Training, supervision and quality monitoring of the COMBINE Study behavioral interventions

Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, Albuquerque, New Mexico 87131-0001, USA.
Journal of studies on alcohol. Supplement 08/2005; 15(15):188-95; discussion 168-9. DOI: 10.15288/jsas.2005.s15.188
Source: PubMed


Current standards for clinical trials require that behavioral interventions be thoroughly specified, that clinicians be well trained and closely supervised and that performance be carefully monitored to ensure and document treatment fidelity. This article describes procedures developed and implemented for this purpose in the COMBINE Study, a multisite trial combining medications and behavioral interventions for alcohol dependence.
Two behavioral treatments were tested in COMBINE: a Medical Management (MM) protocol to accompany the delivery of trial medications and a Combined Behavioral Intervention (CBI) designed as a comprehensive and flexible evidence-based psychotherapy.
Information is provided concerning (1) screening and qualifications of practitioners, (2) training and certification in the interventions, (3) on-site supervision and coordination of the two treatments, (4) central monitoring and coding of treatment sessions and (5) maintenance and documentation of treatment fidelity.
Both interventions were delivered with fidelity. Problems encountered and important choices made in the implementation of training and quality assurance for CBI and MM are briefly described.

Download full-text


Available from: Theresa B Moyers, Jan 08, 2015
  • Source
    • "This variability in the empathic relationship among clients was associated with outcomes, such that relatively small increases in the therapist's usual level of empathy were associated with larger decreases in end-of-treatment drinking. That we were able to see a relationship between empathy and drinking outcomes in this large, randomized Elements of CBI 18 controlled trial is noteworthy since therapists were rigorously screened for their use of empathic listening skills prior to hiring, and were extensively and explicitly trained in the interpersonal context of the CBI treatment (Miller et al., 2005). Further, therapists were monitored in their expression of empathy as the trial progressed and were red-lined (i.e., stopped from taking clients) if empathy ratings were unacceptably low at any point. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Objective: Common factors such as therapist empathy play an important role in treatment for addictive behaviors. The present study was a secondary analysis designed to evaluate the relation between therapist empathy and alcohol treatment outcomes in data from a large, multisite, randomized controlled trial. Method: Audio-recorded psychotherapy sessions for 38 therapists and 700 clients had been randomly selected for fidelity coding from the combined behavioral intervention condition of Project COMBINE. Sessions were evaluated by objective raters for both specific content (coping with craving, building social skills, and managing negative mood) and relational components (empathy level of the therapist). Multilevel modeling with clients nested within therapists evaluated drinks per week at the end of treatment. Results: Approximately 11% of the variance in drinking was accounted for by therapists. A within-therapist effect of empathy was detected (B = -0.381, SE = 0.103, p < .001); more empathy than usual was associated with subsequent decreased drinking. The Social and Recreational Counseling module (B = -0.412, SE = 0.124, p < .001), Coping with Cravings and Urges module (B = -0.362, SE = 0.134, p < .01), and the Mood Management module (B = -0.403, SE = 0.138, p < .01) were also associated with decreased drinking. No between-therapist effect was detected, and the Empathy × Module Content interactions were not significant. Conclusions: The results of the study appear consistent with the hypothesis that skills building and therapist empathy are independent contributions to the overall benefit derived from the combined behavioral intervention. (PsycINFO Database Record
    Full-text · Article · Jan 2016 · Journal of Consulting and Clinical Psychology
    • "When using a manualized intervention or protocol, it is also important to report on the fidelity of the treatment delivery and competence of the interventionist in delivering the intended interventions (Miller et al., 2005). Quantitative ratings of competence and adherence to the intervention (Carroll et al., 2000; Madson and Campbell, 2006) and whether there was ongoing interventionist monitoring and supervision should also be reported (Carroll and Rounsaville, 2007; Miller et al., 2005). "
    [Show abstract] [Hide abstract]
    ABSTRACT: The primary goals in conducting clinical trials of treatments for alcohol use disorders (AUDs) are to identify efficacious treatments and determine which treatments are most efficacious for which patients. Accurate reporting of study design features and results is imperative to enable readers of research reports to evaluate to what extent a study has achieved these goals. Guidance on quality of clinical trial reporting has evolved substantially over the past 2 decades, primarily through the publication and widespread adoption of the Consolidated Standards of Reporting Trials statement. However, there is room to improve the adoption of those standards in reporting the design and findings of treatment trials for AUD. This paper provides a narrative review of guidance on reporting quality in AUD treatment trials. Despite improvements in the reporting of results of treatment trials for AUD over the past 2 decades, many published reports provide insufficient information on design or methods. The reporting of alcohol treatment trial design, analysis, and results requires improvement in 4 primary areas: (i) trial registration, (ii) procedures for recruitment and retention, (iii) procedures for randomization and intervention design considerations, and (iv) statistical methods used to assess treatment efficacy. Improvements in these areas and the adoption of reporting standards by authors, reviewers, and editors are critical to an accurate assessment of the reliability and validity of treatment effects. Continued developments in this area are needed to move AUD treatment research forward via systematic reviews and meta-analyses that maximize the utility of completed studies. Copyright © 2015 by the Research Society on Alcoholism.
    No preview · Article · Aug 2015 · Alcoholism Clinical and Experimental Research
  • Source
    • "; assessing suicide risk, stress, and resource needs; providing education about PTSD; engaging the patient to actively participate in their PTSD treatments; and using motivational interviewing techniques to encourage behavior change [59] [60] [61] "
    [Show abstract] [Hide abstract]
    ABSTRACT: Posttraumatic stress disorder (PTSD) is a common problem in primary care. Although effective treatments are available, little is known about whether such treatments are effective within the context of Federally Qualified Health Centers (FQHCs) that serve as national "safety nets" for providing primary care for low income and underinsured patients. The Violence and Stress Assessment (ViStA) study is the first randomized controlled trial (RCT) to test the impact of a care management intervention for treating PTSD in FQHCs. To develop a PTSD management intervention appropriate for lower resource FQHCs and the predominantly Latino patients they serve, formative work was conducted through a collaborative effort between researchers and an FQHC practice-based research network. This article describes how FQHC stakeholders were convened to review, assess, and prioritize evidence-based strategies for addressing patient, clinician, and system-level barriers to care. This multi-component care management intervention incorporates diagnosis with feedback, patient education and activation; navigation and linkage to community resources; clinician education and medication guidance; and structured cross-disciplinary communication and continuity of care, all facilitated by care managers with FQHC experience. We also describe the evaluation design of this five-year RCT and the characteristics of the 404 English or Spanish speaking patients enrolled in the study and randomized to either the intervention or to usual care. Patients are assessed at baseline, six months, and 12months to examine intervention effectiveness on PTSD, other mental health symptoms, health-related quality-of-life, health care service use; and perceived barriers to care and satisfaction with care.
    Full-text · Article · Apr 2014 · Contemporary clinical trials
Show more