Technology Enhanced Behavioral Activation Treatment for Substance Use

Study Overview
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Brief Summary
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The purpose of this study is to: test the effect of a smartphone enhanced LETS ACT (LETS ACT-SE) on frequency of substance use use functional magnetic resonance imaging (fMRI) to test the relationship between neuromarkers of reward sensitivity on frequency of substance use.

Detailed Description
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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.

Official Title
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Technology Enhanced Behavioral Activation Treatment for Substance Use

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

Intervention / Treatment
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* Behavioral: LETS ACT
* Behavioral: LETS ACT-SE
* Behavioral: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Treatment as Usual<br>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<br>* Participants will receive the treatment typically provided to patients at the substance use treatment facility.<br>* Other names: TAU;|
| Active Comparator: LETS ACT<br>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: LETS ACT<br>* The Life Enhancement Treatment for Substance Use (LETS ACT)<br>* Other names: Life Enhancement Treatment for Substance Use;Behavioral: Treatment as Usual<br>* Participants will receive the treatment typically provided to patients at the substance use treatment facility.<br>* Other names: TAU;|
| Active Comparator: LETS ACT-SE<br>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: LETS ACT-SE<br>* 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.<br>* Other names: Smartphone-Enhanced LETS ACT;Behavioral: Treatment as Usual<br>* Participants will receive the treatment typically provided to patients at the substance use treatment facility.<br>* Other names: TAU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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 | 
| Daily Goals Form | 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 | 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 | Urinalysis is a biological measure of substance use. | Urinalysis is assessed from post treatment to a 12-month follow up period | 
| Breathalyzer | 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) | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mental Disorders, Mood Disorders, Behavioral Activation