Motivational Therapy for Substance Users With Depression (Aftercare)

October 25, 2023 updated by: Suzette Glasner-Edwards, University of California, Los Angeles

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

  1. 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.

  2. Those randomly assigned to TAU, they will attend a weekly 60-minute Dual Recovery Anonymous self-help group.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • UCLA Integrated Substance Abuse Programs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 or over
  2. 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
  3. Diagnostic and Statistical Manual -IV diagnosis of lifetime Major Depressive Disorder (MDD)
  4. BDI-II score of 13 or greater

Exclusion Criteria:

  1. Presence of life threatening or unstable medical illness
  2. Lack of proficiency in English
  3. Current homelessness (unless residing in a recovery home for which contact information can be provided)
  4. Psychiatric symptoms warranting safety concerns or inpatient treatment, including acute suicide risk
  5. Present diagnosis of Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
weekly during active phase and through study completion, up to 6 months
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.
weekly during intervention and through study completion, up to 6 months
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.
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
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.
Baseline, end of treatment, and at follow up, up to 6 months
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.
Baseline, end of treatment and follow up, up to 6 months
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.
Baseline and end of treatment at 3 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Suzette Glasner, PhD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

August 26, 2010

First Submitted That Met QC Criteria

August 26, 2010

First Posted (Estimated)

August 27, 2010

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1K23DA020085 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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