Robert J. Gatchel - US grants

The present proposed study is designed to evaluate the impact of a media-presented dental fear and avoidance reduction program. It represents an important current trend in behavioral medicine/dentistry of employing behavioral principles in educating the public and increasing health via the mass media. The major goal of this study is to demonstrate the therapeutic impact of a one-half hour television-presented dental fear reduction program. Three hundred high-fear dental avoiders and 300 moderate-fear avoiders will be evaluated in the main experimental design. An equal number (50) of these moderate-and high-fear dental avoiders will be randomly assigned to one of six groups according to a 3 x 2 factorial design; television viewing treatment, television viewing placebo, and no television viewing conditions will be crossed with incentive versus no-incentive conditions. Pre- and post-viewing evaluations (before, immediately after, 6-months after, and one-year after) of dental fear, avoidance, and attitudes/reactions to dentistry will be collected for all subjects. It is hypothesized that the televised treatment condition will significantly reduce dental fear and avoidance among the moderate-fear avoiders. Such findings will provide the important groundwork for subsequently validating the educational/therapeutic impact of applying behavioral technology to large populations via the mass media.

The present proposed study is designed to evaluate the effectiveness of a videotaped behavioral treatment program in reducing anticipatory anxiety and perceived distress during emergency oral surgery involving a tooth extraction. Subjects will be randomly assigned to one of three conditions (45 subjects/condition): a videotaped treatment condition which will consist of a number of behavioral techniques that have been found to be effective in modifying dental fear; a videotaped placebo condition which will control for general attention, expectancy, and suggestion effects; a no-treatment control condition. Pre-and posttreatment assessments will be conducted for the following dependent measures: self-reported anxiety as measured by the Spielberger State Anxiety Subscale, and a recently developed anxiety response interval scale developed by Corah and colleagues; physiological reactivity (heart rate, as well as systolic and diastolic blood pressure); and a global behavioral observational rating scale (evaluated only during the posttreatment assessment). It is hypothesized that the videotaped treatment condition will significantly reduce anticipatory anxiety and perceived distress during the emergency oral surgery, relative to the other two conditions. These results will help determine the clinical utility of brief behavioral intervention techniques that can be made available to large numbers of people in a time- and cost-effective manner.

Although there have been a great number of studies evaluating the personality and emotional characteristics of temporomandibular joint (TMJ) dysfunction syndrome and myofascial pain dysfunction (MPD) syndrome patients, the exact nature of the associations are still unclear. A primary reason for this is the absence of a uniform and reliable diagnostic system and nomenclature used across studies to classify patients with chronic pain. The major purpose of the present proposed study is to employ the DSM-III-R multiaxial classification criteria, derived on the basis of a new structured interview format, for classifying TMJ-MPD patients. Five separate groups of subjects will be evaluated: (1) Acute TMJ-MPD patients; (2) Chronic TMJ-MPD patients; (3) Acute low back pain patients; (4) Chronic low back pain patients; (5) Normal pain-free subjects. Besides establishing the incidence of DSM-III-R disorders in these groups, this design will also address three other important issues. First, are there any associations between specific DSM-III-R diagnostic categories and the presence or absence of specific pathophysiological findings? Secondly, are there differences in the psychological-personality category profiles of acute versus chronic patients? Finally, are there unique patterns of psychological-personality disorders associated with specific types and sites of pain (TMJ-MPD versus low back) or are the patterns similar in terms of DSM-III-R diagnoses? This more precise and standard classification of psychological and medical diagnoses of these patients will significantly aid in expanding our knowledge of these syndromes, as well as developing more effective treatment strategies for dealing with the psychological and personality variables associated with them.

DESCRIPTION: (adapted from the applicant's abstract) The present proposed investigation is designed to evaluate the short-and long-term effectiveness of a videotaped behavioral intervention for increasing patient satisfaction, and for reducing anticipatory anxiety and distress during dental prophylaxis, examination, and treatment procedures. The study will be conducted in an actual clinical practice setting. The relative efficacy of a short videotaped intervention versus a longer and more comprehensive intervention will also be assessed. Subjects will be randomly assigned to one of five office groups (60 subjects/groups): (a) a 30-minute videotaped behavioral intervention consisting of a number of techniques that have been found to effectively modify dental anxiety; (b) a 15-minute videotaped behavioral intervention which will be an abbreviated version of the longer one; (c) a 30-minute videotaped placebo intervention which will control for general attention, expectancy, and suggestion effects; (d) a 15-minute videotaped placebo which will be an abbreviated version of the longer one; (e) a no-treatment control condition. There will be an equal number (20) of low, moderate, and high dentally anxious patients in each group. Pre - and post-intervention assessment will be conducted for the following dependent measures: self-reported anxiety as measured by the Spielberger State Anxiety Subscale, and a recently developed anxiety response interval scale; physiological reactivity (heart rate, as well as systolic and diastolic blood pressure); behavioral observational ratings (evaluated only during the post-intervention assessments). In addition, data on perceived satisfaction with the dental experience will also be collected. It is hypothesized that the videotaped behavioral intervention will significantly decrease anticipatory anxiety and perceived distress during the dental procedures, relative to the placebo and no-treatment conditions. Perceived satisfaction with the dental procedures will also be greater in the behavioral intervention conditions.

There has been very little systematic research attempting to isolate useful predictors of when acute low back pain incidents are likely to develop into chronic disability difficulties. With the great economic costs and traditionally poor outcomes among chronic low back pain disability patients, it becomes increasingly important to more effectively treat patients in the acute stage in order to avoid these more chronic problems. The major purpose of the present proposed prospective investigation is to evaluate whether DSM-III-R Axis I and II diagnoses, derived on the basis of a structured interview format (the Structured Clinical Interview for DSM-III-R -- SCID), will serve as useful predictors for those acute low back pain patients who subsequently develop chronic disability problems. This will provide the first important statistics on the incidence of specific psychiatric and personality disorders within an exclusively acute low back pain population that may be linked with subsequent chronicity. This more precise and standard classification of patients should significantly contribute to isolating important psychological and personality variables that may need to be treated, along with the acute pain episode itself, in order to prevent the development of a chronic low back pain syndrome. Three groups of subjects will be evaluated in the present study: (1) Acute low back pain patients (n = 1,000); (2) Non-pain medical patients with acute problems (n = 100); (3) Normal, pain-free and physically healthy subjects (n = 100). Besides comparing the incidence of DSM-III-R Axis I and II disorders in these groups, the major goal of this investigation will be to prospectively follow the acute low back pain patients over the next year in order to determine whether the presence of DSM-III-R disorders in the acute stage are predictive of the development of chronicity. Results will have a great many treatment and prevention implications for this costly and prevalent medical problem.

The proposal presents three separate research projects that will explore the nature of the relationship or comorbidity of psychopathology and physical disability, specifically temporomandibular disorder and low back pain disability. The major goal of the first project is to evaluate whether DSM-III-R Axis I and II diagnoses will serve as useful predictors for those acute low back pain patients who subsequently develop chronic disability problems. A conceptual model of the transition from acute to chronic pain is proposed which guides this research. This study will provide the first important statistics on the incidence of specific psychiatric and personality disorders within an exclusively acute low back pain population that may be linked with subsequent chronicity. The second project will focus on evaluating the active components of a functional restoration treatment program for chronic low back pain disability. For these chronic pain patients, significant psychopathology is often evidenced. Functional restoration has been found to be quite effective at getting these chronically disabled patients back to work. An important question still remaining is what components (both psychological and physical) are most important for treatment success. Addressing this issue may allow the development of a more time- and cost- efficient treatment program. Finally, the third proposed project will be similar to the first project, but it will target a different clinical population--patients with temporomandibular disorder (TMD). It will help test how generalizable the proposed conceptual model is of the transition from acute to chronic pain. It should be noted that chronic TMD and chronic low back pain are disabilities that have many things in common. This is why research in both areas is being simultaneously pursued. For example, there is often great difficulty unequivocally diagnosing organic underpinnings of both of these disorders. Moreover, psychological factors have been implicated to play a very important role in the etiology and maintenance of these syndromes. There have also been many psychological and physical approaches advocated for treating these disorders, although the majority have not been empirically demonstrated to be successful. In addition, there has been an increase in the apparent prevalence and perceived severity of these disorders over the past decade, making them both costly societal and economic problems. Finally, involvement in this work with TMD and chronic low back pain reveals a close relationship or comorbidity of psychopathology and these physical disabilities. These three research projects will further explore the nature of this comorbidity.

DESCRIPTION: (Adapted from the Applicant's Abstract): The major goal of a past funded grant project was to identify predictors of when acute low back pain incidents are likely to develop into chronic disability problems. With the great economic costs and traditionally poor outcomes among chronic low back pain patients, it has become increasingly more important to effectively treat patients in the acute stage in order to prevent these more chronic disability problems. Results of the past project clearly isolated some significant psychosocial risk factors predict the development of chronicity. As an extension of these important findings, a statistical algorithm was developed that can be used to identify acute low back pain patients who are prime candidates for early intervention in order to prevent chronicity. The present project will involve the assessment of a large cohort of acute low back patients (n=700) in order to screen out those patients who are at high risk for developing chronicity. These high risk patients will then be randomly assigned to one of two groups (30 patients/group): a functional restoration intervention group or a nonintervention group. Initial exploratory analyses of individual differences in response to intervention, as well as relationships between personality disorders and coping styles, will also be conducted. One-year follow-up evaluations will be collected in order to assess important socioeconomic outcomes such as return-to-work and health-care-utilization rates. It is hypothesized that early intervention at the acute stage will prevent the development of chronic disability. In addition, as a replication of the previous grant project results, the nonintervention group will be compared to a demographically matched cohort (n=60) of initially assessed acute patients who do not display the at-risk profile. It is hypothesized that the "at-risk" nonintervention patients will display significantly higher rates of chronic disability at one year relative to the "not-at-risk" profile patients. These results will have major implications for effective intervention and resultant significant health-care-cost savings for this prevalent disability problem.

This is a request for a competitive renewal of an NIMH Independent Scientist Award (K02). It will provide important continuity of my research program developed during an original K02 award (1993-98). The proposal presents 3 separate research projects that evaluate an early prediction-intervention approach to 2 costly chronic pain syndromes-low back pain (LBP) and temporomandibular disorder (TMD). Early detection to prevent such chronic disorders is now recognized as a high priority research area in the PHS Report of "Healthy People 2000." The goal of the first project is the assessment of a large cohort of acute LBP patients in order to screen out those patients who are at "high risk" for developing chronic disability. This screening will be accomplished by using a statistical algorithm developed in an earlier RO1 project that successfully identified such "high risk" patients. These "high risk" patients will then be randomly assigned to an early intervention or a nonintervention group. One-year follow-up evaluations will assess important socioeconomic outcomes such as return to work and health- care utilization rates. The second project parallels the earlier conducted study that successfully identified "high risk" acute LBP patients. This project will develop a specific algorithm for predicting the development of chronic TMD. Those acute patients who subsequently develop chronic problems will then participate in a second phase which evaluates the relative efficacy of 4 techniques, 3 of which are biobehovioral approaches. Finally, the third project will also assess an early assessment intervention model with TMD. It will parallel the methodology used in the first project. "High risk" patients, screened on the basis of a statistical algorithm, will be randomly assigned to either early intervention or nonintervention. Long term follow-up of these patients will assess important diagnostic, self-report and functional changes. Finally, interwoven within all 3 projects will be the evaluation of a potentially heuristic theory of the interaction between pain and stress. We are now at a point to identify early signs of chronicity, and then provide early intervention in order to prevent costly problems from developing. These 3 research projects will explore the efficacy of early identification of "high risk" acute patients in order to provide biobehavioral treatment intervention, while simultaneously evaluating cost-effectiveness.

DESCRIPTION: (from the application) A major goal of a past funded grant project was to identify useful predictors of when acute temporomandibular disorder (TMD) incidents were likely to develop into chronic problems. With the great economic cost and traditionally poor outcomes among chronic TMD patients, it has become increasingly more important to effectively treat patients in the acute state in order to prevent these more chronic disability problems. Results of this past project clearly isolated risk factors that predict chronicity. As an extension of these important findings, we now have a statistical algorithm that can be used to identify acute TMD patients who are prime candidates for early intervention in order to prevent chronicity. The present proposed project will involve the assessment of a large cohort of acute TMD patients in order to screen out those patients who are at "high risk" for developing chronicity. These high-risk patients will then be randomly assigned to one of two groups (30 patients/group): an early intervention group or a non-intervention group. The intervention procedure will be modeled after that found to be most effective in our past R01 grant project - a combined biofeedback/cognitive behavioral treatment approach. One-year follow-up evaluations will subsequently be conducted in order to assess important outcomes such as pain, disability, relapse, and health-care utilization rates. It is hypothesized that early intervention at the acute stage will prevent the development of chronic disability. In addition, as a replication of the previous grant project results, the non-intervention group patients will be compared to a demographically matched cohort (n=60) of initially assessed acute TMD patients who do not display the "high risk" profile. It is hypothesized that the "high risk" non-intervention group patients will demonstrate higher rates of pain and disability at one year relative to the "low risk" profile patients. These results will have major implications for effective early intervention and result in significant health-care cost savings for this prevalent pain problem. Finally, an additional goal of this present proposed project will be the evaluation of a potentially heuristic theory of the interaction of pain and stress recently proposed by Mezack (1996). The present proposed project will begin evaluating the potential validity of this theory by assessing a key biological index (cortisol) that Melzack proposes to be intimately involved in the stress-pain interaction process. The better understanding of such a mechanism can potentially yield even more effective assessment and treatment approaches for chronic pain syndromes such as TMD.

[unreadable] DESCRIPTION (provided by applicant): Nowhere do psychiatric and physical pathologies interface more prominently than in pain disorders. Patients with chronic pain are at increased risk for anxiety disorders, substance abuse disorders, depression, suicide and sleep disorders. There is now a consensus that it is important to effectively treat pain patients in the acute stage in order to prevent the development of chronic and costly comorbid mental and physical health disability problems. As a continuation of two earlier NIMH funded projects, the present proposed study is designed to evaluate the therapeutic- and cost effectiveness of a three-component biopsychosocial model of early intervention in order to maximize the prevention of chronicity in high-risk acute low back pain patients. This translational biopsychosocial research will be conducted in partnership with the largest workers' compensation company in the U.S. (Liberty Mutual). For this study, high-risk acute low back pain patients will be randomly assigned to one of four intervention conditions, one of which is a non-intervention condition (45 subjects/condition). The differential impact of these conditions will be evaluated in terms of the prevention of chronic mental and physical health disability evaluated during a one-year follow-up period after intervention. A secondary goal of this project is to begin to evaluate the validity of Melzack's neuromatrix model of the relationship between emotional distress and pain within the context of the present experimental design. Major mental health outcome variables will include DSM-IV Axis I and Axis II diagnoses, anxiety/fear, depression, coping skills, and psychotropic medication use. Major physical health outcomes will include socioeconomic variables such as return-to-work, injury recurrence, healthcare utilization, and functional disability related to pain, as well as associated free cortisol levels. It is hypothesized that the high-risk non-intervention group patients will display significantly higher rates of chronic mental and physical health disability at one year relative to the other intervention groups; the most comprehensive biopsychosocial intervention will be associated with the lowest rates. These results will have implications for potentially significant healthcare cost savings for this highly prevalent co-morbid disability problem. [unreadable] [unreadable]

DESCRIPTION (provided by applicant): This request for an NIMH Senior Scientist Award (K05) focuses on better understanding the biopsychosocial mechanisms associated with the comorbidity of mental disorders and complex pain problems. The program addresses Goal 1 of "Healthy People 2010: Understanding and Improving Health"--to improve health-related quality of life, with a special focus on comorbid mental health disorders and one of the most prevalent and costly forms of pain (chronic back pain). We will also focus on successful translational intervention research, which is a high priority of NIH. My ongoing biopsychosocial research program investigating the comorbidity of mental disorders and pain contains four inter-related components: early intervention translational research; cost-effectiveness translational research; underlying neuromatrix model-related research; and fMRI research. To that end, we will pursue three separate research projects over the next five years and beyond: preventing comorbid mental disorders and physical health disability; an evaluation and early intervention study of comorbid psychiatric and temporomandibular (TMD) disorders; and a randomized trial of comorbid mental disorders and musculoskeletal pain intervention in a military population. All of these projects will focus on early detection to prevent the development of such chronic disorders, recognized as a high priority research area in the PHS Report of "Healthy People 2000." Many of my current and future research projects will also evaluate a potentially heuristic theory of the interaction between pain and stress (the neuromatrix model of pain). In addition, we plan to use new fMRI technology in our future research projects to develop a more comprehensive understanding of biopsychosocial mechanisms of comorbid mental disorders and pain. This Award will enable me to maintain the momentum and clinical research advances of two previous consecutive K02 awards from NIMH.

DESCRIPTION (provided by applicant): With the great economic costs and traditionally poor outcomes among chronic temporomandibular joint and muscle disorder (TMJMD) patients, it has become important to treat patients in the acute state, in order to prevent these more chronic disability problems. This has been the goal of two past funded grant projects. Results of the initial project isolated risk factors that successfully predicted the development of chronicity, with a 91% accuracy rate. A statistical algorithm was developed which was used in the second project to screen out "high-risk" patients. These patients were then randomly assigned an early intervention or non-intervention group. One-year follow-up evaluations documented the treatment efficacy and cost effectiveness of early intervention. These results have major implications for effective early intervention and significant health-care cost savings for this prevalent pain and disability problem. For the present proposed project, we plan to implement this treatment program in order to evaluate its effectiveness in more community-based dental practices. This is in response to NIH's request for the implementation of evidence-based treatment approaches, developed in controlled clinical settings, to the "real world" of diverse practices in the community. Acute TMJMD patients will be recruited from two community clinics. Based upon our "risk" screening algorithm, high-risk patients will be randomly assigned to one of two groups (n=225/group): an early biobehavioral intervention or an attention-control group. It is hypothesized that the attention control "high-risk" patients will display more chronic TMJMD problems, relative to the "high-risk" early intervention patients, at one-year follow-up. Another aim of the project is to evaluate the potential utility of new technologies that will lead to even greater precision in detecting individual differences among TMJMD patients. Measures evaluated include chewing performance, cortisol levels, and other biopsychosocial outcomes. This represents the next step in comprehensively understanding brain-behavior patterns in TMJMD. Also, structural equation modeling methodology will be used. Such a multi-level, multi-systems approach has not been applied to better understand the biopsychosocial underpinnings of TMJMD. Results from this component of the project will greatly aid in stimulating future research leading to the better understanding of TMJMD, as well as better tailoring of prescribed treatment regimens. Project Narrative: Temporomandibular joint and muscle disorder (TMJMD) is a highly prevalent and costly public health problem in the United States, especially when it becomes chronic in nature. This study will further evaluate the treatment- and cost-effectiveness of an early biobehavioral intervention program for preventing chronic TMJMD. Moreover, this evidence-based program will be implemented in actual community-based dental practices to make it more accessible to the general population.

Proposal #: 13-38118 Collaborative Proposal #: 13-37866
PI(s): Makedon, Fillia S PI(s): Betke, Margrit
Athitsos, Vassilis; Gatchel, Robert J; Huang, Heng; Romero-Ortega, Mario I
Institution: University of Texas-Arlington INstitution: Boston Univeristy
Title: MRI/Dev :Collab Dev. of iRehab, an Intelligent Closed-loop Instrument for Adaptive Rehabilitation
Project Proposed:
This project, developing of an instrument referred to as iRehab, aims to enable personalized rehabilitation therapy for individuals suffering from brain injury, motor disabilities, cognitive impairments, and/or psychosocial symptoms. The instrument, a modular rehabilitation device, in its simplest form consists of a computer, a camera, and adaptive software for assessment and training of cognitive functions. In its final, most complex form, the instrument will integrate data from a 4-degree-of-freedom robotic-arm with gimbals and torque sensing, a Kinect sensor, multiple cameras, an eye-tracking device, a touch screen, a microphone, and an fNIRS brain imaging sensor.
The instrument will be developed in two phases. In the first phase, the investigators develop a Barrett robot arm. In the second phase, the instrument will extend to a Kinect sensor, multiple cameras, an eye-tracking device, and related low-cost components, along with the assessment software for assessing motor function and cognitive, emotional, and personality functioning.
iRehab consists integrates multidisciplinary methodologies and sensors to assess and assist the cognitive and physical rehabilitation of persons affected by various impairments. This work highly interdisciplinary work follows a cyber-physical approach. It provides new research opportunities across the fields of human-centered computing, computer vision, assistive technology, robotics, machine learning, and neuroimaging. This work advances research in human brain activity mapping, personalized medicine, and big data.
Broader Impacts:
The proposed instrument exhibits potential for large broader impact as it directly contributes to future healthcare and human wellbeing improving accessibility to affordable rehabilitation for a broad range of patients. The instrument is likely to accelerate the recovery of a large spectrum of injuries and diseases including those causing motor, neurological, and cognitive disorders. An education plan includes course development, internships, workshops and tutorials, and an on-line resource center. In addition to many educational impacts, impact will be felt on the fundamental research in the areas addressed.

Chronic pain is a multidimensional problem that affects nearly 40 percent of the United States population and is estimated to incur $560-$635 billion in incremental healthcare costs and costs related to rehabilitation and lost productivity annually. With a growing number of treatment options and new medications, formulating an evidence-based, individually-tailored treatment plan has become increasingly complex. This research project develops new statistics-based optimization methods for adaptive interdisciplinary pain management that use patient data to recommend an interdisciplinary treatment regime for controlling pain outcomes. The research involves an interdisciplinary research team from the University of Texas (UT) at Arlington and uses data from the UT Southwestern Medical Center at Dallas. Because UT Southwestern uses a prevalent and standardized dataset, the research will be applicable to approximately 100 pain centers across the nation and will influence how interdisciplinary pain management is implemented.

The research addresses four major topics in statistical optimization. One, the research studies how to coordinate the development of statistical meta-models and optimization algorithms. Specifically, several meta-models will be developed, which are accurate representations of the underlying system and can be globally optimized. The second major topic involves using a learning method to impute missing values in which the missing locations are in a block-wise structure. Three, the research develops an inverse-probability-of-treatment weighted estimators method for complex data. Finally, the research evaluates treatment solutions found from optimizing one prediction model with the other prediction models using simulation. Although this research is on pain management, the developed methodologies of this project can potentially be generalized to create complex adaptive treatment regimes for ailments other than pain.