RESUMEN

Background: Antipsychotics carry a higher-risk profile than other psychotropic medications and may be prescribed for youth with conditions in which other first-line treatments are more appropriate. This study aimed to evaluate the population-level effect of the Safer Use of Antipsychotics in Youth (SUAY) trial, which aimed to reduce person-days of antipsychotic use among participants. Methods: We conducted an interrupted time series analysis using segmented regression to measure changes in prescribing trends of antipsychotic initiation rates pre-SUAY and post-SUAY trial at four U.S. health systems between 2013 and 2020. Results: In our overall model, adjusted for age and insurance type, antipsychotic initiation rates decreased by 0.73 (95% confidence interval [CI]: 0.30, 1.16, p = 0.002) prescriptions per 10,000 person-months before the SUAY trial. In the first quarter following the start of the trial, there was an immediate decrease in the rate of antipsychotic initiations of 6.57 (95% CI: 0.99, 12.15) prescriptions per 10,000 person-months. When comparing the posttrial period to the pretrial period, there was an increase of 1.09 (95% CI: 0.32, 1.85) prescriptions per 10,000 person-months, but the increasing rate in the posttrial period alone was not statistically significant (0.36 prescriptions per 10,000 person-months, 95% CI: -0.27, 0.99). Conclusion: The declining trend of antipsychotic initiation seen between 2013 and 2018 (pre-SUAY trial) may have naturally reached a level at which prescribing was clinically warranted and appropriate, resulting in a floor effect. The COVID-19 pandemic, which began in the final three quarters of the posttrial period, may also be related to increased antipsychotic medication initiation.

Asunto(s)

RESUMEN

BACKGROUND: Suicide is the second­leading cause of death among adolescents and young adults in the United States, with rates rising over much of the last decade. The design, testing, and implementation of interventions to prevent suicide in this population is a public health priority. This manuscript outlines the design and methods for a research study that compares two interventions aimed at reducing suicide and suicide attempts in youth. METHODS: We will enroll 300 youth aged 12-24 at high risk for suicide in this randomized controlled parallel group superiority trial. Participants will be randomly assigned to one of two study arms: (1) Zero Suicide Quality Improvement (ZSQI) implemented within the Kaiser Permanente Northwest (KPNW) health system, or (2) ZSQI plus a stepped care intervention for suicide prevention (SC-SP), where the services offered (including care management and dialectical behavior therapy [DBT]) increase based on risk level. Outcomes will be assessed at baseline, as well as 3-, 6-, and 12-months post randomization. The study was conceptualized and designed collaboratively by investigators at UCLA and KPNW. RESULTS: To be reported in future manuscripts. CONCLUSION: The main objective of the study is to determine whether the SC-SP intervention is superior to ZSQI with regard to lowering rates of fatal and nonfatal suicide attempts. Interventions that incorporate the latest research need to be designed and tested under controlled conditions to make progress toward the goal of achieving zero suicide. The results from this trial will directly inform those efforts. CLINICALTRIALS: gov, NCT03092271, https://clinicaltrials.gov/ct2/show/NCT03092271https://clinicaltrials.gov/ct2/show/NCT01379027.

Asunto(s)

RESUMEN

OBJECTIVE: Assess the accuracy of ICD-10-CM coding of self-harm injuries and poisonings to identify self-harm events. MATERIALS AND METHODS: In 7 integrated health systems, records data identified patients reporting frequent suicidal ideation. Records then identified subsequent ICD-10-CM injury and poisoning codes indicating self-harm as well as selected codes in 3 categories where uncoded self-harm events might be found: injuries and poisonings coded as undetermined intent, those coded accidental, and injuries with no coding of intent. For injury and poisoning encounters with diagnoses in those 4 groups, relevant clinical text was extracted from records and assessed by a blinded panel regarding documentation of self-harm intent. RESULTS: Diagnostic codes selected for review include all codes for self-harm, 43 codes for undetermined intent, 26 codes for accidental intent, and 46 codes for injuries without coding of intent. Clinical text was available for review for 285 events originally coded as self-harm, 85 coded as undetermined intent, 302 coded as accidents, and 438 injury events with no coding of intent. Blinded review of full-text clinical records found documentation of self-harm intent in 254 (89.1%) of those originally coded as self-harm, 24 (28.2%) of those coded as undetermined, 24 (7.9%) of those coded as accidental, and 48 (11.0%) of those without coding of intent. CONCLUSIONS: Among patients at high risk, nearly 90% of injuries and poisonings with ICD-10-CM coding of self-harm have documentation of self-harm intent. Reliance on ICD-10-CM coding of intent to identify self-harm would fail to include a small proportion of true self-harm events.

Asunto(s)

RESUMEN

Importance: People at risk of self-harm or suicidal behavior can be accurately identified, but effective prevention will require effective scalable interventions. Objective: To compare 2 low-intensity outreach programs with usual care for prevention of suicidal behavior among outpatients who report recent frequent suicidal thoughts. Design, Setting, and Participants: Pragmatic randomized clinical trial including outpatients reporting frequent suicidal thoughts identified using routine Patient Health Questionnaire depression screening at 4 US integrated health systems. A total of 18 882 patients were randomized between March 2015 and September 2018, and ascertainment of outcomes continued through March 2020. Interventions: Patients were randomized to a care management intervention (n = 6230) that included systematic outreach and care, a skills training intervention (n = 6227) that introduced 4 dialectical behavior therapy skills (mindfulness, mindfulness of current emotion, opposite action, and paced breathing), or usual care (n = 6187). Interventions, lasting up to 12 months, were delivered primarily through electronic health record online messaging and were intended to supplement ongoing mental health care. Main Outcomes and Measures: The primary outcome was time to first nonfatal or fatal self-harm. Nonfatal self-harm was ascertained from health system records, and fatal self-harm was ascertained from state mortality data. Secondary outcomes included more severe self-harm (leading to death or hospitalization) and a broader definition of self-harm (selected injuries and poisonings not originally coded as self-harm). Results: A total of 18 644 patients (9009 [48%] aged 45 years or older; 12 543 [67%] female; 9222 [50%] from mental health specialty clinics and the remainder from primary care) contributed at least 1 day of follow-up data and were included in analyses. Thirty-one percent of participants offered care management and 39% offered skills training actively engaged in intervention programs. A total of 540 participants had a self-harm event (including 45 deaths attributed to self-harm and 495 nonfatal self-harm events) over 18 months following randomization: 172 (3.27%) in care management, 206 (3.92%) in skills training, and 162 (3.27%) in usual care. Risk of fatal or nonfatal self-harm over 18 months did not differ significantly between the care management and usual care groups (hazard ratio [HR], 1.07; 97.5% CI, 0.84-1.37) but was significantly higher in the skills training group than in usual care (HR, 1.29; 97.5% CI, 1.02-1.64). For severe self-harm, care management vs usual care had an HR of 1.03 (97.5% CI, 0.71-1.51); skills training vs usual care had an HR of 1.34 (97.5% CI, 0.94-1.91). For the broader self-harm definition, care management vs usual care had an HR of 1.10 (97.5% CI, 0.92-1.33); skills training vs usual care had an HR of 1.17 (97.5% CI, 0.97-1.41). Conclusions and Relevance: Among adult outpatients with frequent suicidal ideation, offering care management did not significantly reduce risk of self-harm, and offering brief dialectical behavior therapy skills training significantly increased risk of self-harm, compared with usual care. These findings do not support implementation of the programs tested in this study. Trial Registration: ClinicalTrials.gov Identifier: NCT02326883.

Asunto(s)

Asunto(s)

RESUMEN

Objectives: Antipsychotic prescribing in children and adolescents increased sharply beginning in the 1990s, but recent reports among Medicaid enrollees suggest declining trends. However, few studies have included both commercially and publicly insured patients or focused on trends in new antipsychotic medications in children without documented psychotic disorders or other indicated conditions. The objective of the study was to report trends in new antipsychotic prescribing for pediatric patients (age 3-17 years) in a large children's health care system. Methods: Data were abstracted from electronic medical records (January 1, 2013 to December 31, 2017). New antipsychotic medication orders were defined as antipsychotic orders for patients without an order in the 180 days prior. Patients were excluded if the order was initiated in an emergency department or inpatient setting; they were diagnosed with psychotic disorder, mania, autism spectrum disorder, or intellectual disability; or the order was for prochlorperazine. The crude rate of new antipsychotic prescribing is reported quarterly with Poisson 95% confidence intervals in the total sample and by demographic subgroups (child vs. adolescent, female vs. male, public vs. private insurance, and white vs. nonwhite). Results: Antipsychotic orders decreased from 54.9 prescriptions per 10,000 person months in the first quarter of 2013 to 34.1 per 10,000 person months in the last quarter of 2017. Rates of antipsychotic prescribing were significantly higher for adolescents compared with children, patients who were commercially insured compared with Medicaid insured, and at most time points for white compared with non-white patients. However, prescribing rates did not differ significantly based on gender. Conclusions: Antipsychotic prescribing declined for both commercially and Medicaid-insured children in a pediatric hospital-based system, although white and commercially insured patients were more likely to be prescribed antipsychotics. More attention may be needed for reducing potentially avoidable prescribing of antipsychotics in previously understudied subgroups, such as commercially insured patients. Clinical Trial Registration Number: NCT03448575.

Asunto(s)

RESUMEN

OBJECTIVE: To evaluate the cost-effectiveness of screening for depression in patients with acute coronary syndrome (ACS) and no history of depression. METHODS: Cost-effectiveness analysis of a randomized trial enrolling 1500 patients with ACS between 2013 and 2017. Patients were randomized to no screening, screening and notifying the primary care provider (PCP), and screening, notifying the PCP, and providing enhanced depression treatment. Outcomes measured were Healthcare utilization, costs, and incremental cost-effectiveness ratios. RESULTS: 7.1% of patients screened positive for depressive symptoms. There was no significant difference in usage of mental health services, cardiovascular tests and procedures, and medications. Mean total costs in No Screen group ($7440), in Screen, Notify, and Treat group ($6745), and in Screen and Notify group ($6204). The difference was only significant in the Screen and Notify group versus the No Screen group (-$1236, 95% confidence interval -$2388 to -$96). Because mean QALYs were higher (+0.003 QALY in Screen and Notify; +0.004 QALYs in Screen, Notify, and Treat) and mean total costs were lower in both intervention groups, these interventions were cost-effective. There was substantial uncertainty because confidence intervals around cost differences were wide and QALY effects were small. CONCLUSION: Depression screening strategies for patients with ACS may be modestly cost-effective.

Asunto(s)

RESUMEN

BACKGROUND: Programs such as the Pediatric Access Line in Washington state have shown decreases in antipsychotic medication use by youth with non-psychotic disorders. Program outcomes have been studied with observational designs. This manuscript describes the protocol for Targeted and Safer Use of Antipsychotics in Youth (SUAY), a randomized controlled trial of psychiatrist review of prescriptions and facilitated access to psychosocial care. The aim of the intervention is to reduce the number of person-days of antipsychotic use among participants. METHODS: Recruitment occurs at 4 health systems. Targeted enrollment is 800 youth aged 3-17 years. Clinicians are block randomized to intervention versus usual care prior to the study. Youth are nested within the arm of the prescribing clinician. Clinicians in the intervention group receive an EHR-based best practice alert with options to expedite access to psychosocial care and all medication orders are reviewed by a child and adolescent psychiatrist with feedback provided to the prescriber. The primary outcome is person-days of antipsychotic medication use in the 6 months following the initial order. All randomized individuals contribute data regardless of their level of participation (including declining all services). DISCUSSION: The trial has been approved by the institutional review boards at each of the 4 sites. The intervention has 4 novel design features including automated recruitment using a best practice alert, psychiatrist medication order review and consultation, telephone navigation to psychosocial care, and telemental health visits. Recruitment began in March of 2018 and will be completed in June 2020. Follow-up will be completed December 31, 2020. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03448575.

Asunto(s)

RESUMEN

Importance: Patients with acute coronary syndrome (ACS) and elevated depressive symptoms are at increased risk for recurrent cardiovascular events and mortality, worse quality of life, and higher health care costs. These observational findings prompted multiple scientific panels to advise universal depression screening in survivors of ACS prior to evidence from randomized screening trials. Objective: To determine whether systematically screening for depression in survivors of ACS improves quality of life and depression compared with usual care. Design, Setting, and Participants: A 3-group multisite randomized trial enrolled 1500 patients with ACS from 4 health care systems between November 1, 2013, and March 31, 2017, with follow-up ending July 31, 2018. Patients were eligible if they had been hospitalized for ACS in the previous 2 to 12 months and had no prior history of depression. All analyses were performed on an intention-to-treat basis. Interventions: Patients with ACS were randomly assigned 1:1:1 to receive (1) systematic depression screening using the 8-item Patient Health Questionnaire, with notification of primary care clinicians and provision of centralized, patient-preference, stepped depression care for those with positive screening results (8-item Patient Health Questionnaire score ≥10; screen, notify, and treat, n = 499); (2) systematic depression screening, with notification of primary care clinicians for those with positive screening results (screen and notify, n = 501); and (3) usual care (no screening, n = 500). Main Outcomes and Measures: The primary outcome was change in quality-adjusted life-years. The secondary outcome was depression-free days. Adverse effects and mortality were assessed by patient interview and hospital records. Results: A total of 1500 patients (424 women and 1076 men; mean [SD] age, 65.9 [11.5] years) were randomized in the 18-month trial. Only 71 of 1000 eligible survivors of ACS (7.1%) had elevated 8-item Patient Health Questionnaire scores indicating depressive symptoms at screening. There were no differences in mean (SD) change in quality-adjusted life-years (screen, notify and treat, -0.06 [0.20]; screen and notify, -0.06 [0.20]; no screen, -0.06 [0.18]; P = .98) or cumulative mean (SD) depression-free days (screen, notify and treat, 343.1 [179.0] days; screen and notify, 351.3 [175.0] days; no screen, 339.0 [176.6] days; P = .63). Harms including death, bleeding, or sleep difficulties did not differ among groups. Conclusions and Relevance: In patients with ACS without a history of depression, systematic depression screening with or without providing depression treatment did not alter quality-adjusted life-years, depression-free days, or harms. Trial Registration: ClinicalTrials.gov identifier: NCT01993017.

Asunto(s)

RESUMEN

BACKGROUND: Elevated depressive symptoms among survivors of acute coronary syndromes (ACS) confer recurrent cardiovascular events and mortality, worse quality of life, and higher healthcare costs. While multiple scientific groups advise routine depression screening for ACS survivors, no randomized trials exist to inform this screening recommendation. We aimed to assess the effect of screening for depression on change in quality of life over 18 months among ACS patients. METHODS: The Comparison of Depression Identification after Acute Coronary Syndrome on Quality of Life and Cost Outcomes (CODIACS-QoL) trial is a pragmatic, 3-arm trial that randomized ACS patients to 1) systematic depression screening using the 8-item Patient Health Questionnaire (PHQ-8) and if positive screen (PHQ-8 ≥ 10), notification of primary care providers (PCPs) and invitation to participate in centralized, patient-preference, stepped depression care (Screen, Notify, and Treat, N = 499); 2) systematic depression screening and PCP notification only (Screen and Notify, N = 501); and 3) usual care (No Screen, N = 500). Adults hospitalized for ACS in the previous 2-12 months without prior history of depression were eligible for participation. Key outcomes will be quality-adjusted life years (primary), cost of health care utilization, and depression-free days across 18 months. RESULTS: A total of 1500 patients were randomized in the CODIACS-QOL trial (28.3% women; 16.3% Hispanic; mean age 65.9 (11.5) years). Only 7% of ACS survivors had elevated depressive symptoms. CONCLUSIONS: Using a novel randomization schema and pragmatic design principles, the CODIACS-QoL trial achieved its enrollment target. Eventual results of this trial will inform future depression screening recommendations in cardiac patients. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01993017).

Asunto(s)

RESUMEN

OBJECTIVE: Youth depression can be prevented, yet few programs are offered. Decision makers lack cost information. This study evaluated the cost-effectiveness of a cognitive-behavioral prevention program (CBP) versus usual care. METHODS: A cost-effectiveness analysis was conducted with data from a randomized controlled trial of 316 youths, ages 13-17, randomly assigned to CBP or usual care. Youths were at risk of depression because of a prior depressive disorder or subthreshold depressive symptoms, or both, and had parents with a prior or current depressive disorder. Outcomes included depression-free days (DFDs), quality-adjusted life years (QALYs), and costs. RESULTS: Nine months after baseline assessment, youths in CBP experienced 12 more DFDs (p=.020) and .018 more QALYs (p=.007), compared with youths in usual care, with an incremental cost-effectiveness ratio (ICER) of $24,558 per QALY. For youths whose parents were not depressed at baseline, CBP youths had 26 more DFDs (p=.001), compared with those in usual care (ICER=$10,498 per QALY). At 33 months postbaseline, youths in CBP had 40 more DFDs (p=.05) (ICER=$12,787 per QALY). At 33 months, CBP youths whose parents were not depressed at baseline had 91 more DFDs (p=.001) (ICER=$13,620 per QALY). For youths with a currently depressed parent at baseline, CBP was not significantly more effective than usual care at either 9 or 33 months, and costs were higher. CONCLUSIONS: CBP produced significantly better outcomes than usual care and was particularly cost-effective for youths whose parents were not depressed at baseline. Depression prevention programs could improve youths' health at a reasonable cost; services to treat depressed parents may also be warranted.

Asunto(s)

RESUMEN

BACKGROUND: Neurocognitive dysfunction is an understudied and undertreated aspect of psychiatric research and treatment. There is emerging evidence to suggest that repetitive transcranial magnetic stimulation (rTMS) may possess neurocognition-enhancing capabilities. METHODS: This study examined the neurocognitive data from a randomized, double-blind, sham-controlled trial of an investigational 2-coil rTMS device in antidepressant treatment or treatment-intolerant major depressive disorder patients. This device has the potential to stimulate deeper areas of the brain than the Food and Drug Administration-approved TMS devices, which primarily stimulate cortical brain areas and may therefore have different neurocognitive adverse effects. Patients received 20 daily rTMS treatments (10-Hz stimulation; either active or sham) with coil centers positioned over the left dorsolateral prefrontal cortex and dorsomedial prefrontal cortex. Neurocognitive safety was evaluated at baseline and within 72 hours of final treatment session with a computerized battery assessing aspects of attention and memory in 84 participants. RESULTS: There were no observed negative neurocognitive effects of the 2-coil rTMS device. A significant effect of active rTMS was observed on the quality of episodic memory. There were no observed effects for attention or working memory. Baseline quality of episodic memory predicted depression treatment response and remission, in that lower baseline episodic memory was associated with greater likelihood of depression response/remission. This was observed in logistic regression analyses controlling for treatment and baseline depressive symptoms. CONCLUSIONS: The 2-coil rTMS device is a cognitively safe treatment for treatment-resistant depression that may possess episodic memory-enhancing capabilities. Furthermore, baseline episodic memory may reflect an important predictor of subsequent depression treatment response/remission to rTMS.

Asunto(s)

RESUMEN

BACKGROUND AND OBJECTIVES: Adolescents with depression identified in primary care settings often have limited treatment options beyond antidepressant (AD) therapy. We assessed the cost-effectiveness of a brief cognitive behavioral therapy (CBT) program among depressed adolescents who declined or quickly stopped using ADs. METHODS: A total of 212 youth with depression were randomly assigned to treatment as usual (TAU) or TAU plus brief individual CBT. Clinical outcomes included depression-free days (DFDs) and estimated quality-adjusted life-years (QALYs). Costs were adjusted to 2008 US dollars. Incremental cost-effectiveness ratios (ICERs) comparing CBT to TAU were calculated over 12- and 24-month follow-up periods. RESULTS: Youth randomly assigned to CBT had 26.8 more DFDs (P = .044) and 0.067 more QALYs (P = .044) on average compared with TAU over 12 months. Total costs were $4976 less (P = .025) by the end of the 24-month follow-up among youth randomly assigned to CBT. Total costs per DFD were -$51 (ICER = -$51; 95% confidence interval [CI]: -$394 to $9) at 12 months and -$115 (ICER = -$115; 95% CI: -$1090 to -$6) at 24 months. Total costs per QALY were -$20 282 (ICER = -$20 282; 95% CI: -$156 741 to $3617) at 12 months and -$45 792 (ICER = -$45 792; 95% CI: -$440 991 to -$2731) at 24 months. CONCLUSIONS: Brief primary care CBT among youth declining AD therapy is cost-effective by widely accepted standards in depression treatment. CBT becomes dominant over TAU over time, as revealed by a statistically significant cost offset at the end of the 2-year follow-up.

Asunto(s)

RESUMEN

PURPOSE: To examine the longitudinal construct validity in the assessment of changes in depressive symptoms of widely used utility and generic HRQL instruments in teens. METHODS: 392 teens enrolled in the study and completed HRQL and diagnostic measures as part of the baseline interview. HRQL measures included EuroQol (EQ-5D-3L), Health Utilities Index Mark 2 (HUI2) and Mark 3 (HUI3), Quality of Well-Being Scale (QWB), Pediatric Quality of Life Inventory (PEDS-QL), RAND-36 (SF-6D), and Quality of Life in Depression Scale (QLDS). Youth completed follow-up interviews 12 weeks after baseline. Sixteen youth (4.1%) were lost to follow-up. We examined correlations between changes in HRQL instruments and the Children's Depression Rating Scale-Revised (CDRS-R) and assessed clinically meaningful change in multi-attribute utility HRQL measures using mean change (MC) and standardized response mean (SRM) among youth showing at least moderate (20%) improvement in depression symptomology. RESULTS: Spearman's correlation coefficients demonstrated moderate correlation between changes in CDRS-R and the HUI2 (r = 0.38), HUI3 (r = 0.42), EQ-5D-3L (r = 0.36), SF-6D (r = 0.39), and PEDS-QL (r = 0.39) and strong correlation between changes in CDRS-R and QWB (r = 0.52) and QLDS (r = - 0.71). Effect size results are also reported. Among multi-attribute utility measures, all showed clinically meaningful improvements in the sample of youth with depression improvement (HUI2, MC = 0.20, SRM = 0.97; HUI3, MC = 0.32, SRM = 1.17; EQ-5D-3L, MC = 0.08, SRM = 0.51; QWB, MC = 0.11, SRM = 0.86; and SF-6D, MC = 0.12, SRM = 1.02). CONCLUSIONS: Findings support the longitudinal construct validity of included HRQL instruments for the assessment of change in depression outcomes in teens. Results of this study can help inform researchers about viable instruments to include in economic evaluations for this population.

Asunto(s)

RESUMEN

OBJECTIVE: To determine the possible association between insomnia and risk of type 2 diabetes mellitus (T2DM) in the naturalistic clinical setting. RESEARCH DESIGN AND METHODS: We conducted a retrospective cohort study to examine the risk of developing T2DM among patients with pre-diabetes with and without insomnia. Participants with pre-diabetes (identified by a physician or via two laboratory tests) between January 1, 2007 and December 31, 2015 and without sleep apnea were followed until December 31, 2016. Patients were determined to have T2DM when two of the following occurred within a 2-year window: physician-entered outpatient T2DM diagnosis (International Classification of Diseases [ICD]-9 250.00; ICD-10 E11), dispensing of an antihyperglycemia agent, and hemoglobin A1c (A1c) >6.5% (48 mmol/mol) or fasting plasma glucose (FPG) >125 mg/dL. One hospital inpatient stay with an associated T2DM diagnosis was also sufficient for classification of T2DM. RESULTS: Our cohort consisted of 81 233 persons with pre-diabetes, 24 146 (29.7%) of whom had insomnia at some point during the 4.3-year average observation period. After adjustment for traditional risk factors, those with insomnia were 28% more likely to develop T2DM than those without insomnia (HR 1.28; 95% CI 1.24 to 1.33). The estimate was essentially unchanged after adjusting for baseline A1c level (HR 1.32; 95% CI 1.25 to 1.40) or FPG (HR 1.28; 95% CI 1.23 to 1.33). CONCLUSIONS: Insomnia imparts an increased risk of T2DM comparable with that conferred by traditional risk factors (eg, overweight, non-white race, cardiovascular risk factors). This association could have clinical importance because it suggests a new potentially modifiable risk factor that could be targeted to prevent diabetes.

RESUMEN

BACKGROUND: Therapeutic repetitive Transcranial Magnetic Stimulation (rTMS) has emerged as a standard of care for individuals with major depressive disorder (MDD) who do not benefit from, or are unable to tolerate, antidepressant pharmacotherapy. Depth of stimulation is limited with currently approved figure-eight coils and larger coils capable of deeper penetration may be associated with loss of stimulation focality and undesired recruitment of motor cortex. A second generation 2-coil array rTMS system was designed to target converging brain pathways for potentially deeper prefrontal cortex stimulation. METHODS: A randomized, double-blind, sham-controlled trial examined the safety and efficacy of an investigational 2-coil rTMS device. Antidepressant treatment-resistant or treatment-intolerant MDD patients (n = 92) received 20 daily rTMS treatments with coil centers positioned over left dorsolateral prefrontal cortex (dlPFC) and dorsomedial prefrontal cortex (dmPFC). 10 Hz stimulation (maximum summated power for both coils ≤ 120% motor threshold) was delivered. Primary efficacy endpoint was change in HAMD-24 score from baseline to the conclusion of treatments. RESULTS: Data from n = 75 (per-protocol sample) showed significantly greater improvement (mean HAMD-24 change) over time for the active (n = 38) versus sham (n = 37) group after 20 sessions (F = 7.174; p = 0.008) and also at the one-month follow-up (F = 6.748; p = 0.010). Response rates were 55.3% (active) versus 32.4% (sham) (p = 0.063); remission rates were 26.3% versus 18.9% (p > 0.05). Other secondary outcomes were generally supportive. CONCLUSIONS: The results confirmed safety and acute efficacy of the 2-coil rTMS device. Despite modest sample size, primary outcome was clinically and statistically significant, and the effect size was comparable with those reported for regulatory trials with FDA-cleared devices.

Asunto(s)

RESUMEN

PURPOSE: To provide empirical evidence on the performance of common measures in assessing health-related quality of life (HRQL) in depressed and nondepressed youth. These measures can be used in research trials, cost-effectiveness studies, and to help develop policy for treating youth depression. BACKGROUND: Depression is one of the most common mental disorders among adolescents, with a chronic, episodic course marked by considerable impairment. Data on HRQL for teens with depression could more fully demonstrate the burden of depression and help to evaluate the comparative effectiveness of teen depression services, which in turn can be used to inform public and clinical policies. METHODS: We collected data on depression and HRQL from 392 depressed and nondepressed teens aged 13-17. RESULTS: Generic mental health, disease-specific, and generic preference-based measures of HRQL all do a reasonable job of distinguishing teens with and without depression and between teens with differing levels of depression. Generic mental health and disease-specific measures provide valuable information on burden of disease and perform well. For the purpose of economic evaluation, the HUI-3 and EQ-5D perform somewhat better than other preference-based measures. These results can aid future research on teens with depression by helping to guide which HRQL instruments are most useful in this population and can help to quantify the burden of depression in teens for policy and clinical planning.

Asunto(s)

RESUMEN

OBJECTIVE: To assess predictors and moderators of a cognitive-behavioral prevention (CBP) program for adolescent offspring of parents with depression. METHOD: This 4-site randomized trial evaluated CBP compared to usual community care (UC) in 310 adolescents with familial (parental depression) and individual (youth history of depression or current subsyndromal symptoms) risk for depression. As previously reported by Garber and colleagues, a significant prevention effect favored CBP through 9 months; however, outcomes of CBP and UC did not significantly differ when parents were depressed at baseline. The current study expanded on these analyses and examined a range of demographic, clinical, and contextual characteristics of families as predictors and moderators and used recursive partitioning to construct a classification tree to organize clinical response subgroups. RESULTS: Depression onset was predicted by lower functioning (hazard ratio [HR] = 0.95, 95% CI = 0.92-0.98) and higher hopelessness (HR = 1.06, 95% CI = 1.01-1.11) in adolescents. The superior effect of CBP was diminished when parents were currently depressed at baseline (HR = 6.38, 95% CI = 2.38-17.1) or had a history of hypomania (HR = 67.5, 95% CI = 10.9-417.1), or when adolescents reported higher depressive symptoms (HR = 1.04, 95% CI = 1.00-1.08), higher anxiety (HR = 1.05, 95% CI = 1.01-1.08), higher hopelessness (HR = 1.10, 95% CI = 1.01-1.20), or lower functioning (HR = 0.94, 95% CI = 0.89-1.00) at baseline. Onset rates varied significantly by clinical response cluster (0%-57%). CONCLUSION: Depression in adolescents can be prevented, but programs may produce superior effects when timed at moments of relative wellness in high-risk families. Future programs may be enhanced by targeting modifiable negative clinical indicators of response. CLINICAL TRIAL REGISTRATION INFORMATION: Prevention of Depression in At-Risk Adolescents; http://clinicaltrials.gov/; NCT00073671.

Asunto(s)

RESUMEN

IMPORTANCE: Adolescents whose parents have a history of depression are at risk for developing depression and functional impairment. The long-term effects of prevention programs on adolescent depression and functioning are not known. OBJECTIVE: To determine whether a cognitive-behavioral prevention (CBP) program reduced the incidence of depressive episodes, increased depression-free days, and improved developmental competence 6 years after implementation. DESIGN, SETTING, AND PARTICIPANTS: A 4-site randomized clinical trial compared the effect of CBP plus usual care vs usual care, through follow-up 75 months after the intervention (88% retention), with recruitment from August 2003 through February 2006 at a health maintenance organization, university medical centers, and a community mental health center. A total of 316 participants were 13 to 17 years of age at enrollment and had at least 1 parent with current or prior depressive episodes. Participants could not be in a current depressive episode but had to have subsyndromal depressive symptoms or a prior depressive episode currently in remission. Analysis was conducted between August 2014 and June 2015. INTERVENTIONS: The CBP program consisted of 8 weekly 90-minute group sessions followed by 6 monthly continuation sessions. Usual care consisted of any family-initiated mental health treatment. MAIN OUTCOMES AND MEASURES: The Depression Symptoms Rating scale was used to assess the primary outcome, new onsets of depressive episodes, and to calculate depression-free days. A modified Status Questionnaire assessed developmental competence (eg, academic or interpersonal) in young adulthood. RESULTS: Over the 75-month follow-up, youths assigned to CBP had a lower incidence of depression, adjusting for current parental depression at enrollment, site, and all interactions (hazard ratio, 0.71 [95% CI, 0.53-0.96]). The CBP program's overall significant effect was driven by a lower incidence of depressive episodes during the first 9 months after enrollment. The CBP program's benefit was seen in youths whose index parent was not depressed at enrollment, on depression incidence (hazard ratio, 0.54 [95% CI, 0.36-0.81]), depression-free days (d = 0.34, P = .01), and developmental competence (d = 0.36, P = .04); these effects on developmental competence were mediated via the CBP program's effect on depression-free days. CONCLUSIONS AND RELEVANCE: The effect of CBP on new onsets of depression was strongest early and was maintained throughout the follow-up period; developmental competence was positively affected 6 years later. The effectiveness of CBP may be enhanced by additional booster sessions and concomitant treatment of parental depression. TRIAL REGISTRATION: clinicaltrials.gov Identifier:NCT00073671.

Asunto(s)

RESUMEN

IMPORTANCE: Adolescent offspring of depressed parents are at high risk for experiencing depressive disorders themselves. OBJECTIVE: To determine whether the positive effects of a group cognitive-behavioral prevention (CBP) program extended to longer-term (multiyear) follow-up. DESIGN: A 4-site randomized clinical trial with 33 months of follow-up was conducted. Recruitment of participants was from August 2003 through February 2006. SETTING: The study settings included a health maintenance organization, university medical centers, and a community mental health center. PARTICIPANTS: Three hundred sixteen adolescent (aged 13-17 years) offspring of parents with current and/or prior depressive disorders; adolescents had histories of depression, current elevated depressive symptoms, or both but did not currently meet criteria for a depressive disorder. INTERVENTIONS: The CBP program consisted of 8 weekly 90-minute group sessions followed by 6 monthly continuation sessions. Adolescents were randomly assigned to either the CBP program or usual care (UC). MAIN OUTCOMES AND MEASURES: The primary outcome was a probable or definite episode of depression (Depression Symptom Rating score ≥4) for at least 2 weeks through the month 33 follow-up evaluation. RESULTS: Over the 33-month follow-up period, youths in the CBP condition had significantly fewer onsets of depressive episodes compared with those in UC. Parental depression at baseline significantly moderated the intervention effect. When parents were not depressed at intake, CBP was superior to UC (number needed to treat, 6), whereas when parents were actively depressed at baseline, average onset rates between CBP and UC were not significantly different. A 3-way interaction among intervention, baseline parental depression, and site indicated that the impact of parental depression on intervention effectiveness varied across sites. CONCLUSIONS AND RELEVANCE: The CBP program showed significant sustained effects compared with UC in preventing the onset of depressive episodes in at-risk youth over a nearly 3-year period. Important next steps will be to strengthen the CBP intervention to further enhance its preventive effects, improve intervention outcomes when parents are currently depressed, and conduct larger implementation trials to test the broader public health impact of the CBP program for preventing depression in youth. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00073671.

Asunto(s)