Motivational Therapy for Substance Users With Depression

Study Overview
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Brief Summary
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The primary objective of the study is to test the incremental efficacy and outcomes of an aftercare program of Cognitive Behavioral Therapy combined with motivational therapy (CBT-MT) relative to treatment as usual (TAU) in improving depression, substance use, and healthcare outcomes in a population with drug dependence and comorbid major depressive disorder (MDD). The investigators expect that among drug-dependent patients with comorbid MDD, CBT-MT will yield better clinical outcomes relative to TAU in reducing depressive symptoms and substance use and improving healthcare outcomes during treatment. Secondary Objectives: Test efficacy and outcomes of CBT-MT and TAU Evaluate the differential effect of CBT-MT versus TAU on HIV-risk behavior of participants, To evaluate the impact of cognitive functioning on treatment retention and outcomes, and To explore additional psychosocial, demographic, and diagnostic factors (e.g., age, gender, education level, motivation for change, social support) that may be associated with treatment outcome and retention in this high need population.

Detailed Description
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This study will include approximately 80 participants randomized to either 12 weeks of motivational therapy or treatment as usual. Both treatments will meet once weekly for 60 minutes. Participants will be recruited from the Adult Partial Hospitalization program at University of California, Los Angeles. During the active treatment phase, participants will attend clinic weekly for collection of data and urine specimens. For those randomly assigned to CBT-MT, they will meet with a therapist in a group format for 60-minute sessions once weekly. a. Each CBT-MT session will begin with 20 minutes of motivational therapy (MT), followed by 40 minutes of CBT content. Those randomly assigned to TAU, they will attend a weekly 60-minute Dual Recovery Anonymous self-help group.

Official Title
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Motivational Therapy for Substance Users With Depression

Conditions
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Depression, Substance Dependence

Intervention / Treatment
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* Behavioral: Motivational therapy
* Behavioral: Dual Recovery Anonymous/Tx as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or over DSM-IV diagnosis of Substance Dependence (cannabis, stimulant, opioid, or prescription drug) or DSM-IV diagnosis of Alcohol Dependence and abuse of cannabis, stimulant, opioid, or prescription drug Diagnostic and Statistical Manual -IV diagnosis of lifetime Major Depressive Disorder (MDD) BDI-II score of 13 or greater Exclusion Criteria: Presence of life threatening or unstable medical illness Lack of proficiency in English Current homelessness (unless residing in a recovery home for which contact information can be provided) Psychiatric symptoms warranting safety concerns or inpatient treatment, including acute suicide risk Present diagnosis of Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder.

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Therapy Aftercare<br>Twelve, 60 minute weekly structured manualized therapy sessions. | Behavioral: Motivational therapy<br>* Twelve, 60 minute weekly structured manualized therapy sessions.<br>|
| Active Comparator: Dual Recovery Anonymous/Tx as usual<br>Aftercare Treatment as Usual,which is twelve 60 minute weekly sessions of peer led 12-step Dual Recovery Anonymous group. | Behavioral: Dual Recovery Anonymous/Tx as usual<br>* Twelve 60 minute weekly sessions of peer led 12-step Dual Recovery Anonymous group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Substance Use | Participants will provide a sample for a urine drug screen (UDS). Participants will also self report substance use. | weekly during active phase and through study completion, up to 6 months | 
| Change in Depression symptoms | -Participants will complete the Beck's Depression Inventory (BDI) to measure changes in depression symptoms over time. | weekly during intervention and through study completion, up to 6 months | 
| Change in Healthcare utilization | -Participants will self report use of ancillary treatment and healthcare services including ER visits and hospitalizations. | weekly and at follow up, up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and outcomes of CBT-MT and TAU | - Participants will complete the Addiction Severity Index to assess change in psychosocial functioning between baseline, end of treatment and follow up. | Baseline, end of treatment, and at follow up, up to 6 months | 
| HIV-risk behavior of participants | -Participants will complete the Risk Behavior Assessment (RBA) to measure effect of CBT-MT versus TAU on changes in HIV risk behaviors. | Baseline, end of treatment and follow up, up to 6 months | 
| Cognitive functioning | -Participants will complete the MicroCog and Wisconsin Card Sort Test impact of cognitive functioning on treatment retention and outcomes. | Baseline and end of treatment at 3 months post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Co-occurring Disorders, Depression, Substance Dependence, Motivational Therapy, Aftercare, Cognitive Behavioral Therapy