Paul Crits-Christoph - US grants

A major neglected area of psychodynamic psychotherapy research is the target of the proposed study: To determine the extent to which the quality of interpretive interventions by the therapist are associated with (1) patient improvement from psychotherapy, and (2) gains in self-understanding (insight) which are in turn related to global benefits from treatment. Secondary aims of this project are to examine whether the impact of therapist interpretations are moderated by (1) the level of the patient's overall psychological adjustment and (2) the formation of a positive helping alliance. These questions will be addressed in data from two large samples: 60 patients from the Penn Psychotherapy Project and (for cross-validation purposes) 40 patients from the Penn Re-Pairing Study. An extensive outcome assessment and tape recordings of all sessions exist for these patients. Several sessions per patient will be scored for measures of the therapist's response to the patient's main communications, the extent to which the therapist effectively responds to the patient's core conflictual relationship theme, the extent to which the therapist is following recommended guidelines for psychoanalytically oriented psychotherapy, and a measure of errors in technique. Also assessed will be the patient's response to therapist interpretations, especially in terms of insight into aspects of the core conflictual theme. This study represents a unique opportunity to address these important questions in two samples of relatively long-term psychodynamic psychotherapy.

Recent research has indicated that significant numbers of opiate dependent patients have serious, coexisting psychiatric disorders and that the addition of time-limited psychotherapy to treatment- as-usual leads to significant improvements which are evident even 12 months following treatment (Woody et al., 1983). It is now important to understand the effective ingredients of psychotherapy for opiate addiction as a means towards refining and improving treatment so as to maximize the benefits addicts received. It is the aim of the proposed research to apply new psychotherapy process methods to the sessions of a recent project by our group evaluating the usefulness of Supportive-Expressive Psychodynamic psychotherapy and Cognitive-Behavioral psychotherapy in the treatment of opiate addiction. The application of measures from the psychodynamic perspective and the cognitive perspective will allow us to test and compare two major models of the effective ingredients of change. In dynamic therapy, it is proposed that the accuracy of the therapist's interpretations is the central variable, and in cognitive therapy it is proposed that the amount and quality of cognitive therapy provided leads to changes in causal explanations which leads to better outcome. Measures of these concepts will be applied to three early-in-treatment sessions and three late-in-treatment sessions from the treatments of 59 opiate addicts who participated in the Woody et al. (1983) outcome study. We will examine the predictive value of each variable in the context of variables from the other model and also controlling for established predictor variables (e.g., the strength of the therapeutic alliance). Session-by-session changes will be analyzed in a panel regression approach to tease out spurious explanations of correlational findings.

Recent research has indicated that significant numbers of opiate dependent patients have serious, coexisting psychiatric disorders and that the addition of time-limited psychotherapy to treatment- as-usual leads to significant improvements which are evident even 12 months following treatment (Woody et al., 1983). It is now important to understand the effective ingredients of psychotherapy for opiate addiction as a means towards refining and improving treatment so as to maximize the benefits addicts received. It is the aim of the proposed research to apply new psychotherapy process methods to the sessions of a recent project by our group evaluating the usefulness of Supportive-Expressive Psychodynamic psychotherapy and Cognitive-Behavioral psychotherapy in the treatment of opiate addiction. The application of measures from the psychodynamic perspective and the cognitive perspective will allow us to test and compare two major models of the effective ingredients of change. In dynamic therapy, it is proposed that the accuracy of the therapist's interpretations is the central variable, and in cognitive therapy it is proposed that the amount and quality of cognitive therapy provided leads to changes in causal explanations which leads to better outcome. Measures of these concepts will be applied to three early-in-treatment sessions and three late-in-treatment sessions from the treatments of 59 opiate addicts who participated in the Woody et al. (1983) outcome study. We will examine the predictive value of each variable in the context of variables from the other model and also controlling for established predictor variables (e.g., the strength of the therapeutic alliance). Session-by-session changes will be analyzed in a panel regression approach to tease out spurious explanations of correlational findings.

human therapy evaluation; psychotherapy; bipolar depression; cognition; interview; human subject;

This 5-year is a competing renewal application for a Specialized Mental Health Clinical Research Center (CRC) for the Study of Psychotherapy. The primary long-term vision of this CRC is to answer questions about which treatments work for what kinds of psychiatric disorders and to test hypotheses about the means through which effective treatments work. The specific theme that unites CRC research relates to the role of relationship schemas, self-concept schemas, compensatory skills, and the therapeutic alliance as processes that mediate symptom change across diverse treatments and patient populations. The CRC consists of four Core Unites: (1) An Administrative Core that provides overall coordination and approves pilot projects, (2) an Assessment Core that provides state-of-the-art diagnostic and other clinical assessments, (3)a Data Core that provides high level data management and statistical services, and (4) a Treatment Development Core that generates new treatment manuals, trains therapists, tests the adequacy of implementation of treatments, and collects preliminary efficacy/mechanism data through treatment pilot projects. In addition to servicing Ro1 and other studies, the CRC provides a rich environment of research and clinical training.

The main goal of the proposed CRC is to evaluate the clinical utility of two major forms of psychotherapy: cognitive therapy and dynamic therapy. Four disorders will be initially studied: chronic depression, generalized anxiety disorder, and two personality disorders (avoidant and obsessive compulsive). In the first phase of the CRC, six pilot/training projects employing cognitive therapy and dynamic therapy for each of the disorders will be implemented. These pilot projects will allow for trying out new treatment manuals, training therapists, and standardizing procedures across investigators. A seventh pilot project will examine the reformulated learned helplessness theory using a chronic depression population. In the second phase of the CRC, clinical trials (submitted as R01s) comparing the two psychotherapies and standard pharmacotherapy for these disorders will be performed using the therapists trained in the pilot phase. Two additional training/pilot studies focusing on cognitive and dynamic therapies for Dependent Personality Disorder will be performed in years 4 - 5. A final pilot study in years 3 - 5 will pursue the possibility of integrating a brief cognitive therapy based training program with psychodynamic therapy for major depression. In addition, the CRC will support the lines of research in existing ROls, including method development and predictive studies. The current ROls, future ROls, and pilot projects are supported by four integrated cores: 1. Administration, 2. Therapeutics and Training, 3. Assessment and Accrual, and 4. Data Management and Statistics. The CRC will also promote the training of new investigators in this field.

The purpose of this proposal is to further develop a scientific understanding of the efficacy of dynamic/interpersonal psychotherapy for a variety of mental disorders. Four set of studies are proposed. The first set focuses on the development of measures that will assist studies of the process and outcome of dynamic therapies. Included are method development studies on measures of the accuracy of therapists' interventions and measures (both clinician judged and self-report) that assess change in core conflicts. The second set of studies involves analysis of the process of interpersonal and cognitive therapies for major depression in order to better understand the effective ingredients of treatment. Thirdly, treatment development projects designed to standardize dynamic therapy, collect preliminary efficacy data, and train therapists for outcome research will be conducted. Manual guided dynamic treatments will be developed for generalized anxiety disorder, treatment resistant chronic depression, and avoidant and obsessive-compulsive personality disorder. Finally, if successful, the treatment development projects will lead into comparative outcome trials. In addition, a comparative outcome study evaluating dynamic therapy for cocaine dependent patients (particularly those with high levels of non-substance abuse psychiatric symptoms) will be conducted.

This competing continuation application requests 3 years of funding to complete an ongoing multi-site study examining the efficacy of individual cognitive therapy (CT), individual supportive-expressive (SE) psychodynamic therapy, and individual drug counseling (IDC) when combined with group drug counseling compared with group drug counseling (GDC) alone for 480 patients who meet DSM-lV criteria for cocaine dependence. This project has been funded as a Cooperative Agreement involving two NIDA collaborators, a Coordinating Center at the U. of Pennsylvania, and treatment sites at Western Psychiatric Institute and Clinic (Pittsburgh), Brookside Hospital (Nashua, NH), McLean and Mass General Hospitals (Boston), and U. of Pennsylvania. During the last grant period we have recruited and trained our research teams, developed efficient screening procedures, standardized and established the reliability of our assessments, and trained therapists and counselors in state-of-the-art treatment methods that can be administered with a high degree of specificity and fidelity. These goals were accomplished in the course of conducting a pilot study involving 314 randomized patients that provided preliminary evidence for our hypotheses. The main trial began in July 1994 and thus far we have recruited 129 patients. We anticipate recruiting a total of 288 patients between July 1994 and the beginning of the competing continuation in September 1995 and an additional 192 patients in the first year of the renewal. Specifically, we hypothesize that CT, SE, and lDC will be better than GDC; that for patients with high levels of psychiatric severity CT and SE will be better than IDC, and that for patients with an external coping style CT will be better than SE. Treatment consists of a 6-month active phase followed by a 3 month booster phase. Assessments are done monthly through the active phase and at 9, 12, 15, and IS months post randomization to examine the long-term effects of treatment. The main outcome measures include urine results (dine weekly), Addiction Severity Index Drug Use composite, and self- report of cocaine use. A variety of secondary outcome measures are also obtained. The data analysis will use both cross-sectional and longitudinal approaches.

DESCRIPTION (Applicant's Abstract): The principal goal of this R21 study is to test, using patients with a diagnosis of generalized anxiety disorder (GAD), whether psychotherapy emphasizing therapist focus on core conflictual relationship themes (CCRT-Focused Therapy) can be implemented successfully and discriminated from a Reflective Listening Control (RLC) condition designed to provide non-specific elements of psychotherapy. In addition, preliminary (pilot) data on the relative efficacy of the two treatment conditions will be obtained in order to plan a larger efficacy trial. Sixteen weeks of manual-driven CCRT-Focused Therapy will be compared to a Reflective Listening Control (RLC). GAD has relatively high prevalence (lifetime approximately 3%), chronicity (2/3 with duration longer than 2 years), and associated psychosocial impairment. Benzodiazepine therapy is the most widely used treatment, but one-third of patients do not achieve remission, and the psychological and behavioral adverse effects, most notably the dependence and withdrawal liability, substantially reduce the benefit-risk ratio. Cognitive-behavioral therapy has demonstrated some efficacy with GAD, but considerable numbers of patients remain with residual symptomatology. Recent research implicates the relevance of interpersonal/psychodynamic factors in GAD, but no studies have investigated the efficacy of a manual-guided interpersonally oriented therapy with GAD patients. Treatment integrity and discrimination will be assessed through revised versions of adherence/competence scales developed for the respective treatments. Outcome will be assessed at 16 weeks and over a two year follow-up using three primary outcomes measures: the Hamilton Anxiety Rating Scale (assessing general anxiety symptoms), the Penn State Worry Questionnaire (assessing the core features of GAD, namely worry), and the Quality of Life Inventory (assessing the impact of treatment on a broad range of domains of life). The impact of treatment on a variety of secondary outcome measures, including interpersonal functioning and depressive symptoms will also be assessed. We also plan to collect pilot data on mediators of response for CCRT-Focused Therapy. We hypothesize that CCRT-Focused Therapy will be mediated by changes in self-understanding of interpersonal problems. Furhter, we will conduct exploratory analyses of the relation of comorbid Axis I and II disorder, trauma history and symptoms, and gender and ethnicity as main effect predictors and in interaction with treatment modality. To collect data on these hypotheses we propose to randomize 36 patients to 16 weeks of CCRT-Focused Therapy or RLC treatment. Patients will be eligible if they meet DSM-IV criteria for a primary diagnosis of GAD, but without comorbid substance abuse or psychotic disorders.

human therapy evaluation; psychotherapy; major depression; handbook; mental health personnel; training aid; training; behavioral /social science research tag; human subject; clinical research;

Cocaine addiction remains a serious public health problem. Current treatment methods for cocaine addicts, particularly those seeking treatment in urban settings, are generally inadequate. Thus, there is a significant need to develop and test treatments for cocaine dependence. The current proposal requests continued support for further data analysis of the NIDA Collaborative Cocaine Treatment Study, a large, multi-site psychotherapy clinical trial for patients with DSM-IV cocaine dependence. Five research sites in conjunction with the Coordinating Center, using an identical research protocol, examined the efficiency of two psychotherapies, cognitive-behavioral (CT) and psychodynamic supportive- expressive (SE) psychotherapy, and two drug counseling approaches, individuals, individual drug counseling (ICD) and group drug counseling (GCD). Although the project is fully on schedule, further support is needed to conduct a variety of important additional analyses that are of vital importance to understanding the nature of the efficacy results and pointing the way for future studies. The further analyses involve testing a number of hypotheses about predictors and mediators of treatment response. Three general themes organize the hypotheses for further analysis. These are: (1) Which patients benefit most from psychosocial treatment for cocaine dependence? (2) Do intra-session and extra-session processes influence outcome? And, (3) Do changes in theory-specific constructs mediate change in drug use and other outcomes? In addition to further data analyses, a second general aim of the current proposal is to create a public use dataset that will allow other investigations to pursue questions within our large and rich database.

DESCRIPTION (provided by applicant): We propose here treatment development work to create and test a "community-friendly" manual-based individual plus group drug counseling package. The NIDA Collaborative Cocaine Treatment Study (Crits-Christoph et at., 1999) recently reported that manual-based individual drug counseling (IDC) plus group drug counseling (GDC) has superior drug use outcomes compared to cognitive-behavior therapy plus GDC, psychodynamic therapy plus GDC, and GDC alone. Proposed changes to IDC and GDC to make them more "community-friendly" include changes to both the duration and content of the treatment models. The proposed treatment development work will include (1) obtaining feedback on the new treatment manuals by a sample of 15 community-based drug counselors, (2) evaluating whether a group of drug counselors can successfully learn to implement the new manuals, (3) evaluating counselors' experiences in learning and conducting the new treatments, (4) conducting a pilot randomized evaluation of the outcomes of the new package of individual plus group drug counseling compared to group drug counseling alone, (5) obtaining ratings of treatment fidelity to assess whether the new individual and group drug counseling approaches can be differentiated from the original therapies, (6) assessing patient reactions to the new treatment, and (7) conducting a preliminary investigation of potential mediators of change of the new treatments. The pilot randomized trial will involve assignment of 40 patients meeting DSM-IV criteria for cocaine dependence to either new versions of individual plus group drug counseling or group drug counseling alone. Assessments will be done at time of intake and weekly (for urines and self-report of cocaine use) or monthly (for other outcome measures) during a 3-month treatment phase. The primary efficacy measures will be the ASI Drug Use Composite scale and a composite cocaine use measure that incorporates urine data, Addiction Severity Index Interview data, and weekly self-report of cocaine use. Mediation of drug use change will be examined by assessing beliefs about substance use, endorsement of 12-step behaviors and beliefs, and attendance/ participation in 12-step meetings at baseline, weekly for the first month and monthly thereafter. The data gathered from this treatment development project will inform the design of a subsequent larger study.

[unreadable] DESCRIPTION (provided by applicant): [unreadable] [unreadable] Group drug counseling is the primary treatment modality used in community settings for the treatment of cocaine dependence, as well as alcohol and most other substances of abuse. Despite the prevalence of this modality, and data on the efficacy of group approaches to the treatment of substance use disorders, little is known about how the treatment works to achieve positive outcomes. Thus, as described in the RFA, research is needed on the mechanism of action of group treatments for substance abuse. Drawing upon research on individual drug counseling and on group therapy for non-substance abuse problems, we propose to examine several theoretically important therapy process variables as predictors of the outcome of group drug counseling for cocaine dependence. Specifically, we propose to examine degree of patient participation, quality of participation, quality of the therapeutic alliance, and frequency of feedback (and positive feedback), as assessed in group drug counseling sessions, as predictors of treatment outcome. Furthermore, the relation of these process variables to two potential mediators of changes in drug use (changes in beliefs about drug use and endorsement of 12-step philosophy) will be examined. Group drug counseling sessions will be drawn from an archival tape collection from the NIDA Cocaine Collaborative Treatment Study (NIDA CCTS, Crits-Christoph et al., 1999). A second aim of the current proposal is to develop a novel approach to the analysis of group therapy data. Research on the mechanism of group counseling has been hindered by a variety of difficulties in studying treatments delivered in group formats. In particular, statistical analyses of studies using group therapy/counseling needs to address the inherent clustering within the data (i.e., there is an issue of non-independence of observations within a group). While statistical techniques such as mixed-effects models and generalized estimating equations exist for handling clustered data arising in group therapy studies with traditional static group designs, in the real world drug counseling groups typically have a "rolling" or "dynamic" structure, meaning that new members are added on an ongoing basis and existing members dropout over time. Statistical solutions for addressing such "rolling" groups have yet to be developed. Our second aim is to develop a new statistical approach to the analysis of data from "rolling" groups. [unreadable] [unreadable]

[unreadable] DESCRIPTION (provided by applicant): This is an application for an R34 grant to conduct a preliminary efficacy study of combined medication and psychotherapy for generalized anxiety disorder (GAD). Of all the major mood and anxiety disorders, GAD represents one of the most common, but least studied. Although medications and cognitive-behavioral therapies (CBT) have demonstrated efficacy in the treatment of GAD, a substantial number of patients fail to achieve adequate improvements in anxiety symptoms during acute phase treatment. Thus, it is important to attempt to augment acute phase treatment outcomes for GAD. Selective serotonin reuptake inhibitors (SSRI) and serotonin norepinephrine reuptake inhibitor (SNRI) antidepressants have recently been approved by the FDA for the treatment of GAD. However, no studies have examined the efficacy of combining these medications with psychotherapy for diagnosed GAD patients. We therefore propose a preliminary randomized clinical trial to assess whether combined treatment is superior to medication alone in the acute phase treatment of GAD. The proposed study will randomly assign 160 patients with a primary diagnosis of GAD to either 12 weeks of CBT plus venlafaxine XR (N=40) or venlafaxine XR alone (N=120). Responders during the initial 12 week period will be continued on medication and assessed for 6-months to collect preliminary data on relapse. Venlafaxine will be flexibly dosed between 75 and 225 mg/day. The primary efficacy measure will be the Hamilton Anxiety Rating Scale assessed at baseline and treatment weeks 2, 4, 6, 8, and 12. Secondary outcomes will include measures of depressive symptoms, quality of life, and functional impairment. Data analysis will focus on differential rate of change (mixed model analyses) for the two groups. If promising results are obtained for combined treatment, a larger more definitive trial will be planned. [unreadable] [unreadable]

DESCRIPTION (provided by applicant): Although an extensive literature exists on the efficacy of psychotherapy treatments for major depressive disorder (MDD), there is limited data on the effectiveness of such treatments in diverse, community-based real-world practice settings. MDD is of public health concern because it is a common psychiatric disorder that is associated with significant levels of functional impairment, increased health care utilization, and suicide attempts. The purpose of this proposal is to develop an infrastructure within a community mental health center in Philadelphia to support the conduct of effectiveness research on manual-based psychotherapies that have proven efficacious in previous studies. The collaborative venture described in this application will bring together academic intervention and services researchers with administrators, clinicians, and staff working at two clinics that are part of Northwestern Human Services of Philadelphia (NHSP). NHSP is the largest publicly funded provider of mental health services in Philadelphia. Nearly all of the target consumers at NHSP are low-income individuals receiving some form of public assistance or other support and Medicaid for medical and behavioral health services. MDD is the second most common disorder found at these clinics, and the most common of the non-chronic population. Preliminary studies have indicated that while psychotherapy is delivered to many consumers with major depressive disorder in these settings, clinicians at NHSP have not been trained in empirically-supported psychotherapies for MDD. Thus, there is a great need to export empirically-supported psychotherapies for MDD to such settings and to evaluate their effectiveness in the community. Initial work, however, must focus on engaging and retaining consumers because staff at NHSP, as well as our preliminary studies, have identified lack of engagement/attrition as a major problem at these clinics. Specifically, the infrastructure will support (1) collaborative research planning/review meetings between academics and clinical service providers/ administrators, (2) implementation of a systems-wide outcomes assessment program at NHSP, (3) computer/ data analysis expertise within NHSP that will integrate outcomes assessment with clinical information databases, (4) pilot studies focusing initially upon engagement/attrition, and subsequently on the effectiveness of empirically supported psychotherapies for major depressive disorder. The infrastructure support created will work synergistically with existing programs at Penn that focuses on psychotherapy research (Center for the Study of Psychotherapy) and mental health services research (Center for Mental Health Policy and Services Research)

[unreadable] DESCRIPTION (provided by applicant): [unreadable] Quality improvement (Ql) methods are a cornerstone of business and healthcare management throughout the United States yet there have been few studies of Ql interventions in addiction treatment settings. The proposed study tests the effectiveness of one Ql system - Patient Feedback (PF) - at increasing outpatient group therapy attendance and self-reported abstinence. The feasibility and acceptability of PF was established in a six-site study conducted within the National Drug Abuse Clinical Trials Network. In the proposed study, 32 community-based outpatient treatment programs with approximately 250 clinicians will be randomly assigned to PF, or usual clinic practices. In the PF condition, every other week clinic patients are invited to complete a 12-item, self-administered survey in which they rate therapeutic alliance and treatment satisfaction, and report past week substance use. These anonymous surveys are faxed by clinic staff to a University of Pennsylvania data center where a custom software application converts the surveys into feedback reports and posts them to a password protected website. Clinicians can access their caseload feedback reports and aggregated reports for the whole clinic; supervisors can only access the aggregated clinic reports. On a monthly basis staff meet as a team to review the feedback reports and develop Ql plans intended to yield improvements in select Ql indicators. The PF website and the monthly PF e-newsletter provide social recognition, clinical resources, and a virtual community for participating clinicians. After 20- weeks, participants in both conditions complete follow-up measures and then both groups are given open access to PF for 12 additional months. During "sustainability phase" staff usage of the PF website is monitored. Alternate versions of the PF Survey are introduced during the sustainability study, including one that monitors HIV risk behavior and one developed collaboratively by staff from the participating sites. The rapid processing of surveys enables near real time feedback to clinic staff. Organizations may share their feedback reports with funding sources, regulatory agencies, policy makers, and other stakeholders. This centralized, semi-automated feedback system eases fulfillment of accreditation requirements and as such, reduces the cost of clinic operations. A collaborating clinical trial application for this test of PF is being submitted by John Rotrosen, M.D., from New York University, School of Medicine. [unreadable] [unreadable]

DESCRIPTION (provided by applicant): Evidence-based practice is defined as the integration of best research evidence with clinical expertise and consumer preferences. However, little attention has been devoted to how to integrate consumer preferences into evidence-based practice in the treatment of major depressive disorder. No practical clinical methodology is available that provides real-time, consumer-weighting of preferences that would permit empirical findings to be used to individualize treatment choice for each mental health consumer with major depressive disorder. The overall goal of this R34 application is to develop and pilot a multi-attribute decision modeling approach in which clinical treatment decisions for people seeking treatment for major depressive disorder in a community mental health setting are guided by evidence-based practice data that has been customized to the preferences of individual consumers. We will apply multi-attribute decision modeling to match up consumers'ratings of their preferences regarding specific treatment attributes (i.e., efficacy, safety, tolerability) to the performance of available treatments as measured by meta-analytic data on each of the attributes (e.g., response rate;incidence of adverse events). Three development steps are proposed here: (1) compile information from existing meta-analyses, or conduct meta-analyses as needed, on the performance of existing evidence-based pharmacotherapies and psychotherapies for major depressive disorder in regard to a list of salient treatment attributes (efficacy;adverse events;tolerability;time commitment), (2) conduct a survey of 80 consumers and 40 clinicians from a community mental health center to evaluate the importance of various specified treatment attributes, and solicit additional treatment attributes deemed to be important, in the treatment of major depressive disorder, and (3) conduct a study examining the feasibility, ease of use, and predictive validity of 3 measures for assessing consumer preferences in regard to a final list of treatment attributes. This final study will be conducted using 72 consumers seeking treatment for major depressive disorder in a community mental health center, with preferences being used to predict duration of time each consumer stays on the treatment recommended to them at the agency. Results of these studies will be used (in future work) to develop a software product that provides real-time assessment of consumer preferences together with a matching of the preferences to attributes of evidence-based treatments for major depressive disorder so that an individualized treatment recommendation is produced to guide the clinician in decision making. Public Health Relevance: Major depressive disorder is one of the most common psychiatric disorders and is associated with considerable social and occupational disability. Incorporating consumer preferences into treatment will facilitate the tailoring of evidence-based practice to the individual and potentially increase consumer satisfaction and improve outcomes.

DESCRIPTION (provided by applicant): This is a proposal to conduct a study of theoretically-relevant mediators of cognitive therapy (CT) and supportive-expressive psychodynamic therapy (SE) implemented in community mental health centers. The study will be appended to a recently funded comparative effectiveness study of these two psychotherapies. Theories of the mechanism of change in CT have proposed that CT works by changing (1) dysfunctional attitudes, (2) underlying schemas, and/or (3) compensatory skills. SE therapy theoretically works by changing self-understanding in regard to interpersonal patterns. However, no fully adequate and comprehensive test of these potential mediators has been done to date. In particular, studies of the mechanism of CT have rarely used an alternative psychotherapy as a comparison group. In the parent effectiveness study, patients are randomly assigned to receive 12 weeks of CT or SE therapy, with measures of depressive symptoms, functioning, and quality of life completed monthly. We propose to administer a self-report measure of self-understanding of interpersonal patterns, a self-report measure of dysfunctional attitudes, a rater-scored measure of compensatory skills, and a computerized task that assesses underlying cognitive schemas. These measures will be conducted at baseline, month 1, and month 2 for 210 patients in the parent study. Analyses of mediation will be guided by both Baron &Kenny and MacArthur models, with change in the mediators predicting subsequent change in depressive symptoms and functioning in a longitudinal model, so that results are consistent with a model of change in the mediator causing subsequent improvements on outcome measures. The significance of this work is the potential identification of how both CT and SE therapy work in community settings. Results will have implications for the training of therapists in community settings, potential revisions of the CT and SE models of therapy, and decisions about dissemination of evidence-based treatments to community mental health centers. PUBLIC HEALTH RELEVANCE: Major depressive disorder has deleterious effects on both the individual and society, with existing treatments showing a lack of clinical response for many patients. The proposed study will examine the mechanism of action of cognitive therapy and supportive- expressive psychodynamic therapy in a community mental health setting. Results will have implications for the potential modifications of these treatments to enhance effectiveness and for the dissemination of evidence-based treatments to the community mental health setting.

PROJECT SUMMARY (See instructions); The Clinical Assessment Core will provide a range of services to Center investigators to assist in recruitment and the conduct of clinical assessments. Specifically, the Clinical Assessment Core will: (1) Assist in recruitment to Center studies; (2) Assist in assessments in studies by providing clinical and self-report behavioral assessments; (3) Coordinate baseline medical screenings (conducted at the CTSA), (4) Provide diagnostician recruitment, training, and ongoing calibration; (5) Administer a core battery in all Center pilot treatment studies and (where possible) ROIs that includes the Risk Assessment Battery, Beck Depression Inventory, and SF-12. Potential users of the Core will be alerted of the resource availability of the Penn CFAR Clinical Core (co-director: Gross) through a wide variety of mechanisms and by highlighting its services as part of Center wide dissemination efforts. The Clinical Assessment Core will continuously monitor and regularly evaluate each of the services that it will provide. In addition, the functioning of the Clinical Assessment Core as a whole will be evaluated through the use of a standard evaluation form, asking about strengths and weaknesses of the Core, completed by all Center investigators who have had contact with the Core over the previous year. Summary of the feedback from investigators will be given to the Center Executive Committee, Internal Advisory Board, and External Advisory Committee for comments and suggestions. The Clinical Assessment Core will be directed by Paul Crits-Christoph, who has extensive experience as an NIH Center Director and in the assessment of patients for psychiatric studies, and co directed by Pablo Tebas and Robert Gross, who have extensive experience in the treatment of patients with HIV/AIDS and in recruiting such patients for clinical research studies.

DESCRIPTION (provided by applicant): Intimate partner violence (IPV) remains a major source of morbidity and mortality in the United States, with women suffering the majority of adverse long-term consequences. While both men and women perpetrate IPV at similar rates, this grant will focus on IPV-involved women drinkers (victims, perpetrators, or both). IPV and heavy drinking (4 or more drinks/day for women) are commonly seen in as co-occurring conditions in the emergency department (ED) setting, both acutely and chronically, with apparent bi-directional causation; but these two conditions are rarely addressed together. There is evidence that brief opportunistic interventions in the ED setting are effective in reducing subsequent hazardous drinking and alcohol-related injuries, but results have been less clear in women. Interventions that take a collaborative treatment approach to IPV and substance abuse have resulted in improved outcomes but have focused almost exclusively on male perpetrators, even though heavy drinking is also associated with IPV victimization and perpetration in women; indeed a woman's perpetration of IPV puts her at increased risk of violent victimization. Advised by international experts on gender and alcohol use and motivational enhancement therapy, the multidisciplinary group of investigators with experience in IPV, emergency medicine, brief ED interventions, motivational interviewing, psychotherapy efficacy research, and the modeling of complex psychosocial data, propose a randomized controlled trial with 600 women ED patients who self-disclose co-occurring problem drinking and intimate partner violence to assess whether a brief motivational intervention can decrease primary outcomes of episodes of heavy drinking and incidents of IPV, assessed weekly using an Interactive Voice Response System for 12 weeks. Both the intervention and the assessed control group will also be contacted every at 3, 6 and 12 months using individualized safe phone contact by interviewers blinded to group assignment for 12 months following the ED visit. To identify the impact of assessment alone, we will include a no-contact control group assessed for outcomes only at 3 months. All groups will receive standard written referrals. Secondary outcomes include IPV severity, alcohol quantity/frequency, self-rated health, health behaviors, quality of life, and relationship satisfaction. We will explore likely mediators and moderators of the intervention. The brief 25 minute manual-guided motivational intervention, which will be monitored for fidelity, will be delivered by trained social workers at the time of the ED visit, followed by a 15 minute phone booster at 10 days, as this is a model that could be generalizable to other acute health care settings.

? DESCRIPTION (provided by applicant): Major depressive disorder (MDD) is a severe and disabling disorder afflicting 7% of individuals in the United States annually and approximately 17% of individuals across their lifetime. Despite multiple investigations demonstrating that both medications and psychotherapeutic interventions are effective in the treatment of MDD, response rates in well-done efficacy trials still reach only 40 to 60%. Response rates in the public sector are even lower. One psychosocial treatment that holds promise for use in the publicly-funded community mental health centers (CMHC) is Behavioral activation (BA). This treatment has been found to be efficacious in the treatment of MDD, particularly severe MDD, and has been used effectively by the types of non-doctoral level clinicians that often deliver treatment in CMHC settings. The purpose of the study proposed here is to examine the feasibility of conducting a study of behavioral activation when implemented in community mental health settings where many patients suffer from severe MDD. In the first phase of the project, consumers, clinicians, and staff at a CMHC will provide input on an existing BA treatment model to tailor it to the CMHC environment. In the second phase of the project, the final treatment manual will be used to train clinicians in BA at the CMHC through workshops, training cases, and a novel online training module designed for training CMHC clinicians in BA. In the third phase of the project, a total of 80 patients with MDD who score 14 or above on the 17-item Hamilton Rating Scale for Depression (HAM-D) will be randomly assigned in a 3:1 ratio to 9 sessions of BA or treatment-as-usual (TAU) at a community mental health center (CMHC). In addition to feasibility/acceptability of BA and TAU, the study is designed to test whether theoretically important targets of BA (increased activation; increased reward value of activities) change over the course of BA treatment, and whether such changes as associated with changes in depressive symptoms. Patients will also be assessed at baseline and then weekly using the BASIS-24 and at week 6 and week 12 using the HAM-D administered by independent raters. A measure of trait reward processing will be measured at baseline using the Effort- Expenditure for Rewards Task to pilot the use of this measure as a potential moderator of BA treatment effects. The ability of CMHC therapists to adequately implement BA will be assessed by rating taped sessions on BA adherence and competence scales. Successful completion of this project will lead a larger scale effectiveness study of BA in the CMHC setting.

The goal of this proposal is to develop a novel web-based software program to evaluate consumer preferences in the treatment of depression and potentially other disorders. During year 1 we will develop the requisite software, and during year 2 we will pilot the software with 20 clinicians and 75 consumers in a community mental health setting to determine feasibility and clarity. We will also assess the stability of preference scores over a two month period. The method for assessing preferences, developed and n validated with a previous NIMH R34 award, involves first asking consumers to provide input on their preferences regarding the attributes of different treatments for depression. Attributes of treatments are primarily the side effects of antidepressants, the time commitment for and nature of psychotherapy. Based on our initial R34 work that involved clinicians and consumer input, we arrived at a final list of 18 attributes. The software will use a MAXDIFF (maximum difference scaling, also known as ?best worst scaling?) method that presents 4 (of the 18) attribute choices to consumers at a time interatively, and the consumer chooses the most and least preferred of the 4. Scores are then output that rank the attributes from most preferred to least preferred. For each consumer, these preference scores are then compared to actual atrtributes of treatments for depression using multiattribute decision modeling to arrive at a final ranking of treatments from most preferred to least preferred. Our previous research has shown that receiving a non-preferred treamtent leads to considerably longer durations of treatment and significantly greater likelihood of changing treatments. To move this program of research forward, software is needed so that preferred treatments can be measured in real time so consumer preferences can be integrated into actual treatment decisions made at the initial visits to the clinic.Incorporating consumer preferences into the decision-making process for the treatment of depression and other disorders can help expand the use of available options, better meet consumers' needs, and potentially yield better outcomes. Programming the software will involve integrating a web interface for MAXDIFF assessment programming for scoring MAXDIFF output, conducting MADM analyses, and outputing a report that will inform clinicians about consumer treatment preferences.

CORE C Abstract/Summary The Clinical Assessment Core provides a range of services to Center investigators related to clinical assessments. Specifically, the Clinical Assessment Core will: (1) provide to PMHARC-related studies clinical and self-report behavioral assessments administered by highly trained core personnel; (2) provide diagnostician recruitment, training, and ongoing calibration in order to maintain high quality; (3) oversee the administration of a core battery in all Center pilot treatment studies and (where possible) R01s that includes the Risk Assessment Battery, Quick Inventory of Depressive Symptoms, the BASIS-24, and SF-12; (4) provide consultation on a broad range of behavioral, neuropsychological, and medication adherence measures to PMHARC investigators. By providing a shared diagnostic assessment resource, the Clinical Assessment Core maximizes the quality of assessments and minimizes cost for all Center investigators (diagnostic assessments are provided to PMHARC pilot studies at no cost to the investigator). By administering the same core battery measures across all studies, the Core is able to compile a pooled database with substantially larger sample sizes. This larger database enables Center investigators to ask broader questions about the interactions of psychiatric status and HIV disease status and examine subpopulations stratified by gender, race, and ethnicity. The Clinical Assessment Core will continuously monitor and regularly evaluate each of the services that it will provide. Summary of the feedback from investigators will be given to the Center Executive Committee, Internal Advisory Board, and External Advisory Committee for comments and suggestions. The Clinical Assessment Core will be directed by Paul Crits-Christoph, who has extensive experience as an NIH Center Director and in the assessment of patients for psychiatric studies, and co- directed by Robert Gross, who has extensive experience in the treatment of patients with HIV/AIDS and in assessing adherence to medications, and Cobb Scott, who is experienced in the neuropsychological assessment of HIV+ patients.