Clinical trial NCT02707887: Technology Enhanced Behavioral Activation Treatment for Substance Use
Official title: Technology Enhanced Behavioral Activation Treatment for Substance Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance-Related Disorders
Depressive Disorder
Behavioral Symptoms
Risk-Taking
Sexual Behavior
Keywords: Mental Disorders
Mood Disorders
Behavioral Activation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-03-14
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Between 18 and 55
* Meet criteria for DSM-V substance use disorder
* Elevated depressive symptoms (BDI ≥ 14)

Exclusion Criteria:

* Limited mental competency (MMSE \< 23)
* Psychosis
* The use of psychotropic medication for \< 3 months
* The inability to give informed, voluntary, written consent to participate

Primary outcomes:
measure: Timeline Followback (TLFB)
timeFrame: TLFB will be assessed from baseline to a 12-month follow up period.
Secondary outcomes:
measure: Behavioral Activation for Depression Scale (BADS)
timeFrame: BADS will be assessed from baseline to a 12-month follow up period.
measure: Reward Probability Index (RPI)
timeFrame: RPI will be assessed from baseline to a 12-month follow up period.
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: BDI-II will be evaluated from baseline to a 12-month follow up period
measure: Daily Goals Form
timeFrame: Baseline to a 3-months post treatment.
measure: Texas Christian University (TCU) HIV/AIDS Risk Assessment Form
timeFrame: TCU will be assessed from baseline to a 12-month follow up period.
measure: Urinalysis
timeFrame: Urinalysis is assessed from post treatment to a 12-month follow up period
measure: Breathalyzer
timeFrame: Breathalyzer will be assessed from baseline to a 12-month follow up period.
measure: Short Form Health Survey (SF-12)
timeFrame: SF-12 will be assessed from baseline to a 12-month follow up period.
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Raleigh
country: United States
facility: Southlight Healthcare
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Stacey Daughters, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paquette CE, Rubalcava DT, Chen Y, Anand D, Daughters SB. A Mobile App to Enhance Behavioral Activation Treatment for Substance Use Disorder: App Design, Use, and Integration Into Treatment in the Context of a Randomized Controlled Trial. JMIR Form Res. 2021 Nov 3;5(11):e25749. doi: 10.2196/25749.