Serious adverse events in randomized psychosocial treatment studies: Safety or arbitrary edicts?

Human subjects protection policies developed for pharmaceutical trials are now being widely applied to psychosocial intervention studies. This study examined occurrences of serious adverse events (SAEs) reported in multicenter psychosocial trials of the National Institute on Drug Abuse Clinical Trials Network. Substance-abusing participants (N = 1,687) were randomized to standard care or standard care plus either contingency management or motivational enhancement. Twelve percent of participants experienced 1 or more SAEs during the 27,198 person-weeks of follow-up. Of the 260 SAEs recorded, none were judged by the data safety monitoring board to be study related, and there were no significant differences between experimental and control conditions in SAE incidence rates. These data underscore the need to reconsider the rationale behind, and appropriate methods for, monitoring safety during psychosocial therapy trials. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

We Don't Train in Vain: A Dissemination Trial of Three Strategies of Training Clinicians in Cognitive-Behavioral Therapy.

There has been little research on the effectiveness of different training strategies or the impact of exposure to treatment manuals alone on clinicians' ability to effectively implement empirically supported therapies. Seventy-eight community-based clinicians were assigned to 1 of 3 training conditions: review of a cognitive-behavioral therapy (CBT) manual only, review of the manual plus access to a CBT training Web site, or review of the manual plus a didactic seminar followed by supervised casework. The primary outcome measure was the clinicians' ability to demonstrate key CBT interventions, as assessed by independent ratings of structured role plays. Statistically significant differences favoring the seminar plus supervision over the manual only condition were found for adherence and skill ratings for 2 of the 3 role plays, with intermediate scores for the Web condition. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Internal validity of Project MATCH treatments: discriminability and integrity

Project MATCH (Matching Alcoholism Treatments to Client Heterogeneity) is a multisite collaborative project designed to evaluate patient-treatment interactions in alcoholism treatment. To evaluate whether major threats to the internal validity of the independent (treatment) variable in Project MATCH could be ruled out, we investigated several aspects of treatment integrity and discriminability. In this study, 1,726 alcohol-dependent participants at 10 sites were randomized to 3 treatments: cognitive-behavioral treatment (CBT), motivational enhancement therapy (MET), and 12-step facilitation (TSF). Participants received treatment either as outpatients or as aftercare following a more intensive inpatient or day hospital treatment. For both the outpatient and aftercare arms of the study, treatments were discriminable in that therapists implemented each of the treatments according to manual guidelines and rarely used techniques associated with comparison approaches. Participants received a high level of exposure to their study treatments, and the intended contrast in treatment dose between MET and the 2 more intensive treatments (CBT and TSF) was obtained. Alcoholics Anonymous involvement was significantly higher for participants assigned to TSF versus MET or CBT, whereas the treatments did not differ in utilization of other nonstudy treatments. Nonspecific aspects of treatment such as therapist skillfulness and level of the therapeutic alliance were comparable across treatment conditions.     

Personality, temperament, and character dimensions and the DSM-IV personality disorders in substance abusers.

The authors evaluated the relationship between P. T. Costa and R. R. McCrae's (1992) NEO 5-factor model, C. R. Cloninger's (1993) 7-factor Temperament and Character Inventory (TCI), and the American Psychiatric Association's (1994) Diagnostic and Statistical Manual of Mental Disorders, 4th ed., personality disorders in 370 inpatient and outpatient alcohol, cocaine, and opiate abusers. NEO Neuroticism was associated with many disorders, and different patterns for Agreeableness, Conscientiousness, and Extraversion emerged for the different disorders. Several TCI scales were associated with different personality disorders, although not as strongly as the NEO dimensions. Results did not support most predictions made for the TCI. Normal personality dimensions contributed significantly to the prediction of personality disorder severity above and beyond substance abuse and depression symptoms. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Cross system agreement for substance use disorders: DSM-III-R, DSM-IV and ICD-10

This report presents results of a field trial of Substance Use Disorders as defined by DSM-III-R, DSM-IV (proposed) and ICD-10. Diagnoses based on the three systems were derived from interviews using the Composite International Diagnostic Interview (CIDI) in a heterogeneous sample of 521 adults drawn from clinical and community settings. Two issues are addressed: (1) cross system agreement; and (2) syndrome coherence of proposed criterion sets for Substance Dependence in each of the three systems. Findings were as follows: (1) Cross system agreement for Dependence was generally high, especially between DSM-III-R and DSM-IV. (2) Cross system agreement was lower for DSM-III-R and DSM-IV Abuse and very low for DSM-IV Abuse and ICD-10 Harmful Use. (3) Agreement varied across drug categories with lowest DSM-III-R/DSM-IV agreement for alcohol abuse and DSM-IV/ICD-10 agreement for marijuana use disorders. (4) Overall prevalence differed for the three systems with DSM-IV yielding highest rates followed by DSM-III-R and ICD-10 in that order. (5) Factor analysis of Dependence criteria showed high loadings of all items on a single factor across the three diagnostic systems and for all categories of drugs. Implications for validity of the dependence syndrome construct and for revisions in DSM-IV are discussed.     

Blind man's bluff: Effectiveness and significance of psychotherapy and pharmacotherapy blinding procedures in a clinical trial.

No study has reported on the comparative effectiveness of blinding procedures for psychotherapy and pharmacotherapy conditions in treatment efficacy studies or the potential impact of failure to maintain a psychotherapy blind. In a randomized clinical trial, the authors found, from the perspective of clinical evaluators who were unaware of the patient's treatment assignment, procedures intended to protect the psychotherapy blind were only modestly effective but comparable to standard procedures used to maintain pharmacotherapy blinds. Second, accuracy of guessing each form of treatment (psychotherapy or pharmacotherapy) was not independent of the other. Third, findings suggested the importance of maintaining both psychotherapy and pharmacotherapy blinds, as subjective ratings of treatment outcome were significantly different depending on whether the clinical evaluator had correctly guessed the patients' true treatment condition. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Fluoxetine treatment for dually diagnosed methadone maintained opioid addicts: a pilot study

Twenty-two methadone maintained opioid addicts with either depression or persistent cocaine use received open label fluoxetine in addition to their methadone. Fluoxetine significantly decreased depressive symptoms from pre-treatment to endpoint in subjects with depression, while its effect on substance use was inconclusive.     

The use of contingency management and motivational/skills-building therapy to treat young adults with marijuana dependence.

Marijuana-dependent young adults (N = 136), all referred by the criminal justice system, were randomized to 1 of 4 treatment conditions: a motivational/skills-building intervention (motivational enhancement therapy/cognitive-behavioral therapy; MET/CBT) plus incentives contingent on session attendance or submission of marijuana-free urine specimens (contingency management; CM), MET/CBT without CM, individual drug counseling (DC) plus CM, and DC without CM. There was a significant main effect of CM on treatment retention and marijuana-free urine specimens. Moreover, the combination of MET/CBT plus CM was significantly more effective than MET/CBT without CM or DC plus CM, which were in turn more effective than DC without CM for treatment attendance and percentage of marijuana-free urine specimens. Participants assigned to MET/CBT continued to reduce the frequency of their marijuana use through a 6-month follow-up. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Role of manual-guided training in the conduct and efficacy of interpersonal psychotherapy for depression.

This article reviews findings from manual-guided training programs in short-term interpersonal psychotherapy (IPT) for depression, an exploratory treatment that focuses on symptom reduction and improvement of social functioning. The literature revealed (a) that experienced, dynamically trained therapists were able to achieve a high level of competence in IPT after comparatively brief training and were able to maintain adherence to the manual over a lengthy study; (b) that general dimensions of the psychotherapy process, including therapist warmth and patient difficulty, were highly correlated with ratings of therapist competence in the performance of IPT; and (c) that therapists judged as performing IPT more competently tended to be more effective. Although definitive evidence on the effectiveness of manual-guided training is lacking, the use of manuals and systematic therapist training appear to be useful for the conduct of psychotherapy efficacy research. Findings showing that manual adherence is related to therapist efficacy suggest a role for these procedures in clinical training and competency determination. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

The relation between specific and general dimensions of the psychotherapy process in interpersonal psychotherapy of depression.

This article examines the relation between general dimensions of the psychotherapy process, rated with the Vanderbilt Psychotherapy Process Scale (VPPS), and a type of manual-guided psychotherapy, Short-Term Interpersonal Psychotherapy of Depression (IPT). With the use of data from a training program in IPT, two types of analyses were performed. First, VPPS factors were correlated with IPT therapist competence ratings. This analysis showed that all VPPS-rated dimensions of patient and therapist behaviors were significantly correlated with IPT competence ratings. Especially strong correlations occurred between IPT competence ratings and the VPPS therapist factors of (a) Exploration and (b) Warmth and Friendliness. Second, to evaluate whether the general process features that influenced IPT competence ratings were also related to the therapy's effectiveness, correlations between VPPS process dimensions and patient outcome were performed. This analysis indicated that VPPS-rated therapist behaviors were significantly predictive of patient outcome, whereas patient behaviors were generally not significantly related to outcome. Taken together, the findings indicate the importance of general aspects of the psychotherapy process in therapist evaluation and efficacy of manual-guided psychotherapy. (PsycINFO Database Record (c) 2010 APA, all rights reserved)