Showing papers by "Robert Gallop published in 2009"

Prediction of Response to Medication and Cognitive Therapy in the Treatment of Moderate to Severe Depression

Abstract: A recent randomized controlled trial found nearly equivalent response rates for antidepressant medications and cognitive therapy in a sample of moderate to severely depressed outpatients. In this article, the authors seek to identify the variables that were associated with response across both treatments as well as variables that predicted superior response in one treatment over the other. The sample consisted of 180 depressed outpatients: 60 of whom were randomly assigned to cognitive therapy; 120 were assigned to antidepressant medications. Treatment was provided for 16 weeks. Chronic depression, older age, and lower intelligence each predicted relatively poor response across both treatments. Three prescriptive variables-marriage, unemployment, and having experienced a greater number of recent life events-were identified, and each predicted superior response to cognitive therapy relative to antidepressant medications. Thus, 6 markers of treatment outcome were identified, each of which might be expected to carry considerable clinical utility. The 3 prognostic variables identify subgroups that might benefit from alternative treatment strategies; the 3 prescriptive variables identify groups who appear to respond particularly well to cognitive therapy.

Unique and common mechanisms of change across cognitive and dynamic psychotherapies.

Abstract: The goal of this article was to examine theoretically important mechanisms of change in psychotherapy outcome across different types of treatment. Specifically, the role of gains in self-understanding, acquisition of compensatory skills, and improvements in views of the self were examined. A pooled study database collected at the University of Pennsylvania Center for Psychotherapy Research, which includes studies conducted from 1995 to 2002 evaluating the efficacy of cognitive and psychodynamic therapies for a variety of disorders, was used. Patient samples included major depressive disorder, generalized anxiety disorder, panic disorder, borderline personality disorder, and adolescent anxiety disorders. A common assessment battery of mechanism and outcome measures was given at treatment intake, termination, and 6-month follow-up for all 184 patients. Improvements in self-understanding, compensatory skills, and views of the self were all associated with symptom change across the diverse psychotherapies. Changes in self-understanding and compensatory skills across treatment were predictive of follow-up symptom course. Changes in self-understanding demonstrated specificity of change to dynamic psychotherapy.

Multilevel modeling of longitudinal data for psychotherapy researchers: I. The basics

Abstract: Psychotherapy researchers are often interested in change or development over time (i.e., pre- to posttreatment to follow-up or the development of process variables across multiple sessions). Traditional methods of assessing change and development are often unsatisfactory because of violations of statistical assumptions and because they do not model individual change. Modern longitudinal data analysis methods, including multilevel models (MLMs), provide an opportunity to model dynamic fluctuations in individual data across time. The objective of this article is to focus on the fundamentals of MLMs for longitudinal data analysis in psychotherapy research. To do so, the authors illustrate basic equations of MLMs and a strategy for developing increasingly complex models. They also present data from a psychotherapy research as an example of the application of MLMs. Finally, they offer some caveats and advice for conducting and presenting MLMs.

Mediation Analysis with Principal Stratification

Abstract: In assessing the mechanism of treatment efficacy in randomized clinical trials, investigators often perform mediation analyses by analyzing if the significant intent-to-treat treatment effect on outcome occurs through or around a third intermediate or mediating variable: indirect and direct effects, respectively. Standard mediation analyses assume sequential ignorability, i.e., conditional on covariates the intermediate or mediating factor is randomly assigned, as is the treatment in a randomized clinical trial. This research focuses on the application of the principal stratification approach for estimating the direct effect of a randomized treatment but without the standard sequential ignorability assumption. This approach is used to estimate the direct effect of treatment as a difference between expectations of potential outcomes within latent sub-groups of participants for whom the intermediate variable behavior would be constant, regardless of the randomized treatment assignment. Using a Bayesian estimation procedure, we also assess the sensitivity of results based on the principal stratification approach to heterogeneity of the variances among these principal strata. We assess this approach with simulations and apply it to two psychiatric examples. Both examples and the simulations indicated robustness of our findings to the homogeneous variance assumption. However, simulations showed that the magnitude of treatment effects derived under the principal stratification approach were sensitive to model mis-specification.

Wide Variation in Clinicians' Assessment of New York Heart Association/World Health Organization Functional Class in Patients With Pulmonary Arterial Hypertension

Abstract: OBJECTIVE To assess interrater reliability of the New York Heart Association/World Health Organization functional classification as applied by clinicians (defined as both physicians and nurses in this article) to patients with pulmonary arterial hypertension (PAH). PATIENTS AND METHODS Between March 16 and August 31, 2007, a survey that described 10 hypothetical patients was completed by physicians and nurses attending a conference on PAH. Results were subsequently validated with physicians and nurses who were contacted online through the Pulmonary Hypertension Association. Respondents were asked to assign each patient's functional class as they would normally in clinical practice. RESULTS The functional class evaluations were completed by 113 clinicians, 87 (77%) of whom had participated in PAH trials; 106 (94%) reported using functional class when determining therapy. Clinicians reported a broad range of factors they considered when evaluating functional class, and their assessments of functional class varied widely. The intraclass correlation coefficient was 0.58 for the initial patient survey and 0.62 for the online survey. At best, one patient was ranked as either class II (by 60 clinicians [53%]) or class III (by 53 [47%]). Clinicians' rankings spanned at least 3 functional classes for each of the other patients. Equally divergent rankings were observed among nurses and physicians. Cluster analysis identified clinicians' tendencies toward "higher" or "lower" functional class rankings. Of the 113 clinicians, 101 (89%) thought that the patients described resembled those seen in their practices. CONCLUSION Despite the wide use of the New York Heart Association/World Health Organization functional class in clinical care and as a research tool, interrater agreement may be inadequate. Efforts to promote a uniform approach to evaluating functional class might help to standardize PAH care and research.

Multilevel modeling of longitudinal data for psychotherapy researchers: II. The complexities.

Abstract: The authors previously reviewed the basic elements and steps to building multilevel models (MLMs) for longitudinal data typically found in psychotherapy research. The objective of this article is to focus on complexities associated with the MLM for longitudinal data analysis in psychotherapy research, which may result in proper use or misuse of the modeling structure. To do so, the authors illustrate complex scenarios and discuss issues in the implementation and interpretation of the MLM: (a) impact of missing data in the MLM, (b) determination of the complexity of the covariance structure and its implication on model interpretation, (c) issues with centering, (d) model diagnostics for MLM, (e) model formation, including implementation dependent on the treatment of time and distribution of outcome, and (f) model estimation. The authors also present data from psychotherapy research settings as examples of these complex situations. Finally, they offer some caveats and advice for recognizing these c...

The alliance in motivational enhancement therapy and counseling as usual for substance use problems.

Abstract: Data from a community-based multicenter study of motivational enhancement therapy (MET) and counseling as usual (CAU) for outpatient substance users were used to examine questions about the role of the alliance in MET and CAU. Most (94%) of the sample met diagnostic criteria for abuse or dependence (primarily alcohol and/or cocaine). Sixteen therapists for CAU and 14 for MET participated. No reliable differences in patient ratings (n = 319) on the Helping Alliance Questionnaire-II (HAq-II) were evident for MET compared to CAU, but significant differences between therapists were found within each condition in mean patient-rated HAq-II scores. Overall, average levels of alliance were high. The between-therapists component of the alliance, but not the within-therapist component, was significantly associated with self-reported days of primary substance use during the follow-up period from Week 4 to Week 16 (Cohen's d = 0 .39; n = 257). Therapists with either low or very high alliances had relatively poorer average outcomes (quadratic effect, d = 0.44). For therapists in both MET and CAU, increased use of MET fundamental techniques and MET advanced techniques during treatment sessions was associated with higher levels of alliance. Implications of the findings for conceptualization of the alliance and for training of therapists are discussed.

A simple clinical predictive index for objective estimates of mortality in acute lung injury.

Abstract: Objective: We sought to develop a simple point score that would accurately capture the risk of hospital death for patients with acute lung injury (ALI). Design: This is a secondary analysis of data from two randomized trials. Baseline clinical variables collected within 24 hours of enrollment were modeled as predictors of hospital mortality using logistic regression and bootstrap resampling to arrive at a parsimonious model. We constructed a point score based on regression coefficients. Setting: Medical centers participating in the Acute Respiratory Distress Syndrome Clinical Trials Network (ARDSnet). Patients: Model development: 414 patients with nontraumatic ALI participating in the low tidal volume arm of the ARDSnet Acute Respiratory Management in ARDS study. Model validation: 459 patients participating in the ARDSnet Assessment of Low tidal Volume and elevated End-expiratory volume to Obviate Lung Injury study. Model Validation: 459 patients participating in the ARDSnet Assessment of Low tidal Volume and elevated End-expiratory volume to Obviate Lung Injury trial. Interventions: None. Measurements and Main Results: Variables comprising the prognostic model were hematocrit 2 mg/dL (1 point), fluid balance >2.5 L positive (1 point), and age (1 point for age 40‐64 years, 2 points for age >65 years). Predicted mortality (95% confidence interval) for 0, 1, 2, 3, and 4 point totals was 8% (5% to 14%), 17% (12% to 23%), 31% (26% to 37%), 51% (43% to 58%), and 70% (58% to 80%), respectively. There was an excellent agreement between predicted and observed mortality in the validation cohort. Observed mortality for 0, 1, 2, 3, and 4 point totals in the validation cohort was 12%, 16%, 28%, 47%, and 67%, respectively. Compared with the Acute Physiology Assessment and Chronic Health Evaluation III score, areas under the receiver operating characteristic curve for the point score were greater in the development cohort (0.72 vs. 0.67, p 0.09) and lower in the validation cohort (0.68 vs. 0.75, p 0.03). Conclusions: Mortality in patients with ALI can be predicted using an index of four readily available clinical variables with good calibration. This index may help inform prognostic discussions, but validation in nonclinical trial populations is necessary before widespread use. (Crit Care Med 2009; 37:1913‐1920)

Sweet Liking Phenotype, Alcohol Craving and Response to Naltrexone Treatment in Alcohol Dependence

Abstract: Aims: To investigate the relationship between the sweet liking/sweet disliking phenotype (a putative probe of brain opioid function), craving for alcohol and response to treatment with naltrexone in individuals with alcohol dependence. Methods: Forty individuals with alcohol dependence were enrolled in a 12-week open-label study of 50 mg of naltrexone with four sessions of motivational enhancement therapy. Prior to treatment, individuals completed a sweet preference test and the Penn Alcohol Craving Scale. Subjects were categorized as sweet liking (SL), n = 15, or sweet disliking (SDL), n = 25, via a standard sweet tasting paradigm. The sweet tasting results were blinded to the subjects and to treatment staff. SL status, pretreatment craving and their interaction were examined as predictors of frequency of abstinent days and heavy drinking days during treatment with naltrexone. Results: SL and SDL subjects achieved similar reductions in percent heavy drinking days with treatment. During treatment, SDL subjects had 48% abstinent days compared to 30% for SL subjects (P = 0.034). Pretreatment craving did not predict % heavy drinking days or % abstinent days. An interaction effect was found between the SL/SDL phenotype and pretreatment craving such that SL subjects with high craving demonstrated higher rates of percent abstinent days whereas SDL subjects with high craving demonstrated lower rates of percent abstinent days, P < 0.001. Conclusions: These findings indicate that the SL/SDL phenotype may predict variation in response to naltrexone and/or counseling treatment. Furthermore, the SL/SDL phenotype may interact with craving to provide a more robust prediction of outcome with naltrexone or counseling.

Depression precipitated by alcohol use in patients with co-occurring bipolar and substance use disorders.

Abstract: Objective Bipolar disorder and substance use disorder frequently co-occur. However, little is known about the near-term effects of substance use on bipolar disorder. Thus, the present study tests whether alcohol use precipitates depression among patients with co-occurring bipolar disorder and substance use disorder. Method This study uses data collected as part of 2 clinical trials (the first study was conducted from March 1999 through March 2004 and the second study was conducted from August 2003 through May 2007) of a manualized group therapy for patients with co-occurring bipolar disorder and substance dependence. One hundred fifteen participants were assessed at baseline and each month through month 8. Baseline diagnoses were made using the Structured Clinical Interview for DSM-IV, and monthly substance use and mood data were collected using the Longitudinal Interval Follow-Up Evaluation and the Addiction Severity Index. Generalized estimating equation methodology was used to analyze these longitudinal data. Results Our primary hypotheses were supported: days of alcohol use and an increase in days of alcohol use each significantly predicted the presence of a depressive episode in the subsequent month when controlling for current depression and current drug use. Conclusion These data suggest that alcohol use in patients with bipolar disorder and substance dependence increases the risk of a depressive episode in the near term. Trial registration This study draws on data generated during 2 clinical trials. One was exempt from trial registration; clinicaltrials.gov Identifier for other trial: NCT00227838.

Mother–Child Conflict and Its Moderating Effects on Depression Outcomes in a Preventive Intervention for Adolescent Depression

Abstract: This article reports on mother-child conflict as an outcome and moderator of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), a preventive intervention for depression. Forty-one adolescents (average age = 13.37, SD = 1.19) with elevated depression symptoms were randomized to receive IPT-AST or school counseling (SC). Adolescents in IPT-AST showed significantly greater reductions in mother-child conflict. Baseline mother-child conflict moderated the programs' effects on depression symptoms. Adolescents in IPT-AST who had high baseline conflict showed significantly greater decreases in depression symptoms than adolescents in SC who had high conflict. Among those adolescents with low baseline conflict, the difference between the two interventions was not significant.

Do personality problems improve during psychodynamic supportive-expressive psychotherapy? Secondary outcome results from a randomized controlled trial for psychiatric outpatients with personality disorders.

Abstract: Studies involving patients with personality disorders (PDs) have not focused on improvement of core aspects of the PD. The authors examined changes in quality of object relations, interpersonal problems, psychological mindedness, and personality traits in a sample of 156 patients with Diagnostic and Statistical Manual of Mental Disorders (4th ed.) PD diagnoses being randomized to either manualized or nonmanualized dynamic psychotherapy. Effect sizes adjusted for symptomatic change and reliable change indices were calculated. The authors found that both treatments were equally effective at reducing personality pathology. Only in neuroticism did the nonmanualized group do better during the follow-up period. The largest improvement was found in quality of object relations. For the remaining variables, only small and clinically insignificant magnitudes of change were found. (PsycINFO Database Record

Assessment of anxiety and depression in primary care: value of a four-item questionnaire.

Abstract: Anxiety and depression are psychiatric disorders frequently seen in family practice.1,2 A 2005 national survey3 reported 12-month prevalence estimates of 18.1% for anxiety and 9.5% for depression. Because these disorders are costly, recognizing these conditions and treating afflicted patients are of substantial public health interest.4,5 In addition, 1-year prevalence of family practice patients barely missing diagnostic criteria for anxiety or depression (ie, patients with subthreshold diagnoses) as defined by the Diagnostic and Statistical Manual for Mental Disorders (4th ed; DSM-IV)6 were reported as 25.7% and 13.1%, respectively.7 While the impact of anxiety and depression on patients’ work performance is considerably higher than that of subthreshold diagnoses, patients in both groups can benefit from treatment.8,9 Several screening tools have been recommended for use in family practice to identify potential patients who have anxiety or depression.10–13 However, none are regularly used.14 One of the most frequently studied self-administered surveys is the Hopkins Symptom Checklist (HSCL), which is an established rating scale to assess anxiety and depression symptomatology.15 Although a short 25-item version of the HSCL can clearly identify patients with anxiety or depression who might be in need of treatment,16 this tool is still too long for use in family practice. Likewise, the original Primary Care Evaluation of Mental Disorders (PRIME-MD)17 and the revised self-administered PRIME-MD Patient Health Questionnaire18 have proven helpful in clinical settings, but physicians’ time constraints limit the use of such tools. The present study was initiated to evaluate the usefulness of a concise screening tool in family practice—specifically, if it could help family physicians determine whether or not to explore a patient’s emotional state and assess his or her need for treatment.