Mentalizing in and out of awareness: A meta-analytic review of implicit and explicit mentalizing.

BACKGROUND: Mentalizing, making sense of mental states, is hypothesized to have a central role in self-organization and social learning. Findings support this notion, but the extent of the association between mentalizing and various correlates has not been meta-analyzed. Furthermore, mentalizing presumably occurs with (explicit) and without (implicit) awareness but few studies have attempted to disentangle these aspects. We conducted a meta-analysis of implicit and explicit mentalizing in relation to the domains of attachment security, personality, affect, psychopathology, and functioning. METHODS: We searched for studies of adult mentalizing in PsycINFO and in related reviews. Overall, 511 studies (N = 78,733) met criteria and were analyzed using multi-level meta-analysis. RESULTS: Implicit (r = 0.19-0.29) and explicit (r = 0.26-0.40) mentalizing were moderately correlated with psychopathology, functioning, personality, affect, and attachment security. The correlations of implicit mentalizing were stronger with more objectively measured correlates (b = 0.02, p < .001) while the correlations of explicit mentalizing were not (b = -0.07, p = .21). CONCLUSIONS: Mentalizing is associated with better intra- and interpersonal functioning. Implicit mentalizing is more strongly associated with objectively measured correlates. These findings underscore the importance of an integrative approach considering both implicit and explicit mentalizing.

Trading Patients: Applying the Alternative Model for Personality Disorders to Two Cases of DSM-5 Borderline Personality Disorder Over Time and Across Therapists.

The DSM-5 Alternative Model for Personality Disorders (AMPD) dimensionally defines personality pathology using severity of dysfunction and maladaptive style. As the empirical literature on the clinical utility of the AMPD grows, there is a need to examine changes in diagnostic profiles and personality expression in treatment over time. Assessing these changes in individuals diagnosed with borderline personality disorder (BPD) is complicated by the tendency for patients to cycle through multiple therapists over the course of treatment leaving the potential for muddled diagnostic clarity and disjointed case conceptualizations. Following patient trajectories across therapists offers a unique opportunity to examine the AMPD's sensitivity to and utility for capturing personality stability and change over time for patients with BPD. This article demonstrates the utility of the AMPD for two clinical cases in three distinct ways: (i) highlighting heterogeneity in BPD between patients, (ii) comparing improvements in personality severity and style over time, and (iii) elucidating profile change across therapist ratings. We present two patients diagnosed with DSM-5 Section II BPD, crossing between two therapists over the course of 3 years of psychodynamic psychotherapy. Treating clinicians rated patients for their respective treatment phases using the Level of Personality Functioning Scale (LPFS), capturing severity, and the Personality Inventory for the DSM-5 (PID-5), capturing style. AMPD diagnostic profiles differentiated patients with BPD in both severity and style, and captured within-patient change beyond within-therapist response bias. Results indicated greater improvements in personality severity while personality style remained more stable. Implications for the patients' treatment progress and associated challenges are discussed, as are considerations for the utility of the AMPD in therapy.

Community and Clinical Epidemiology of Borderline Personality Disorder.

Several studies of the prevalence of borderline personality disorder in community and clinical settings have been carried out to date. Although results vary according to sampling method and assessment method, median point prevalence is roughly 1%, with higher or lower rates in certain community subpopulations. In clinical settings, the prevalence is around 10% to 12% in outpatient psychiatric clinics and 20% to 22% among inpatient clinics. Further research is needed to identify the prevalence and correlates of borderline personality disorder in other clinical settings (eg, primary care) and to investigate the impact of demographic variables on borderline personality disorder prevalence.

The role of emotion regulation difficulties in the connection between childhood emotional abuse and borderline personality features.

In the present report from the Rhode Island Methods to Improve Diagnostic Assessment and Services project, we examined the role of emotion dysregulation as a mediator between childhood abuse and borderline personality disorder (BPD) feature severity among a sample of 964 adults presenting for treatment at an outpatient clinic. A structural equation model suggested that emotional abuse relates to BPD features both directly and through difficulties with emotion regulation, whereas physical abuse showed only a weak indirect relation with BPD features. There was no link between sexual abuse and BPD feature severity in the model. Results add specificity to etiological theories of BPD and suggest that future research in treatment should focus on developing and strengthening emotion regulation strategies in clinical populations with a history of emotional abuse. Clinicians should be sure to assess the presence of childhood emotional abuse in addition to sexual and physical abuse. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Inclusion/exclusion criteria in late life depression antidepressant efficacy trials.

OBJECTIVE: The generalizability of antidepressant efficacy trials (AETs) has been questioned. No studies have examined the inclusion/exclusion criteria used in placebo-controlled studies of late life depression and compared them to the criteria used in non-late life AETs. METHOD: We conducted a comprehensive literature review of placebo-controlled AETs published from January, 1995 through December, 2014. We compared the inclusion/exclusion criteria used in the 18 studies of late life depression to those used in non-late life depression. RESULTS: There were nine inclusion/exclusion criteria that were used in more than half of the late life depression AETs: minimum severity on a symptom severity scale (100.0%), significant suicidal ideation (77.8%), psychotic features during the current episode of depression or history of a psychotic disorder (94.4%), history of bipolar disorder (77.8%), diagnosis of alcohol or drug abuse or dependence (83.3%), presence of a comorbid nondepressive, nonsubstance use Axis I disorder (55.6%), episode duration too short (66.7%), and an insufficient score on a cognitive screen (88.3%) or the presence of a cognitive disorder (55.6%). There were some differences between the late life and non-late life depression studies-use of a screening measure of cognitive functioning, presence of a cognitive disorder such as dementia, and the minimum depression severity cutoff score required at baseline. CONCLUSIONS: The inclusion/exclusion criteria in AETs of late life depression were generally similar to the criteria used in non-late life depression AETs. Copyright © 2016 John Wiley & Sons, Ltd.

The Psychiatric Inclusion and Exclusion Criteria in Placebo-Controlled Monotherapy Trials of Bipolar Depression: An Analysis of Studies of the Past 20 Years.

BACKGROUND: Concerns about the generalizability of pharmacotherapy efficacy trials to "real-world" patients have been raised for more than 40 years. Almost all of this literature has focused on treatment studies of major depressive disorder (MDD). OBJECTIVE: The aim of the study was to review the psychiatric inclusion and exclusion criteria used in placebo-controlled trials that assessed the efficacy of medications for bipolar depression (bipolar disorder efficacy trials [BDETs]) and compare the criteria used in BDETs with those used in efficacy trials of antidepressants to treat MDD (antidepressant efficacy trials [AETs]). METHODS: We searched the MEDLINE, Embase, and PsycINFO databases for articles published from January 1995 through December 2014. We identified 170 placebo-controlled AETs and 22 BDETs published during these 20 years. Two of the authors independently reviewed each article and completed a pre-specified information extraction form listing the psychiatric inclusion and exclusion criteria used in the study. RESULTS: Six inclusion/exclusion criteria were used in at least half of the BDETs: minimum severity on a depression symptom severity scale, significant suicidal ideation, diagnosis of alcohol or drug use disorder, presence of a comorbid nondepressive, nonsubstance use Axis I disorder, current episode of depression being too long, and absence of current manic symptoms. BDETs were significantly less likely than AETs to exclude patients with a history of psychotic features/disorders, borderline personality disorder, and post-traumatic stress disorder and more likely to exclude individuals who scored too low on the first item of the Hamilton Depression Rating Scale. Nearly two-thirds of the BDETs placed an upper limit on the duration of the current depressive episode, three times higher than the rate in the AETs. There was no difference on other variables between the AETs and BDETs. CONCLUSIONS: Similar to treatment studies of nonbipolar MDD, the treatment studies of bipolar depression frequently excluded patients with comorbid psychiatric and substance use disorders and insufficient severity of depressive symptoms as rated on standardized scales. These findings indicate that concerns about the generalizability of data from trials of recently approved medications for the treatment of bipolar depression are as relevant as the concerns that have been raised about studies of antidepressants for nonbipolar depression.

Variability in the substance use disorder exclusion criterion in antidepressant efficacy trials.

BACKGROUND: Substance use disorders are the most commonly excluded psychiatric disorder in antidepressant efficacy trials (AETs). In a recent review of AETs we noticed variability in the definition of the substance use disorder exclusion criterion. In the present report we examined in greater detail the variability in defining the substance use disorder exclusion criterion, the potential impact of this variability on excluding patients from an AET, and whether the definition of the criterion has changed in the past 20 years. METHODS: We identified 170 AETs published during the past 20 years and compared the studies published during the past 5 years (n=56) to the studies published during the 15 prior years (n=114). RESULTS: Substance abuse was more frequently used as an exclusion criterion than substance dependence. Six time frames have been used as the basis of exclusion, the most frequent being the past 12 months. The time frame had a greater impact on the number of patients who would be excluded than the abuse/dependence distinction. The definition of the substance use exclusion criterion was no different in the studies of the past 5 years compared to the prior 15 years. LIMITATIONS: A limitation of the present analysis is that it was based on published placebo-controlled studies of antidepressants. CONCLUSION: Studies varied in whether abuse or dependence was the basis of exclusion, whether alcohol or illicit drugs or both were the basis of exclusion, and the time frame of the disorders' presence. We raise the question of whether the routine exclusion of patients with a substance use disorder should be reflected in a product's label.

Symptom Severity and the Generalizability of Antidepressant Efficacy Trials: Changes During the Past 20 Years.

The most commonly used inclusion/exclusion criterion in antidepressant efficacy trials (AETs) is a minimum score on a symptom severity scale. In the present study, we reviewed placebo-controlled AETs published during the past 20 years to determine whether there has been a change in the symptom severity inclusion criterion threshold subsequent to publications that highlighted the unrepresentativeness of the depressed patients studied in AETs. We identified 170 AETs published during the past 20 years and compared the studies published during the past 5 years (2010-2104, n = 56) with the studies published during the previous 15 years (n = 114). The symptom severity threshold for inclusion has increased in the more recent cohort of studies. On the 17-item Hamilton Depression Rating Scale, almost half of the studies of the past 5 years used a cutoff of 22 or greater to select patients versus less than one-fifth of the studies during the previous 15 years (44.0% vs 17.5%; χ(2) = 7.4; P < 0.01). Similarly, the cutoff on the Montgomery-Asberg Depression Rating Scale required for study inclusion has been higher in studies of the past 5 years with approximately three-quarters of the recent studies using a cutoff of at least 25, in contrast to one-quarter of the older studies (76.2% vs 25.0%; χ(2) = 8.2; P < 0.01). A significantly higher percentage of patients in our clinical practice would be excluded on the basis of the severity thresholds of the past 5 years (59.3 ± 13.5 vs 49.0 ± 15.1; t121 = 3.1; P < 0.005). These findings suggest that the results of AETs may not be applicable to less severely depressed patients who make up at least half of the patients treated in routine clinical practice. Questions are raised about the Food and Drug Administration labeling of antidepressants.

Problems in the Descriptions of the Psychiatric Inclusion and Exclusion Criteria in Publications of Antidepressant Efficacy Trials: A Qualitative Review and Recommendations for Improved Clarity.

We recently conducted a comprehensive review of the psychiatric inclusion and exclusion criteria used in 170 placebo-controlled antidepressant efficacy trials (AETs) that were published between 1995 and 2014. In conducting this literature review, we identified a number of instances in which the descriptions of the inclusion/exclusion criteria were vague, redundant, or difficult to interpret. In the present article, we describe nine problems we encountered in our literature review. We recommend that future publications follow the examples found in a few studies in which the inclusion/exclusion criteria are clearly defined and listed in a table.

Inclusion/exclusion criteria in placebo-controlled studies of vortioxetine: Comparison to other antidepressants and implications for product labeling.

BACKGROUND: We recently conducted a comprehensive review of the psychiatric inclusion/exclusion criteria used in 170 placebo-controlled antidepressant efficacy trials (AETs) published during the past 20 years and found that the criteria of more recent studies were significantly more restrictive than prior studies. Vortioxetine is the most recently approved medication for the treatment of major depressive disorder (MDD). We compared the inclusion/exclusion criteria of the vortioxetine studies to the criteria used in other AETs, and discuss the broader issue of the generalizability of AETs and the implications this might have for the labeling of antidepressants receiving FDA approval. METHODS: We conducted a comprehensive literature review of placebo-controlled AETs published from January, 1995 through December, 2014. We identified 170 AETs published during this 20 year period and compared the inclusion/exclusion criteria used in the 12 studies of vortioxetine to those used in the nonvortioxetine studies. A second analysis compared vortioxetine to the 3 antidepressants most recently approved prior to vortioxetine (desvenlafaxine, levomilnacipran extended release, vilazodone). RESULTS: Compared to the nonvortioxetine AETs, the vortioxetine studies significantly more often excluded patients with any comorbid Axis I disorder (p<.001) and more often required the current depressive episode to be longer than the DSM minimum symptom duration requirement of 2 weeks (p<.01). The cutoff on the Montgomery Asberg Depression Rating Scale required for inclusion in the vortioxetine studies was higher than the cutoff used in the other AETs (p<.01). LIMITATIONS: A limitation of the present analysis is that it was based on published placebo-controlled studies of antidepressants. CONCLUSION: The inclusion/exclusion criteria in the studies of vortioxetine were more restrictive than the criteria used in other AETs. Inconsistent with FDA guidelines on the labeling of medications, the label of vortioxetine does not include a description of the limits to the group of patients with MDD for whom the medication has been shown to be effective.

Have Treatment Studies of Depression Become Even Less Generalizable? A Review of the Inclusion and Exclusion Criteria Used in Placebo-Controlled Antidepressant Efficacy Trials Published During the Past 20 Years.

OBJECTIVE: To compare the inclusion and exclusion criteria used in antidepressant efficacy trials (AETs) published during the past 5 years with those used in studies published during the previous 15 years. PATIENTS AND METHODS: We conducted a comprehensive literature review of placebo-controlled AETs published from January 1995 through December 2014. We included trials whether or not the medication has received regulatory approval for the treatment of depression. We compared the inclusion and exclusion criteria of studies published during the past 5 years (2010-2014) with those of studies published during the previous 15 years (1995-2009). RESULTS: We identified 170 placebo-controlled AETs published during the past 20 years, 56 of which were published during the past 5 years. The more recent studies were significantly more likely to exclude patients with comorbid Axis I disorders and personality disorders, patients with the episode duration either too long or too short, and patients who had made a suicide attempt in the past. The severity threshold on depression rating scales required for inclusion was higher in the more recent studies. CONCLUSION: The inclusion and exclusion criteria of AETs have become more stringent over the past 5 years, thereby suggesting that AETs may be even less generalizable than they were previously (when concerns about their generalizability had already been raised).