Individual Treatment of Posttraumatic Stress Disorder Using Mantram Repetition: A Randomized Clinical Trial.

OBJECTIVE: Previous studies suggest that group "mantram" (sacred word) repetition therapy, a non-trauma-focused complementary therapy for posttraumatic stress disorder (PTSD), may be an effective treatment for veterans. The authors compared individually delivered mantram repetition therapy and another non-trauma-focused treatment for PTSD. METHOD: The study was a two-site, open-allocation, blinded-assessment randomized trial involving 173 veterans diagnosed with military-related PTSD from two Veterans Affairs outpatient clinics (January 2012 to March 2014). The mantram group (N=89) learned skills for silent mantram repetition, slowing thoughts, and one-pointed attention. The comparison group (N=84) received present-centered therapy, focusing on currently stressful events and problem-solving skills. Both treatments were delivered individually in eight weekly 1-hour sessions. The primary outcome measure was change in PTSD symptom severity, as measured by the Clinician-Administered PTSD Scale (CAPS) and by self-report. Secondary outcome measures included insomnia, depression, anger, spiritual well-being, mindfulness, and quality of life. Intent-to-treat analysis was conducted using linear mixed models. RESULTS: The mantram group had significantly greater improvements in CAPS score than the present-centered therapy group, both at the posttreatment assessment (between-group difference across time, -9.98, 95% CI=-3.63, -16.00; d=0.49) and at the 2-month follow-up (between-group difference, -9.34, 95% CI=-1.50, -17.18; d=0.46). Self-reported PTSD symptom severity was also lower in the mantram group compared with the present-centered therapy group at the posttreatment assessment, but there was no difference at the 2-month follow-up. Significantly more participants in the mantram group (59%) than in the present-centered therapy group (40%) who completed the 2-month follow-up no longer met criteria for PTSD (p<0.04). However, the percentage of participants in the mantram group (75%) compared with participants in the present-centered therapy group (61%) who experienced clinically meaningful changes (≥10-point improvements) in CAPS score did not differ significantly between groups. Reductions in insomnia were significantly greater for participants in the mantram group at both posttreatment assessment and 2-month follow-up. CONCLUSIONS: In a sample of veterans with PTSD, individually delivered mantram repetition therapy was generally more effective than present-centered therapy for reducing PTSD symptom severity and insomnia.

Mental Health Providers' Decision-Making Around the Implementation of Evidence-Based Treatment for PTSD.

It is estimated that <15% of veterans with posttraumatic stress disorder (PTSD) have engaged in two evidence-based psychotherapies highly recommended by VA-cognitive processing therapy (CPT) and prolonged exposure (PE). CPT and PE guidelines specify which patients are appropriate, but research suggests that providers may be more selective than the guidelines. In addition, PTSD clinical guidelines encourage "shared decision-making," but there is little research on what processes providers use to make decisions about CPT/PE. Sixteen licensed psychologists and social workers from two VA medical centers working with ≥1 patient with PTSD were interviewed about patient factors considered and decision-making processes for CPT/PE use. Qualitative analyses revealed that patient readiness and comorbid conditions influenced decisions to use or refer patients with PTSD for CPT/PE. Providers reported mentally derived and instances of patient-involved decision-making around CPT/PE use. Continued efforts to assist providers in making informed and collaborative decisions about CPT/PE use are discussed.

Is DSM-IV criterion A2 associated with PTSD diagnosis and symptom severity?

The diagnostic criteria for posttraumatic stress disorder (PTSD) have received significant scrutiny. Several studies have investigated the utility of Criterion A2, the subjective emotional response to a traumatic event. The American Psychiatric Association (APA) has proposed elimination of A2 from the PTSD diagnostic criteria for DSM-5; however, there is mixed support for this recommendation and few studies have examined A2 in samples at high risk for PTSD such as veterans. In the current study of 908 veterans who screened positive for a traumatic event, A2 was not significantly associated with having been told by a doctor that the veteran had PTSD. Those who endorsed A2, however, reported greater PTSD symptom severity in the 3 DSM-IV symptom clusters of reexperiencing (d = 0.45), avoidance (d = 0.61), and hyperarousal (d = 0.44), and A2 was significantly associated with PTSD symptom severity for all 3 clusters (R(2) = .25, .25, and .27, respectively) even with trauma exposure in the model. Thus, although A2 may not be a necessary criterion for PTSD diagnosis, its association with PTSD symptom severity warrants further exploration of its utility.

Incremental efficacy of adding bupropion to the nicotine patch for smoking cessation in smokers with a recent history of alcohol dependence: results from a randomized, double-blind, placebo-controlled study.

AIMS: The primary aim of this study was to compare the efficacy of smoking cessation treatment using a combination of nicotine patch and bupropion vs. nicotine patch and placebo bupropion. A secondary aim was to investigate whether the efficacy of bupropion is moderated by belief about whether one is receiving active or placebo medication. METHODS: Participants were recruited from a residential substance abuse treatment program and the community. We randomly assigned 148 smokers with between 2 and 12 months of alcohol abstinence to nicotine patch plus bupropion or nicotine patch plus placebo. All participants also received seven counseling sessions. RESULTS: At follow up, differences between medication conditions were not significant. Seven-day point prevalence quit rates in the patch plus bupropion vs. patch plus placebo conditions at week 24 were 6% and 11%, respectively. Differences between groups on prolonged abstinence and time to first smoking lapse were also not significant. However, among participants who received bupropion, those who accurately "guessed" that they were receiving bupropion were more likely to remain abstinent than those who incorrectly believed they were receiving placebo. CONCLUSIONS: Findings do not support combining nicotine patch and bupropion for smoking cessation in this population. However, findings support previous studies suggesting the importance of assessing the blind in smoking cessation studies and its possible moderating effect on medication efficacy. Future directions for enhancing smoking cessation outcome in these smokers include investigations of intensive behavioral and pharmacological interventions, including studies of potential interactions between individual genetic differences and medication efficacy.

The incremental value of self-reported mental health measures in predicting functional outcomes of veterans.

Research on patient-centered care supports use of patient/consumer self-report measures in monitoring health outcomes. This study examined the incremental value of self-report mental health measures relative to a clinician-rated measure in predicting functional outcomes among mental health service recipients. Participants (n = 446) completed the Behavior and Symptom Identification Scale, the Brief Symptom Inventory, and the Veterans/Rand Short Form-36 at enrollment in the study (T1) and 3 months later (T2). Global Assessment of Functioning (GAF) ratings, mental health service utilization, and psychiatric diagnoses were obtained from administrative data files. Controlling for demographic and clinical variables, results indicated that improvement based on the self-report measures significantly predicted one or more functional outcomes (i.e., decreased likelihood of post-enrollment psychiatric hospitalization and increased likelihood of paid employment), above and beyond the predictive value of the GAF. Inclusion of self-report measures may be a useful addition to performance measurement efforts.

Measurement of treatment adherence with antipsychotic agents in patients with schizophrenia.

The importance of medication adherence in sustaining control of schizophrenic symptoms has generated a great deal of interest in comparing levels of treatment adherence with different antipsychotic agents. However, the bulk of the research has yielded results that are often inconsistent. In this prospective, observational study, we assessed the measurement properties of 3 commonly used, pharmacy-based measures of treatment adherence with antipsychotic agents in schizophrenia using data from the Veterans Health Administration during 2000 to 2005. Patients were selected if they were on antipsychotics and diagnosed with schizophrenia (N = 18,425). A gap of >/=30 days (with no filled index medication) was used to define discontinuation of treatment as well as medication "episodes," or the number of times a patient returned to the same index agent after discontinuation of treatment within a 1-year period. The study found that the 3 existing measures differed in their approaches in measuring treatment adherence, suggesting that studies using these different measures would generate different levels of treatment adherence across antipsychotic agents. Considering the measurement problems associated with each existing approach, we offered a new, medication episode-specific approach, which would provide a fairer comparison of the levels of treatment adherence across different antipsychotic agents.

Association of co-morbidities with prescribing patterns and cost savings: olanzapine versus risperidone for schizophrenia.

BACKGROUND: Olanzapine and risperidone are two commonly prescribed atypical antipsychotics for schizophrenia. Prior studies have shown inconsistent results in terms of advantage in cost saving in prescribing these agents. Our preliminary analysis showed that a small percentage of intensive healthcare utilizers had substantial impact on healthcare costs. This study analysed the cost effects of olanzapine and risperidone among those who had intensive utilisation of medical care prior to drug initiation, and the relationship between the choice of the two drugs and patients' co-morbid condition. METHODS: We retrospectively investigated patients first treated with either risperidone or olanzapine between 1 April 1999 and 31 March 2000. According to patients' medication history during the 6 months prior to initial prescription of a study medication we categorised patients into three groups: (i) not receiving olanzapine or risperidone; (ii) not receiving any atypical antipsychotic agent; or (iii) not receiving any antipsychotic agent. We then compared the difference in cost saving by type of care in the 10% most expensive patients through bivariate and multivariate analyses. Based on the records of 18 499 patients with schizophrenia prescribed either olanzapine or risperidone between 1 April 1999 and 31 March 2000 we defined intensive users of healthcare as those who incurred an annual total cost in the top tenth percentile. We measured co-morbidity by number of diseases, and healthcare costs ($US, 1998-2001 values) in the year prior and the year after treatment initiation in six categories of care (inpatient medical/surgical, inpatient psychiatric care, other inpatient, outpatient psychiatric care, other outpatient and outpatient pharmacy). RESULTS: The top 10% most expensive patients accounted for about half of the total cost of the entire cohort and had nearly a 40% cost reduction for the year after treatment initiation versus the prior year, while the entire cohort increased cost between 2% and 12%. Compared with those prescribed olanzapine, patients prescribed risperidone had more medical co-morbidities, higher inpatient medical/surgical costs and lower psychiatric costs. Patients taking olanzapine had greater cost reduction in inpatient psychiatric care, whereas those taking risperidone had greater reduction in inpatient medical/surgical care. CONCLUSIONS: Among the top 10% most expensive patients, olanzapine and risperidone treatments were associated with comparable cost reductions in inpatient care. The choice of agent was associated with patients' co-morbid condition and was correlated with cost reduction in inpatient medical/surgical or psychiatric care.

Development and validation of a psychiatric case-mix system.

BACKGROUND: Although difficulties in applying risk-adjustment measures to mental health populations are increasingly evident, a model designed specifically for patients with psychiatric disorders has never been developed. OBJECTIVE: Our objective was to develop and validate a case-mix classification system, the "PsyCMS," for predicting concurrent and future mental health (MH) and substance abuse (SA) healthcare costs and utilization. SUBJECTS: Subjects included 914,225 veterans who used Veterans Administration (VA) healthcare services during fiscal year 1999 (FY99) with any MH/SA diagnosis (International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9-CM] codes 290.00-312.99, 316.00-316.99). METHODS: We derived diagnostic categories from ICD-CM codes using Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition definitions, clinical input, and empiric analyses. Weighted least-squares regression models were developed for concurrent (FY99) and prospective (FY00) MH/SA costs and utilization. We compared the predictive ability of the PsyCMS with several case-mix systems, including adjusted clinical groups, diagnostic cost groups, and the chronic illness and disability payment system. Model performance was evaluated using R-squares and mean absolute prediction errors (MAPEs). RESULTS: Patients with MH/SA diagnoses comprised 29.6% of individuals seen in the VA during FY99. The PsyCMS accounted for a distinct proportion of the variance in concurrent and prospective MH/SA costs (R=0.11 and 0.06, respectively), outpatient MH/SA utilization (R=0.25 and 0.07), and inpatient MH/SA utilization (R=0.13 and 0.05). The PsyCMS performed better than other case-mix systems examined with slightly higher R-squares and lower MAPEs. CONCLUSIONS: The PsyCMS has clinically meaningful categories, demonstrates good predictive ability for modeling concurrent and prospective MH/SA costs and utilization, and thus represents a useful method for predicting mental health costs and utilization.

The impact of enhanced incentives on vocational rehabilitation outcomes for dually diagnosed veterans.

This study evaluated the efficacy of adding contingency management techniques to vocational rehabilitation (VR) to improve treatment outcome as measured by entry into competitive employment. Nineteen dually diagnosed veterans who entered VR in the Veterans' Administration's compensated work therapy (CWT) program were randomly assigned to CWT (n = 8) or to CWT with enhanced incentives (n = 11). Over the first 16 weeks of rehabilitation, those in the incentives condition could earn up to dollar 1,006 in cash for meeting two sets of clinical goals: (a) remaining abstinent from drugs and alcohol and (b) taking steps to obtain and maintain a competitive job. Results indicate that relative to participants in the CWT-only group, those in the incentives condition engaged in more job-search activities, were more likely to remain abstinent from drugs and alcohol, were more likely to obtain competitive employment, and earned an average of 68% more in wages. These results suggest that rehabilitation outcomes may be enhanced by restructuring traditional work-for-pay contingencies to include direct financial rewards for meeting clinical goals.

Patient characteristics and the likelihood of initiation on olanzapine or risperidone among patients with schizophrenia.

Although pharmacologic treatments are available for patients with schizophrenia, little is known about how prescription patterns of atypical antipsychotic agents are related to patient characteristics. In this study, we examined the association between patient characteristics and the likelihood of being initiated on olanzapine or risperidone, two of the most frequently prescribed atypical agents for schizophrenia. We selected patients who were diagnosed with schizophrenia or schizoaffective disorder based on > or = 1 inpatient or > or = 2 outpatient ICD-9-CM codes (> or = 7 days apart) between 7/1/98 and 6/30/99 from the Veterans Health Administration (VA). We classified patients into one of three types of initiation: (a) not on olanzapine or risperidone, (b) not on any atypical agents, or (c) not on any antipsychotic agents for 6 months, and then subsequently being prescribed the target drugs. Using logistic regression, we examined whether the odds ratio of being initiated on olanzapine versus risperidone are related to patient sociodemographic and clinical characteristics. Compared to risperidone initiators, olanzapine initiators used more drugs for psychiatric conditions (including antiparkinsonian agents, typical antipsychotics, and mood stabilizers) than risperidone initiators. On the other hand, risperidone initiators had more medical comorbidities and more non-psychiatric hospitalizations. Olanzapine and risperidone appear to be prescribed to patients with different characteristics. Initiation of risperidone was more common among patients who presented with more medical comorbid conditions, whereas initiation of olanzapine was more common among patient who presented with more mental comorbid conditions. Future research needs to determine the reasons for those differences.

Added donepezil for stable schizophrenia: a double-blind, placebo-controlled trial.

RATIONALE: Schizophrenia is a disorder with cognitive deficits that could stem from cholinergic dysfunction. OBJECTIVES: Our aim was to examine if donepezil administered to stable, medicated outpatients with schizophrenia improves cognition and psychopathology. METHODS: We conducted a double-blind placebo-controlled trial of donepezil up to 10 mg/day added for 8 weeks to ongoing antipsychotic treatment in 36 typical community-treated schizophrenia patients not selected for cognitive impairment. RESULTS: Donepezil did not improve measures of cognition or psychopathology. It was well tolerated. CONCLUSION: Consistent with other studies, addition of donepezil to stable patients with schizophrenia did not improve cognition or measures of psychopathology. This result does not support the hypothesis that residual symptoms and cognitive problems result from a cholinergic deficit that can be remedied by an acetylcholinesterase inhibitor. A donepezil add-on strategy might make sense in selected schizophrenia cases where a pathological process is known to affect cholinergic neurons (e.g., history of head injury or comorbid dementia).

A six-month, placebo-controlled trial of D-cycloserine co-administered with conventional antipsychotics in schizophrenia patients.

RATIONALE: D-Cycloserine, a partial agonist at the glycine site of the N-methyl-D-aspartate receptor, has demonstrated inconsistent efficacy for negative and cognitive symptoms of schizophrenia. The strongest evidence for efficacy has come from studies using D-cycloserine at a dose of 50 mg/day added to conventional antipsychotics in trials of 8 weeks duration or less. OBJECTIVE: To assess the efficacy for negative symptoms and cognitive impairment of D-cycloserine augmentation of conventional antipsychotics in a 6-month trial. METHODS: Fifty-five schizophrenia patients with prominent negative symptoms, treated with conventional antipsychotics, were randomly assigned to treatment with D-cycloserine 50 mg/day or placebo for 6 months in a double-blind, parallel group design. RESULTS: Twenty-six subjects completed the 6-month trial; drop-out rates did not differ between treatment groups. D-Cycloserine treatment did not differ from placebo treatment on any primary outcome measure at 8 or 24 weeks, including response of negative symptoms and performance on a cognitive battery. Serum D-cycloserine concentrations did not correlate with response of negative symptoms. CONCLUSION: D-Cycloserine did not exhibit therapeutic effects in this trial, possibly reflecting the high drop-out rate, a narrow range of therapeutic serum concentrations, a modest magnitude of therapeutic effect for the selected outcome measures, or loss of efficacy over time. Because D-cycloserine is a partial agonist with relatively low affinity for the glycine site, the magnitude of potential therapeutic effect may be smaller than that achieved by the higher-affinity full agonists, glycine and D-serine.

Documenting pathways to dementia care: relative validity of questionnaire, interview, and medical record formats.

One of the shortcomings of the pathways-to-care literature is the lack of empirical support for the validity of the data collection methods. This study uses three common formats to collect retrospective pathways-to-care data for adults who have been diagnosed with possible or probable Alzheimer's disease (AD) and compares indicators to evaluate their relative validity. Forty family caregivers of adults diagnosed with possible or probable AD were recruited from the caregiver registry of the Boston University Alzheimer's Disease Core Center (BU ADCC). In each of three formats (questionnaire, structured interview, and medical record review), data were collected regarding four key events in the pathway to dementia care: first appearance of symptoms, first verbalized recognition of symptoms, first effort to seek professional help, and first diagnosis by a professional. In addition to the dates of these events, researchers attempted to determine: the first verbalized concern about the symptoms, who first sought professional help, what professional was first approached, and what professional made the first diagnosis. In a consensus meeting, data collected in all three formats were reviewed, and a consensus on the most likely answers to all questions was recorded and compared to data collected in each format. The results suggest that the three formats are not equivalent in terms of concurrent validity. While substantial agreement is found among data collection methods, the validity of the structured interview format and the medical record review is most consistently supported by the data in this study. Questionnaire data resulted in underestimates of delays and correlated poorly with other data sources, including the consensus judgment. Recommendations for pathways-to-care data collection procedures that maximize validity are discussed.

Effectiveness and cost of olanzapine and haloperidol in the treatment of schizophrenia: a randomized controlled trial.

CONTEXT: Although olanzapine has been widely adopted as a treatment of choice for schizophrenia, its long-term effectiveness and costs have not been evaluated in a controlled trial in comparison with a standard antipsychotic drug. OBJECTIVE: To evaluate the effectiveness and cost impact of olanzapine compared with haloperidol in the treatment of schizophrenia. DESIGN AND SETTING: Double-blind, randomized controlled trial with randomization conducted between June 1998 and June 2000 at 17 US Department of Veterans Affairs medical centers. PARTICIPANTS: Three hundred nine patients with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of schizophrenia or schizoaffective disorder, serious symptoms, and serious dysfunction for the previous 2 years. Fifty-nine percent fully completed and 36% partially completed follow-up assessments. INTERVENTIONS: Patients were randomly assigned to receive flexibly dosed olanzapine, 5 to 20 mg/d, with prophylactic benztropine, 1 to 4 mg/d (n = 159); or haloperidol, 5 to 20 mg/d (n = 150), for 12 months. MAIN OUTCOME MEASURES: Standardized measures of symptoms, quality of life, neurocognitive status, and adverse effects of medication. Veterans Affairs administrative data and interviews concerning non-VA service use were used to estimate costs from the perspective of the VA health care system and society as a whole (ie, consumption of all resources on behalf of these patients). RESULTS: There were no significant differences between groups in study retention; positive, negative, or total symptoms of schizophrenia; quality of life; or extrapyramidal symptoms. Olanzapine was associated with reduced akathisia in the intention-to-treat analysis (P<.001) and with lower symptoms of tardive dyskinesia in a secondary analysis including only observations during blinded treatment with study drug. Small but significant advantages were also observed on measures of memory and motor function. Olanzapine was also associated with more frequent reports of weight gain and significantly greater VA costs, ranging from 3000 dollars to 9000 dollars annually. Differences in societal costs were somewhat smaller and were not significant. CONCLUSION: Olanzapine does not demonstrate advantages compared with haloperidol (in combination with prophylactic benztropine) in compliance, symptoms, extrapyramidal symptoms, or overall quality of life, and its benefits in reducing akathisia and improving cognition must be balanced with the problems of weight gain and higher cost.

Measuring the quality of depression care in a large integrated health system.

BACKGROUND: Guideline-based depression process measures provide a powerful way to monitor depression care and target areas needing improvement. OBJECTIVES: To assess the adequacy of depression care in the Veterans Health Administration (VHA) using guideline-based process measures derived from administrative and centralized pharmacy records, and to identify patient and provider characteristics associated with adequate depression care. RESEARCH DESIGN: This is a cohort study of patients from 14 VHA hospitals in the Northeastern United States which relied on existing databases. Subject eligibility criteria: at least one depression diagnosis during 1999, neither schizophrenia nor bipolar disease, and at least one antidepressant prescribed in the VHA during the period of depression care profiling (June 1, 1999 through August 31, 1999). Depression care was evaluated with process measures defined from the 1997 VHA depression guidelines: antidepressant dosage and duration adequacy. We used multivariable regression to identify patient and provider characteristics predicting adequate care. SUBJECTS: There were 12,678 patients eligible for depression care profiling. RESULTS: Adequate dosage was identified in 90%; 45% of patients had adequate duration of antidepressants. Significant patient and provider characteristics predicting inadequate depression care were younger age (<65), black race, and treatment exclusively in primary care. CONCLUSIONS: Under-treatment of depression exists in the VHA, despite considerable mental health access and generous pharmacy benefits. Certain patient populations may be at higher risk for inadequate depression care. More work is needed to align current practice with best-practice guidelines and to identify optimal ways of using available data sources to monitor depression care quality.