Technology Enhanced Behavioral Activation Treatment for Substance Use

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Depression Treatment for Low Income Substance Users

NCT01189552

Substance Use Disorder

COMPLETED NA

Behavioral Depression Treatment for African American HIV-infected Substance Users

NCT01351454

Depression Substance Use

COMPLETED NA

Development and Validation of Learning and Decision-Making Tasks

NCT05707806

Normal Physiology

RECRUITING

Socializing a Science-Based Digital Therapeutic for Substance Use Disorders

NCT05648786

Substance Use Disorders Substance-Related Disorders

ACTIVE_NOT_RECRUITING NA

EEG/Event-related Brain Potential Risk Markers as Predictors and Outcomes of SUD Treatment in Adolescents

NCT02016378

Alcohol Use Disorder

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type PLACEBO_COMPARATOR

Treatment as Usual

Intervention Type BEHAVIORAL

Participants will receive the treatment typically provided to patients at the substance use treatment facility.

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.

Group Type ACTIVE_COMPARATOR

LETS ACT

Intervention Type BEHAVIORAL

The Life Enhancement Treatment for Substance Use (LETS ACT)

Treatment as Usual

Intervention Type BEHAVIORAL

Participants will receive the treatment typically provided to patients at the substance use treatment facility.

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.

Group Type ACTIVE_COMPARATOR

LETS ACT-SE

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Participants will receive the treatment typically provided to patients at the substance use treatment facility.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LETS ACT

The Life Enhancement Treatment for Substance Use (LETS ACT)

Intervention Type 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.

Intervention Type BEHAVIORAL

Treatment as Usual

Participants will receive the treatment typically provided to patients at the substance use treatment facility.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Behavioral Activation Life Enhancement Treatment for Substance Use Behavioral Activation Smartphone-Enhanced LETS ACT TAU

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No