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Trial record 4 of 23 for:    0815

Technology Enhanced Behavioral Activation Treatment for Substance Use

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT02707887
First received: May 27, 2015
Last updated: June 1, 2016
Last verified: May 2016
  Purpose

The purpose of this study is to:

  1. determine if a smartphone enhanced treatment for LETS ACT (LETS ACT-SE) is associated with increased long term treatment engagement, and in turn, improved long term treatment outcomes, and
  2. use functional magnetic resonance imaging (fMRI) to identify the effects of LETS ACT-SE on the neuromarkers of reward sensitivity.

Condition Intervention Phase
Substance-Related Disorders
Depressive Disorder
Behavioral Symptoms
Risk-Taking
Sexual Behavior
Behavioral: LETS ACT
Behavioral: LETS ACT-SE
Behavioral: Treatment as Usual
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Technology Enhanced Behavioral Activation Treatment for Substance Use

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Timeline Followback (TLFB) [ Time Frame: TLFB will be assessed from baseline to a 12-month follow up period. ] [ Designated as safety issue: No ]
    The Time Line Follow Back is a self-report measure of drug and alcohol use.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Urinalysis is a biological measure of substance use.

  • Breathalyzer [ Time Frame: Breathalyzer will be assessed from baseline to a 12-month follow up period. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The Beck Depression Inventory is a 21-item self-report measure of depressive symptoms


Estimated Enrollment: 300
Study Start Date: January 2016
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02707887

Contacts
Contact: Stacey B Daughters, Ph.D. 919-962-9925 daughter@unc.edu

Locations
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-3270
Contact: Stacey B Daughters, Ph.D.    919-962-9924    daughter@unc.edu   
Principal Investigator: Stacey B Daughters, Ph.D.         
Southlight Healthcare Not yet recruiting
Raleigh, North Carolina, United States, 27604
Contact: Stacey Daughters       daughter@unc.edu   
Principal Investigator: Stacey B Daughters, Ph.D.         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Stacey Daughters, Ph.D. University of North Carolina
  More Information

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02707887     History of Changes
Other Study ID Numbers: 15-0815  R01DA026424 
Study First Received: May 27, 2015
Last Updated: June 1, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of North Carolina, Chapel Hill:
Mental Disorders
Mood Disorders
Behavioral Activation

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Substance-Related Disorders
Behavioral Symptoms
Pathologic Processes
Mood Disorders
Mental Disorders
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on December 09, 2016