Technology Enhanced Behavioral Activation Treatment for Substance Use

Depressive Disorder Clinical Trial

Official title:

Technology Enhanced Behavioral Activation Treatment for Substance Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707887
• Other study ID #: 15-0815
• Secondary ID: R01DA026424
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2020

Study information

• Verified date: January 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Southlight Healthcare	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timeline Followback (TLFB)	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	Behavioral Activation for Depression Scale (BADS)	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.
Secondary	Reward Probability Index (RPI)	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.
Secondary	Beck Depression Inventory-II (BDI-II)	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
Secondary	Daily Goals Form	The Daily Goals Form is used to measure Treatment Engagement.	Baseline to a 3-months post treatment.
Secondary	Texas Christian University (TCU) HIV/AIDS Risk Assessment Form	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.
Secondary	Urinalysis	Urinalysis is a biological measure of substance use.	Urinalysis is assessed from post treatment to a 12-month follow up period
Secondary	Breathalyzer	Breathalyzer is a biological measure of alcohol use.	Breathalyzer will be assessed from baseline to a 12-month follow up period.
Secondary	Short Form Health Survey (SF-12)	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.