Associations of antidepressant medication consumption with changes in personality pathology and quality of life among community-dwelling adults.

BACKGROUND: Although antidepressant medication (ADM) has produced small advantages over pill placebo in randomized controlled trials, consuming ADM has predicted prospectively increasing depressive symptom severity in samples of community-dwelling adults. OBJECTIVE: We extended the community literature by testing ADM's relations to changes in personality and quality of life that may underpin depression. METHOD: In this longitudinal, observational study, community-dwelling adults (N = 601) were assessed twice, 8 months apart on average. Assessments included depressive symptoms, personality, life satisfaction and quality, and prescription medication consumption. RESULTS: Consuming ADM at time 1 predicted relative increases in depressive symptoms (dysphoria), maladaptive traits (negative affect, negative temperament, disinhibition, low conscientiousness), personality dysfunction (non-coping, self-pathology), and decreases in life satisfaction and quality from time 1 to 2, before and after adjustment for age, gender, race, income, education, physical health problems, and use of other psychotropics. In no analysis did ADM use predict better outcomes. CONCLUSION: Among community-dwelling adults, ADM use is a risk factor for psychosocial deterioration in domains including depressive symptoms, personality pathology, and quality of life. Until mechanisms connecting ADM to poor outcomes in community samples are understood, additional caution in use of ADM and consideration of empirically supported non-pharmacologic treatments is prudent.

Disinhibition domain and facets uniquely predict changes in depressive symptoms and psychosocial functioning.

This study aimed to understand the role of disinhibition (low conscientiousness)-in conjunction with the other major personality traits of negative affectivity, detachment, antagonism, and psychoticism-in predicting changes in depressive symptoms and psychosocial functioning. Both the disinhibition trait domain and its primary facets (i.e., irresponsibility, impulsivity, and distractibility) were examined. In a large sample (Time 1 N = 605, Time 2 N = 497) of psychiatric outpatients and high-risk community residents, personality traits, depressive symptoms (both self-reported and interviewer-rated), and psychosocial functioning levels (i.e., daily functioning, interpersonal functioning, health-related quality of life, and global quality of life) were collected across two time points. Results showed that the disinhibition domain was the strongest predictor of changes in depressive symptoms and general quality of life levels. Disinhibition facets also predicted changes in depressive symptoms but showed a less consistent pattern compared to the broader trait domain. Finally, the irresponsibility and distractibility facets significantly and uniquely explained changes in interpersonal functioning. The study highlights the importance of assessing the disinhibition trait rather than only negative and positive affectivity (which are well-known correlates of depression), for understanding changes in depressive symptoms and psychosocial functioning. The findings identify potential targets in psychotherapy for individuals with disinhibition traits and depressive disorders.

Evaluating a Comprehensive Model of Euthymia.

INTRODUCTION: In research and treatment of mood disorders, "euthymia" traditionally denotes the absence of clinically significant mood disturbance. A newer, expanded definition of euthymia also includes positive affect and psychological well-being. OBJECTIVE: We aimed to test this comprehensive model of euthymia and estimate the coherence and predictive power of each factor in the model. METHODS: Community-dwelling adults (N = 601), including both mental health outpatients and non-patients at high risk for personality pathology, completed a battery of interviews and questionnaires at time 1. Most (n = 497) were reassessed on average 8 months later (time 2). We modeled euthymia using standard mood, personality, and psychosocial functioning assessments rather than measures designed specifically for euthymia. RESULTS: The hypothesized model of euthymia was supported by confirmatory factor analysis: specific measures loaded on three lower order factors (mood disturbance, positive affect, and psychological well-being) that reflected general euthymia at time 1. Each factor (general euthymia plus lower order factors) demonstrated moderately strong concurrent (time 1) and predictive (time 1-2) correlations with outcomes, including employment status, income, mental health treatment consumption, and disability. Compared to positive affect and psychological well-being, mood disturbance had stronger incremental (i.e., nonoverlapping) relations with these outcomes. CONCLUSIONS: Support for a comprehensive model of euthymia reinforces efforts to improve assessment and treatment of mood and other disorders. Beyond dampening of psychological distress, euthymia-informed treatment goals encompass full recovery, including enjoyment and meaning in life.

Mindful Self-Care for Caregivers: A Proof of Concept Study Investigating a Model for Embedded Caregiver Support in a Pediatric Setting.

We conducted an open-trial proof of concept study to determine the safety, acceptability, and feasibility of Mindful Self-Care for Caregivers (MSCC) for parents of children with Autism Spectrum Disorders (ASD) (N = 13). The intervention was offered as a co-located care model in a pediatric specialty center where the participants' children received care. Results demonstrated that the intervention was: highly acceptable to all stakeholders (i.e., participants, the group facilitator, and center administration) and could be conducted safely by a masters-level practitioner with minimal resources. Further, secondary measures support a hypothesized interventional model of MSCC, demonstrating gains in mindfulness skills and sense of competency in the parenting role reduced perceived stress and depression in parents of children with ASD.

Predictors of attrition in an interdisciplinary pain management program.

PURPOSE/OBJECTIVE: This study sought to investigate the extent to which demographic and clinical characteristics predict which patients drop out of an interdisciplinary pain management program (IPP). RESEARCH METHOD/DESIGN: Participants (N = 178 outpatients, 18-75 years of age) received treatment for various chronic pain conditions in an IPP (including biopsychosocial assessment, cognitive-behavioral, and physical therapies). Separate logistic regression analyses identified the demographic and clinical variables most predictive of attrition across five domains: (a) demographics, (b) number of medical and non/psychiatric diagnoses, (c) opioid use (yes versus no)/risk of misuse, (d) pain-related cognition and behavior, and (e) physical, social, and mental well-being. Significant predictors from the five domains were integrated in a final multivariable logistic regression model. RESULTS: Among patients exposed to a 4-week IPP, 34% dropped out. In the final model, significant predictors of higher odds of attrition included younger age or being unemployed. Also, patients on opioids at preintervention had higher odds of completing the IPP than patients not on opioids at preintervention. Follow-up analyses revealed 24 of 37 completers (65%) on opioids at preintervention reduced or eliminated use over the course of the IPP. CONCLUSIONS/IMPLICATIONS: Because findings are limited by sample and design characteristics, they require replication yet offer novel hypotheses for identifying patients at risk of attrition. Specifically, patients with preintervention opioid use (contrasted with opioid dependence) may particularly benefit from an IPP. Patients at highest risk for early dropout can be targeted for specific engagement interventions to promote completion and effectiveness of IPP. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

How can the DSM-5 alternative model of personality disorders advance understanding of depression?

BACKGROUND: The DSM-5 introduced an alternative model of personality disorder (AMPD) that includes personality dysfunction plus maladaptive-range traits. This study clarifies relations of depression diagnoses and symptoms with AMPD personality pathology. METHOD: Two samples (Ns 402 and 601) of outpatients and community-dwelling adults completed four depression (criteria met for major depressive disorder and dysthymia; dysphoria and low well-being scales), ten trait (two scales for each of five domains-negative affectivity, detachment, disinhibition, antagonism, psychoticism), and eight dysfunction (four scales for each of two domains-self- and interpersonal pathology) measures. Diagnoses were made using a semi-structured interview; other measures were self-reports. We quantified cross-sectional relations between depression and personality pathology with correlation and multiple regression analyses. RESULTS: Collectively (median R2; ps < 0.0001), the trait (0.46) and dysfunction (0.50) scales predicted the depression measures strongly, with most predictive power shared (0.41) between traits and dysfunction. However, trait and dysfunction scales altogether predicted depression (median R2 = 0.54) more strongly than either domain alone, ps < 0.0001. Participants with depression diagnoses showed elevations on all nonadaptive trait and personality dysfunction measures, particularly negative temperament/affectivity and self-pathology measures. LIMITATIONS: Generalization of findings to other populations (e.g., adolescents), settings (e.g., primary care), and measures (e.g., traditional personality disorder diagnoses) is uncertain. Cross-sectional analyses did not test changes over time or establish causality. CONCLUSIONS: The AMPD is highly relevant to depression. Assessment of personality pathology, including both personality dysfunction and maladaptive-range traits, stands to advance understanding of depression in adults.

Does Symptom Linkage Density Predict Outcomes in Cognitive Therapy for Recurrent Depression?

Background: Acute-phase cognitive therapy (CT) is an efficacious treatment for major depressive disorder (MDD), but how CT helps patients is incompletely understood. As a potential means to clarify CT mechanisms, we defined "symptom linkage density" (SLD) as a patient's mean time-lagged correlation among nine depressive symptoms across 13 weekly assessments. We hypothesized that patients with higher SLD during CT have better outcomes (treatment response, and fewer symptoms after response), and we explored whether SLD correlated with other possible CT processes (growth in social adjustment and CT skills). Method: Data were drawn from two clinical trials of CT for adult outpatients with recurrent MDD (primary sample n = 475, replication sample n = 146). In both samples, patients and clinicians completed measures of depressive symptoms and social adjustment repeatedly during CT. In the primary sample, patients and cognitive therapists rated patients' CT skills. After CT, responders were assessed for 32 (primary sample) or 24 (replication sample) additional months to measure long-term depression outcomes. Results: Higher SLD predicted increases in social adjustment (both samples) and CT skills (primary sample) during CT, CT response (both samples), and lower MDD severity for at least 2 years after CT response (both samples). Analyses controlled patient-level symptom means and variability to estimate SLD's incremental predictive validity. Conclusions: These novel findings from two independent samples with longitudinal follow-up require further replication and extension. SLD may reflect or facilitate generalization of CT skills, improvement in social functioning, or other processes responsible for CT's shorter and longer term benefits.

Using quantitative sensory testing to predict attrition in an interdisciplinary pain management program: a pilot study.

Aim: To determine the extent to which quantitative sensory testing (QST) predicted attrition in an interdisciplinary pain program (IPP). Patients & methods: Participants (n = 53) enrolled in an IPP completed pretreatment assessments of QST and the PROMIS-29 quality of life survey. Results & conclusion: Compared with completers, non-completers (24.5%) reported significantly higher pain intensity (7.1, 95% CI [5.8, 8.4] versus 5.4, 95% CI [4.8, 6.1]) and cold hyperalgesia (14.6°C, 95% CI [8.8, 20.4] versus 7.5°C, 95% CI [4.8, 6.1]), with both variables also predicting attrition. This finding highlights a potentially novel and clinically significant use of QST. Higher overall pain intensity and the presence of remote cold hyperalgesia may identify patients at risk for dropping out of an IPP.

The purpose of this research study was to determine the extent to which quantitative sensory testing (QST) predicted which patients enrolled in an interdisciplinary pain program (IPP) would drop out. Fifty-three patients with chronic pain enrolled in an IPP were assessed before treatment with mechanical and thermal QST at a painful and a non-painful site, as well as with the PROMIS-29 quality of life survey. Pretreatment findings were compared between non-completers (i.e., attended five or fewer sessions for any component of the IPP) and completers. Resulting significant predictors were included in a logistic regression to predict attrition. Compared with those who completed the program, non-completers (24.5%) reported significantly higher pain intensity and oversensitivity to cold at a non-painful site pretreatment, with both variables also predicting completion of the IPP. In summary, these preliminary findings suggest that higher overall pain intensity and the presence of cold oversensitivity (at baseline) may identify patients at risk for dropping out of an IPP.

Stability and Change in Relations Between Personality Traits and the Interpersonal Problems Circumplex During Cognitive Therapy for Recurrent Depression.

Both personality impairment and maladaptive-range traits are necessary for diagnosis in the alternative model of personality disorder. We clarified personality impairment-trait connections using measures of the interpersonal problems circumplex and personality traits among adult outpatients (N = 351) with major depressive disorder receiving cognitive therapy (CT). The trait scales' circumplex projections were summarized by elevation (correlations with general interpersonal problems), amplitude (specific relations to the circumplex dimensions of dominance and affiliation), and angle (predominant orientation in the two-dimensional circumplex). Most trait scales showed hypothesized circumplex relations, including substantive elevation (e.g., negative temperament, mistrust), amplitude (e.g., aggression, detachment), and expected angles (e.g., positive temperament and manipulativeness oriented toward overly nurturant/intrusive or domineering/vindictive problems, respectively), that were stable across time during CT. These results revealed meaningful and consistent impairment-trait connections, even during CT when mean depressive affect decreased substantially.

Levels of depressed mood and low interest for two years after response to cognitive therapy for recurrent depression.

BACKGROUND: Major depressive disorder (MDD) involves depressed mood (high negative affect, predominantly) and low interest/pleasure (low positive affect). In past research, negative affect has improved more than positive affect during acute-phase antidepressant medication or cognitive therapy (CT). We extended this literature by differentiating depressed mood and two dimensions of low interest (general and sexual), assessing persistence of symptom differences after acute-phase CT response, and testing whether continuation treatment acted differently on depressed mood versus low interest. METHODS: We analyzed data from two randomized controlled trials. Patients with recurrent MDD first received acute-phase CT. Then, responders were randomized to 8-month continuation treatments and assessed for 16-24 additional months. RESULTS: Depressed mood and low general interest improved more than low sexual interest during acute-phase CT. Among responders, these symptom differences persisted for at least 2 years and were not changed by continuation CT or antidepressant medication. LIMITATIONS: Generalization of findings to other patient populations and treatments is uncertain. Depressed mood and low interest scales were constructed from standard symptom measures and overlapped empirically. CONCLUSIONS: Less improvement during CT, and persistent low sexual interest despite continuation treatment, highlights the need for MDD treatments more effectively targeting this positive affective symptom.

Improved symptoms of complex regional pain syndrome after novel lymphatic treatment and interdisciplinary pain management.

INTRODUCTION: Complex regional pain syndrome (CRPS) is a pain syndrome with no singular mechanism and no specific cure. The aim of this case report is to study the impact of Lymphatic Enhancement Technology (LET) treatment on CRPS-related symptoms. METHODS: A 51 year-old female presented with a chief complaint of severe, refractory ankle pain and CRPS related to a tibial and fibular fracture sustained three years earlier. The patient completed twelve cognitive behavioral therapy sessions over a 4-week period, and eleven physical therapy sessions over a four-month period, six of which utilized LET. RESULTS: Pain and swelling were largely unchanged with interdisciplinary treatment before the introduction of LET. A within-session change of 37.5% in pain intensity and 87.5% in ankle girth was observed immediately after the first application of LET. Three months after beginning LET treatment, the patient maintained a 43.8% improvement in pain intensity and 100% improvement in measurements of lower extremity girth and ankle range of motion. No side effects or adverse events were associated with the LET treatment. CONCLUSION: Swelling, pain, and mobility loss are common symptoms and features of CRPS. LET is a novel, non-invasive treatment that appears to be quite safe and effective for improving pain, swelling, and mobility loss related to CRPS.

Advancing health through research: A scoping review of and model for adjunctive psychosocial interventions to improve outcomes for perinatal women with bipolar disorder.

BACKGROUND: We aimed to identify randomized clinical trials (RCTs) which evaluated the efficacy of adjunctive psychosocial interventions to improve outcomes during the perinatal period for women with bipolar disorder (BD). METHODS: We scanned the literature to identify RCTs evaluating the efficacy of adjunctive psychosocial therapies or interventions provided during the perinatal period to women with BD. We searched from 1946 to July 2020 using Embase, Ovid Medline, PsycINFO, and Scopus. We then searched for future, current, and recently completed RCTs described on www.ClinicalTrials.gov. RESULTS: This scoping review (1946 - July 2020) revealed no published RCTs for this population. The findings expose an important gap in research and knowledge, as well as a health disparity. CONCLUSION: We heuristically tied a mechanistic stress reduction model to relevant findings. The initial hypotheses are informed by effective stress reducing psychosocial interventions for: a) people with BD outside the perinatal period and b) perinatal women with major depressive disorder (MDD may improve the health of perinatal women with BD). We hypothesize that the perinatal trajectory of health for women with BD will improve by adding psychosocial interventions or therapies to treatment as usual. We propose maternal stress reduction as a potential mediator/mechanism. LIMITATIONS: Findings reported are limited to the methods of a scoping review. Reproductive status tends to be a missing variable; we highlight the need for its inclusion. Interdisciplinary, collaborative research to improve the treatment outcome for perinatal women with BD is warranted and ripe for advancement.

Quality of life after response to acute-phase cognitive therapy for recurrent depression.

BACKGROUND: Adults with major depressive disorder (MDD) often experience reduced quality of life (QOL). Efficacious acute-phase treatments, including cognitive therapy (CT) or medication, decrease depressive symptoms and, to a lesser degree, increase QOL. We tested longer-term changes in QOL after response to acute-phase CT, including the potential effects of continuation treatment for depression and time-lagged relations between QOL and depressive symptoms. METHODS: Responders to acute-phase CT (N = 290) completed QOL and depressive symptom assessments repeatedly for 32 post-acute months. Higher-risk responders were randomized to 8 months of continuation treatment (CT, fluoxetine, or pill placebo) and then entered a 24-month follow-up. Lower-risk responders were only assessed for 32 months. RESULTS: On average, large gains in QOL made during acute-phase CT response were maintained for 32 months. Continuation CT or fluoxetine did not improve QOL relative to pill placebo. Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence. Higher QOL predicted subsequent reductions in depressive symptom severity, but depressive symptom severity did not predict subsequent changes in QOL. LIMITATIONS: Generalization of results to other patient populations, treatments, and measures is uncertain. The clinical trial was not designed to test relations between QOL and depression. Replication is needed before clinical application of these results. CONCLUSIONS: Gains in QOL made during response to acute-phase CT are relatively stable and may help protect against relapse/recurrence. Continuation CT or fluoxetine may not further improve QOL among acute-phase CT responders.

Assessment of patient and provider attitudes towards therapeutic drug monitoring to improve medication adherence in low-income patients with hypertension: a qualitative study.

OBJECTIVES: Previous studies have implicated therapeutic drug monitoring (TDM), by measuring serum or urine drug levels, as a highly reliable technique for detecting medication non-adherence but the attitudes of patients and physicians toward TDM have not been evaluated previously. Accordingly, we solicited input from patients with uncontrolled hypertension and their physicians about their views on TDM. DESIGN: Prospective analysis of responses to a set of questions during semistructured interviews. SETTING: Outpatient clinics in an integrated health system which provides care for a low-income, uninsured population. PARTICIPANTS: Patients with uncontrolled hypertension with either systolic blood pressure of at least 130 mm Hg or diastolic blood pressure of at least 80 mm Hg despite antihypertensive drugs and providers in the general cardiology and internal medicine clinics. PRIMARY AND SECONDARY OUTCOME MEASURES: Attitudes towards TDM and the potential impact on physician-patient relationship. RESULTS: We interviewed 11 patients and 10 providers and discussed the findings with 13 community advisory panel (CAP) members. Of the patients interviewed, 91% (10 of 11) and all 10 providers thought TDM was a good idea and should be used regularly to better understand the reasons for poorly controlled hypertension. However, 63% (7 of 11) of patients and 20% of providers expressed reservations that TDM could negatively impact the physician-patient relationship. Despite some concerns, the majority of patients, providers and CAP members believed that if test results are communicated without blaming patients, the potential benefits of TDM in identifying suboptimal adherence and eliciting barriers to adherence outweighed the risks. CONCLUSION: The idea of TDM is well accepted by patients and their providers. TDM information if delivered in a non-judgmental manner, to encourage an honest conversation between patients and physicians, has the potential to reduce patient-physician communication obstacles and to identify barriers to adherence which, when overcome, can improve health outcomes.

Do Cognitive Therapy Skills Neutralize Lifetime Stress to Improve Treatment Outcomes in Recurrent Depression?

Cognitive therapy (CT) is an efficacious treatment for major depressive disorder (MDD), but not all patients respond. Past research suggests that stressful life events (SLE; e.g., childhood maltreatment, emotional and physical abuse, relationship discord, physical illness) sometimes reduce the efficacy of depression treatment, whereas greater acquisition and use of CT skills may improve patient outcomes. In a sample of 276 outpatient participants with recurrent MDD, we tested the hypothesis that patients with more SLE benefit more from CT skills in attaining response and remaining free of relapse/recurrence. Patients with more pretreatment SLE did not develop weaker CT skills, on average, but were significantly less likely to respond to CT. However, SLE predicted non-response only for patients with relatively weak skills, and not for those with stronger CT skills. Similarly, among acute-phase responders, SLE increased risk for MDD relapse/recurrence among patients with weaker CT skills. Thus, the combination of more SLE and weaker CT skills forecasted negative outcomes. These novel findings are discussed in the context of improving CT for depression among patients with greater lifetime history of SLE and require replication before clinical application.

Do patients' cognitive therapy skills predict personality change during treatment of depression?

BACKGROUND: Psychological interventions can change personality, including increasing positive temperament (extraversion) and decreasing negative temperament (neuroticism), but why these changes occur is unclear. The current study tested the extent to which patients' acquisition and use of skills taught in cognitive therapy (CT) correlated with changes in positive and negative temperament during treatment of depression. METHOD: Outpatients (N = 351) with recurrent major depressive disorder (MDD) were enrolled in a 12-week CT protocol. Temperament (early and late in CT), patient skills (mid and late in CT), and depressive symptoms (early, mid, and late in CT) were measured repeatedly. RESULTS: Patients with greater acquisition and use of CT skills showed significantly larger increases in positive temperament and larger decreases in negative temperament in path analyses. Effect sizes were small, median standardized |beta| = 0.13. Models controlled depressive symptom levels and changes. CONCLUSIONS: Skills taught in CT for recurrent depression correlate with personality change during this efficacious treatment. The absence of measures of CT skills at baseline and personality mid-CT allows several interpretations of the current findings. Future research is needed to clarify whether patients' use of CT skills facilitates adaptive changes in personality during CT.

Psychometric properties of the Marital Adjustment Scale during cognitive therapy for depression: New research opportunities.

Poor dyadic adjustment in marital or similar relationships is common among patients seeking individual cognitive therapy (CT) for major depressive disorder (MDD). Here we examined the psychometric properties of the marital adjustment subscale (MAS) of the Social Adjustment Scale-Self-report (SAS-SR; Weissman & Bothwell, 1976). Among married or cohabiting patients receiving individual CT for recurrent MDD (N = 306) in the context of two randomized controlled trials, the MAS demonstrated moderate internal consistency and test-retest reliability, strong convergence with the Dyadic Adjustment Scale (Spanier, 1976), and moderate relations with interpersonal problems and depressive symptoms. Controlling baseline depressive symptom severity, greater pre-CT relationship discord on the MAS predicted less reduction in depressive symptom severity and lower odds of depression remission during CT. These results support the reliability, validity, and potential utility of the MAS. Using the MAS may help investigators "mine" existing data sets including the SAS-SR to further understanding of dyadic functioning and its potential impact on depression treatment and other health outcomes. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Psychotherapy or medication for depression? Using individual symptom meta-analyses to derive a Symptom-Oriented Therapy (SOrT) metric for a personalised psychiatry.

BACKGROUND: Antidepressant medication (ADM) and psychotherapy are effective treatments for major depressive disorder (MDD). It is unclear, however, if treatments differ in their effectiveness at the symptom level and whether symptom information can be utilised to inform treatment allocation. The present study synthesises comparative effectiveness information from randomised controlled trials (RCTs) of ADM versus psychotherapy for MDD at the symptom level and develops and tests the Symptom-Oriented Therapy (SOrT) metric for precision treatment allocation. METHODS: First, we conducted systematic review and meta-analyses of RCTs comparing ADM and psychotherapy at the individual symptom level. We searched PubMed Medline, PsycINFO, and the Cochrane Central Register of Controlled Trials databases, a database specific for psychotherapy RCTs, and looked for unpublished RCTs. Random-effects meta-analyses were applied on sum-scores and for individual symptoms for the Hamilton Rating Scale for Depression (HAM-D) and Beck Depression Inventory (BDI) measures. Second, we computed the SOrT metric, which combines meta-analytic effect sizes with patients' symptom profiles. The SOrT metric was evaluated using data from the Munich Antidepressant Response Signature (MARS) study (n = 407) and the Emory Predictors of Remission in Depression to Individual and Combined Treatments (PReDICT) study (n = 234). RESULTS: The systematic review identified 38 RCTs for qualitative inclusion, 27 and 19 for quantitative inclusion at the sum-score level, and 9 and 4 for quantitative inclusion on individual symptom level for the HAM-D and BDI, respectively. Neither meta-analytic strategy revealed significant differences in the effectiveness of ADM and psychotherapy across the two depression measures. The SOrT metric did not show meaningful associations with other clinical variables in the MARS sample, and there was no indication of utility of the metric for better treatment allocation from PReDICT data. CONCLUSIONS: This registered report showed no differences of ADM and psychotherapy for the treatment of MDD at sum-score and symptom levels. Symptom-based metrics such as the proposed SOrT metric do not inform allocation to these treatments, but predictive value of symptom information requires further testing for other treatment comparisons.

Development of a Novel Adult Congenital Heart Disease-Specific Patient-Reported Outcome Metric.

Background Patient-reported outcome metrics (PROs) quantify important outcomes in clinical trials and can be sensitive measures of patient experience in clinical practice. Currently, there is no validated disease-specific PRO for adults with congenital heart disease (ACHD). Methods and Results We conducted a preliminary psychometric validation of a novel ACHD PRO. ACHD patients were recruited prospectively from 2 institutions and completed a series of questionnaires, a physician health assessment, and a 6-minute walk test. Participants returned to complete the same questionnaires and assessment 3 months±2 weeks later. We tested the internal consistency and test-retest reliability by comparing responses among clinically stable patients at the 2 study visits. We assessed convergent and divergent validity by comparison of ACHD PRO responses to existing validated questionnaires. We assessed responsiveness by comparison with patient-reported clinical change. One hundred three patients completed 1 study visit and 81 completed both. The ACHD PRO demonstrated good internal consistency in each of its 5 domains (Cronbach's α: 0.87; 0.74; 0.74; 0.90; and 0.89, respectively) and in the overall summary score (0.92). Test-retest reliability was good with an intraclass correlation ≥0.73 for all domains and 0.78 for the Summary Score. The ACHD PRO accurately assessed domain concepts based on comparison with validated standards. Preliminary estimates of responsiveness suggest sensitivity to clinical status. Conclusions These studies provide initial support for the validity and reliability of the ACHD PRO. Further studies are needed to assess its sensitivity to changes in clinical status.