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Motivational Interviewing to Reduce Substance Use Among Depression Patients

Primary Purpose

Depression, Substance-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Control (brochure)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression focused on measuring Depression, Substance-Related Disorders, Mental Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente Medical Center Southern Alameda County

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motivational Interviewing

Control

Arm Description

The motivational interviewing (MI) intervention consisted of one 45-minute in-person MI session followed by two 15-minute telephone "booster" sessions

Participants received a brochure on alcohol and drug use risks.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
April 7, 2015
Last Updated
June 8, 2015
Sponsor
University of California, San Francisco
Collaborators
Kaiser Foundation Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02420561
Brief Title
Motivational Interviewing to Reduce Substance Use Among Depression Patients
Official Title
Motivational Interviewing to Reduce Substance Use Among Depression Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Kaiser Foundation Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Substance-Related Disorders
Keywords
Depression, Substance-Related Disorders, Mental Health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
307 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational Interviewing
Arm Type
Experimental
Arm Description
The motivational interviewing (MI) intervention consisted of one 45-minute in-person MI session followed by two 15-minute telephone "booster" sessions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants received a brochure on alcohol and drug use risks.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Control (brochure)
Intervention Description
Participants received a brochure on alcohol and drug use risks.
Primary Outcome Measure Information:
Title
Hazardous drinking in the prior 30 days (Self-reported number of days of hazardous drinking)
Description
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.
Time Frame
6 months
Title
Drug use in the prior 30 days (Self-reported number of days of drug use)
Description
Self-reported number of days of drug use (illegal drug use or misuse of prescription drugs) in the 30 prior days.
Time Frame
6 months
Title
Hazardous drinking in the prior 30 days (Self-reported number of days of hazardous drinking)
Description
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.
Time Frame
12 months
Title
Drug use in the prior 30 days (Self-reported number of days of drug use)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Depression symptoms (Patient health questionnaire (PHQ-9) score)
Description
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.
Time Frame
12 months
Title
Adequate mental health treatment (Number of participants receiving 12 weeks' continuous treatment at the Kaiser Permanente Outpatient Psychiatry Department)
Description
Number of participants receiving 12 weeks' continuous treatment at the Kaiser Permanente Outpatient Psychiatry Department
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek D Satre, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Medical Center Southern Alameda County
City
Union City
State/Province
California
ZIP/Postal Code
94545
Country
United States

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Motivational Interviewing to Reduce Substance Use Among Depression Patients

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