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Motivational Interviewing to Reduce Substance Use Among Depression Patients

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ClinicalTrials.gov Identifier: NCT02420561
Recruitment Status : Completed
First Posted : April 20, 2015
Last Update Posted : June 10, 2015
Sponsor:
Collaborator:
Kaiser Foundation Research Institute
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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 depression.

Condition or disease Intervention/treatment Phase
Depression Substance-Related Disorders Behavioral: Motivational Interviewing Behavioral: Control (brochure) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 307 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Motivational Interviewing to Reduce Substance Use Among Depression Patients
Study Start Date : October 2010
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Motivational Interviewing
The motivational interviewing (MI) intervention consisted of one 45-minute in-person MI session followed by two 15-minute telephone "booster" sessions
Behavioral: 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

Active Comparator: Control
Participants received a brochure on alcohol and drug use risks.
Behavioral: Control (brochure)
Participants received a brochure on alcohol and drug use risks.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Depression symptoms (Patient health questionnaire (PHQ-9) score) [ Time Frame: 12 months ]
    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.

  2. Adequate mental health treatment (Number of participants receiving 12 weeks' continuous treatment at the Kaiser Permanente Outpatient Psychiatry Department) [ Time Frame: 3 months ]
    Number of participants receiving 12 weeks' continuous treatment at the Kaiser Permanente Outpatient Psychiatry Department



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Current mania or psychosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02420561


Locations
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United States, California
Kaiser Permanente Medical Center Southern Alameda County
Union City, California, United States, 94545
Sponsors and Collaborators
University of California, San Francisco
Kaiser Foundation Research Institute
Investigators
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Principal Investigator: Derek D Satre, PhD University of California, San Francisco
Publications:
Substance 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
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC: American Psychiatric Association, 2000.
National 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
Satre DD, Wolfe W, Eisendrath S, et al. Alcohol and drug use in outpatient mental health: prevalence, motivation to reduce drinking, and impact on treatment retention. Annual meeting of the American Psychological Association, San Francisco, CA, Aug 19, 2007
National Institute on Alcohol Abuse and Alcoholism. Helping patients who drink too much: a clinician's guide, updated 2005 edition. Rockville, MD: National Institute on Alcohol Abuse and Alcoholism; 2005: http://pubs.niaaa.nih.gov/publications/Practitioner/CliniciansGuide2005/clinicians_guide.htm. Updated 2007 Jan. Accessed Jul
Helzer JE, Bucholz K, Robins LN. Five communities in the United States: results of the Epidemiologic Catchment Area study. In: Helzer JE, Canino GJ, eds. Alcoholism in North American, Europe, and Asia. New York: Oxford University Press, 1992:71-95
Substance Abuse and Mental Health Services Administration. National Household Survey on Drug Abuse: Population Estimates 1998. Vol H-11. Rockville, MD: Department of Health and Human Services, Office of Applied Studies, 1999
National Cannabis Prevention and Information Centre (NCPIC). Cannabis and prescribed medications. http://ncpic.org.au/ncpic/publications/factsheets/article/cannabis-and-prescribed-medications;. Published 2008. Accessed Sep 28, 2009
National Institute on Drug Abuse. Depression elevates suicide risk in substance-abusing adolescents. NIDA Notes. 2005;19(6). http://www.drugabuse.gov/NIDA_notes/NNvol19N6/Depression.html. Accessed Oct 15, 2009.
National Institute of Mental Health. Depression. http://www.nimh.nih.gov/publicat/depression.cfm. Published 2000. Updated 2006 Sep 13. Accessed 2007 Jan 8
National Institute of Mental Health. Medications. http://www.nimh.nih.gov/health/publications/medications/complete-publication.shtml#pub8. Published 2008. Accessed Oct 15, 2009.
Prochaska J, DiClemente C. Toward a comprehensive model of change. In: Miller W, Heather N, eds. Treating Addictive Behaviors: Processes of Change. New York: Plenum, 1984:3-27
Miller WR, Sanchez VC. Motivating young adults for treatment and lifestyle change. In: Howard GS, Nathan PE, eds. Alcohol Use and Misuse by Young Adults. Notra Dame, IN: University of Notre Dame Press, 1994:55-82
Janis IL, Mann L. Decision Making : A Psychological Analysis of Conflict, Choice, and Commitment New York: Free Press, 1977
Miller WR, Rollnick S. Motivational Interviewing: Preparing People for Change. 2nd ed. New York: Guilford Press, 2002
Satre DD, Sterling S, Weisner C. Treatment of alcohol and drug problems in older women. Women in Recovery: Kaiser Permanente Women's Chemical Dependency Committee Newsletter. 2007;Winter:1-2
Chi F, Weisner C. Continuity of care and costs among patients dually diagnosed with substance use disorders and parity psychiatric conditions in private managed care. Addiction Health Services Research Conference, Santa Monica, CA, Oct 25, 2005
Kaiser Permanente Northern California Dual Diagnosis Best Practices Committee. Recommendations for Improving Treatment of Co-Occurring Disorders. Oakland, Ca: Kaiser Permanente Medical Care Program; Sep 2007
Kaiser Permanente Care Management Institute. Depression clinical practice guidelines. http://www.guideline.gov/summary/summary.aspx?doc_id=9632&nbr=005152&string=kaiser. Published 2006. Accessed Jan 9, 2009
Beck AT, Rush AJ, Shaw BF, et al. Cognitive Therapy of Depression. New York: Guildford Press, 1979
Sobell LC, Sobell MB. Alcohol Consumption Measures. In: Allen JP, Wilson VB, eds. Assessing Alcohol Problems. A Guide for Clinicians and Researchers. 2nd ed. Bethesda, MD: National Institute on Alcohol Abuse and Alcoholism, 2003:75-100
National Institute on Drug Abuse. Screening for tobacco, alcohol and other drug use. http://www.drugabuse.gov/nidamed/screening/. Published 2009. Updated Sep 22, 2009. Accessed Oct 9, 2009

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02420561    
Other Study ID Numbers: 10-03323
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015
Keywords provided by University of California, San Francisco:
Depression
Substance-Related Disorders
Mental Health
Additional relevant MeSH terms:
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Substance-Related Disorders
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Chemically-Induced Disorders