fMRI Study of a Dual Process Treatment Protocol With Substance Dependent Adults
|ClinicalTrials.gov Identifier: NCT01320748|
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : January 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Substance Abuse Substance Dependence Alcohol Abuse Drug Use Relapse||Behavioral: Dual Processing Behavioral: Relapse Prevention||Not Applicable|
The substance abuse literature consistently shows that negative emotional states and subjective stress are highly predictive of relapse and significantly influence behavioral motivation. From a neurobiological perspective, stress associated with withdrawal and substance abuse experiences stimulates chemical and hormonal changes in the brain creating a protracted hyperaroused state. Further, cognitive control resources (i.e., cognitive coping skills/relapse prevention training) have been shown to exert minimal impact on behavioral decision-making in the presence of intense affective material. Thus, implicit cognitive processes play a significant role in drug use behavior, decreasing self regulation capacities and increasing risk of. Specifically, high levels of stress can compromise prefrontal cortex functioning, with the nucleus accumbens, orbitofrontal cortex and amygdala functional changes related to increased cue reactivity.
Taken together, the current literature strongly suggests that verbally-based therapies may have limited utility as a singular form of treatment in early substance abuse recovery, as the brain may not be functionally ready for executive level processing. Instead, the multidisciplinary substance abuse literature suggests that psychosocial treatment methods need to include a range of learning approaches that allow for visual-sensory processing, in addition to traditional verbal-based processing. Integrated multi-modal interventions are needed to offer opportunities for activation of these different brain regions to facilitate cognitive-affective balance in behavioral decision-making.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||fMRI Study of a Dual Process Treatment Protocol With Substance Dependent Adults|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||January 2013|
|Experimental: Dual Processing||
Behavioral: Dual Processing
A 10-week, 20-session program, which meets two times per week for 2 hours each time. It is a psychosocial intervention that combines a visual processing (structured drawing activities to engage in sensory-based cue exposure) and a verbal processing component (structured cognitive-behavioral therapy). The treatment focuses on sensory-based emotional expression and cognitive reappraisal and containment strategies that facilitate emotional regulation around a patient's drug and alcohol use experiences.
|Active Comparator: Relapse Prevention||
Behavioral: Relapse Prevention
The program's standard care outpatient program is a Relapse Prevention 10-week, 20-session, psychosocial intervention program, which meets two times per week for 2 hours each time. This RP program is based on Gorski's Relapse Prevention model and is a primarily didactic approach.
- fMRI blood-oxygenation-level-dependent (BOLD) signal change as a measure of emotional reactivity related to the visual presentation of drug-imagery. [ Time Frame: 10 weeks ]In a subset of approximately 26 subjects, fMRI technology will be employed to examine brain structure and function change (pre-treatment and post-treatment) in the amygdaloid region, orbitofrontal cortex, in the anterior cingluate cortex (structure implicated in drug cue attention); in medial prefrontal cortex and right dorsolateral prefrontal cortex (associated with effective behavioral decision-making in substance abusers).
- Heart rate during MRI scanning as a measure of emotional reactivity related to the visual presentation of drug-imagery. [ Time Frame: 10 weeks ]Changes in heart rate related to the visual presentation of drug-imagery during MRI scanning, to assess cue reactivity differences across the treatment and control groups at two time-points (pre-intervention and post-intervention).
- Quality of Life Inventory (QOLI) as a measure of the subject's quality of life. [ Time Frame: 10 weeks ]Questionnaire completed by subjects at baseline and at the end of the study. We will measure changes in Overall QOLI score and Weighted Satisfaction Profile score at the two time-points (pre-intervention and post-intervention).
- Brief Symptoms Inventory (BSI), as a measure of subjective craving, anxiety, and somatization [ Time Frame: 10 weeks ]Questionnaire completed by subjects at baseline and at the end of the study. We will measure changes in Nonpatient T Score and Percentile in the 12 domains at the two time-points (pre-intervention and post-intervention).
- Hamilton - Depression Inventory (HAM-D) as a measure of depression. [ Time Frame: 10 weeks ]Questionnaire completed by subjects at baseline and at the end of the study. We will measure changes in the total Hamilton depression scale score at the two time-points (pre-intervention and post-intervention).
- Urine specimen toxicology analysis as a measure of treatment retention. [ Time Frame: Weekly for 10 weeks ]Urine specimen collection and analysis to track patient drug use on a weekly basis during the 10 weeks in treatment.
- Blood Alcohol Level analysis as a measure of treatment retention. [ Time Frame: Weekly for 10 weeks ]Breathalizer test for alcohol to track patient alcohol use on a weekly basis during the 10 weeks in treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320748
|United States, District of Columbia|
|Georgetown Center for Functional And Molecular Imaging, Georgetown University Medical Center|
|Washington, District of Columbia, United States, 22057|
|United States, Virginia|
|Inova Heath Services Comprehensive Addictions Treatment Services (ICATS)|
|Falls Church, Virginia, United States, 22042|
|Principal Investigator:||Holly C Matto, PhD||Virginia Commonwealth University, School of Social Work|