden-Württemberg and AOK Bundesverband.