Technology Enhanced Behavioral Activation Treatment for Substance Use

Not Applicable

Completed

• Conditions: Risk-Taking; Substance-Related Disorders; Behavioral Symptoms; Depressive Disorder; Sexual Behavior
• Interventions: Behavioral: LETS ACT; Behavioral: LETS ACT-SE; Behavioral: Treatment as Usual

• Registration Number: NCT02707887
• Lead Sponsor: University of North Carolina, Chapel Hill

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 Timeline

• Study First Submitted: 2015-05-27
• Study Start: 2016-01
• Study First Submitted QC: 2016-03-11
• Study First Posted: 2016-03-14
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2021-01
• Last Update Submitted: 2023-10-13
• Last Update Posted: 2023-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LETS ACT	Treatment as Usual	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.
Treatment as Usual	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.
LETS ACT	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.
LETS ACT-SE	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.
LETS ACT-SE	Treatment as Usual	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.

Primary Outcome Measures

Name	Time	Method
Timeline Followback (TLFB)	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

Name	Time	Method
Behavioral Activation for Depression Scale (BADS)	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)	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)	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	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	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	Urinalysis is assessed from post treatment to a 12-month follow up period	Urinalysis is a biological measure of substance use.
Short Form Health Survey (SF-12)	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.
Breathalyzer	Breathalyzer will be assessed from baseline to a 12-month follow up period.	Breathalyzer is a biological measure of alcohol use.

Trial Locations

Locations (2)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Southlight Healthcare; 🇺🇸 Raleigh, North Carolina, United States