LETS ACT
BehavioralThe Life Enhancement Treatment for Substance Use (LETS ACT)
Other names: Behavioral Activation, Life Enhancement Treatment for Substance Use
NCT Number: NCT02707887
The purpose of this study is to:
1. test the effect of a smartphone enhanced LETS ACT (LETS ACT-SE) on frequency of substance use 2. use functional magnetic resonance imaging (fMRI) to test the relationship between neuromarkers of reward sensitivity on frequency of substance use.
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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Comorbid substance use disorder (SUD) and depression is highly prevalent and associated with elevated rates of post treatment relapse to substance use, HIV risk behavior, and associated poor mental and physical health outcomes. Further, rates of substance use and depression disproportionately affect minority groups and those living in poverty. Although efficacious, the often complex, specialized nature of CBT poses problems in its integration into substance use treatment programs. Budget cuts for mental health and substance use treatment both nationally and in the state of North Carolina, reduce availability of publically funded treatment programs and staff to patient ratios. To address this limitation, a behavioral activation (BA) treatment, the Life Enhancement Treatment for Substance Use (LETS ACT), was developed to treat depressive symptoms among a predominantly African American sample of low income illicit drug users currently receiving residential substance use treatment. Collectively, two Stage I studies and 1 year follow-up data from the investigators Stage II R01DA026424 indicate that compared to a control condition, LETS ACT is associated with significantly better outcomes for treatment retention, post treatment abstinence, HIV sexual risk behavior, depressive symptoms, and environmental reward.
Although these strong outcomes suggest that LETS ACT may be ready for a Stage III dissemination trial, it is of note that there was a significant indirect effect of LETS ACT homework compliance on post treatment substance use and HIV sexual risk behavior via the theoretically proposed BA mechanism of action, environmental reward. In the context of limited access to care, these findings point to the need to identify cost-effective delivery-vehicles to increase treatment engagement outside of clinician sessions. Further, identifying neuroscience based biomarkers (neuromarkers) underlying key theoretical aspects of BA (i.e., reward sensitivity), and their relation to heterogeneity in BA treatment response among substance users with depression, are critical for the identification of accurately targeted interventions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Life Enhancement Treatment for Substance Use (LETS ACT)
Other names: Behavioral Activation, Life Enhancement Treatment for Substance Use
Participants assigned to the smartphone-enhanced LETS ACT (LETS ACT-SE) condition will be provided the exact same treatment as outlined in LETS ACT, except that LETS ACT-SE participants will record their daily goals using smartphone technology.
Other names: Behavioral Activation, Smartphone-Enhanced LETS ACT
Participants will receive the treatment typically provided to patients at the substance use treatment facility.
Other names: TAU
Time frame: TLFB will be assessed from baseline to a 12-month follow up period.
The Time Line Follow Back is a self-report measure of drug and alcohol use.
Time frame: BADS will be assessed from baseline to a 12-month follow up period.
The BADS is a 25-item self-report measure of overall level of activity involvement
Time frame: RPI will be assessed from baseline to a 12-month follow up period.
The RPI is a 20-item self-report measure used to assess environmental reward and punishment.
Time frame: BDI-II will be evaluated from baseline to a 12-month follow up period
The Beck Depression Inventory is a 21-item self-report measure of depressive symptoms
Time frame: Baseline to a 3-months post treatment.
The Daily Goals Form is used to measure Treatment Engagement.
Time frame: TCU will be assessed from baseline to a 12-month follow up period.
The TCU is a self-structured interview that measures HIV risk behavior in the domains of drug use and sex
Time frame: Urinalysis is assessed from post treatment to a 12-month follow up period
Urinalysis is a biological measure of substance use.
Time frame: Breathalyzer will be assessed from baseline to a 12-month follow up period.
Breathalyzer is a biological measure of alcohol use.
Time frame: SF-12 will be assessed from baseline to a 12-month follow up period.
The SF-12 is a 12-item self-report measure of mental and physical health-related functioning.
University of North Carolina, Chapel Hill
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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