DepressionAftercareNCT01189799
Motivational Therapy for Substance Users With Depression
A study testing Motivational therapy and Dual Recovery Anonymous/Tx as usual in people with Depression and Substance Dependence, run by University of California, Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Substance Dependence
- What is being tested?
- Motivational therapy and Dual Recovery Anonymous/Tx as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Integrated Substance Abuse Programs
Los Angeles, California, 90025
About this study
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:
- Test efficacy and outcomes of CBT-MT and TAU
- Evaluate the differential effect of CBT-MT versus TAU on HIV-risk behavior of participants,
- To evaluate the impact of cognitive functioning on treatment retention and outcomes, and
- 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.
Read the 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.
- For those randomly assigned to CBT-MT, they will meet with a therapist in a group format for 60-minute sessions once weekly.
- 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.
- Conditions
- Depression, Substance Dependence
- Being tested
- Motivational therapy, Dual Recovery Anonymous/Tx as usual
- Keywords
- Co-occurring Disorders, Depression, Substance Dependence, Motivational Therapy, Aftercare, Cognitive Behavioral Therapy
- Medical subject headings
- Depression, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational therapyBehavioural
Twelve, 60 minute weekly structured manualized therapy sessions.
Dual Recovery Anonymous/Tx as usualBehavioural
Twelve 60 minute weekly sessions of peer led 12-step Dual Recovery Anonymous group.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Therapy Aftercare | Experimental | Twelve, 60 minute weekly structured manualized therapy sessions. Receives: 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. Receives: Behavioral: Dual Recovery Anonymous/Tx as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Substance Use
- Participants will provide a sample for a urine drug screen (UDS).
- Participants will also self report substance use.
Measured: 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.
Measured: 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.
Measured: weekly and at follow up, up to 6 months
Secondary outcomes (3)
Efficacy and outcomes of CBT-MT and TAU
- Participants will complete the Addiction Severity Index to assess change in psychosocial functioning between baseline, end of treatment and follow up.
Measured: Baseline, end of treatment, and at follow up, up to 6 months
HIV-risk behavior of participants
-Participants will complete the Risk Behavior Assessment (RBA) to measure effect of CBT-MT versus TAU on changes in HIV risk behaviors.
Measured: Baseline, end of treatment and follow up, up to 6 months
Cognitive functioning
-Participants will complete the MicroCog and Wisconsin Card Sort Test impact of cognitive functioning on treatment retention and outcomes.
Measured: Baseline and end of treatment at 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startSep 2007
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Suzette Glasner-Edwards, University of California, Los Angeles
- Investigators
- Suzette Glasner, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189799
- Sponsor's protocol ID
- 1K23DA020085
- Other IDs
- 1K23DA020085
- Acronym
- Aftercare
- Status last verified
- Oct 2023
- First submitted
- 26 Aug 2010
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Therapy for Substance Users With Depression
- ClinicalTrials.gov ID
- NCT01189799
- Acronym / sponsor ID
- Aftercare / 1K23DA020085
- Conditions
- Depression, Substance Dependence
- Keywords
- Co-occurring Disorders, Depression, Substance Dependence, Motivational Therapy, Aftercare, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2007
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 27 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Test efficacy and outcomes of CBT-MT and TAU
- Evaluate the differential effect of CBT-MT versus TAU on HIV-risk behavior of participants,
- To evaluate the impact of cognitive functioning on treatment retention and outcomes, and
- 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.
- For those randomly assigned to CBT-MT, they will meet with a therapist in a group format for 60-minute sessions once weekly.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Therapy Aftercare | Experimental | Behavioral: Motivational therapyTwelve, 60 minute weekly structured manualized therapy sessions. |
| Dual Recovery Anonymous/Tx as usual | Active comparator | Behavioral: Dual Recovery Anonymous/Tx as usualAftercare Treatment as Usual,which is twelve 60 minute weekly sessions of peer led 12-step Dual Recovery Anonymous group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational therapyTwelve, 60 minute weekly structured manualized therapy sessions. | Behavioural | Motivational Therapy Aftercare |
| Dual Recovery Anonymous/Tx as usualTwelve 60 minute weekly sessions of peer led 12-step Dual Recovery Anonymous group. | Behavioural | Dual Recovery Anonymous/Tx as usual |
Primary outcome
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.
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.
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.
3 secondary outcomes
Efficacy and outcomes of CBT-MT and TAU
Time frame: 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
Cognitive functioning
Time frame: Baseline and end of treatment at 3 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzette Glasner, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational therapy and Dual Recovery Anonymous/Tx as usual in people with Depression and Substance Dependence, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Substance Use (time frame: weekly during active phase and through study completion, up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.