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Completed

NCT Number: NCT01189799

Motivational Therapy for Substance Users With Depression

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:

1. Test efficacy and outcomes of CBT-MT and TAU 2. Evaluate the differential effect of CBT-MT versus TAU on HIV-risk behavior of participants, 3. To evaluate the impact of cognitive functioning on treatment retention and outcomes, and 4. 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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Chemically-Induced Disorders Mental Disorders Substance Dependence Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Integrated Substance Abuse Programs

Los Angeles, California, 90025, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Motivational therapy

Behavioral

Twelve, 60 minute weekly structured manualized therapy sessions.

Dual Recovery Anonymous/Tx as usual

Behavioral

Twelve 60 minute weekly sessions of peer led 12-step Dual Recovery Anonymous group.

Primary outcomes

  1. Change in Substance Use

    Time frame: weekly during active phase and through study completion, up to 6 months

    • Participants will provide a sample for a urine drug screen (UDS).
    • Participants will also self report substance use.

  2. Change in Depression symptoms

    Time frame: weekly during intervention and through study completion, up to 6 months

    -Participants will complete the Beck's Depression Inventory (BDI) to measure changes in depression symptoms over time.

  3. Change in Healthcare utilization

    Time frame: weekly and at follow up, up to 6 months

    -Participants will self report use of ancillary treatment and healthcare services including ER visits and hospitalizations.

Secondary outcomes

  1. Efficacy and outcomes of CBT-MT and TAU

    Time frame: Baseline, end of treatment, and at follow up, up to 6 months

    • Participants will complete the Addiction Severity Index to assess change in psychosocial functioning between baseline, end of treatment and follow up.

  2. HIV-risk behavior of participants

    Time frame: Baseline, end of treatment and follow up, up to 6 months

    -Participants will complete the Risk Behavior Assessment (RBA) to measure effect of CBT-MT versus TAU on changes in HIV risk behaviors.

  3. Cognitive functioning

    Time frame: Baseline and end of treatment at 3 months post treatment

    -Participants will complete the MicroCog and Wisconsin Card Sort Test impact of cognitive functioning on treatment retention and outcomes.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: Aftercare

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Aug 27, 2010
Registry last updated
Oct 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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