Edward Blanchard, Ph.D. - US grants

This project will target a specific population, individuals with moderate to severe essential hypertension whose disease requires at least two drugs, diuretics and sympathetic blocking agents, to manage. We will determine if either of two behavioral, or non-pharmacological, treatments, abbreviated progressive relaxation or thermal biofeedback, can be substituted for the second stage, or sympatholytic, drug in the management of the hypertension in a controlled trial. Furthermore, we will compare two follow-up maintenance procedures over one year, monthly booster sessions of behavioral treatment versus standard medical care, to see if the former leads to improved maintenance vis-a-vis the latter. More specifically, l00 individuals suffering from moderate to severe essential hypertension will, after an extensive physical, biochemical, psychological and psychophysiological assessment, be randomly assigned to receive either abbreviated progressive relaxation or thermal biofeedback. Each sub-set of 50 will be further sub-divided such that half will receive behavioral treatment while on two drugs while the other half will receive the treatment after the second stage medication is discontinued. From the pre-treatment assessment battery we will develop a scheme to predict who responds positively to behavioral treatment and who does not. Extensive biochemical assessments will allow us to understand the mechanism through which the behavioral treatments work.

This study will be jointly conducted at two sites: SUNY-Albany in Albany, NY, and the USSR Cardiology Research Center in Moscow, USSR. At each site 30 males with mild hypertension will be randomly assigned to receive either (1) Temperature Biofeedback, an American procedure, or (2) Autogenic Training, a Soviet procedure, or (3) instructions to practice relaxation regularly on their own. Identical Pre-Treatment, Post-Treatment and Follow-Up (over 12 months) assessments will be conducted at each site utilizing psychological and physiological testing as well as physical examinations. The study will thus seek to learn if behavioral treatments for hypertension can be exported across cultures, from the USSR to the USA and vice versa. At a more basic level, the study will seek to learn if non-pharmacological therapies can be used in place of drug therapy for mild hypertension. Secondary purposes of the study include the controlled evaluation of temperature biofeedback as a treatment for mild hypertension and, at the American site, possible identification of biochemical mechanisms underlying changes in blood pressure resulting from behavioral treatments.

This is a somewhat complex proposal consisting of 5 parts which contain a total of 15 studies. The major foci of the proposal are (1) to discover possible mechanisms ionvolved in the psychological treatment of headache; (2) to investigate possible psychological and cognitive mechanisms in th etiology of chronic headache and the relation of these mechanisms to treatment processes; (3) to extend prospective followup data collection on chronic headache patients treated with psychological techniques associated with their headache disorder; (4) to utilize the existing data base of the improved procedures for predicting treatment outcome an matching patients to treatments as well as identifying "high risk" patients who are likely to do poorly with psychological treatments; and (5) to evaluate the addition of cognitive stress coping procedures to previously tested physiologicaly oriented treatmets such as relaxation and biofeedback. Two separate, but parallel and similar, studies with new patients are proposed to answer similar mechanisms questions for both vascular (migraine and combined migraine and tension) and tension headache. We will evaluate the possible role of expectancy factors and of regular monitoring of headache activity in the relaxation treatment of tension headache and in the treatment of vascular headache with thermal biofeedback combined with relaxation training through the controlled comparison of a credible attention placebo condition and a headache monitoring condition to our standard treatments. In each of these two studies, we will also evaluate the effect of adding cognitive stress coping training to our standard treatments. We will follow-up treated patients for one year to investigate maintenance of treatment effects. The third study with new patients will evaluate the role of home practice and its application in the biofeedback and relaxation treatment of vascular headache. Data for the remaining 12 proposed studies will come both from our existing data base and from additional data gathered in the new treatment studies.

This proposal will gather data relevant to the mechanisms by which widely used, non-drug treatments of headache (HA) have their benefits. While the long-term goal of this program of research is to compare three different models of the mechanisms by which non-drug treatments (thermal biofeedback [TBF] and progressive muscle relaxation [PMR] lead to the alleviation of chronic HA, the present proposal is designed to gather preliminary data to assist in the design of later, large scale, more definitive studies. The three models are the older psychophysiological model which posits that treatment leads to physiological change which in turn leads to HA relief. A new cognitive-attributional model posits that treatment leads to cognitive or attributional changes which lead re-interpretation of stressful, headache-causing events, which in turn leads to HA relief. A third interactional model posits that it is the interaction of the psychophysiological effects and cognitive- attributional effects which lead to HA relief. In Study 1 of this proposal, four different biofeedback conditions will be compared in the treatment of vascular HA: (1) TBF for hand warming, the most widely used non-drug treatment for vascular HA; (2) TBF for hand cooling, which some studies have shown is equally effective as (1); (3) TBF for hand temperature stabilization, which some claim is central to TBF's therapeutic effects; and (4) EEG alpha biofeedback for alpha suppression, to control for any vascular effects. We will also examine whether patients with pure migraine HA and those with mixed migraine and tension HA respond in the same way to the treatments. In Study 2 tension HA patients will receive PMR with computerized end of session feedback on degree of relaxation (to manipulate attributions of success) in order to have the equivalent of 2X2 design, two levels of cognitive-attributional change by varying degrees of physiological change. The results and models will be evaluated both with headache outcome measures (relative degree of headache relief) and with process measures evaluating psychophysiological change, cognitive and attributional change, and change in life stresses, mood and coping as they all relate to headache relief.

This project will target a specific population, individuals with moderate to severe essential hypertension whose disease requires at least two drugs, diuretics and sympathetic blocking agents, to manage. We will determine if either of two behavioral, or non-pharmacological, treatments, abbreviated progressive relaxation or thermal biofeedback, can be substituted for the second stage, or sympatholytic, drug in the management of the hypertension in a controlled trial. Furthermore, we will compare two follow-up maintenance procedures over one year, monthly booster sessions of behavioral treatment versus standard medical care, to see if the former leads to improved maintenance vis-a-vis the latter. More specifically, l00 individuals suffering from moderate to severe essential hypertension will, after an extensive physical, biochemical, psychological and psychophysiological assessment, be randomly assigned to receive either abbreviated progressive relaxation or thermal biofeedback. Each sub-set of 50 will be further sub-divided such that half will receive behavioral treatment while on two drugs while the other half will receive the treatment after the second stage medication is discontinued. From the pre-treatment assessment battery we will develop a scheme to predict who responds positively to behavioral treatment and who does not. Extensive biochemical assessments will allow us to understand the mechanism through which the behavioral treatments work.

This project will evaluate a multi-component psychological treatment program for the treatment of irritable bowel syndrome (IBS) in a controlled group outcome study. Thirty IBS sufferers will be assigned to each of three conditions: I. the multi- component psychological treatment program which is comprised of (1) relaxation training, (2) thermal biofeedback, (3) cognitive stress coping training and (4) educational information; II. an attention- placebo control comprised of psuedo-meditation and EEG alpha suppression biofeedback; III. a symptom-monitoring control. Detailed psychological, psychophysiological, psychiatric, medical and GI symptom monitoring evaluations will be made pre-treatment, post-treatment and at a one-year follow-up. Establishment of the long-term efficacy of a non-drug treatment for IBS would be of great potential benefit since IBS is a very widespread functional disorder. A second major aspect will be a detailed examination of major and minor life stresses in the exacerbation of IBS symptoms and the role of various cognitive and other coping strategies in dealing with those symptoms. We will also examine the effects of treatment on perception of life stresses and IBS symptoms. Thus, it will provide new information of a basic nature on life stress and physical symptoms in a population with a common stress-related disorder. Data from the 90 IBS patients will be used in 4 other subsidiary studies including: (1) prediction of treatment outcome; (2) comparisons to patients with Anxiety Disorders, chronic headaches and normal controls; (3) changes in psychological distress accompanying treatment; (4) identification of mechanisms involved in the treatments.

This proposal has two inter-related specific aims which will be accomplished as part of a single large study: (1) to evaluate thermal biofeedback (TBF) in a controlled trial as a non-drug treatment for mild essential hypertension; (2) to compare two different maintenance conditions in a 12-month follow-up of the initial treatment successes. Study 1 will provide a more definitive test of the efficacy of TBF in the treatment of mild hypertension than has previously been available while Study 2 will provide preliminary data on how to improve maintenance of initial BP reductions. Forty unmedicated patients with mild hypertension will be randomly assigned to 16 sessions of TBF conducted in smll groups, over 8 weeks of TBF, or an 8-week program of BP monitoring (as a control condition) to meet Aim 1. Initial outcome, successful reduction of BP, will be evaluated both by office BPs with random zero sphygmomanometers and by 24-hour ambulatory BP monitoring. Successfully treated patients (estimated to be 70-80%) will be randomly assigned to one of two maintenance conditions and followed for up to 12 months: (a) a standard follow-up with once-per-3-month laboratory visits and instructions to continue home-practice of the TBF and regular monitoring of home BPs; (b) an enhanced maintenance condition with once-per-month booster treatments, use of electronic home TBF devices, and increased expectations of success.

This research seek to gain general knowledge about factors contributing to the etiology and natural history of Post-Traumatic Stress Disorder (PTSD) through an examination of individuals injured in motor vehicle accidents (MVAs), some of whom subsequently develop PTSD. Two-hundred (200) individuals who are involved in a MVA and subsequently seek medical attention because of the MVA will be carefully assessed approximately 1 month after the MVA. In addition to details concerning the MVA and the subject's reactions to it, patients will be assessed for current psychopathology, especially presence of PTSD or sub-syndromal PTSD, using the ADIS-R, for previous diagnosable psychopathology using the SADS-L, and for current psychological state and psychophysiological reactivity to cues reminiscent of the MVA. One-hundred (100) age, sex, SES matched-controls who have not had a recent MVA will also be assessed. All MVA victims will be followed up using the LIFE methodology of Keller et al (18) for at least one year, and up to 2 years when initially positive for PTSD or sub-syndromal PTSD. Factors related to development of PTSD, its remission (with or without treatment) and its recurrence will be identified as will factors associated with delayed onset of PTSD. In addition, descriptive information on MVA-related PTSD, using state-of-the-art assessment procedures, will become available.

DESCRIPTION: In order to gather information on the potential roles of stress, mood and psychological state in the etiology and exacerbation of migraine headache (and of other types of benign headache [HA] disorders), the project will gather prospective daily diary data over a six-week period on six variables: headache intensity, frequency of stressful events, perceived level of stress, mood states, medication consumed for headache, and, when appropriate, indications of two key points in the menstrual cycle of premenopausal women not on oral contraceptives: time of ovulation and time of onset of menstruation. The investigators believe the interrelations of these variables, HA, mood and stress, are complex. Available research on the topic has failed to examine all three in a prospective fashion using appropriate data analytic procedures and has failed to account for medication effects. This project will remedy these deficits and in so doing potentially point the way for the development of more effective drug non-drug treament of chronic, benign HA, especially a matching of treatment to the patient. Two-hundred and twenty-five patients with chronic HA (75 with migraine HA, 75 with tension-type HA, and 75 with combined or mixed migraine and tension-type HA) will monitor HA, perceived stress and mood states 4 times per day for 6 weeks using hand-held computers (HHCs). Subjects will be paid for participation. Subjects will also record all medications consumed and frequency of stressful events on a daily basis, and as appropriate, key points in their menstrual cycle. Although the focus is on migraine HA, two other groups are being run (tension-type HA and mixed HA) to help isolate factors and relations idiosyncratic to pure migraine as opposed to being related to chronic HA, per se. Similar perceived stress and mood ratings, as well as data on frequency of stressful events will be gathered from 50 paid control volunteers who do not suffer from a chronic HA disorder. New, sophisticated data analytic procedures will enable examination of the data on several temporal bases: 4 times per day, daily and weekly.

DESCRIPTION (Adapted from applicant's abstract): Evidence from several surveys indicates that posttraumatic stress disorder (PTSD) may be one of the most widespread psychiatric problems in the USA, and that a sizeable proportion of PTSD cases may arise secondary to motor vehicle accidents (MVAs). To date, the published reports of treatment with this population have been uncontrolled, with the exception of one controlled early intervention trial which failed to find an advantage of brief treatment over no treatment. (The latter finding may be due to a fairly sizeable spontaneous remission rate over the first 6 to 9 months post-MVA, identified in the work of the investigators submitting this proposal.) Other controlled evaluations of treatment of PTSD have focused on very chronic cases such as Vietnam veterans and on rape victims. These investigators propose to evaluate a brief (ten session) multicomponent cognitive behavioral treatment regimen which they have piloted, administered by experienced community-based therapists, in comparison to a brief (ten session) supportive psychotherapy and a waiting list control, in a controlled clinical trial using 105 individuals with recent (6 to 24 months post MVA) but technically chronic PTSD or severe sub-syndromal PTSD secondary to a motor vehicle accident. The investigators will screen approximately 320 MVA victims who sought medical attention and who are less than 24 months post-MVA in order to identify and recruit the sample of 105; this will include reassessment after 6 months for recent (less than 6 month) cases. Assessors, blind to treatment condition, will evaluate all treated subjects and wait list controls at post-treatment and follow-ups of 3 and 12 months using the CAPS, LIFE, and various psychological tests. Waiting list controls will receive the cognitive behavioral treatment after their reassessment.

DESCRIPTION (adapted from investigator's abstract): Irritable Bowel Syndrome (IBS) is a widespread, chronic, disorder of the lower gastrointestinal tract which seems relatively refractory to standard medical care. Recent research from our laboratory strongly suggests that cognitive therapy (CT) is highly effective (70-80 percent clinically improved) in the short-term (out to 3 months post-treatment). The current application seeks to replicate and extend our previous small-scale studies by conducting a controlled clinical trial of CT vs. a self-help support group as an attention placebo control and symptoms monitoring wait list of 240 chronic IBS patients and follow up the treated patients for at least 12 months. To complete the project in a timely fashion a second site, University of Buffalo Medical Scholl, will be added to run half of the sample. Within this overall project 5 studies will be conducted: (a) examination of relations between stress, especially minor stressful events, and IBS symptoms; (b) controlled comparison of brief (10 sessions) CT administered in small groups to (SG) and to (sic) symptom monitoring. The latter will subsequently be treated to increase the sample sizes for studies c, d, and e; (c) identification of the processes of change within the CT treatment of IBS by examining, at various levels of analysis, the relations between changes in cognitive variables and changes in GI symptoms; (d) prospective one-year follow-up of the effect of CT and SG on IBS; (e) prediction algorithm for the results of the CT treatment of IBS from variables derived from the careful pretreatment assessment of participants; we will determine prediction schemes of end of treatment and a 3-month follow-up as well as what variables predict maintenance of symptom relief over the 12 month follow-up.