Technology Enhanced Behavioral Activation Treatment for Substance Use

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02707887
Study type	Interventional
Source	University of North Carolina, Chapel Hill
Contact
Status	Completed
Phase	N/A
Start date	January 2016
Completion date	December 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01316926` - Paxil CR Bioequivalence Study Brazil	Phase 1
Recruiting	`NCT06187454` - Transcranial Direct Current Stimulation for Depression	N/A
Completed	`NCT04469322` - Pharmacogenetic Implementation Trial in Veterans With Treatment Refractory Depression	N/A
Recruiting	`NCT05768126` - Prediction of ECT Treatment Response and Reduction of Cognitive Side-effects Using EEG and Rivastigmine	Phase 4
Completed	`NCT03219879` - Telephone-administered Relapse Prevention for Depression	N/A
Recruiting	`NCT06038721` - Unified Protocol: Community Connections	N/A
Completed	`NCT03043560` - Study to Treat Major Depressive Disorder With a New Medication	Phase 2
Completed	`NCT04091139` - Research of Unified Protocol for the Treatment of Common Mental Disorders in Adolescents in Hong Kong	Phase 2/Phase 3
Completed	`NCT00069459` - Seasonal Affective Depression (SAD) Study	Phase 1
Recruiting	`NCT05503966` - Combining Antidepressants and Attention Bias Modification in Depression	N/A
Recruiting	`NCT03001245` - Interpersonal Counseling (IPC) for Treatment of Depression in Adolescents	N/A
Completed	`NCT02939560` - TMS for Adults With Autism and Depression	N/A
Completed	`NCT02542891` - European Comparative Effectiveness Research on Internet-based Depression Treatment	N/A
Completed	`NCT02452892` - Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD)	N/A
Completed	`NCT02306551` - Well Being And Resilience: Mechanisms of Transmission of Health and Risk
Withdrawn	`NCT02238730` - Ultrabrief Right Unilateral and Brief Pulse Bitemporal Electroconvulsive Therapy	N/A
Completed	`NCT02224508` - Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks	N/A
Completed	`NCT01407575` - Buprenorphine for Treatment Resistant Depression	Phase 3
Completed	`NCT01597661` - Bupropion & Cardio Birth Defect (Slone)	N/A
Completed	`NCT01093053` - Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.