EMDR therapy vs. supportive therapy as adjunctive treatment in trauma-exposed bipolar patients: A randomised controlled trial.

INTRODUCTION: Patients with bipolar disorder (BD) are frequently exposed to traumatic events which worsen disease course, but this study is the first multicentre randomised controlled trial to test the efficacy of a trauma-focused adjunctive psychotherapy in reducing BD affective relapse rates. MATERIALS AND METHODS: This multicentre randomised controlled trial included 77 patients with BD and current trauma-related symptoms. Participants were randomised to either 20 sessions of trauma-focused Eye Movement Desensitization and Reprocessing (EMDR) therapy for BD, or 20 sessions of supportive therapy (ST). The primary outcome was relapse rates over 24-months, and secondary outcomes were improvements in affective and trauma symptoms, general functioning, and cognitive impairment, assessed at baseline, post-treatment, and at 12- and 24-month follow-up. The trial was registered prior to starting enrolment in clinical trials (NCT02634372) and carried out in accordance with CONSORT guidelines. RESULTS: There was no significant difference between treatment conditions in terms of relapse rates either with or without hospitalisation. EMDR was significantly superior to ST at the 12-month follow up in terms of reducing depressive symptoms (p=0.0006, d=0.969), manic symptoms (p=0.027, d=0.513), and improving functioning (p=0.038, d=0.486). There was no significant difference in dropout between treatment arms. CONCLUSIONS: Although the primary efficacy criterion was not met in the current study, trauma-focused EMDR was superior to ST in reducing of affective symptoms and improvement of functioning, with benefits maintained at six months following the end of treatment. Both EMDR and ST reduced trauma symptoms as compared to baseline, possibly due to a shared benefit of psychotherapy. Importantly, focusing on traumatic events did not increase relapses or dropouts, suggesting psychological trauma can safely be addressed in a BD population using this protocol.

High incidence of PTSD diagnosis and trauma-related symptoms in a trauma exposed bipolar I and II sample.

Background: Post-traumatic stress disorder (PTSD) is an established comorbidity in Bipolar Disorder (BD), but little is known about the characteristics of psychological trauma beyond a PTSD diagnosis and differences in trauma symptoms between BD-I and BD-II. Objective: (1) To present characteristics of a trauma-exposed BD sample; (2) to investigate prevalence and trauma symptom profile across BD-I and BD-II; (3) to assess the impact of a lifetime PTSD diagnosis vs. a history of trauma on BD course; and (4) to research the impacts of sexual and physical abuse. Methods: This multi-center study comprised 79 adult participants with BD with a history of psychological trauma and reports baseline data from a trial registered in Clinical Trials (https://clinicaltrials.gov; ref: NCT02634372). Clinical variables were gathered through clinical interview, validated scales and a review of case notes. Results: The majority (80.8%) of our sample had experienced a relevant stressful life event prior to onset of BD, over half of our sample 51.9% had a lifetime diagnosis of PTSD according to the Clinician Administered PTSD scale. The mean Impact of Event Scale-Revised scores indicated high levels of trauma-related distress across the sample, including clinical symptoms in the PTSD group and subsyndromal symptoms in the non-PTSD group. Levels of dissociation were not higher than normative values for BD. A PTSD diagnosis (vs. a history of trauma) was associated with psychotic symptoms [2(1) = 5.404, p = 0.02] but not with other indicators of BD clinical severity. There was no significant difference between BD-I and BD-II in terms of lifetime PTSD diagnosis or trauma symptom profile. Sexual abuse significantly predicted rapid cycling [2(1) = 4.15, p = 0.042], while physical abuse was not significantly associated with any clinical indicator of severity. Conclusion: Trauma load in BD is marked with a lack of difference in trauma profile between BD-I and BD-II. Although PTSD and sexual abuse may have a negative impact on BD course, in many indicators of BD severity there is no significant difference between PTSD and subsyndromal trauma symptoms. Our results support further research to clarify the role of subsyndromic PTSD symptoms, and highlight the importance of screening for trauma in BD patients.

Measurement equivalence of PROMIS depression in Spain and the United States.

In this study, we assessed the psychometric properties of the Spanish Patient-Reported Outcomes Measurement Information System (PROMIS) Depression in an adult population-representative sample from Spain (n = 1,503). We tested unidimensionality and local independence item response theory (IRT) assumptions with confirmatory factor and bifactor models under the exploratory structural equations modeling framework. We evaluated item monotonicity assumption with Mokken scaling analysis. We calibrated the items with an IRT-graded response model and assessed score reliability and test information, and evidence of validity with regard to scores on external measures. To examine differential item functioning by age, sex, education, and country (United States vs. Spain, N = 2,271), we used ordinal logistic regression. Results support compliance with IRT assumptions. We found few signs of differential item functioning: Only one item showed country differential functioning between the United States (n = 768) and Spain, with minimal impact on the overall score. Information values were equivalent to reliabilities over 0.90 from -1 (low depression) to +4 SD (high depression) around the population score mean. Evidence of validity in relation to concurrent measures was supported by the expected correlation pattern with external variables of depression, but higher than expected correlations with anxiety were found. Results indicate that the Spanish version of PROMIS Depression is adequate for assessing and monitoring depression levels in the general population and that PROMIS Depression is especially suitable for cross-national comparisons. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Change in functioning outcomes as a predictor of the course of depression: a 12-month longitudinal study.

PURPOSE: Functioning is a necessary diagnostic criterion for depression, and thus routinely assessed in depressive patients. While it is highly informative of disorder severity, its change has not been tested for prognostic purposes. Our study aimed to analyze to what extent early functioning changes predict depression in the mid-term. METHODS: Longitudinal study (four occasions: baseline, 1, 3, and 12 months) of 243 patients with depressive symptomatology at three different services (primary care, outpatients, and hospital). Functioning was assessed on the first three occasions using the Global Assessment of Functioning (GAF), the WHODAS-2.0, and a self-reported functioning (SRF) rating scale. Growth mixture modeling of initial assessments served to estimate individual person-change parameters of each outcome. Person-growth parameters were used as predictors of major depressive episode at 12 months in a logistic regression model, adjusted by sex, age, healthcare level, and depression clinical status at third month. Predictive accuracy of all measures was assessed with area under the receiver operating curve (AUC). RESULTS: Of the 179 patients who completed all assessments, 58% had an active depression episode at baseline and 20% at 12 months (64% non-recoveries and 36% new onsets). Individual trends of change in functioning significantly predicted patient depression status a year later (AUCWHODAS = 0.76; AUCGAF = 0.92; AUCSRF = 0.93). CONCLUSIONS: Longitudinal modeling of functioning was highly predictive of patients' clinical status after 1 year. Although clinical and patient-reported assessment had high prognostic value, the use of very simple patient-reported outcome measures could improve case management outside specialized psychiatric services.

Asking patients about their general level of functioning: Is IT worth IT for common mental disorders?

Functional disability (FD) is a diagnostic criterion for the psychiatric diagnosis of many mental disorders (e.g. generalized anxiety disorder (GAD); major depressive episode (MDE)). We aimed to assess the contribution of measuring FD to diagnosing GAD and MDE using clinical (Global Assessment of Functioning, GAF) and self-reported methods (Analog scale of functioning, ASF and World Health Organization Disability Assessment Schedule WHODAS 2.0). Patients seeking professional help for mood/anxiety symptoms (N=244) were evaluated. The MINI interview was used to determine the presence of common mental disorders. Symptoms were assessed with two short checklists. Logistic and hierarchical logistic models were used to determine the diagnostic accuracy and the added diagnostic value of FD assessment in detecting GAD and MDE. For GAD, FD alone had a diagnostic accuracy of 0.79 (GAF), 0.79 (ASF) and 0.78 (WHODAS) and for MDE of 0.83, 0.84 and 0.81, respectively. Self-reported measures of FD improved the diagnostic performance of the number of symptoms (4% AUC increase) for GAD, but not for MDE. If assessed before symptom evaluation, FD can discriminate well between patients with and without GAD/MDE. When assessed together with symptoms, self-reported methods improve GAD detection rates.

DETECTION OF ANXIETY DISORDERS IN PRIMARY CARE: A META-ANALYSIS OF ASSISTED AND UNASSISTED DIAGNOSES.

BACKGROUND: Evidence suggests that general practitioners (GPs) fail to diagnose up to half of common mental disorder cases. Yet no previous research has systematically summarized the evidence in the case of anxiety disorders. The aim of this review was to systematically assess and meta-analyze the diagnostic accuracy of GPs' assisted (i.e., using severity scales/diagnostic instruments) and unassisted (without such tools) diagnoses of anxiety disorders. METHODS: Systematic review (PROSPERO registry CRD42013006736) was conducted. Embase, Ovid Journals--Ovid SP Medline, Pubmed, PsycINFO, Scopus, Web of Science, and Science Direct were searched from January 1980 through June 2014. Seven investigators, working in pairs, evaluated studies for eligibility. The quality of included studies was assessed with the Quality Assessment of Diagnostic Accuracy Studies tool version 2 (QUADAS-2). The main outcome measures were sensitivity and specificity of clinical diagnoses of any anxiety disorder. We pooled sensitivity and specificity levels from included studies using bivariate meta-analyses. RESULTS: Twenty-four studies were included in the meta-analysis with a total sample of 34,902 patients. Pooled sensitivity and specificity were estimated at 44.5% (95% CI 33.7-55.9%) and 90.8% (95% CI 87-93.5%). GPs' sensitivity was higher when diagnoses were assisted (63.6%, 95% CI 50.3-75.1%) than when unassisted (30.5%, 95% CI 20.7-42.5%) to the expense of some specificity loss (87.9%, 95% CI 81.3-92.4% vs. 91.4%, 95% CI 86.6-94.6%, respectively). Identification rates remained constant over time (P-value = .998). CONCLUSIONS: The use of diagnostic tools might improve detection of anxiety disorders in "primary care."

Diagnostic accuracy and adequacy of treatment of depressive and anxiety disorders: A comparison of primary care and specialized care patients.

BACKGROUND: Clinical diagnosis of depressive and anxiety disorders has poor sensitivity, and treatment is often not guideline-concordant. This longitudinal study aims to compare diagnostic validity and treatment adequacy in primary care (PC) and specialized care (SC), to assess associated risk factors, and to evaluate their impact on clinical outcome at one-month and three-month follow-ups. METHODS: Two hundred twelve patients with depressive and anxious symptoms were recruited from 3 PC and 1 SC centers in Barcelona, Spain. Sensitivity and specificity were calculated comparing medical records׳ diagnoses with a reference (MINI interview). Adequate treatment was defined according to clinical guidelines. Logistic regression was used to estimate associations with risk factors. Impact on outcome was assessed with MANOVA models. RESULTS: Valid diagnosis of depression was more frequent in patients attending SC. Sensitivity for depression was 0.75 in SC and 0.49 in PC (adjusted OR=17.34, 95% CI=4.73-63.61). Detection of anxious comorbidity in depressed patients was low (50%) in SC. Treatment adequacy of depressive disorders was higher in SC than in PC (94.4% vs. 80.6%, adjusted OR=8.11, 95% CI=1.39-47.34). Depression severity was associated with valid diagnosis. LIMITATIONS: Only four disorders (major depression, dysthymia, panic disorder and generalized anxiety disorder) were evaluated with the MINI interview in a convenience clinical sample. Treatment dosage was unavailable. CONCLUSIONS: Our results suggest that GPs need tools to improve detection of depression and its severity. Psychiatrists should enhance recognition of anxious comorbidity. Evaluation of the impact on outcome deserves further research.

Validation of clinical symptom IRT scores for diagnosis and severity assessment of common mental disorders.

PURPOSE: We studied the validity and responsiveness of an item response theory (IRT) scoring method for assessing major depressive episode (MDE) and generalized anxiety disorder (GAD) severity based on direct assessment of DSM-IV-TR symptoms. METHODS: Prospective cohort study (baseline, 1-month, 3-months assessments) of patients seeking help for incident or aggravated mood or anxiety symptoms from primary, outpatient and inpatient mental health centers (N = 244; 67.81 % active cases - 100 % under psychiatric treatment). The drop-out rate at 3 months was 24.89 %. Patients were assessed at each follow-up for presence/absence of DSM-IV symptoms of MDE (nine symptoms) and GAD (eight symptoms). IRT scores for depression (INS-D) and anxiety (INS-G), based on response patterns, were obtained by means of a 2-parameter model. Diagnostic accuracy was assessed with receiver operating characteristic analysis, using a blinded MINI interview as gold standard. Scores' construct validity was compared with external clinician-administered (Hamilton Depression Rating Scale, HRSD; Hamilton Anxiety Rating Scale, HAM-A) and self-reported severity measures (PHQ-9; Beck Anxiety Inventory-Subjective Aspects, BAI-Sub). Responsiveness was analyzed based on the evolution of HRSD and HAM-A scores. RESULTS: Both severity scores showed excellent reliability (INS-D: 0.92; INS-G: 0.93) and yielded high diagnostic accuracy (INS-D: AUC = 0.96; INS-G: AUC = 0.91) with respect to MINI diagnoses. INS-D and INS-G had higher correlations with clinician-administered measures of the same disorder (INS-D-HRSD: 0.73; INS-G-HAM-A: 0.53) than with self-reported measures (INS-D-PHQ-9: 0.69; INS-G-BAI-Sub: 0.49). Patients who recovered during follow-up showed important decreases in severity (Cohen's d INS-D:-1.38; INS-G: -1.75). About 90 % variance of INS-D and INS-G score changes over time was associated with changes in clinical status. CONCLUSIONS: INS-D and INS-G are short reliable, valid, and responsive measures that can be used for diagnostic and severity assessment of mood and anxiety disorders in outpatient care.