DepressionNCT02420561
Motivational Interviewing to Reduce Substance Use Among Depression Patients
A study testing Motivational Interviewing in people with Depression and Substance-Related Disorders, run by University of California, San Francisco at 1 site in United States.
Trial summary
The study aims to evaluate the effectiveness of an intervention to reduce alcohol and drug use and depression symptoms, improve functional status and promote appropriate health services utilization, in a sample of 300 adults seeking treatment for depression who also report hazardous drinking or drug use with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Substance-Related Disorders
- What is being tested?
- Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Aug 2014
- 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
- Hazardous drinking (i.e., ≥ 3 drinks in a day for women and ≥ 4 drinks in a day for men)
- Drug use (including any illicit drug use and non-prescribed use of prescription drugs in the prior 30 days)
- Moderate or greater symptoms of depression based on a score of ≥ 5 on the Patient Health Questionnaire (PHQ-9)
Who cannot join
- Current mania or psychosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Medical Center Southern Alameda County
Union City, California, 94545
About this study
The study aims to evaluate the effectiveness of an intervention to reduce alcohol and drug use and depression symptoms, improve functional status and promote appropriate health services utilization, in a sample of 300 adults seeking treatment for depression who also report hazardous drinking or drug use with depression.
Read the detailed description
This study addresses important questions regarding how to identify and treat patients in Psychiatry who present for services with alcohol or drug use that may exacerbate depression. The investigators propose a study of Brief Motivational Intervention (BMI) to reduce drug and alcohol use among patients with depression, and to enhance engagement with a Kaiser Chemical Dependency Recovery Program (CDRP) as needed. Patients with depression who use drugs or alcohol even at sub-diagnostic levels are at high risk for escalation of substance problems. BMI is an innovative, evidence-based approach that could decrease drug and alcohol use and improve outcomes. But it has not been tested among depression patients. This study sample will include 300 outpatients in treatment for depression in Kaiser Permanente Northern California Hayward/Fremont Psychiatry. Inclusion criteria are based on drug use (any illicit drug use and non-prescribed use of prescription drugs) and hazardous drinking (i.e., ≥ 3 drinks in a day for women and ≥ 4 drinks in a day for men), and moderate to severe depression symptoms at intake. Three hundred patients will be randomized to receive one in-person BMI session and two telephone BMI sessions within 6 weeks of intake (intervention) or a brochure on risks of drug and alcohol use (control). The investigators anticipate that the intervention will be effective in reducing frequency of drug use and hazardous drinking at 3-, 6-, and 12-month telephone follow-up interviews; improving mood and functional outcomes; increasing depression treatment retention (number of psychiatry visits, based on Healthcare Effectiveness Data and Information Set (HEDIS) standards); and facilitating patient initiation of chemical dependency program treatment if needed, and will be cost effective. For the improvement of patient care, it will also yield important information on integrating alcohol and drug intervention in Psychiatry and how best to help patients access specialty CDRP services when needed.
- Conditions
- Depression, Substance-Related Disorders
- Being tested
- Motivational Interviewing, Control (brochure)
- Keywords
- Depression, Substance-Related Disorders, Mental Health
- Medical subject headings
- Depression, Substance-Related Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
- One in-person motivational interviewing session intervention that lasts for 45-minutes
- Additional two 15-minute telephone "booster" sessions post in-person 45 minute sessions
Control (brochure)Behavioural
Participants received a brochure on alcohol and drug use risks.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Experimental | The motivational interviewing (MI) intervention consisted of one 45-minute in-person MI session followed by two 15-minute telephone "booster" sessions Receives: Behavioral: Motivational Interviewing |
| Control | Active comparator | Participants received a brochure on alcohol and drug use risks. Receives: Behavioral: Control (brochure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hazardous drinking in the prior 30 days (Self-reported number of days of hazardous drinking)
Self-reported number of days of hazardous drinking (3+ drinks per day for women / 4+ drinks per day for men) in the prior 30 days.
Measured: 6 months
Drug use in the prior 30 days (Self-reported number of days of drug use)
Self-reported number of days of drug use (illegal drug use or misuse of prescription drugs) in the 30 prior days.
Measured: 6 months
Hazardous drinking in the prior 30 days (Self-reported number of days of hazardous drinking)
Self-reported number of days of hazardous drinking (3+ drinks per day for women / 4+ drinks per day for men) in the prior 30 days. We examine the change between use at 6 months and use at 12 months to measure long term intervention impact.
Measured: 12 months
Drug use in the prior 30 days (Self-reported number of days of drug use)
Self-reported number of days of drug use (illegal drug use or misuse of prescription drugs) in the 30 prior days. We examine the change in use between 6 months and 12 months to measure long term intervention impact.
Measured: 12 months
Secondary outcomes (2)
Depression symptoms (Patient health questionnaire (PHQ-9) score)
measured at follow up telephone interviews.The PHQ-9 assesses frequency of 9 types of problems over the past 2 weeks; answers range from 0 (not at all) to 3 (nearly every day). If at least 4 of 9 are >0, the sum of item scores is used to indicate severity of depression: 1-4 Minimal; 5-9 Mild; 10-14 Moderate; 15-19 Moderately Severe; 20-27 Severe.
Measured: 12 months
Adequate mental health treatment (Number of participants receiving 12 weeks' continuous treatment at the Kaiser Permanente Outpatient Psychiatry Department)
Number of participants receiving 12 weeks' continuous treatment at the Kaiser Permanente Outpatient Psychiatry Department
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startOct 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (245)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Foundation Research Institute
- Responsible party
- Sponsor
- Investigators
- Derek D Satre, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420561
- Sponsor's protocol ID
- 10-03323
- Status last verified
- Jun 2015
- First submitted
- 7 Apr 2015
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Babor TF, McRee BG, Kassebaum PA, Grimaldi PL, Ahmed K, Bray J. Screening, Brief Intervention, and Referral to Treatment (SBIRT): toward a public health approach to the management of substance abuse. Subst Abus. 2007;28(3):7-30. doi: 10.1300/J465v28n03_03.
PubMed 18077300Madras BK, Compton WM, Avula D, Stegbauer T, Stein JB, Clark HW. Screening, brief interventions, referral to treatment (SBIRT) for illicit drug and alcohol use at multiple healthcare sites: comparison at intake and 6 months later. Drug Alcohol Depend. 2009 Jan 1;99(1-3):280-95. doi: 10.1016/j.drugalcdep.2008.08.003. Epub 2008 Oct 16.
PubMed 18929451Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment. Screening, brief intervention, and referral to treatment. What is SBIRT? . http://sbirt.samhsa.gov/index.htm. Published 2008. Accessed September 1, 2009
Carroll KM, Ball SA, Nich C, Martino S, Frankforter TL, Farentinos C, Kunkel LE, Mikulich-Gilbertson SK, Morgenstern J, Obert JL, Polcin D, Snead N, Woody GE; National Institute on Drug Abuse Clinical Trials Network. Motivational interviewing to improve treatment engagement and outcome in individuals seeking treatment for substance abuse: a multisite effectiveness study. Drug Alcohol Depend. 2006 Feb 28;81(3):301-12. doi: 10.1016/j.drugalcdep.2005.08.002. Epub 2005 Sep 28.
PubMed 16169159Carroll KM, Libby B, Sheehan J, Hyland N. Motivational interviewing to enhance treatment initiation in substance abusers: an effectiveness study. Am J Addict. 2001 Fall;10(4):335-9. doi: 10.1080/aja.10.4.335.339.
PubMed 11783748Dunn C, Deroo L, Rivara FP. The use of brief interventions adapted from motivational interviewing across behavioral domains: a systematic review. Addiction. 2001 Dec;96(12):1725-42. doi: 10.1046/j.1360-0443.2001.961217253.x.
PubMed 11784466American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC: American Psychiatric Association, 2000.
McCabe SE, West BT, Morales M, Cranford JA, Boyd CJ. Does early onset of non-medical use of prescription drugs predict subsequent prescription drug abuse and dependence? Results from a national study. Addiction. 2007 Dec;102(12):1920-30. doi: 10.1111/j.1360-0443.2007.02015.x. Epub 2007 Oct 4.
PubMed 17916222Zahradnik A, Otto C, Crackau B, Lohrmann I, Bischof G, John U, Rumpf HJ. Randomized controlled trial of a brief intervention for problematic prescription drug use in non-treatment-seeking patients. Addiction. 2009 Jan;104(1):109-17. doi: 10.1111/j.1360-0443.2008.02421.x.
PubMed 19133895Weingartner K, Robison J, Fogel D, Gruman C. Depression and substance use in a middle aged and older Puerto Rican population. J Cross Cult Gerontol. 2002;17(2):173-93. doi: 10.1023/a:1015861002809.
PubMed 14617972Compton WM, Volkow ND. Abuse of prescription drugs and the risk of addiction. Drug Alcohol Depend. 2006 Jun;83 Suppl 1:S4-7. doi: 10.1016/j.drugalcdep.2005.10.020. Epub 2006 Mar 23.
PubMed 16563663Weisner C, McLellan AT, Hunkeler EM. Addiction severity index data from general membership and treatment samples of HMO members. One case of norming the ASI. J Subst Abuse Treat. 2000 Sep;19(2):103-9. doi: 10.1016/s0740-5472(99)00103-8.
PubMed 10963921Braden JB, Sullivan MD, Ray GT, Saunders K, Merrill J, Silverberg MJ, Rutter CM, Weisner C, Banta-Green C, Campbell C, Von Korff M. Trends in long-term opioid therapy for noncancer pain among persons with a history of depression. Gen Hosp Psychiatry. 2009 Nov-Dec;31(6):564-70. doi: 10.1016/j.genhosppsych.2009.07.003. Epub 2009 Aug 27.
PubMed 19892215Weisner CM, Campbell CI, Ray TG, Saunders K, Merrill JO, Banta-Green C, Sullivan MD, Silverberg MJ, Mertens JR, Boudreau D, Von Korff M. Trends in prescribed opioid therapy for non-cancer pain for individuals with prior substance use disorders. Pain. 2009 Oct;145(3):287-293. doi: 10.1016/j.pain.2009.05.006. Epub 2009 Jul 5.
PubMed 19581051National Institute on Drug Abuse. NM Assist: Screening for drug use in general medical settings. http://ww1.drugabuse.gov/nmassist/. Published 2009. Updated Sep 17, 2009. Accessed Oct 8, 2009
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing to Reduce Substance Use Among Depression Patients
- ClinicalTrials.gov ID
- NCT02420561
- Acronym / sponsor ID
- 10-03323
- Conditions
- Depression, Substance-Related Disorders
- Keywords
- Depression, Substance-Related Disorders, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Kaiser Foundation Research Institute
- Study start
- Oct 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 Apr 2015 (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 study aims to evaluate the effectiveness of an intervention to reduce alcohol and drug use and depression symptoms, improve functional status and promote appropriate health services utilization, in a sample of 300 adults seeking treatment for depression who also report hazardous drinking or drug use with depression.
Detailed description
This study addresses important questions regarding how to identify and treat patients in Psychiatry who present for services with alcohol or drug use that may exacerbate depression. The investigators propose a study of Brief Motivational Intervention (BMI) to reduce drug and alcohol use among patients with depression, and to enhance engagement with a Kaiser Chemical Dependency Recovery Program (CDRP) as needed. Patients with depression who use drugs or alcohol even at sub-diagnostic levels are at high risk for escalation of substance problems. BMI is an innovative, evidence-based approach that could decrease drug and alcohol use and improve outcomes. But it has not been tested among depression patients. This study sample will include 300 outpatients in treatment for depression in Kaiser Permanente Northern California Hayward/Fremont Psychiatry. Inclusion criteria are based on drug use (any illicit drug use and non-prescribed use of prescription drugs) and hazardous drinking (i.e., ≥ 3 drinks in a day for women and ≥ 4 drinks in a day for men), and moderate to severe depression symptoms at intake. Three hundred patients will be randomized to receive one in-person BMI session and two telephone BMI sessions within 6 weeks of intake (intervention) or a brochure on risks of drug and alcohol use (control). The investigators anticipate that the intervention will be effective in reducing frequency of drug use and hazardous drinking at 3-, 6-, and 12-month telephone follow-up interviews; improving mood and functional outcomes; increasing depression treatment retention (number of psychiatry visits, based on Healthcare Effectiveness Data and Information Set (HEDIS) standards); and facilitating patient initiation of chemical dependency program treatment if needed, and will be cost effective. For the improvement of patient care, it will also yield important information on integrating alcohol and drug intervention in Psychiatry and how best to help patients access specialty CDRP services when needed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Behavioral: Motivational InterviewingThe motivational interviewing (MI) intervention consisted of one 45-minute in-person MI session followed by two 15-minute telephone "booster" sessions |
| Control | Active comparator | Behavioral: Control (brochure)Participants received a brochure on alcohol and drug use risks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hazardous drinking (i.e., ≥ 3 drinks in a day for women and ≥ 4 drinks in a day for men)
- Drug use (including any illicit drug use and non-prescribed use of prescription drugs in the prior 30 days)
- Moderate or greater symptoms of depression based on a score of ≥ 5 on the Patient Health Questionnaire (PHQ-9)
Key exclusion criteria (1 listed)
- Current mania or psychosis
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 Interviewing* One in-person motivational interviewing session intervention that lasts for 45-minutes * Additional two 15-minute telephone "booster" sessions post in-person 45 minute sessions | Behavioural | Motivational Interviewing |
| Control (brochure)Participants received a brochure on alcohol and drug use risks. | Behavioural | Control |
Primary outcome
Hazardous drinking in the prior 30 days (Self-reported number of days of hazardous drinking)
Time frame: 6 months
Self-reported number of days of hazardous drinking (3+ drinks per day for women / 4+ drinks per day for men) in the prior 30 days.
Drug use in the prior 30 days (Self-reported number of days of drug use)
Time frame: 6 months
Self-reported number of days of drug use (illegal drug use or misuse of prescription drugs) in the 30 prior days.
Hazardous drinking in the prior 30 days (Self-reported number of days of hazardous drinking)
Time frame: 12 months
Self-reported number of days of hazardous drinking (3+ drinks per day for women / 4+ drinks per day for men) in the prior 30 days. We examine the change between use at 6 months and use at 12 months to measure long term intervention impact.
Drug use in the prior 30 days (Self-reported number of days of drug use)
Time frame: 12 months
Self-reported number of days of drug use (illegal drug use or misuse of prescription drugs) in the 30 prior days. We examine the change in use between 6 months and 12 months to measure long term intervention impact.
2 secondary outcomes
Depression symptoms (Patient health questionnaire (PHQ-9) score)
Time frame: 12 months
Adequate mental health treatment (Number of participants receiving 12 weeks' continuous treatment at the Kaiser Permanente Outpatient Psychiatry Department)
Time frame: 3 months
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 10 Jun 2015.
- Background: PubMed 18077300Babor TF, McRee BG, Kassebaum PA, Grimaldi PL, Ahmed K, Bray J. Screening, Brief Intervention, and Referral to Treatment (SBIRT): toward a public health approach to the management of substance abuse. Subst Abus. 2007;28(3):7-30. doi: 10.1300/J465v28n03_03.
- Background: PubMed 18929451Madras BK, Compton WM, Avula D, Stegbauer T, Stein JB, Clark HW. Screening, brief interventions, referral to treatment (SBIRT) for illicit drug and alcohol use at multiple healthcare sites: comparison at intake and 6 months later. Drug Alcohol Depend. 2009 Jan 1;99(1-3):280-95. doi: 10.1016/j.drugalcdep.2008.08.003. Epub 2008 Oct 16.
- BackgroundSubstance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment. Screening, brief intervention, and referral to treatment. What is SBIRT? . http://sbirt.samhsa.gov/index.htm. Published 2008. Accessed September 1, 2009
- Background: PubMed 16169159Carroll KM, Ball SA, Nich C, Martino S, Frankforter TL, Farentinos C, Kunkel LE, Mikulich-Gilbertson SK, Morgenstern J, Obert JL, Polcin D, Snead N, Woody GE; National Institute on Drug Abuse Clinical Trials Network. Motivational interviewing to improve treatment engagement and outcome in individuals seeking treatment for substance abuse: a multisite effectiveness study. Drug Alcohol Depend. 2006 Feb 28;81(3):301-12. doi: 10.1016/j.drugalcdep.2005.08.002. Epub 2005 Sep 28.
- Background: PubMed 11783748Carroll KM, Libby B, Sheehan J, Hyland N. Motivational interviewing to enhance treatment initiation in substance abusers: an effectiveness study. Am J Addict. 2001 Fall;10(4):335-9. doi: 10.1080/aja.10.4.335.339.
- Background: PubMed 11784466Dunn C, Deroo L, Rivara FP. The use of brief interventions adapted from motivational interviewing across behavioral domains: a systematic review. Addiction. 2001 Dec;96(12):1725-42. doi: 10.1046/j.1360-0443.2001.961217253.x.
- BackgroundAmerican Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC: American Psychiatric Association, 2000.
- Background: PubMed 17916222McCabe SE, West BT, Morales M, Cranford JA, Boyd CJ. Does early onset of non-medical use of prescription drugs predict subsequent prescription drug abuse and dependence? Results from a national study. Addiction. 2007 Dec;102(12):1920-30. doi: 10.1111/j.1360-0443.2007.02015.x. Epub 2007 Oct 4.
- Background: PubMed 19133895Zahradnik A, Otto C, Crackau B, Lohrmann I, Bischof G, John U, Rumpf HJ. Randomized controlled trial of a brief intervention for problematic prescription drug use in non-treatment-seeking patients. Addiction. 2009 Jan;104(1):109-17. doi: 10.1111/j.1360-0443.2008.02421.x.
- Background: PubMed 14617972Weingartner K, Robison J, Fogel D, Gruman C. Depression and substance use in a middle aged and older Puerto Rican population. J Cross Cult Gerontol. 2002;17(2):173-93. doi: 10.1023/a:1015861002809.
- Background: PubMed 16563663Compton WM, Volkow ND. Abuse of prescription drugs and the risk of addiction. Drug Alcohol Depend. 2006 Jun;83 Suppl 1:S4-7. doi: 10.1016/j.drugalcdep.2005.10.020. Epub 2006 Mar 23.
- Background: PubMed 10963921Weisner C, McLellan AT, Hunkeler EM. Addiction severity index data from general membership and treatment samples of HMO members. One case of norming the ASI. J Subst Abuse Treat. 2000 Sep;19(2):103-9. doi: 10.1016/s0740-5472(99)00103-8.
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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.
Derek D Satre, PhD principal investigator
University of California, San Francisco
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 Interviewing in people with Depression and Substance-Related Disorders, run by University of California, San Francisco 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 3 inclusion and 1 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 10 Jun 2015. 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?
Hazardous drinking in the prior 30 days (Self-reported number of days of hazardous drinking) (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02420561, which also lists 245 linked publications.
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 10 Jun 2015.