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Completed

NCT Number: NCT02420561

Motivational Interviewing to Reduce Substance Use Among Depression Patients

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Chemically-Induced Disorders Mental Disorders Personal Satisfaction Psychological Well-Being Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Medical Center Southern Alameda County

Union City, California, 94545, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interviewing

Behavioral
  • 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)

Behavioral

Participants received a brochure on alcohol and drug use risks.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Kaiser Foundation Research Institute

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Apr 20, 2015
Registry last updated
Jun 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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