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Completed

NCT Number: NCT02707887

Technology Enhanced Behavioral Activation Treatment for Substance Use

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.

Completed

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LETS ACT

Behavioral

The Life Enhancement Treatment for Substance Use (LETS ACT)

Other names: Behavioral Activation, Life Enhancement Treatment for Substance Use

LETS ACT-SE

Behavioral

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

Treatment as Usual

Behavioral

Participants will receive the treatment typically provided to patients at the substance use treatment facility.

Other names: TAU

Primary outcomes

  1. Timeline Followback (TLFB)

    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.

Secondary outcomes

  1. Behavioral Activation for Depression Scale (BADS)

    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

  2. Reward Probability Index (RPI)

    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.

  3. Beck Depression Inventory-II (BDI-II)

    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

  4. Daily Goals Form

    Time frame: Baseline to a 3-months post treatment.

    The Daily Goals Form is used to measure Treatment Engagement.

  5. Texas Christian University (TCU) HIV/AIDS Risk Assessment Form

    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

  6. Urinalysis

    Time frame: Urinalysis is assessed from post treatment to a 12-month follow up period

    Urinalysis is a biological measure of substance use.

  7. Breathalyzer

    Time frame: Breathalyzer will be assessed from baseline to a 12-month follow up period.

    Breathalyzer is a biological measure of alcohol use.

  8. Short Form Health Survey (SF-12)

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 14, 2016
Registry last updated
Oct 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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