Technology Enhanced Behavioral Activation Treatment for Substance Use

University of North Carolina (UNC)

Status: Completed

Conditions: Sexual Behavior; Substance-Related Disorders; Behavioral Symptoms; Risk-Taking; Depressive Disorder

Treatments: Behavioral: LETS ACT; Behavioral: LETS ACT-SE; Behavioral: Treatment as Usual

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02707887

15-0815

R01DA026424 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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206 participants in 3 patient groups, including a placebo group

Treatment as Usual

Placebo Comparator group

Description:

Patients are offered substance use group therapy including relapse prevention. They are also provided medical consultation on an ongoing basis as needed.

Treatment:

Behavioral: Treatment as Usual

LETS ACT

Active Comparator group

Description:

The Life Enhancement Treatment for Substance Use (LETS ACT) involves the discussion of the treatment rationale, identification of values and goals in various life areas and activities in line with chosen life areas, and training for patients to identify their cycle of negative mood and behavior using forms to track their daily goals.

Treatment:

Behavioral: Treatment as Usual

Behavioral: LETS ACT

LETS ACT-SE

Active Comparator group

Description:

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.

Treatment:

Behavioral: Treatment as Usual

Behavioral: LETS ACT-SE