Los Angeles, California 90025


Purpose:

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. 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 UCLA. 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.


Criteria:

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. DSM-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 is Available At:


Original ID:

1K23DA020085


NCT ID:

NCT01189799


Secondary ID:


Study Acronym:

Aftercare


Brief Title:

Motivational Therapy for Substance Users With Depression


Official Title:

Motivational Therapy for Substance Users With Depression


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Los Angeles


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

80


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Anne Bellows, MSW
310-267-5232
abellows@mednet.ucla.edu

Study Dates

Verification Date:August 2010
Last Changed Date:August 26, 2010
First Received Date:August 26, 2010

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Behavioral
Name:Motivational therapy
Description:Twelve, 60 minute weekly structured manualized therapy sessions.
Arm Name:Motivational Therapy Aftercare
Intervention Type:Other
Name:Dual Recovery Anonymous/Treatment as usual
Description:Twelve 60 minute weekly sessions of peer led 12-step Dual Recovery Anonymous group.
Arm Name:Dual Recovery Anonymous

Study Arms

Study Arm Type:Experimental
Arm Name:Motivational Therapy Aftercare
Study Arm Type:Other
Arm Name:Dual Recovery Anonymous
Description:Aftercare Treatment as Usual

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Los Angeles
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Drug Abuse (NIDA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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