2009 — 2013 |
Rosenthal, Mark Z. |
R01Activity Code Description: To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies. |
Randomized Controlled Trial Computer-Base Intervention to Augment Drug Counseling
DESCRIPTION (provided by applicant): Although interventions using cue exposure for addiction have a sound theoretical rationale and are well grounded in animal learning studies, treatments using this approach have not been well supported. Two particular problems related to exposure- based treatments for addiction are: (1) reliably re-creating conditioned responding and extinguishing cravings to a variety of conditioned stimuli in the therapeutic environment and (2) generalization of extinguished responses to drug-related stimuli in the patient's natural environment. In a previous Stage Ia/b treatment development project (DA-R01- 018311), our group developed and found promising empirical support for the use of a novel computer-based intervention as an adjunct to a manualized and NIDA approved weekly Individual and Group Drug Counseling for cocaine dependence (Combined IDC and GDC; I/GDC; Daley et al., 2003; Mercer & Woody, 1999). Consistent with the mission of Stage II behavioral therapy development (Rounsaville, Carroll, & Onken, 2001), the primary aim of the present application is to follow the earlier Stage Ia/b project by examining the efficacy of a virtual reality-based (VR) cue exposure and cellular phone-based extinction reminder (ER) platform as an adjunctive intervention to I/GDC. Using a treatment manual previously developed that details the rationale and parameters of the VR/ER intervention, we will conduct a Stage II randomized controlled trial in order to rigorously evaluate the efficacy of this novel intervention. Specifically, 180 adult outpatients with crack cocaine dependence will be randomly assigned to receive 6 months of I/GDC alone (weekly individual and group counseling) or I/GDC + VR/ER. In addition to primary analyses examining treatment effects on cocaine use through thrice weekly urinalyses, additional analyses will evaluate differences in retention, other substance use, HIV risk behavior, and mediators/ moderators of treatment outcome across conditions. Comprehensive assessment measures, including measures of physiological and subjective cue reactivity, will be administered at pre-treatment, post- treatment, and 6-month follow-up. PUBLIC HEALTH RELEVANCE: In this project, we will evaluate the efficacy of a new intervention that uses two computer-based interventions as an addition to weekly group and individual drug counseling for cocaine addiction. Specifically, (1) inside the clinic we will use virtual reality to directly train new biobehavioral responses (i.e., less craving) to people, places, and things associated with drug use, and (2) outside the clinic we will use an automated server and cellular phones to provide reminders of newly learned biobehavioral responses from the virtual reality training. If the combination of the new intervention with weekly drug counseling leads to significantly better retention in treatment and less cocaine use compared to drug counseling alone, the results will provide a novel empirically supported approach to the treatment of addiction.
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0.97 |
2012 — 2015 |
Rosenthal, Mark Z. |
R01Activity Code Description: To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies. |
Evaluating a Novel Method of Generalizing Emotion Regulation
DESCRIPTION (provided by applicant): For over 100 years, behavioral scientists have been concerned with the need to generalize learned behavior from a training environment to more relevant contexts (e.g., Thorndike & Woodworth, 1901; Skinner, 1938). Basic scientists continue to identify exciting novel approaches to transfer trained behavior into new environments. However, clinical scientists have been slow to translate these findings into new interventions for psychiatric populations. New approaches to generalizing adaptive behavior outside the clinic setting are needed that are not diagnosis specific, but instead target basic processes relevant across many psychiatric problems. Difficulties regulating negative emotions are common across many psychiatric disorders (e.g., mood, anxiety, eating, substance use disorders), and may be central to some of the most severe and difficult-to-treat populations (e.g., borderline personality disorder; BPD). In the present application, we will translate findings from basic behavioral science into a simple and brief method to reduce negative emotions outside of a lab/clinic setting. We propose to test the effects of habituation reminders (HRs) following emotional arousal to personally-relevant emotional stressors, as a method of reducing acute negative emotions in novel contexts inside and outside the laboratory. Grounded in modern learning theory and basic science, the primary aim of this application is to evaluate across three experiments whether novel auditory HRs: (a) can reduce acute negative emotions in novel contexts inside (Exp. 1) and outside the laboratory (Exp. 2-3) and (b) are feasible and acceptable as an adjunctive intervention (Exp. 3). Specifically, we will recruit 208 adult psychiatric outpatients who have severe difficulties with emotion regulation. In Exp. 1, 208 participants will be randomly assigned to receive the HR (n = 104) or no HR (n = 104) after habituating to emotional stressors during a Learning Phase, followed by a Testing Phase one week later in either the same or different context with either the HR or no HR. In Exp. 2, 104 participants from Exp. 1 will be randomly assigned to hear the HR or a sham reminder via an automated phone-based platform when acute negative emotions occur, over 1 week of 8x daily calls. In Exp. 3, 52 participants who received the HR during Learning and Testing Phases in Exp. 1 will be asked to use a study cellular phone to call into the automated system in order to hear the HR when acute negative emotions occur in their daily lives, during a 2-week period. Using the same participants from Exp. 1 in Exp. 2-3 will permit analyses of the effects of HRs in the lab on emotional arousal, valence, and HR effects outside the lab, within and across participants, and over time. Results from this project will be the first to provide evidence regarding the use of novel reminders of a habituation context as a method of generalizing emotion regulation from a lab/clinic setting into naturalistic settings. If successful, HRs could b used as an inexpensive and simple new adjunctive intervention to facilitate generalization of learning outside the therapeutic setting in behavioral treatments.
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0.97 |