Donald Baucom - US grants

Divoices are occurring at an alamingly high rate in the United States. Behavioral marital therapy (BMT) has been shown to be effective in helping distressed married couples. The current investigator recently completed a 4-year marital therapy outome study (n=72 couples) which establishes the usefulness of each major component of a BMT treatment program. Investigators have begun to call for expanding marital treatment to include other components, such as teaching a couple to examine their cognitions and attitudes, and express their emotions. The overall goal of the current investigation is to assist distressed couples through an even more effective marital treatment strategy by supplementing the previously validated BMT program (a) cognitive restructuring and (b) emotional expressiveness training. Cognitive restructuring techniques, developed within the field of cognitive behavior therapy, have been found to be effective in alleviating various types of emotional distress. A program for teaching emotional expressiveness training has been found to be effective in improving the quality of several types of dyadic relationships. In the currently proposed psychotherapy outcome study, 60 maritallydistressed couples will be randomly assigned to one of three therapists and one of the following five treatment conditions: (a) BMT Alone; (b) Cognitive Restructuring Plus BMT; (c) BMT Plus Emotional Expressiveness Training; (d) Cognitive Restructuring Plus BMT Plus Emotional Expressiveness Training; (e) Waiting list. Treatment will consist of 12 weekly sessions lasting 1 1/2 hours each. Outcome measures wil include self-reports and behavioral observations gathered at pretest and posttest, and self-reports for one year after therapy is terminated. The study will attempt to: (a) determine the relative effectiveness of BMT Alone compared to BMT plus the other treatment components, noting specific changes produced by eah treatment component; (b) establish the effectiveness of the therapy conditions compared to a waiting list condition; (c) determine long-term effectivenessof the treatments by examining one-year followup data; (d) determine effects of treatment of individual psychological functional and marital interaction; (e) isolate characteristics of individuals that predict treatment success.

DESCRIPTION (provided by applicant): The diagnosis and treatment of breast cancer has a significant and enduring impact not only on the patient, but also on the patient's spouse or partner, and the couple's relationship as well. Breast cancer frequently leads to emotional distress for both the patient and partner, disturbances in the patient's body image, role functioning, and sexual functioning, and maladaptive patterns of interaction between the patient and partner, all of which impact both the patient's adjustment and the couple's relationship functioning. The ultimate goal of our research is to help couples in which one partner has cancer improve their ability to assist each other, both to address areas of concern and to maximize positive aspects of life. The proposed study evaluates the efficacy of a newly developed, cognitive-behavioral couple-based intervention entitled CanThrive. 292 women recently diagnosed with early stage breast cancer and their partners will be randomly assigned to one of three conditions: (1) CanThrive, which teaches couples well-validated specific relationship skills to improve their ability to communicate effectively and problem-solve about cancer-related issues, maintain satisfactory sexual functioning, and maximize positive interactions; (2) Cancer Education which provides couples with information about breast cancer and its treatment; or (3) Treatment-As-Usual, in which couples receive no active intervention. Assessment conducted before and after treatment and at 6 and 12 months follow-up includes patients' reports of communication with the husband, support from the husband, sexual adjustment and self-schema, benefit finding, mood and emotional well being, social role functioning, pain, fatigue, and physical well being; and husbands' ratings of communication with the patient, support from the patient, sexual functioning, benefit finding, mood, and psychological well being. Patients also complete daily diaries regarding perceived partner support, mood, symptoms, and role function. Also at each evaluation, couples engage in three videotaped cancer-related conversations that will be rated on dimensions of partner support and communication skills. This study may lead to major advances in our understanding of the role of relationship skills and partner involvement in the adjustment of cancer patients. If successful, it will enlarge our repertoire of methods for effectively enhancing the well being of both cancer patients and their partners.

DESCRIPTION (provided by applicant): This R01 is submitted in response to RFA-MH-07-090 Innovative Trials for the Treatment of Anorexia Nervosa in Late Adolescence and Adulthood. With a specific focus on adult anorexia nervosa (AN), we propose to unite the expertise of a team skilled in the treatment of AN with world leaders in the development of couple-based interventions to develop an innovative intervention for couples in which one member is suffering from AN. The intervention "UCAN: Uniting Couples (in the treatment of) Anorexia Nervosa" acknowledges that AN occurs in an interpersonal context, both being affected by the person's social environment and impacting important interpersonal relationships. Moreover, the demonstrated success of family therapy for younger individuals with AN underscores the importance of leveraging family support in the treatment of AN. UCAN tailors cognitive-behavioral couple-based interventions that have been employed successfully for the treatment of depression, anxiety disorders, smoking cessation, and cancer to address the core psychopathology of AN, while also addressing the unique and challenging stresses that AN places on intimate relationships. Our initial conceptualization of the intervention focuses first on addressing AN within the context of the relationship with foci such as altering interactions around eating and weight, normalizing activity and health behaviors, body image, physical affection, and sexuality and second on addressing the broader relationship to maintain treatment gains, prevent relapse, and foster relationship satisfaction. The specific aims are: 1) to develop and standardize a manualized intervention for couples in which one member suffers from AN;2) to determine feasibility and acceptability of a beta- version of UCAN in an open trial as an augmentation to treatment as usual (TAU) and to refine UCAN based on feedback from the preliminary trial;3) to test UCAN+TAU versus TAU in a randomized controlled trial of 24 couples in which one member has AN;and 4) to adapt an observational couples assessment measure with the eventual goal of incorporating biological measures of affiliation and stress. Our primary patient outcomes will be BMI and global improvement, and our secondary patient outcomes will be depression, anxiety, and relationship adjustment and communication. Partner outcomes will also include caregiving measures. This trial will be designed explicitly to gather preliminary outcome data to inform sample size and power calculations for a subsequent larger randomized controlled trial. Findings from this investigation have the potential to result in the creation of an effective, acceptable, developmentally tailored intervention that will improve both core AN pathology as well as couple functioning. Future extensions of the intervention will include couple-based interventions for eating disorders such as bulimia nervosa and binge eating disorder. We propose to develop a couple-based intervention for adults with anorexia nervosa entitled "UCAN: Uniting Couples (in the treatment of) Anorexia Nervosa." We will create an effective, acceptable, developmentally tailored intervention that leverages the support of partners to improve both core anorexia nervosa pathology as well as couple functioning.

DESCRIPTION (provided by applicant): No single, conventional treatment has been shown to significantly benefit adults with anorexia nervosa (AN), which ranks among the leading causes of disability and premature death in young women. We propose to test the hypothesis that a novel, couple-based intervention developed for adult AN (UCAN [Uniting Couples (in the treatment of) Anorexia Nervosa]) developed under RFA-MH-07-090 significantly enhances treatment outcome and reduces risk of relapse compared with treatment conducted entirely on an individual basis, the standard mode of treatment delivery in the community. This application, submitted in response to PA-10-067 Research Project Grant (Parent R01) will further establish the efficacy of UCAN. UCAN mutually engages patients and partners in reducing the psychopathology of AN and its impact on relationship functioning. Encouraging results from our pilot - significant weight gain and unprecedentedly low treatment drop out - support this application. In order to determine whether UCAN is superior to individual treatment alone, we propose a randomized controlled trial comparing: 1) UCAN plus individual cognitive-behavioral therapy (UCAN+CBT) to 2) Individual CBT. All patients receive the same core of interventions used in conventional AN treatment, specifically: 1) medical management, 2) nutrition counseling, and 3) individual CBT. Further, participants will be randomly assigned either to: 1) UCAN or 2) a higher dose of individual CBT. The design addresses a question of clinical, developmental, and conceptual importance heretofore unexplored: Is treatment of adult AN optimized when it includes active participation of the patient's partner, compared with the community standard of individual therapy only. The primary aims are to compare the efficacy of UCAN+CBT with Individual CBT in: 1) increasing BMI and improving global clinical improvement, and 2) increasing retention in and satisfaction with treatment. Exploratory aims will address whether: 1) evidence exists to suggest that improvement in primary outcome variables may be partially mediated by improvements in relationship functioning and patient readiness to change; and 2) illness duration, subtype (restricting vs. binge/purge), and baseline level of emotion dysregulation should be considered as candidate moderators of treatment outcome in subsequent trials. We will collect data to guide the design of a more comprehensive cost-effectiveness analysis if a subsequent multi-site trial is warranted. The primary outcomes are change in BMI, global improvement, retention, and treatment satisfaction. We will recruit 50 couples (40 completers) over 3.75 years and follow all patients for one year. The Data Monitoring Group (DMG) will monitor recruitment, treatment fidelity, assessments, and human subject protections. Results from this trial will guide future, more definitive trials and inform therapeutic perspectives guiding the treatment of adults with AN. The development of innovative, efficacious treatments for adult AN is essential to reducing the chronic morbidity, high risk of mortality, and substantial personal, familial, and public health burdens incurred by this debilitating and recalcitrant illness.

Project Summary This application is in response to PAR-17-158, ?Secondary Data Analyses to Explore NIMH Research Domain Criteria (R03).? We propose to examine interpersonal regulation of prosody associated with symptoms of depression and anxiety. Prosody (paralinguistic features of speech), part of the RDoC ?Systems for Social Processes? domain, is indicative of emotional arousal and has essential communicative functions. While intraindividual emotion regulation has been widely studied in psychiatric disorders, research on interpersonal emotion regulation has been focused on healthy individuals. That is, little is known about how close relationships help or hinder emotion regulation for individuals with psychopathology. We propose a unique approach using prosody during negatively valenced couple conversations to examine moment-by-moment patterns of interpersonal emotion regulation associated with psychopathology. Given the prevalence and transdiagnostic relevance, this study will focus on symptoms of depression and anxiety. We pool data from eight previous investigations, including couples selected for psychiatric diagnoses (depression, OCD, eating disorders) or the presence/absence of relationship distress, resulting in a sample of N = 398 couples (796 individuals). Consistent with the RFA, this pooled sample provides a unique opportunity to examine RDoC constructs (non-facial communication, arousal), symptom clusters (depression and anxiety), and relationship distress in a dimensional manner ranging from healthy individuals and relationships to marked disturbances in both. All couples completed recorded conversations about a problem in the relationship (if applicable, related to the psychiatric disorder), and measures of depression, anxiety, and relationship satisfaction. Integrative Data Analysis, a framework to analyze data in pooled samples across different measures of a construct will be employed. Emotional arousal encoded in prosody will be measured continuously during couple conversations. We capitalize on advances in the statistical modeling of dynamic interpersonal processes and will use dyadic time-series and dynamic systems modeling to examine interpersonal emotion regulation. Adaptive interpersonal regulation during negatively valenced conversations is defined as (a) the couple?s ability to keep emotional arousal from escalating and to deescalate arousal after increases, and (b) the degree to which partners aid in the return of the other partner?s emotional arousal to baseline. Accordingly, the central focus will be to examine the associations of depression, anxiety, relationship distress, and their interaction with (a) the overall trajectories of emotional arousal across the conversation, and (b) the degree to which bidirectional moment-to-moment associations between partners? emotional arousal help or hinder the return of arousal to baseline. Findings from this investigation can contribute substantially to the understanding of the RDoC ?Social communication? construct and its relevance to emotion regulation in psychopathology, with the long term goal of identifying specific social processes as treatment targets that can optimize interventions in the future.

Project Summary/Abstract Psychosocial treatments for binge-eating disorder (BED) and bulimia nervosa (BN) have demonstrated efficacy in specialty settings, yet, most treatment for BED/BN occurs in outpatient settings with more limited resources. In response to RFA-MH-16-410, we propose to test the preliminary effectiveness of a couple-based intervention for BED/BN (UNiting couples In the Treatment of Eating disorders [UNITE]) relative to an established evidence-based individual treatment (cognitive-behavioral therapy-enhanced; CBT-E) in a community clinic setting. One strategy to bolster effectiveness is to activate resources in the patient?s environment (e.g., include partners in treatment). Unless partners understand BED/BN and how to be of assistance, relationships can be a stressor. Indeed, relationship stressors are common binge/purge triggers and adverse interpersonal environments contribute to illness maintenance. Individuals with BED/BN report high levels of relationship distress, negative interactions, and poor communication skills. Including a partner in treatment can transform the relationship from a stressor into an agent of positive change. We propose to augment effectiveness of BED/BN treatment by addressing interpersonal factors directly by including partners in treatment. We will test the preliminary effectiveness of UNITE in a small randomized controlled trial (RCT) of 28 adult patients and their partners (24 completing couples) in a community clinic. We hypothesize that results will yield evidence supporting enhanced outcomes in UNITE compared with CBT-E on the primary outcome of binge abstinence (and purge abstinence in BN) and other measures of psychopathology and general functioning, and significantly greater treatment satisfaction. Moreover, we propose that treatment gains will be achieved and maintained by engaging eating disorder-related relationship targets, including improved (T1) communication around BED/BN, (T2) problem-solving/behavioral change skills specific to BED/BN, and (T3) partner-assisted emotion regulation. Assessment will include observational and speech prosody measures during couples? clinic interactions and self-reports reflecting functioning outside of the clinic. The Data Monitoring Group will oversee recruitment, assessments, and human subject protections. If we demonstrate preliminary effectiveness and target engagement in a community clinic setting, we will plan a larger RCT isolating our relationship targets and, if effective, progress towards implementation science. Our ultimate is to expand the community clinician?s armamentarium for treating BED and BN and increase the available treatment options for individuals with these illnesses.