Technology Enhanced Behavioral Activation Treatment for Substance Use

October 13, 2023 updated by: University of North Carolina, Chapel Hill

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-3270
        • University of North Carolina at Chapel Hill
      • Raleigh, North Carolina, United States, 27604
        • Southlight Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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: Treatment as Usual
Participants will receive the treatment typically provided to patients at the substance use treatment facility.
Other Names:
  • TAU
Behavioral: LETS ACT
The Life Enhancement Treatment for Substance Use (LETS ACT)
Other Names:
  • Behavioral Activation
  • Life Enhancement Treatment for Substance Use
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: Treatment as Usual
Participants will receive the treatment typically provided to patients at the substance use treatment facility.
Other Names:
  • TAU
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
TLFB will be assessed from baseline to a 12-month follow up period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
BADS will be assessed from baseline to a 12-month follow up period.
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.
RPI will be assessed from baseline to a 12-month follow up period.
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
BDI-II will be evaluated from baseline to a 12-month follow up period
Daily Goals Form
Time Frame: Baseline to a 3-months post treatment.
The Daily Goals Form is used to measure Treatment Engagement.
Baseline to a 3-months post treatment.
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
TCU will be assessed from baseline to a 12-month follow up period.
Urinalysis
Time Frame: Urinalysis is assessed from post treatment to a 12-month follow up period
Urinalysis is a biological measure of substance use.
Urinalysis is assessed from post treatment to a 12-month follow up period
Breathalyzer
Time Frame: Breathalyzer will be assessed from baseline to a 12-month follow up period.
Breathalyzer is a biological measure of alcohol use.
Breathalyzer will be assessed from baseline to a 12-month follow up period.
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.
SF-12 will be assessed from baseline to a 12-month follow up period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

May 27, 2015

First Submitted That Met QC Criteria

March 11, 2016

First Posted (Estimated)

March 14, 2016

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 13, 2023

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-0815
  • R01DA026424 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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