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Technology Enhanced Behavioral Activation Treatment for Substance Use

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ClinicalTrials.gov Identifier: NCT02707887
Recruitment Status : Completed
First Posted : March 14, 2016
Last Update Posted : October 16, 2023
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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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.

Condition or disease Intervention/treatment Phase
Substance-Related Disorders Depressive Disorder Behavioral Symptoms Risk-Taking Sexual Behavior Behavioral: LETS ACT Behavioral: LETS ACT-SE Behavioral: Treatment as Usual Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Technology Enhanced Behavioral Activation Treatment for Substance Use
Actual Study Start Date : January 2016
Actual Primary Completion Date : December 2020
Actual Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Treatment as Usual
Patients are offered substance use group therapy including relapse prevention. They are also provided medical consultation on an ongoing basis as needed.
 Behavioral: Treatment as Usual
Participants will receive the treatment typically provided to patients at the substance use treatment facility.
Other Name: TAU
Active Comparator: LETS ACT
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.
 Behavioral: LETS ACT
The Life Enhancement Treatment for Substance Use (LETS ACT)
Other Names:
  • Behavioral Activation
  • Life Enhancement Treatment for Substance Use

Behavioral: Treatment as Usual
Participants will receive the treatment typically provided to patients at the substance use treatment facility.
Other Name: TAU
Active Comparator: LETS ACT-SE
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.
 Behavioral: LETS ACT-SE
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

Behavioral: Treatment as Usual
Participants will receive the treatment typically provided to patients at the substance use treatment facility.
Other Name: TAU


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707887


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-3270
Southlight Healthcare
Raleigh, North Carolina, United States, 27604
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Stacey Daughters, Ph.D. University of North Carolina
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02707887    
Other Study ID Numbers: 15-0815
R01DA026424 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: October 16, 2023
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of North Carolina, Chapel Hill:
Mental Disorders
Mood Disorders
Behavioral Activation
Additional relevant MeSH terms:
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Substance-Related Disorders
Depressive Disorder
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Chemically-Induced Disorders