Motivational Therapy for Substance Users With Depression

NCT01189799 | Completed DMC

• 1 other identifier: 1K23DA020085
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression; Substance Dependence

Keywords

Co-occurring Disorders; Depression; Substance Dependence; Motivational Therapy; Aftercare; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Efficacy and outcomes of CBT-MT and TAU

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

• HIV-risk behavior of participants

  Baseline, end of treatment and follow up, up to 6 months

• Cognitive functioning

  Baseline and end of treatment at 3 months post treatment

Study Arms (2)

Motivational Therapy Aftercare

EXPERIMENTAL

Twelve, 60 minute weekly structured manualized therapy sessions.

Behavioral: Motivational therapy

Dual Recovery Anonymous/Tx as usual

ACTIVE COMPARATOR

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

Interventions

Motivational therapy BEHAVIORAL

Twelve, 60 minute weekly structured manualized therapy sessions.

Motivational Therapy Aftercare

Dual Recovery Anonymous/Tx as usual BEHAVIORAL

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

Dual Recovery Anonymous/Tx as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UCLA Integrated Substance Abuse Programs

Los Angeles, California, 90025, United States

Location

MeSH Terms

Conditions

Depression; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Suzette Glasner, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: August 27, 2010
• Study Start: September 1, 2007
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: October 30, 2023

Record last verified: 2023-10

Locations

US (1)