Motivational Interviewing to Reduce Substance Use Among Depression Patients

Depression Clinical Trial

Official title:

Motivational Interviewing to Reduce Substance Use Among Depression Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02420561
• Other study ID #: 10-03323
• Status: Completed
• Phase: N/A
• First received: April 7, 2015
• Last updated: June 8, 2015
• Start date: October 2010
• Est. completion date: August 2014

Study information

• Verified date: June 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 depression.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Substance-Related Disorders

Intervention

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
• Control (brochure)
Participants received a brochure on alcohol and drug use risks.

Locations

Country	Name	City	State
United States	Kaiser Permanente Medical Center Southern Alameda County	Union City	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Kaiser Foundation Research Institute

Country where clinical trial is conducted

United States, 

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* Note: There are 245 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No