Clinical trial NCT01189799: Motivational Therapy for Substance Users With Depression
Official title: Motivational Therapy for Substance Users With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Substance Dependence
Keywords: Co-occurring Disorders
Depression
Substance Dependence
Motivational Therapy
Aftercare
Cognitive Behavioral Therapy
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-08-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

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.

Eligibility 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. 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.

Primary outcomes:
measure: Change in Substance Use
timeFrame: weekly during active phase and through study completion, up to 6 months
measure: Change in Depression symptoms
timeFrame: weekly during intervention and through study completion, up to 6 months
measure: Change in Healthcare utilization
timeFrame: weekly and at follow up, up to 6 months
Secondary outcomes:
measure: Efficacy and outcomes of CBT-MT and TAU
timeFrame: Baseline, end of treatment, and at follow up, up to 6 months
measure: HIV-risk behavior of participants
timeFrame: Baseline, end of treatment and follow up, up to 6 months
measure: Cognitive functioning
timeFrame: Baseline and end of treatment at 3 months post treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Integrated Substance Abuse Programs
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Suzette Glasner, PhD
role: PRINCIPAL_INVESTIGATOR
References: