Technology Enhanced Behavioral Activation Treatment for Substance Use

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

Tracking Information

• First Submitted Date: May 27, 2015
• First Posted Date: March 14, 2016
• Last Update Posted Date: October 16, 2023
• Actual Study Start Date: January 2016
• Actual Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 11, 2016)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 15, 2018)

• 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
• 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.
• 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
• Daily Goals Form [ Time Frame: Baseline to a 3-months post treatment. ]
  The Daily Goals Form is used to measure Treatment Engagement.
• 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
• Urinalysis [ Time Frame: Urinalysis is assessed from post treatment to a 12-month follow up period ]
  Urinalysis is a biological measure of substance use.
• Breathalyzer [ Time Frame: Breathalyzer will be assessed from baseline to a 12-month follow up period. ]
  Breathalyzer is a biological measure of alcohol use.
• 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.

Original Secondary Outcome Measures (submitted: March 11, 2016)

• Psychiatric Research Interview for Substance and Mental Disorders (PRISM-5) [ Time Frame: PRISM will be assessed from baseline to a 12-month follow up period. ]
  The PRISM is a diagnostic interview with subscales that will be used to screen for psychosis and assess lifetime and current DSM-5 Axis-I psychopathology
• 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.
• 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
• Daily Goals Form [ Time Frame: Daily Goals Forms will be assessed on an ongoing basis between baseline to a 12-month follow up period. ]
  The Daily Goals Form is used to measure Treatment Engagement.
• 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.
• 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
• Drug Use History Questionnaire (DUQ) [ Time Frame: DUQ will be assessed once at baseline. ]
  The DUQ is a 12-item self-report measure used to determine lifetime and past year substance use history.
• Urinalysis [ Time Frame: Urinalysis is assessed from post treatment to a 12-month follow up period ]
  Urinalysis is a biological measure of substance use.
• Breathalyzer [ Time Frame: Breathalyzer will be assessed from baseline to a 12-month follow up period. ]
  Breathalyzer is a biological measure of alcohol use.
• 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Technology Enhanced Behavioral Activation Treatment for Substance Use
• Official Title: Technology Enhanced Behavioral Activation Treatment for Substance Use

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Substance-Related Disorders
• Depressive Disorder
• Behavioral Symptoms
• Risk-Taking
• Sexual Behavior

Intervention

• Behavioral: LETS ACT
  The Life Enhancement Treatment for Substance Use (LETS ACT)
  Other Names:

  • Behavioral Activation
  • Life Enhancement Treatment for Substance Use
• 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

Study Arms

• 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.
  Intervention: Behavioral: Treatment as Usual
• 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.
  Interventions:

  • Behavioral: LETS ACT
  • Behavioral: Treatment as Usual
• 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.
  Interventions:

  • Behavioral: LETS ACT-SE
  • Behavioral: Treatment as Usual

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 13, 2019): 206
• Original Estimated Enrollment (submitted: March 11, 2016): 300
• Actual Study Completion Date: December 2020
• Actual Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02707887
• Other Study ID Numbers: 15-0815; R01DA026424 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of North Carolina, Chapel Hill
• Original Responsible Party: Same as current
• Current Study Sponsor: University of North Carolina, Chapel Hill
• Original Study Sponsor: Same as current
• Collaborators: National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Stacey Daughters, Ph.D.; University of North Carolina

• PRS Account: University of North Carolina, Chapel Hill
• Verification Date: January 2021