An adaptive randomized trial of dialectical behavior therapy and cognitive behavior therapy for binge-eating.

BACKGROUND: Early weak treatment response is one of the few trans-diagnostic, treatment-agnostic predictors of poor outcome following a full treatment course. We sought to improve the outcome of clients with weak initial response to guided self-help cognitive behavior therapy (GSH). METHOD: One hundred and nine women with binge-eating disorder (BED) or bulimia nervosa (BN) (DSM-IV-TR) received 4 weeks of GSH. Based on their response, they were grouped into: (1) early strong responders who continued GSH (cGSH), and early weak responders randomized to (2) dialectical behavior therapy (DBT), or (3) individual and additional group cognitive behavior therapy (CBT+). RESULTS: Baseline objective binge-eating-day (OBD) frequency was similar between DBT, CBT+ and cGSH. During treatment, OBD frequency reduction was significantly slower in DBT and CBT+ relative to cGSH. Relative to cGSH, OBD frequency was significantly greater at the end of DBT (d = 0.27) and CBT+ (d = 0.31) although these effects were small and within-treatment effects from baseline were large (d = 1.41, 0.95, 1.11, respectively). OBD improvements significantly diminished in all groups during 12 months follow-up but were significantly better sustained in DBT relative to cGSH (d = -0.43). At 6- and 12-month follow-up assessments, DBT, CBT and cGSH did not differ in OBD. CONCLUSIONS: Early weak response to GSH may be overcome by additional intensive treatment. Evidence was insufficient to support superiority of either DBT or CBT+ for early weak responders relative to early strong responders in cGSH; both were helpful. Future studies using adaptive designs are needed to assess the use of early response to efficiently deliver care to large heterogeneous client groups.

Distribution-free Inference of Zero-inated Binomial Data for Longitudinal Studies.

Count reponses with structural zeros are very common in medical and psychosocial research, especially in alcohol and HIV research, and the zero-inflated poisson (ZIP) and zero-inflated negative binomial (ZINB) models are widely used for modeling such outcomes. However, as alcohol drinking outcomes such as days of drinkings are counts within a given period, their distributions are bounded above by an upper limit (total days in the period) and thus inherently follow a binomial or zero-inflated binomial (ZIB) distribution, rather than a Poisson or zero-inflated Poisson (ZIP) distribution, in the presence of structural zeros. In this paper, we develop a new semiparametric approach for modeling zero-inflated binomial (ZIB)-like count responses for cross-sectional as well as longitudinal data. We illustrate this approach with both simulated and real study data.

Saccharomyces boulardii viability and efficacy in horses with antimicrobial-induced diarrhoea.

Saccharomyces boulardii has been successfully used in the prevention and treatment of antimicrobial-associated diarrhoea in humans. We hypothesised that a viable, dried lyophilised preparation of S boulardii would survive in the gastrointestinal tract of horses with antimicrobial-associated enterocolitis, and significantly decrease the duration of diarrhoea. Twenty-one horses, over one year of age, with antimicrobial-associated diarrhoea of up to 72 hours duration, were consecutively randomised in a controlled prospective study. The treatment group received S boulardii (25 g, orally, every 12 hours) until the cessation of clinical signs. S boulardii was successfully cultured in 58.3 per cent of treatment horses on day 3. No statistically significant differences were found in days to return to normal faecal consistency; resolution of watery diarrhoea; return to normal heart rate, respiratory rate and temperature; resolution of leucopaenia; attitude improvement; appetite improvement; and survival at discharge. This is the first study to demonstrate survival of S boulardii in horses with gastrointestinal illness. Further study of the efficacy and safety of S boulardii in horses with antimicrobial-associated diarrhoea in a larger group is warranted.

Distribution-free models for longitudinal count responses with overdispersion and structural zeros.

Overdispersion and structural zeros are two major manifestations of departure from the Poisson assumption when modeling count responses using Poisson log-linear regression. As noted in a large body of literature, ignoring such departures could yield bias and lead to wrong conclusions. Different approaches have been developed to tackle these two major problems. In this paper, we review available methods for dealing with overdispersion and structural zeros within a longitudinal data setting and propose a distribution-free modeling approach to address the limitations of these methods by utilizing a new class of functional response models. We illustrate our approach with both simulated and real study data.

The Self-Injury Questionnaire: evaluation of the psychometric properties in a clinical population.

This paper presents the findings, from a clinical study, on the reliability and validity of a new measure for intentions in self-harm behaviour, the Self-Injury Questionnaire (SIQ). Eighty-three patients, who had presented to an emergency department with an episode of self-harm/suicidal behaviour, were given the SIQ as part of a battery of measures to evaluate differentiation in self-harm intentions based upon a history of childhood physical and/or sexual abuse. The internal consistency for the total scale was strong (alpha = 0.83). Construct validity demonstrated significant correlations with standardized measures. A principle component analysis of responses yielded a five-factor solution with 'affect regulation' items loading on the first factor. Cronbach's alphas were adequate for each subscale (alpha = 0.72-0.77). These preliminary findings indicate that the SIQ is a valid and reliable measure for research in an acute self-harming population.

Power analyses for correlations from clustered study designs.

Power analysis constitutes an important component of modern clinical trials and research studies. Although a variety of methods and software packages are available, almost all of them are focused on regression models, with little attention paid to correlation analysis. However, the latter is arguably a simpler and more appropriate approach for modelling concurrent events, especially in psychosocial research. In this paper, we discuss power and sample size estimation for correlation analysis arising from clustered study designs. Our approach is based on the asymptotic distribution of correlated Pearson-type estimates. Although this asymptotic distribution is easy to use in data analysis, the presence of a large number of parameters creates a major problem for power analysis due to the lack of real data to estimate them. By introducing a surrogacy-type assumption, we show that all nuisance parameters can be eliminated, making it possible to perform power analysis based only on the parameters of interest. Simulation results suggest that power and sample size estimates obtained under the proposed approach are robust to this assumption.

Putting it all together: dealing with complexity in the understanding of the human condition.

In this paper, two mental health nurses who have experienced long academic careers reflect on the way their own thinking and teaching about the human condition has changed over the course of their careers. Three major paradigms that have attempted to explain the human condition, the biological sciences, psychodynamic theory, and socio-cultural theory, are discussed. It is argued that no single approach is sufficient to address the complexities of providing care within psychiatric and mental health nursing. It is further argued that the integration of these perspectives has not been well considered or articulated in practice. The authors conclude that the arguments presented in this paper are likely to challenge people's loyalties to a particular perspective of the human condition.

Alcohol craving predicts drinking during treatment: an analysis of three assessment instruments.

OBJECTIVE: The purpose of this investigation was to examine the utility of thee craving instruments to predict drinking during treatment. The three assessments used were the Penn Alcohol Craving Scale (PACS), the Alcohol Urge Questionnaire (AUQ) and Items 1-6 of the Obsessive subscale (OBS) of the Obsessive Compulsive Drinking Scale (OCDS). METHOD: The three instruments were administered during the course of a 9-month, double-blind, placebo-controlled trial of 100 mg/day of naltrexone, and a manual-based psychosocial intervention using the BRENDA manual conducted at the University of Pennsylvania's Treatment Research Center. Participants (133 men and 50 women at the initiation of the study) used these instruments to self-report craving on a weekly or biweekly basis. The weekly number of drinks was reported using the Timeline Followback interview. The data were analyzed with generalized estimating equations using craving scores at 1 week as the independent variable and number of drinks in the subsequent treatment week as the dependent variable. RESULTS: Each of the three scales predicted drinking during the subsequent treatment week. The PACS was the strongest predictor followed closely by the OBS and then the AUQ. Most important, craving as measured by the three scales was a stronger predictor of subsequent drinking than was drinking during the prior treatment week. CONCLUSIONS: Craving assessment provides a useful means of predicting drinking during treatment. Such information would be helpful in designing clinical trials and for many treatment modalities.

Relationship between nurses' pain knowledge and pain management outcomes for their postoperative cardiac patients.

Nurses' knowledge and perceived barriers related to pain management have been examined extensively. Nurses have evaluated their pain knowledge and management practices positively despite continuing evidence of inadequate pain management for patients. However, the relationship between nurses' stated knowledge and their pain management practices with their assigned surgical cardiac patients has not been reported. Therefore, nurses (n=94) from four cardiovascular units in three university-affiliated hospitals were interviewed along with 225 of their assigned patients. Data from patients, collected on the third day following their initial, uncomplicated coronary artery bypass graft (CABG) surgery, were aggregated and linked with their assigned nurse to form 80 nurse-patient combinations. Nurses' knowledge scores were not significantly related to their patients' pain ratings or analgesia administered. Critical deficits in knowledge and misbeliefs about pain management were evident for all nurses. Patients reported moderate to severe pain but received only 47% of their prescribed analgesia. Patients' perceptions of their nurses as resources with their pain were not positive. Nurses' knowledge items explained 7% of variance in analgesia administered. Hospital sites varied significantly in analgesic practices and pain education for nurses. In summary, nurses' stated pain knowledge was not associated with their assigned patients' pain ratings or the amount of analgesia they received.

Early improvement during manual-guided cognitive and dynamic psychotherapies predicts 16-week remission status.

This study examined the extent to which improvement from baseline to weeks 2, 3, and 4 on the Beck Depression Inventory and Beck Anxiety Inventory predict week 16 clinical remission for patients with major depressive disorder, generalized anxiety disorder, and/or obsessive-compulsive or avoidant personality disorders who were receiving manual-based psychotherapies. Logistic regression and receiver-operator characteristic analyses revealed relatively accurate identification of remitters and nonremitters based on improvement from baseline to sessions 2 to 4 in both original and cross-validation samples. Predictive success did not vary as a function of diagnosis, treatment type (cognitive or dynamic), or treatment status (short-term or long-term). The clinical implications of the results are discussed.

Effectiveness of St John's wort in major depression: a randomized controlled trial.

CONTEXT: Extracts of St John's wort are widely used to treat depression. Although more than 2 dozen clinical trials have been conducted with St John's wort, most have significant flaws in design and do not enable meaningful interpretation. OBJECTIVE: To compare the efficacy and safety of a standardized extract of St John's wort with placebo in outpatients with major depression. DESIGN AND SETTING: Randomized, double-blind, placebo-controlled clinical trial conducted between November 1998 and January 2000 in 11 academic medical centers in the United States. PARTICIPANTS: Two hundred adult outpatients (mean age, 42.4 years; 67.0% female; 85.9% white) diagnosed as having major depression and having a baseline Hamilton Rating Scale for Depression (HAM-D) score of at least 20. INTERVENTION: Participants completed a 1-week, single-blind run-in of placebo, then were randomly assigned to receive either St John's wort extract (n = 98; 900 mg/d for 4 weeks, increased to 1200 mg/d in the absence of an adequate response thereafter) or placebo (n = 102) for 8 weeks. MAIN OUTCOME MEASURES: The primary outcome measure was rate of change on the HAM-D over the treatment period. Secondary measures included the Beck Depression Inventory (BDI), Hamilton Rating Scale for Anxiety (HAM-A), the Global Assessment of Function (GAF) scale, and the Clinical Global Impression-Severity and -Improvement scales (CGI-S and CGI-I). RESULTS: The random coefficient analyses for the HAM-D, HAM-A, CGI-S, and CGI-I all showed significant effects for time but not for treatment or time-by-treatment interaction (for HAM-D scores, P<.001, P =.16, and P =.58, respectively). Analysis of covariance showed nonsignificant effects for BDI and GAF scores. The proportion of participants achieving an a priori definition of response did not differ between groups. The number reaching remission of illness was significantly higher with St John's wort than with placebo (P =.02), but the rates were very low in the full intention-to-treat analysis (14/98 [14.3%] vs 5/102 [4.9%], respectively). St John's wort was safe and well tolerated. Headache was the only adverse event that occurred with greater frequency with St John's wort than placebo (39/95 [41%] vs 25/100 [25%], respectively). CONCLUSION: In this study, St John's wort was not effective for treatment of major depression.

Therapeutic alliance as a predictor of outcome and retention in the National Institute on Drug Abuse Collaborative Cocaine Treatment Study.

The authors examined the relation between therapeutic alliance, retention, and outcome for 308 cocaine-dependent outpatients participating in the National Institute on Drug Abuse Collaborative Cocaine Treatment Study. High levels of alliance were observed in supportive-expressive therapy (SE), cognitive therapy (CT), and individual drug counseling (IDC), and alliance levels increased slightly but significantly from Session 2 to Session 5 in all groups. In contrast to other studies, alliance was not a significant predictor of drug outcome. However, alliance did predict patient retention differentially across the 3 treatments. In SE and IDC, either higher levels of alliance were associated with increased retention or no relationship between alliance and retention was found, depending on the time alliance was measured. In CT, higher levels of alliance were associated with decreased retention.

Treatment of tardive dyskinesia with donepezil: a pilot study.

BACKGROUND: Tardive dyskinesia (TD) remains a significant clinical problem for which there is no uniformly effective treatment. Earlier trials with acetylcholine precursors may have been disappointing because of underlying damage to striatal cholinergic neurons in patients with TD. In contrast, new cholinesterase inhibitors, developed for the treatment of dementia, may improve TD by directly increasing cholinergic synaptic transmission. METHOD: We conducted an 8-week open-label trial of donepezil in the treatment of TD. Ten patients with schizophrenia or schizoaffective disorder who received stable doses of antipsychotics and met DSM-IV criteria for TD were treated with donepezil, 5 to 10 mg/day, for 6 weeks after a 2-week baseline period. Changes in total Abnormal Involuntary Movement Scale (AIMS) scores measured every 2 weeks were assessed for significance. Patients were also assessed using the Brief Psychiatric Rating Scale, the Mini-Mental State Examination, the Barnes Akathisia Scale, and the Simpson-Angus Scale. RESULTS: Total AIMS scores decreased significantly (p = .0009), with no changes in other measures. Nine patients showed a positive response. Improvement was greatest in orofacial and upper extremity movements. No significant interactions were noted between the total AIMS scores and age (p > .29), duration of TD (p > .38), or duration of antipsychotic treatment (p > .14). CONCLUSION: Donepezil appeared to be effective in suppressing TD in this pilot study. However, placebo-controlled, double-blind studies are necessary before donepezil can be recommended as a treatment for TD.

Predictors of self-help group attendance in cocaine dependent patients.

OBJECTIVE: While referral to self-help groups for patients dependent on drugs other than alcohol has become widespread in the substance abuse treatment field, little is known about the characteristics of people who attend these groups. This study examines particular sociodemographic and clinical characteristics as possible predictors of attendance at self-help groups in the National Institute on Drug Abuse Collaborative Cocaine Treatment Study. METHOD: A multicenter study randomly assigned 487 patients (76.8% men) to one of four psychosocial treatments for cocaine dependence. Patients were treated for 24 weeks. Among other measures, the Weekly Self-Help Questionnaire was administered each week and completed, at least once, by 411 subjects. RESULTS: Approximately two thirds of the patients attended one or more self-help meetings during the 24-week period. Patients initially more likely to attend self-help groups frequently were those who were unemployed, had no religious preference, had more severe baseline drug use and reported treatment for prior substance-related problems. Patients with more severe baseline drug use and those who previously received treatment for substance-related problems were more likely to maintain frequent attendance throughout the study period. Only severity of baseline drug use predicted more frequent attendance during Month 6, although there was a trend in Month 6 favoring more frequent attendance by women. These findings remained significant when treatment condition was added to the models. CONCLUSIONS: Although these findings are consistent with past research on alcohol dependent individuals, they challenge popular clinical notions about the types of people who attend self-help groups. These findings demonstrate that self-help groups can appeal to a wide variety of cocaine dependent patients.

The impact of nurses' empathic responses on patients' pain management in acute care.

BACKGROUND: Although nurses have the major responsibility for pain management, little is known about nurses' responses to patients in the process of managing acute pain. OBJECTIVE: To examine the relationship between nurses' empathic responses and their patients' pain intensity and analgesic administration after surgery. METHODS: Two hundred twenty-five patients from four cardiovascular units in three university-affiliated hospitals were interviewed on the third day after their initial, uncomplicated coronary artery bypass graft (CABG) surgery about their pain and current pain management. Concurrently, their nurses' (n = 94) empathy and pain knowledge and beliefs were assessed. Patient data were aggregated and linked with the assigned nurse to form 80 nurse-patient pairs. RESULTS: Nurses were moderately empathic, and their responses did not significantly influence their patients' pain intensity or analgesia administered. Patients reported moderate to severe pain but received only 47% of their prescribed analgesia. Patients' perceptions of their nurse's attention to their pain were not positive, and empathy explained only 3% of variance in patients' pain intensity. Deficits in knowledge and misbeliefs about pain management were evident for nurses independent of empathy, and knowledge explained 7% of variance in analgesia administered. Hospital sites varied significantly in analgesic practices and pain inservice education for nurses. CONCLUSIONS: Empathy was not associated with patients' pain intensity or analgesic administration.

Self-help group attendance and participation among cocaine dependent patients.

The authors examined frequency and patterns of self-help group attendance and active participation over a 6-month period among 411 patients receiving treatment in the NIDA Collaborative Cocaine Treatment Study. Nearly two-thirds of patients attended at least one self-help group, and nearly all of these actively participated. Alcoholics Anonymous and Narcotics Anonymous meetings were attended most frequently. Statistical analyses included chi square, one-way analyses of variance, and cluster techniques. While patterns of attendance were relatively consistent over time, findings suggest that a treatment emphasizing the importance of self-help groups is likely to encourage more self-help group attendance and participation over time.

Emotional abuse, self-blame, and self-silencing in women with irritable bowel syndrome.

OBJECTIVE: The purpose of this study was to investigate the presence of emotional abuse and two psychosocial constructs (self-blame and self-silencing) in a sample of women diagnosed with irritable bowel syndrome (IBS) relative to a comparison sample of women diagnosed with inflammatory bowel disease (IBD). METHODS: Women diagnosed with IBS (N = 25) were compared with women diagnosed with IBD (N = 25) on measures of history of abuse, self-blame, and self-silencing. RESULTS: It was found that women in the IBS sample scored significantly higher on emotional abuse, self-blame, and self-silencing than did women in the IBD sample. These three variables were also found to be significantly intercorrelated in both the IBS and IBD samples. Finally, emotional abuse was significantly higher in IBS patients than in IBD patients beyond the differences accounted for by physical and/or sexual abuse history. CONCLUSIONS: These findings empirically demonstrate an association between IBS and emotional abuse, as well as a possible connection with psychosocial variables, that may mediate the connection between emotional abuse and functional bowel symptoms. We suggest that these variables be further evaluated in the context of clinically relevant research on IBS.

Detecting nurse-perceived patient treatment difficulty of psychiatric patients in hospital: an evaluation of a patient assessment sheet.

Many changes have occurred in hospital psychiatric care, including decreased length of hospital stay and increased patient acuity. These changes highlight the need for nurses to adequately assess and formally document patient treatment difficulties. The purposes of this study were to determine the ability of the Patient Assessment Sheet (PAS) to predict patient 'problems' that psychiatric nurses perceived as associated with patient treatment difficulty, and to identify the patient problems missing from the PAS. These purposes were accomplished by comparing the PAS to the Hospital Treatment Rating Scale (HTRS). A correlational design and multiple linear regression technique were used. Eight psychiatric registered nurses assessed a total of 110 patients, admitted consecutively to one inpatient psychiatric unit. The HTRS and the PAS were used independently for each patient. Four PAS items (active affect, passive affect, aggression toward self, and patient confusion) significantly predicted 38% of the variance from the HTRS; and three HTRS items (isolation and withdrawal from relationships, noninvolvement in treatment, and wide variability in mood) significantly predicted 22% of the residual variance from the HTRS. The identified PAS and HTRS items help to make visible patient problems associated with nurse-perceived patient treatment difficulty. This identification is potentially important for both clinical and political purposes.

Relationship between self-soothing, aloneness, and evocative memory in bulimia nervosa.

OBJECTIVE: The relationship between characteristics of self-soothing ability, the capacity for evocative memory, and aloneness was investigated in a clinical sample of 50 bulimia nervosa (BN) patients. METHOD: Individuals meeting DSM-III-R criteria for BN who participated in a randomized trial of guided imagery completed measures of Soothing Receptivity and a modified version of the UCLA-Loneliness scale, resulting in the Aloneness/Evocative Memory Scale. RESULTS: A lower level of soothing receptivity (indicating a decreased capacity for self-soothing) was correlated with a decreased capacity for evocative memory. A lower level of soothing receptivity and decreased capacity for evocative memory were associated with a greater experience of aloneness. DISCUSSION: Results suggest the need for a more comprehensive understanding of the role of affect regulation and the experience of aloneness in BN and the need to develop treatments to specifically address these features of the illness.

Culturally competent care for psychiatric clients who have a history of sexual abuse.

Canadian psychiatric nurses (N = 1,701) participated in a survey in which they-assessed their ability to nurse clients with a history of sexual abuse when cultural differences are present. Thirty-nine percent worked at a facility having a significant number of clients from a different culture. Only 4.6% rated themselves as "very competent." Four themes emerged from nurses' assessment of their ability: culture is not the problem, culture is not an issue, culture influences perspective and responses, and culturally specific competence. Only one cultural group, First Nations, was identified by sufficient numbers of nurses to generate themes concerning the challenge of working with clients from a particular culture. These themes (abuse as a cultural norm, concurrent and related health and social problems, reluctance to talk about problems, a need to learn about First Nations culture, and developing culturally competent caregivers), critical areas of concern, and possible solutions suggested by the nurses are discussed.