Development and Evaluation of a Pragmatic Measure of Adherence to Dialectical Behavior Therapy: The DBT Adherence Checklist for Individual Therapy.

This paper presents two studies conducted to develop and evaluate a new pragmatic measure of therapist adherence to Dialectical Behavior Therapy (DBT): the DBT Adherence Checklist for Individual Therapy (DBT AC-I). Study 1 used item response analysis to select items from the gold standard DBT Adherence Coding Scale (DBT ACS) using archival data from 1271 DBT sessions. Items were then iteratively refined based on feedback from 33 target end-users to ensure relevance, usability, and understandability. Study 2 examined the psychometric properties of the DBT AC-I as a therapist self-report and observer-rated measure in 100 sessions from 50 therapist-client dyads, while also evaluating predictors of therapist accuracy in self-rated adherence. When used as a therapist self-report measure, concordance between therapist and observer ratings was at least moderate (AC1 ≥ 0.41) for all DBT AC-I items but overall concordance (ICC = 0.09) as well as convergent (r = 0.05) and criterion validity (AUC = 0.54) with the DBT ACS were poor. Higher therapist accuracy was predicted by greater DBT knowledge and adherence as well as more severe client suicidal ideation. When used by trained observers, the DBT AC-I had excellent interrater reliability (ICC = 0.93), convergent validity (r = 0.90), and criterion validity (AUC = 0.94). While therapists' self-rated adherence on the DBT AC-I should not be assumed to reflect their actual adherence, some therapists may self-rate accurately. The DBT AC-I offers an effective and relatively efficient method of evaluating adherence to DBT when used by trained observers.

Plasma sTNFR1 and IL8 for prognostic enrichment in sepsis trials: a prospective cohort study.

BACKGROUND: Enrichment strategies improve therapeutic targeting and trial efficiency, but enrichment factors for sepsis trials are lacking. We determined whether concentrations of soluble tumor necrosis factor receptor-1 (sTNFR1), interleukin-8 (IL8), and angiopoietin-2 (Ang2) could identify sepsis patients at higher mortality risk and serve as prognostic enrichment factors. METHODS: In a multicenter prospective cohort study of 400 critically ill septic patients, we derived and validated thresholds for each marker and expressed prognostic enrichment using risk differences (RD) of 30-day mortality as predictive values. We then used decision curve analysis to simulate the prognostic enrichment of each marker and compare different prognostic enrichment strategies. MEASUREMENTS AND MAIN RESULTS: An admission sTNFR1 concentration > 8861 pg/ml identified patients with increased mortality in both the derivation (RD 21.6%) and validation (RD 17.8%) populations. Among immunocompetent patients, an IL8 concentration > 94 pg/ml identified patients with increased mortality in both the derivation (RD 17.7%) and validation (RD 27.0%) populations. An Ang2 level > 9761 pg/ml identified patients at 21.3% and 12.3% increased risk of mortality in the derivation and validation populations, respectively. Using sTNFR1 or IL8 to select high-risk patients improved clinical trial power and efficiency compared to selecting patients with septic shock. Ang2 did not outperform septic shock as an enrichment factor. CONCLUSIONS: Thresholds for sTNFR1 and IL8 consistently identified sepsis patients with higher mortality risk and may have utility for prognostic enrichment in sepsis trials.

SCHOOL-RELATED OUTCOMES FROM A RANDOMIZED CONTROLLED TRIAL OF ADOLESCENT DEPRESSION PREVENTION PROGRAMS.

Previous research has demonstrated the effectiveness of school-based depression prevention programs in reducing depressive symptoms and improving functioning. This study examined whether these programs have positive effects on school-related outcomes. Students at 10 middle and high schools in New Jersey were randomized to weekly sessions of Interpersonal Psychotherapy - Adolescent Skills Training (IPT-AST) or group counseling (GC). Analyses examined whether there were intervention effects on participants' grades, attendance rates, and disciplinary outcomes over approximately one year post-intervention. Although there were no significant main effects of intervention condition, moderation analyses indicated more favorable effects of IPT-AST among certain higher-risk subgroups (e.g., those from low-income families). Participants who experienced meaningful improvement in their depressive symptoms had significantly more positive outcomes on overall grades than those who did not experience meaningful improvement, regardless of intervention condition. Further research is needed to clarify the effects of depression prevention programs on these school-related outcomes.

What changes when? The course of improvement during a stage-based treatment for suicidal and self-injuring women with borderline personality disorder and PTSD.

OBJECTIVE: Dialectical Behavior Therapy (DBT) with the DBT Prolonged Exposure (DBT PE) protocol is an integrated treatment for suicidal and self-injuring individuals with PTSD and borderline personality disorder (BPD) that occurs in three stages: Stage 1 targets behavioral dyscontrol, Stage 2 targets posttraumatic stress disorder (PTSD) via the DBT PE protocol, and Stage 3 addresses remaining problems. We evaluated the course of change in multiple outcomes across these three stages and compared them to changes found in DBT alone. METHOD: Participants were 38 women with BPD, PTSD and recent suicidal and/or non-suicidal self-injury. Data were collected weekly or bi-weekly to assess PTSD, BPD, global well-being, state dissociation, and urges to engage in problem behaviors. RESULTS: In DBT + DBT PE, there was a significant improvement in PTSD in Stage 2 and in PTSD, BPD, and state dissociation in Stage 3. Compared to DBT, DBT + DBT PE led to significantly higher global well-being and moderately, but non-significantly, lower PTSD and BPD in Stages 2 and/or 3. CONCLUSIONS: PTSD does not improve until it is directly targeted and changes in other comorbid problems occur after PTSD is treated. Adding the DBT PE protocol to DBT was associated with improvement rather than worsening of outcomes.

Predicting Change in an Integrated Dual Diagnosis Substance Abuse Intensive Outpatient Program.

Research on routine outcome monitoring in psychotherapy settings is plentiful but not without implementation obstacles. In fact, there is a relative dearth of real-time outcome monitoring in substance use treatment settings. Numerous barriers to the development and implementation of clinical decision support tools and outcome monitoring of substance use patients, including the need to establish expected trajectories of change and use of reliable change indices have been identified (Goodman, McKay, & DePhilippis, 2013 ). The current study was undertaken to develop expected trajectories of change and to demonstrate the treatment effectiveness of a dual diagnosis intensive outpatient program. The expected trajectories of change for days of substance use and depression scores were developed using predictive equation models from derivation samples and then applied to cross-validation samples. Predictive equations to monitor substance use were developed and validated for all patients and for only patients who were actively using substance at the time of admission, as well as to monitor severity of their depression symptom on a weekly basis. Validation of the equations was assessed through the use of Cohen's kappa (κ), receiver operating characteristic curves, reliable change index, and percentage improvement. Large effect sizes for reductions in substance use (Cohen's d = .76) and depressive symptoms (d = 1.10) are reported. The best predictive models we developed had absolute accuracy rates ranging from 95 to 100%. The findings from this study indicate that predictive equations for depressive symptoms and days of substance use can be derived and validated on dual diagnosis samples.

Predicting individual change during the course of treatment.

OBJECTIVE: An empirically derived prediction model was developed in a private practice setting to monitor on-track and off-track weekly treatment progress in an intensive outpatient program (IOP). METHOD: The predictive equation was derived as a function of the baseline measure and time. The formulae for the predictive equations were derived from two groups of psychiatric patients (N = 400 each) in an IOP diagnosed with major depression. Each equation was cross-validated between these two psychiatric IOP samples and a dual diagnosis sample (N = 198) using κ, the reliable change index (RCI), receiver operating characteristic curves, and Youden's J. RESULTS: Using varying RCI classifications, approximately 66-75% of both samples reliably improved, 23-24% were indeterminant, and only 1-3% deteriorated. Of patients identified as off-track, which included patients classified as indeterminant and deteriorated, 83% were correctly identified. Of those identified as on-track, 85% were correctly classified. Those identified as on-track (85%) are highly likely to respond to treatment as expected. CONCLUSIONS: The overall efficiency index (hit rate) for the correct classification of all patients was 85%. Implications for using this predictive model as a clinical support decision tool with relatively homogeneous populations in other practice settings are discussed.

Impact of prenatal maternal depression on gestational length: post hoc analysis of a randomized clinical trial.

Background: Shortened gestation is a leading cause of childhood morbidity and mortality with lifelong consequences for health. There is a need for public health initiatives on increasing gestational age at birth. Prenatal maternal depression is a pervasive health problem robustly linked via correlational and epidemiological studies to shortened gestational length. This proof-of-concept study tests the impact of reducing prenatal maternal depression on gestational length with analysis of a randomized clinical trial (RCT). Methods: Participants included 226 pregnant individuals enrolled into an RCT and assigned to receive either interpersonal psychotherapy (IPT) or enhanced usual care (EUC). Recruitment began in July 2017 and participants were enrolled August 10, 2017 to September, 8 2021. Depression diagnosis (Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; DSM 5) and symptoms (Edinburgh Postnatal Depression Scale and Symptom Checklist) were evaluated at baseline and longitudinally throughout gestation to characterize depression trajectories. Gestational dating was collected based on current guidelines via medical records. The primary outcome was gestational age at birth measured dichotomously (≥39 gestational weeks) and the secondary outcome was gestational age at birth measured continuously. Posthoc analyses were performed to test the effect of reducing prenatal maternal depression on gestational length. This trial is registered with ClinicalTrials.gov (NCT03011801). Findings: Steeper decreases in depression trajectories across gestation predicted later gestational age at birth, specifically an increase in the number of full-term babies born ≥39 gestational weeks (EPDS linear slopes: OR = 1.54, 95% CI 1.10-2.16; and SCL-20 linear slopes: OR = 1.67, 95% CI 1.16-2.42). Causal mediation analyses supported the hypothesis that participants assigned to IPT experienced greater reductions in depression symptom trajectories, which in turn, contributed to longer gestation. Supporting mediation, the natural indirect effect (NIE) showed that reduced depression trajectories resulting from intervention were associated with birth ≥39 gestational weeks (EPDS, OR = 1.65, 95% CI 1.02-2.66; SCL-20, OR = 1.85, 95% CI 1.16-2.97). Interpretation: We used a RCT design and found that reducing maternal depression across pregnancy was associated with lengthened gestation. Funding: This research was supported by the NIH (R01 HL155744, R01 MH109662, R21 MH124026, P50 MH096889).

Higher prenatal anxiety predicts lower neonatal hair cortisol.

BACKGROUND: Prenatal glucocorticoids are one of the most widely proposed prenatal programming mechanisms, yet few studies exist that measure fetal cortisol via neonatal hair. Neonatal hair provides a window into the fetal experience and represents cortisol accumulation in the third trimester of pregnancy. In the current study, we test the links between two types of anxiety over the course of gestation (pregnancy-related anxiety and general anxiety) with neonatal hair cortisol. METHOD: Pregnant individuals (N = 107) and their neonates (59.8% female) participated in the current study. Prenatal pregnancy-related anxiety and general anxiety were measured using the Pregnancy Related Anxiety Scale (PRAS) and the State-Trait Anxiety Inventory (STAI), in each trimester of pregnancy. Hierarchical linear modeling was used to model the intercept and slope of each type of anxiety over gestation. Neonatal hair samples were collected shortly after birth (Median days = 1.17, IQR = 0.75-2.00). RESULTS: Both higher pregnancy-related anxiety and general anxiety at the beginning of pregnancy and a flatter decline of pregnancy-related anxiety over gestation were associated with lower neonatal hair cortisol. After inclusion of gestational age at birth and parity as covariates, pregnancy-related anxiety (intercept: ß = -0.614, p =.012; slope: ß = -0.681, p =.006), but not general anxiety (intercept: ß = -0.389, p =.114; slope: ß = -0.302, p =.217) remained a significant predictor. Further, when both general and pregnancy-related anxiety were entered into the same model, only pregnancy-related anxiety (intercept and slope) were significant predictors of neonatal hair cortisol, indicating an association with pregnancy-related anxiety above and beyond general anxiety. CONCLUSION: Cortisol plays a central role in maturation of fetal organ systems, and at the end of gestation, higher cortisol has beneficial effects such as promoting fetal lung maturation. Further, lower maternal cortisol is linked to less optimal cognitive development and altered brain development. As maternal higher anxiety in early pregnancy and a flatter decrease over time are both associated with lower neonatal hair cortisol, maternal pregnancy-related anxiety could be a target of future intervention efforts.

Altered neuregulin 1-erbB4 signaling contributes to NMDA receptor hypofunction in schizophrenia.

Recent molecular genetics studies implicate neuregulin 1 (NRG1) and its receptor erbB in the pathophysiology of schizophrenia. Among NRG1 receptors, erbB4 is of particular interest because of its crucial roles in neurodevelopment and in the modulation of N-methyl-D-aspartate (NMDA) receptor signaling. Here, using a new postmortem tissue-stimulation approach, we show a marked increase in NRG1-induced activation of erbB4 in the prefrontal cortex in schizophrenia. Levels of NRG1 and erbB4, however, did not differ between schizophrenia and control groups. To evaluate possible causes for this hyperactivation of erbB4 signaling, we examined the association of erbB4 with PSD-95 (postsynaptic density protein of 95 kDa), as this association has been shown to facilitate activation of erbB4. Schizophrenia subjects showed substantial increases in erbB4-PSD-95 interactions. We found that NRG1 stimulation suppresses NMDA receptor activation in the human prefrontal cortex, as previously reported in the rodent cortex. NRG1-induced suppression of NMDA receptor activation was more pronounced in schizophrenia subjects than in controls, consistent with enhanced NRG1-erbB4 signaling seen in this illness. Therefore, these findings suggest that enhanced NRG1 signaling may contribute to NMDA hypofunction in schizophrenia.

Seeking safety therapy for pathological gambling and PTSD: a pilot outcome study.

This pilot study evaluated Seeking Safety (SS) therapy for seven outpatients with current comorbid pathological gambling (PG) and posttraumatic stress disorder (PTSD). This represents the first treatment outcome study of this population, and included both genders and 29% minorities. We found significant improvements in: PTSD/trauma (the PTSD Checklist criterion B symptoms; the Trauma Symptom Inventory overall mean and subscales anxiety, dissociation, sexual abuse trauma index, sex problems; and the World Assumptions Scale benevolence subscale); gambling (the Gamblers Beliefs Questionnaire overall mean and subscales illusion of control); functioning (the Basis-32 overall mean and depression/anxiety subscale); psychopathology (the Brief Symptom Inventory overall mean and subscales anxiety and depression; and the Addiction Severity Index, ASI, psychiatric composite score); self-compassion (the Self-Compassion Scale overall mean and subscales isolation, overidentified, and self-judgment); and helping alliance (the Helping Alliance Questionnaire overall mean). One variable indicated worsening (employment composite subscale on the ASI), possibly reflecting measurement issues. SS attendance was excellent. PTSD onset occurred prior to PG onset for most of the sample, and most believed the two disorders were related. Overall, we found that SS can be effectively conducted for comorbid PTSD and PG, with improvements in numerous domains and high acceptability. Limitations are discussed.

Evaluation of a decision aid for early pregnancy loss: A pilot randomized controlled trial in Philadelphia, Pennsylvania.

OBJECTIVES: To evaluate the effect of a decision aid on decisional conflict scale in patients choosing management for early pregnancy loss. STUDY DESIGN: We conducted a pilot randomized control trial to assess the effect of the Healthwise patient decision aid on decisional conflict scale in patients with early pregnancy loss as compared with a control website. Patients 18years and older were eligible if they had an early pregnancy loss between 5 and 12 completed weeks of gestation. Participants completed surveys at baseline, poststudy intervention, after consultation, and 1week postconsultation. Surveys assessed participant scores on the decisional conflict scale (scale 0-100), knowledge, assessment of shared decision-making, satisfaction, and decision regret. Our primary outcome was the poststudy-intervention decisional conflict scale score. RESULTS: From July 2020 through March 2021 we randomized 60 participants. After the intervention, the median decisional conflict scale score for the control group was 10 [0-30] and 0 [0-20] for the intervention group (p = 0.17). When assessing the decisional conflict scale subscales postintervention, the informed subscale for the control group was 16.7 [0-33.3] as opposed to 0 [0] for the patient decision aid group (p = 0.003). Knowledge remained significantly higher in the experimental arm from the postintervention to the 1-week follow-up. We found no differences between groups when assessing our other metrics. CONCLUSIONS: Use of a validated decision aid did not result in statistically significant differences in the total decisional conflict scale scores as compared with the control. Participants allocated to the intervention were more informed postintervention and had consistently higher knowledge scores. IMPLICATIONS: Use of a validated decision aid prior to early pregnancy loss management consultation did not affect overall decisional conflict but resulted in improved knowledge.

Preservation of ß-cell Function in Pancreatic Insufficient Cystic Fibrosis With Highly Effective CFTR Modulator Therapy.

CONTEXT: Elexacaftor/tezacaftor/ivacaftor (ETI; Trikafta) enhances aberrant cystic fibrosis transmembrane conductance regulator function and may improve the insulin secretory defects associated with a deterioration in clinical outcomes in pancreatic insufficient cystic fibrosis (PI-CF). OBJECTIVE: This longitudinal case-control study assessed changes in ß-cell function and secretory capacity measures over 2 visits in individuals with PI-CF who were initiated on ETI after the baseline visit (2012-2018) and (1) restudied between 2019 and 2021 (ETI group) vs (2) those restudied between 2015 and 2018 and not yet treated with cystic fibrosis transmembrane conductance regulator modulator therapy (controls). METHODS: Nine ETI participants (mean ± SD age, 25 ± 5 years) and 8 matched controls were followed up after a median (interquartile range) 5 (4-7) and 3 (2-3) years, respectively (P < .01), with ETI initiation a median of 1 year before follow-up. Clinical outcomes, glucose-potentiated arginine, and mixed-meal tolerance test measures were assessed with comparisons of within- and between-group change by nonparametric testing. RESULTS: Glucose-potentiated insulin and C-peptide responses to glucose-potentiated arginine deteriorated in controls but not in the ETI group, with C-peptide changes different between groups (P < .05). Deterioration in basal proinsulin secretory ratio was observed in controls but improved, as did the maximal arginine-induced proinsulin secretory ratio, in the ETI group (P < .05 for all comparisons). During mixed-meal tolerance testing, early insulin secretion improved as evidenced by more rapid insulin secretory rate kinetics. CONCLUSION: ETI preserves ß-cell function in CF through effects on glucose-dependent insulin secretion, proinsulin processing, and meal-related insulin secretion. Further work should determine whether early intervention with ETI can prevent deterioration of glucose tolerance in PI-CF.

Effect of Brief Interpersonal Therapy on Depression During Pregnancy: A Randomized Clinical Trial.

Importance: Prenatal depression is prevalent with negative consequences for both the mother and developing fetus. Brief, effective, and safe interventions to reduce depression during pregnancy are needed. Objective: To evaluate depression improvement (symptoms and diagnosis) among pregnant individuals from diverse backgrounds randomized to brief interpersonal psychotherapy (IPT) vs enhanced usual care (EUC). Design, Setting, and Participants: A prospective, evaluator-blinded, randomized clinical trial, the Care Project, was conducted among adult pregnant individuals who reported elevated symptoms during routine obstetric care depression screening in general practice in obstetrics and gynecology (OB/GYN) clinics. Participants were recruited between July 2017 and August 2021. Repeated measures follow-up occurred across pregnancy from baseline (mean [SD], 16.7 [4.2] gestational weeks) through term. Pregnant participants were randomized to IPT or EUC and included in intent-to-treat analyses. Interventions: Treatment comprised an engagement session and 8 active sessions of brief IPT (MOMCare) during pregnancy. EUC included engagement and maternity support services. Main Outcomes and Measures: Two depression symptom scales, the 20-item Symptom Checklist and the Edinburgh Postnatal Depression Scale, were assessed at baseline and repeatedly across pregnancy. Structured Clinical Interview for DSM-5 ascertained major depressive disorder (MDD) at baseline and the end of gestation. Results: Of 234 participants, 115 were allocated to IPT (mean [SD] age, 29.7 [5.9] years; 57 [49.6%] enrolled in Medicaid; 42 [36.5%] had current MDD; 106 [92.2%] received intervention) and 119 to EUC (mean [SD] age, 30.1 [5.9] years; 62 [52.1%] enrolled in Medicaid; 44 [37%] had MDD). The 20-item Symptom Checklist scores improved from baseline over gestation for IPT but not EUC (d = 0.57; 95% CI, 0.22-0.91; mean [SD] change for IPT vs EUC: 26.7 [1.14] to 13.6 [1.40] vs 27.1 [1.12] to 23.5 [1.34]). IPT participants more rapidly improved on Edinburgh Postnatal Depression Scale compared with EUC (d = 0.40; 95% CI, 0.06-0.74; mean [SD] change for IPT vs EUC: 11.4 [0.38] to 5.4 [0.57] vs 11.5 [0.37] to 7.6 [0.55]). MDD rate by end of gestation had decreased significantly for IPT participants (7 [6.1%]) vs EUC (31 [26.1%]) (odds ratio, 4.99; 95% CI, 2.08-11.97). Conclusions and Relevance: In this study, brief IPT significantly reduced prenatal depression symptoms and MDD compared with EUC among pregnant individuals from diverse racial, ethnic, and socioeconomic backgrounds recruited from primary OB/GYN clinics. As a safe, effective intervention to relieve depression during pregnancy, brief IPT may positively affect mothers' mental health and the developing fetus. Trial Registration: ClinicalTrials.gov Identifier: NCT03011801.

Interpersonal psychotherapy-adolescent skills training: anxiety outcomes and impact of comorbidity.

Given the frequent comorbidity of anxiety and depression, it is important to study the effects of depression interventions on anxiety and the impact of comorbid anxiety on depression outcomes. This article reports on pooled anxiety and depression data from two randomized trials of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), a depression prevention program. Ninety-eight adolescents were randomized to receive IPT-AST or school counseling (SC). Outcome and predictor analyses were performed utilizing hierarchical linear models. IPT-AST adolescents had significantly greater reductions in anxiety and depressive symptoms than SC adolescents during the intervention. Baseline anxiety symptoms predicted change in depressive symptoms for adolescents in both intervention conditions, with adolescents low in baseline anxiety demonstrating more rapid change in depressive symptoms than adolescents high in baseline anxiety. These findings indicate that IPT-AST is effective at decreasing both depressive and anxiety symptoms. For adolescents with comorbid symptoms of anxiety, there may be slower rates of change in depressive symptoms following prevention programs.

Evaluation of a group cognitive-behavioral depression prevention program for young adolescents: a randomized effectiveness trial.

Depression is a common psychological problem in adolescence. Recent research suggests that group cognitive-behavioral interventions can reduce and prevent symptoms of depression in youth. Few studies have tested the effectiveness of such interventions when delivered by school teachers and counselors (as opposed to research team staff). We evaluated the effectiveness of the Penn Resiliency Program for adolescents (PRP-A), a school-based group intervention that targets cognitive behavioral risk factors for depression. We randomly assigned 408 middle school students (ages 10-15) to one of three conditions: PRP-A, PRP-AP (in which adolescents participated in PRP-A and parents were invited to attend a parent intervention component), or a school-as-usual control. Adolescents completed measures of depression and anxiety symptoms, cognitive style, and coping at baseline, immediately after the intervention, and at 6-month follow-up. PRP-A reduced depression symptoms relative to the school as usual control. Baseline levels of hopelessness moderated intervention effects. Among participants with average and high levels of hopelessness, PRP (A and AP) significantly improved depression symptoms, anxiety symptoms, hopelessness, and active coping relative to control. Among participants with low baseline hopelessness, we found no intervention effects. PRP-AP was not more effective than PRP-A alone. We found no intervention effects on clinical levels of depression or anxiety. These findings suggest that cognitive-behavioral interventions can be beneficial when delivered by school teachers and counselors. These interventions may be most helpful to students with elevated hopelessness.

The temporal relationships between therapist adherence and patient outcomes in dialectical behavior therapy.

OBJECTIVE: Although Dialectical Behavior Therapy (DBT) is a well-established evidence-based psychotherapy, little is known about the role of therapist adherence in promoting positive outcomes. This study evaluated the temporal relationships between therapist adherence to DBT and patient outcomes, as well as potential moderators of these relationships. METHOD: Data were from six clinical trials conducted in research and community settings with a variety of patient populations. In these trials, trained observers rated 83 therapists for adherence during 1,262 DBT individual therapy sessions with 288 patients. Patient outcomes included suicide attempts, nonsuicidal self-injury (NSSI), treatment dropout, psychiatric hospitalizations, and global functioning. Longitudinal mixed-effects models evaluated the time-ordered, bidirectional relationships between adherence and outcomes. RESULTS: Higher therapist adherence significantly predicted fewer subsequent suicide attempts (p = .002, η = 0.32) and a lower risk of dropout (p = .002, η = 0.33), and the latter relationship was strongest among patients with comorbid opioid dependence. Higher therapist adherence predicted fewer subsequent hospitalizations among community therapists (p = .001, η = 0.35) and patients that were not exclusively suicidal/self-injuring (p < .001, η = 0.41). Conversely, more frequent NSSI (p = .03, η = 0.22) and worse global functioning (p = .01, η = 0.26) predicted higher subsequent therapist adherence, and the latter relationship was moderated by patient population. CONCLUSIONS: Therapist adherence improves several key patient outcomes and retention, highlighting the importance of delivering DBT with adherence to the manual. Therapists may find it easier to deliver DBT adherently to more severely impaired patients. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Evaluation of Clinical Metrics for Identifying Defective Physiologic Responses to Hypoglycemia in Long-Standing Type 1 Diabetes.

Repeated hypoglycemia exposure leads to impaired awareness of hypoglycemia (IAH) and the development of defective counterregulatory responses. To date, only pancreas or islet transplantation has demonstrated normalization of hypoglycemia awareness and the endogenous glucose production (EGP) response to defend against insulin-induced hypoglycemia in long-standing type 1 diabetes (T1D). This study aims to validate clinical metrics of IAH (Clarke score), hypoglycemia severity (HYPO score), glycemic lability (lability index), and continuous glucose monitoring (CGM) as predictors of absent autonomic symptom (AS) recognition and defective glucose counterregulation during insulin-induced hypoglycemia, thus enabling early identification of individuals with compromised physiologic defense against clinically significant hypoglycemia. Forty-three subjects with mean ± standard deviation age 43 ± 13 years and T1D duration 28 ± 13 years, including 32 with IAH and 11 with hypoglycemia awareness (Aware), and 12 nondiabetic control subjects, underwent single-blinded randomized-paired hyperinsulinemic-euglycemic and hypoglycemic clamp experiments. Receiver operating characteristic (ROC) curves and sensitivity analyses were performed to assess metric prediction of absent AS recognition and defective EGP responses to hypoglycemia. Clarke score and CGM measures of hypoglycemia exposure demonstrated good ability to predict absent AS recognition (area under the curve ≥0.80). A composite threshold of IAH-Clarke ≥4 with ROC curve-derived thresholds for CGM measures of hypoglycemia exposure showed high specificity and predictive value in identifying an absent AS response during the hypoglycemic clamp. Metrics demonstrated poor ability to predict defective glucose counterregulation by the EGP response, which was impaired even in the Aware group. Screening for IAH alongside assessment of CGM data can increase the specificity for identifying individuals with absent hypoglycemia symptom recognition who may benefit from further intervention.

The Dialectical Behavior Therapy Adherence Coding Scale (DBT ACS): Psychometric properties.

The Dialectical Behavior Therapy Adherence Coding Scale (DBT ACS) is an observer-rated measure used to evaluate the extent to which therapists deliver individual and group DBT with adherence to the manual. Despite its frequent use in clinical trials of DBT, relatively little is known about its psychometric properties. The present study utilized data from six clinical trials conducted in research and community settings with a variety of patient populations. Across these studies, the DBT ACS was used to code a total of 1,271 DBT individual therapy sessions and 180 DBT group sessions. Results indicate the DBT ACS computed global score has good internal consistency (α = .81) and excellent interrater reliability (ICC = .93). A confirmatory factor analysis found that a single factor yielded acceptable goodness of fit indices. The DBT ACS discriminated between DBT and another treatment and between research and community therapists. Across studies, variability in adherence scores was attributable more to therapists (33%) than to patients (15%). Both therapist and patient variability were higher in effectiveness than efficacy trials. Generalizability coefficients indicated that 5 sessions are needed to estimate a dependable adherence score at the patient level, whereas 9-15 sessions are needed to achieve adequate generalizability at the therapist level. Fewer sessions were needed to yield dependable scores for community therapists compared to research therapists. The DBT ACS appears to be a reliable, valid, and dependable method of assessing therapist adherence to individual and group DBT across diverse treatment settings, therapist types, and patient populations. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Does Adding the Dialectical Behavior Therapy Prolonged Exposure (DBT PE) Protocol for PTSD to DBT Improve Outcomes in Public Mental Health Settings? A Pilot Nonrandomized Effectiveness Trial With Benchmarking.

The Dialectical Behavior Therapy Prolonged Exposure (DBT PE) protocol improves DBT's effects on PTSD in research settings, but its effectiveness in community settings is largely unknown. This pilot nonrandomized controlled trial examined DBT with and without DBT PE in four public mental health agencies. Patients (N = 35, 12-56 years old, 80.0% female, 64.7% racial/ethnic minorities, 44.1% sexual minorities) had PTSD, were receiving DBT, and completed assessments every four months over one year. Sixteen patients (45.7%) initiated DBT PE, 19 (54.3%) did not, and dropout did not differ between groups (31.3% vs. 26.3%). The primary barrier to initiating DBT PE was clinician turnover (57.9% of non-initiators). After adjusting for confounds, DBT PE initiators (g = 1.1) and completers (g = 1.4) showed a greater reduction in PTSD than patients who received DBT only (g = 0.5; p's < .05). Rates of reliable improvement in PTSD were 71.4% (DBT PE completers), 53.8% (DBT PE initiators), and 31.3% (DBT). Similar patterns were observed for posttraumatic cognitions, emotion dysregulation, general psychological distress, and limited activity days. There was no worsening of self-injurious behavior or crisis service use among patients who received DBT PE. Benchmarking analyses indicated comparable feasibility, acceptability, and safety, but a smaller magnitude of clinical change, than in efficacy studies. Results require replication in a randomized trial but suggest that DBT PE can be transported effectively to community settings.

Efficacy and tolerability of baclofen in a U.S. community population with alcohol use disorder: a dose-response, randomized, controlled trial.

Identification of new medications for alcohol use disorder (AUD) is important for improving treatment options. Baclofen, a GABAB agonist, has been identified as a potential pharmacotherapy for AUD. In a 16-week double-blind, randomized, placebo-controlled trial, we investigated 30 and 90 mg/day of baclofen compared to placebo and examined effects of dose, sex, and level of pretreatment drinking. One hundred and twenty participants with DSM-IV alcohol dependence (age 46.1 (sd = 10.1) years, 51.7% male) were randomized after exclusion for unstable medical/psychiatric illness and/or dependence on drugs other than nicotine. Seventy-three participants completed the trial. A main effect of baclofen was found [%HDD (F(2,112) = 4.16, p = 0.018, d = 0.51 95%CI (0.06-0.95), 13.6 fewer HDD) and %ABST (F(2,112) = 3.68, p = 0.028, d = 0.49 95%CI (0.04-0.93), 12.9 more abstinent days)] and was driven by the 90 mg/day dose. A sex × dose interaction effect was present for both %HDD (F(2,110) = 5.48, p = 0.005) and %ABST (F(2,110) = 3.19, p = 0.045). Men showed a marginally positive effect for 90 mg/day compared to PBO (%HDD t(110) = 1.88, p = 0.063, d = 0.36 95%CI (-0.09-0.80), 15.8 fewer HDD days; %ABST t(110) = 1.68 (p = 0.096, d = 0.32 95%CI (-0.12-0.76), 15.7 more ABST)) with no effect for 30 mg/day. Women showed a positive effect for 30 mg/day (%HDD, t(110) = 3.19, p = 0.002, d = 0.61 95%CI (0.16-1.05), 26.3 fewer HDD days; %ABST t(110) = 2.73, p = 0.007, d = 0.52 95%CI (0.07-0.96), 25.4 more ABST days) with marginal effects for 90 mg/day on %ABST (p = 0.06) with drop-outs/dose reduction from sedative side-effects of 59% in women at 90 mg/day compared to 5% for men. These findings support the hypothesis that baclofen has efficacy in AUD and suggest that dose and sex be further explored as potential moderators of baclofen response and tolerability.