Efficacy of sertraline in preventing relapse of posttraumatic stress disorder: results of a 28-week double-blind, placebo-controlled study.

OBJECTIVE: The study examined the efficacy of sertraline, compared with placebo, in sustaining improvement and preventing relapse over 28 weeks in patients with posttraumatic stress disorder (PTSD) who had completed a 12-week double-blind, placebo-controlled acute treatment study and a subsequent 24-week open-label study of continuation treatment with sertraline. METHOD: Ninety-six patients were randomly assigned, in a double-blind design, to 28 weeks of maintenance treatment with sertraline (50-200 mg, N=46; 78% were women) or placebo (N=50; 62% were women). Measures used in biweekly assessments included the Clinician-Administered PTSD Scale, the Impact of Event Scale, and the Clinical Global Impression severity and improvement ratings. Kaplan-Meier analyses were used to estimate time to discontinuation from the study due to relapse, relapse or study discontinuation due to clinical deterioration, and acute exacerbation. RESULTS: Continued treatment with sertraline yielded lower PTSD relapse rates than placebo (5% versus 26%). Patients who received placebo were 6.4 times as likely to experience relapse as were patients who received sertraline. Kaplan-Meier analyses confirmed the protective effect of sertraline in significantly extending time in remission. The ability of sertraline to sustain improvement was comparable across the three core PTSD symptom clusters (reexperiencing/intrusion, avoidance/numbing, and hyperarousal). A regression analysis found early response during acute treatment to be associated with a more than 16-fold reduced risk of relapse after placebo substitution. Sertraline, at a mean endpoint dose of 137 mg, was well tolerated, with no sertraline-related adverse events observed at a rate of 10% or higher. CONCLUSIONS: The results provide evidence for the ability of sertraline both to sustain improvement in PTSD symptoms and to provide prophylactic protection against relapse.

Improving primary care for depression in late life: the design of a multicenter randomized trial.

BACKGROUND: Late life depression can be successfully treated with antidepressant medications or psychotherapy, but few depressed older adults receive effective treatment. RESEARCH DESIGN: A randomized controlled trial of a disease management program for late life depression. SUBJECTS: Approximately 1,750 older adults with major depression or dysthymia are recruited from seven national study sites. INTERVENTION: Half of the subjects are randomly assigned to a collaborative care program where a depression clinical specialist supervised by a psychiatrist and a primary care expert supports the patient's regular primary care provider to treat depression. Intervention services are provided for 12 months using antidepressant medications and Problem Solving Treatment in Primary Care according to a stepped care protocol that varies intervention intensity according to clinical needs. The other half of the subjects are assigned to care as usual. EVALUATION: Subjects are independently assessed at baseline, 3 months, 6 months, 12 months, 18 months, and 24 months. The evaluation assesses the incremental cost-effectiveness of the intervention compared with care as usual. Specific outcomes examined include care for depression, depressive symptoms, health-related quality of life, satisfaction with depression care, health care costs, patient time costs, market and nonmarket productivity, and household income. CONCLUSIONS: The study blends methods from health services and clinical research in an effort to protect internal validity while maximizing the generalizability of results to diverse health care systems. We hope that this study will show the cost-effectiveness of a new model of care for late life depression that can be applied in a range of primary care settings.

Sertraline treatment of posttraumatic stress disorder: results of 24 weeks of open-label continuation treatment.

BACKGROUND: Posttraumatic stress disorder (PTSD) is typically associated with a high degree of chronicity, comorbidity, and psychosocial disability. The efficacy of sertraline in the acute treatment of PTSD has been confirmed based on the results of 2 large, placebo-controlled studies, but almost no prospective long-term treatment studies have been reported. METHOD: One hundred twenty-eight patients who completed 12 weeks of double-blind, placebo-controlled, acute-phase treatment for DSM-III-R-defined PTSD with sertraline were continued into a 24-week open-label continuation phase. Efficacy was evaluated using the endpoint change in the 17-item Clinician Administered PTSD Scale Part 2 (CAPS-2) severity score, the 15-item patient-rated Impact of Event Scale, and the Clinical Global Impressions-Improvement and -Severity of Illness scales as primary outcome measures. Treatment response was defined as > or =30% decrease in the CAPS-2 total severity score (compared with acute-phase baseline score) and a Clinical Global Impressions-Improvement score of 1 or 2. RESULTS: Ninety-two percent of acute-phase responders maintained their response during the full 6 months of continuation treatment. In addition, 54% of acute-phase nonresponders converted to responder status during continuation therapy. Over the 36-week course of acute and continuation therapy, 20% to 25% of the improvement in the CAPS-2 severity score occurred during the continuation phase. Sertraline was well tolerated, with 8.6% of patients discontinuing due to adverse events. A high pretreatment CAPS-2 score (> 75) predicted a longer time to response and a greater likelihood that response occurred after 12 weeks of acute treatment. CONCLUSION: The acute efficacy of sertraline is sustained in the vast majority of patients, and at least half of nonresponders to acute treatment will eventually respond to continued treatment.

Treatment of dysthymia and minor depression in primary care: a randomized trial in patients aged 18 to 59 years.

OBJECTIVE: The researchers evaluated the effectiveness of paroxetine and Problem-Solving Treatment for Primary Care (PST-PC) for patients with minor depression or dysthymia. STUDY DESIGN: This was an 11-week randomized placebo-controlled trial conducted in primary care practices in 2 communities (Lebanon, NH, and Seattle, Wash). Paroxetine (n=80) or placebo (n=81) therapy was started at 10 mg per day and increased to a maximum 40 mg per day, or PST-PC was provided (n=80). There were 6 scheduled visits for all treatment conditions. POPULATION: A total of 241 primary care patients with minor depression (n=114) or dysthymia (n=127) were included. Of these, 191 patients (79.3%) completed all treatment visits. OUTCOMES: Depressive symptoms were measured using the 20-item Hopkins Depression Scale (HSCL-D-20). Remission was scored on the Hamilton Depression Rating Scale (HDRS) as less than or equal to 6 at 11 weeks. Functional status was measured with the physical health component (PHC) and mental health component (MHC) of the 36-item Medical Outcomes Study Short Form. RESULTS: All treatment conditions showed a significant decline in depressive symptoms over the 11-week period. There were no significant differences between the interventions or by diagnosis. For dysthymia the remission rate for paroxetine (80%) and PST-PC (57%) was significantly higher than for placebo (44%, P=.008). The remission rate was high for minor depression (64%) and similar for each treatment group. For the MHC there were significant outcome differences related to baseline level for paroxetine compared with placebo. For the PHC there were no significant differences between the treatment groups. CONCLUSIONS: For dysthymia, paroxetine and PST-PC improved remission compared with placebo plus nonspecific clinical management. Results varied for the other outcomes measured. For minor depression, the 3 interventions were equally effective; general clinical management (watchful waiting) is an appropriate treatment option.

Differential reinforcement of other behavior (DRO) to reduce aggressive behavior following traumatic brain injury.

Severe brain injury can result in significant neurobehavioral and social functioning impairment. In rehabilitation settings, behavioral problems of aggression and nonadherence to therapeutic activities can pose barriers to maximal recovery of function. Behavioral interventions seem to be effective in reducing problem behavior among individuals recovering from severe brain trauma, but well-controlled studies examining the efficacy of such interventions are sparse. This article presents a single-case, multiple-baseline study of a differential reinforcement of other behavior (DRO) procedure in a 28-year-old, brain-injured male with aggressive behavior problems. The procedure successfully reduced the frequency of problem behavior by up to 74%, maintained at 1-month follow-up. Implications of this intervention for individuals with brain injury are discussed, and testing of this procedure using a between-group design seems indicated.

The treatment effectiveness project. A comparison of the effectiveness of paroxetine, problem-solving therapy, and placebo in the treatment of minor depression and dysthymia in primary care patients: background and research plan.

This report describes the background, rationale, and research plan for a comparative treatment trial of the effectiveness of paroxetine, problem-solving therapy (PST-PC), and placebo in the treatment of minor depression and dysthymia in primary care patients. Patients were recruited from a variety of primary care practice settings in four separate geographic locations (Hanover, New Hampshire; Pittsburgh, Pennsylvania, San Antonio, Texas; and Seattle, Washington). Patients were randomly assigned to each of the three intervention conditions the medication/placebo conditions were double-blinded. The treatment trial was 11 weeks, with independent assessments of patient clinical status at baseline, 6 weeks, and 11 weeks. There was a follow-up at 25 weeks. Since there are relatively few placebo-controlled trials in primary care settings on patients with these disorders, the background of this project and a description of it are presented at this time, prior to the availability of outcome data, to provide methodological detail and to increase awareness in the research community of this treatment trial, with results to appear subsequently.

Cognitive-behavioral therapy helps prevent relapse and recurrence of panic disorder following alprazolam discontinuation: a long-term follow-up of the Peoria and Dartmouth studies.

The present research evaluated patients from 2 previous studies (1 conducted in Peoria, the other at Dartmouth) during a 2- to 5-year posttreatment period. Results showed that 75% of the Peoria sample and 76% of the Dartmouth sample were able to discontinue alprazolam therapy, remain abstinent of any type of treatment for panic disorder, and maintain their acute-treatment clinical gains over this follow-up period. The degree to which patients' anxiety sensitivity declined during treatment predicted relapse versus survival during the 1st 6 months of follow-up, when most relapses occurred. Implications of these findings for benzodiazepine discontinuation, combined pharmacotherapy and psychotherapy, and relapse prevention in panic disorder are discussed.

Behavioral treatment of pulsatile tinnitus and headache following traumatic head injury. Objective polygraphic assessment of change.

Pulsatile tinnitus is a disorder that can be extremely disabling. Nonetheless, it has not been well-researched in the fields of psychology or behavioral therapy. This article describes the evaluation and behavioral treatment of a gentleman with pulsatile tinnitus. The evaluation included polygraphic assessment of vasomotor and electromyographic function both before and after treatment. The results show that the combination of lifestyle modifications and specific behavioral interventions were successful in modifying not only self-report indices of functioning, but also the underlying physiology related to the disorder. The potential role of the various treatment components and the value of including polygraphic assessment for informing treatment and evaluating outcome are discussed.

Psychophysiological assessment of respiratory function in panic disorder: evidence for a hyperventilation subtype.

OBJECTIVE: Previous research has found differences in respiratory function between panic disorder and other anxiety disorder populations. These differences have been explained as reflecting either a) a specific feature of panic disorder, b) merely a sign of increased general arousal, or c) a result of population sampling error. The current study addressed the question of such differences by using improved methodology over previous research. A preliminary evaluation of respiratory symptoms during panic attacks was undertaken as a means of identifying a respiratory-sensitive subtype of the panic patient. METHOD: Seventeen panic disorder patients (PD), 18 patients with generalized anxiety disorder (GAD), and 20 normal control (NC) subjects were administered a psychophysiological evaluation composed of baseline, stressor, and recovery phases. Panic patients were measured for the severity of respiratory symptoms during panic attacks. End-tidal CO2 (EtCO2) and respiration rate were measured throughout the psychophysiological evaluation. RESULTS: PDs demonstrated significantly lower baseline EtCO2 levels than the GADs and NCs, in spite of being equivalent to GADs on baseline anxiety levels. Moreover, panic patients reporting a high level of respiratory symptoms during panic attacks seemed to account for the bulk of observed differences. CONCLUSIONS: These findings lend support to a group of studies showing differences in respiratory function between panic disorder and other anxiety disorder populations. In addition, this study provides preliminary support for the presence of a distinct "hyperventilation subtype" of panic disorder. The implications of these findings for future research and treatment are discussed.

Anxiety and depression in patients receiving implanted cardioverter-defibrillators: a longitudinal investigation.

OBJECTIVE: The implantable cardioverter-defibrillator (ICD) has dramatically improved survival rates following sudden cardiac death episodes. However, researchers have devoted little attention to the psychosocial consequences of living with the device. The current study used a longitudinal design to evaluate the impact of adaptation to the ICD on incidence and severity of anxiety and depression. METHOD: ICD recipients were administered standardized anxiety and depression questionnaires as well as questions evaluating quality of life related to the ICD in two consecutive yearly assessments. A preliminary evaluation of potentially important theoretical variables, such as the perceived predictability and controllability of shock onset was also conducted. RESULTS: One-third of the study population (N = 38) had clinically significant levels of anxiety, depressed mood, and fear of symptoms of autonomic arousal. These negative affective states persisted over time, with 40 to 63 percent of subjects continuing to have ongoing difficulties over a one-year time period. Anxiety about the ICD firing was closely associated with the occurrence of depression, while avoidance of activities was associated with anxiety. "Worry" about the ICD and a belief that ICD firing can be predicted were associated with anxiety sensitivity. CONCLUSIONS: Depressive and anxiety states in ICD recipients may be frequent, clinically significant, and resistant to spontaneous resolution. Early signs of anxiety and depression in ICD recipients should be evaluated. Implications for future research are discussed.

Behavioral analysis and treatment of reflexive vomiting associated with visceral sensations: a case study of interoceptive conditioning?

Behavior analytic methods are applied to the conceptualization and treatment of a complex case of interoceptive classical conditioning. The subject exhibited a gagging and vomiting response to bladder and/or similar visceral sensations. A two-factor learning model of the problem led to a successful exposure and response prevention intervention, which was based on single-case experimental methodology. We discuss the possible relevance of this case in the context of the growing attention to interoceptive conditioning in behavioral problems, and comment upon the importance of behavior analytic principles and procedures to the behavioral clinician.

Improving adherence to fluid restrictions in male hemodialysis patients: a comparison of cognitive and behavioral approaches.

A cognitive intervention and a behavioral intervention were compared to determine their relative effectiveness in reducing interdialytic weight gain (IWG) among eight adult male hemodialysis patients. The behavioral model consisted of positive reinforcement, shaping, and self-monitoring. The cognitive model consisted of a counseling intervention designed to modify health beliefs. Three small-sample experimental studies showed that both interventions produced immediate reductions in IWG. However, the behavioral intervention was superior to the cognitive intervention in producing maintenance of reduced weight gain. Combining the interventions resulted in no improvement over the behavioral intervention alone. Continuation of self-monitoring procedures produced maintenance of improvements up to 2 months posttreatment. Repeated-measures analysis of variance showed changes for only the "barriers" dimension of the health belief model (Hartman & Becker, 1978) (p < .001), and this occurred only following or concurrent with adherence behavior change. Suggestions for treatment and future research are offered.

Development of a sleep diary for chronic pain patients.

The present study examined the psychometric properties of the Daily Sleep Diary (DSD), an instrument developed for monitoring sleep among chronic pain patients. As part of a comprehensive evaluation, 46 chronic pain patients completed the DSD each morning. Items assessed the number of hours slept, length of sleep onset, frequency of awakenings during the night that resulted in trouble falling back to sleep, early morning awakening, quality of sleep, lack of restfulness, and the previous night's sleep compared to usual sleep. Reliability coefficients were significant. The sleep diary items significantly correlated with other retrospective measures of sleep. Duration of pain complaint was related to delayed sleep onset and lower quality of sleep. Pain severity was related to fewer hours slept and delayed sleep onset. The DSD items correlated with measures of both depression and anxiety. The results emphasize the importance of including sleep in both assessment and treatment of chronic pain patients.

Behavioral treatment of angina-like chest pain in patients with hyperventilation syndrome.

The hyperventilation syndrome is present in as many as 50% of patients with non-cardiac chest pain. This study evaluated a behavioral treatment of this disorder in three adult females. They had long histories of chest pain and were documented to be free of coronary artery disease. Each subject met the DSM-III-R diagnostic criteria for an anxiety disorder. Following treatment, all subjects showed a marked decrease in the frequency and intensity of chest pain episodes and in the frequency of shortness of breath episodes. Two subjects maintained their progress at one-year follow-up. The results lend support to the efficacy of controlled breathing and relaxation training for the treatment of hyperventilation-related chest pain and to the inclusion of a hyperventilation provocation test in the diagnosis of the syndrome as well as its role in changing cognitions regarding cardiac status. Also discussed is the rationale for treating hyperventilation related chest pain in a medical care setting.

Application of a token economy with a non-compliant closed head-injured male.

This study examined the application of several principles and procedures of operant conditioning in the rehabilitation of a closed head-injured 18-year-old male. The patient exhibited frequent and extreme verbal outbursts during therapy sessions, and he did not comply with rehabilitation exercises. After a goal-setting plus extinction procedure failed to improve compliance or to decrease disruptive vocalizations a contingent token reinforcement intervention was implemented to increase compliance with therapeutic activities. Frequency of disruptive vocalizations was measured as a covarying behaviour. The intervention was evaluated using a single-case experimental design. Results showed that both compliance with therapeutic activities and frequency of disruptive vocalizations changed as a function of contingent token reinforcement. The effect was replicated across three settings. This study demonstrates the generality of behavioural principles and procedures with closed head-injured populations in an acute rehabilitation setting. The functional equivalence of topographically dissimilar behaviours and the situation-specific control of behaviour is discussed.

Summation in the chimpanzee (Pan troglodytes).

In this research, we asked whether 2 chimpanzee (Pan troglodytes) subjects could reliably sum across pairs of quantities to select the greater total. Subjects were allowed to choose between two trays of chocolates. Each tray contained two food wells. To select the tray containing the greater number of chocolates, it was necessary to sum the contents of the food wells on each tray. In experiments where food wells contained from zero to four chocolates, the chimpanzees chose the greater value of the summed wells on more than 90% of the trials. In the final experiment, the maximum number of chocolates assigned to a food well was increased to five. Choice of the tray containing the greater sum still remained above 90%. In all experiments, subjects reliably chose the greater sum, even though on many trials a food well on the "incorrect" tray held more chocolates than either single well on the "correct" tray. It was concluded that without any known ability to count, these chimpanzees used some process of summation to combine spatially separated quantities. Speculation regarding the basis for summation includes consideration of perceptual fusion of pairs of quantities and subitization.