Motivational Interviewing to Reduce Substance Use Among Depression Patients

Study Overview
=================
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.

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.

Official Title
-----------------
Motivational Interviewing to Reduce Substance Use Among Depression Patients

Conditions
-----------------
Depression, Substance-Related Disorders

Intervention / Treatment
-----------------
* Behavioral: Motivational Interviewing
* Behavioral: Control (brochure)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Interviewing<br>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<br>* 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<br>|
| Active Comparator: Control<br>Participants received a brochure on alcohol and drug use risks. | Behavioral: Control (brochure)<br>* Participants received a brochure on alcohol and drug use risks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Substance-Related Disorders, Mental Health