Motivational Interviews for Depression in Primary Care

NCT01114334 | Completed Results DMC

• 1 other identifier: K23MH082997
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine whether motivational interviewing with guideline-based medical management for depression will significantly improve time to depression recovery and increase the proportion of subjects in recovery compared to guideline-based medical management alone over 9 months.

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

• Depression Remission

  The primary outcome is depression remission ascertained with the Patient Health Questionnaire-9. A score of less than 5 is considered to represent remission. The secondary clinical outcome is the continuous measure of depressive symptoms.

  36 weeks

Secondary Outcomes (2)

• Adherence to Treatment With Antidepressant Medication

  36 weeks

• Patient Health Questionnaire-9 Instrument for Assessing Depressive Symptoms

  36 weeks

Study Arms (2)

Guideline-based Medical Management

ACTIVE COMPARATOR

Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study. The evidence-based algorithm covers medical management of depression including indications for treatment, selection of initial therapy, starting dosages, dose escalation, switching or augmenting treatment, assessing efficacy, treatment goals and duration, a schedule of follow-up visits and referral indications

Behavioral: Guideline-Based Medical Management

Motivational Interview with GBMM

EXPERIMENTAL

Motivational Interviewing for Depression combined with guideline-based medical management for depression

Behavioral: Guideline-Based Medical Management; Behavioral: Motivational Interviewing for Depression

Interventions

Guideline-Based Medical Management BEHAVIORAL

We used the Colorado Clinical Guidelines Collaborative treatment guideline for Major Depression. It recommends treatment options e.g. specialty mental health counseling, antidepressant treatment, physical activity, depending upon presenting symptoms severity and other factors. The assessor notifies the clinician at the baseline visit about the patient's PHQ-9 depressive symptom severity score.

Also known as: GBMM

Guideline-based Medical Management; Motivational Interview with GBMM

Motivational Interviewing for Depression BEHAVIORAL

Intervention providers receive training to utilize Motivational Interviewing to frame discussions around depression, and to improve treatment uptake and treatment adherence for depression. Primary care providers are encouraged to apply MI to a broad conceptualization of 'treatment' including specialty mental health referral, antidepressant treatment, physical activity, and to targeting contributing factors e.g. loss of job or physical health problems.

Also known as: MI with GBMM

Motivational Interview with GBMM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and men aged 18 or older presenting at one of the seven DHH study clinics with a new treatment episode for depression will be considered for the study.
• The PHQ-9 is used to define depression category with a sensitivity and specificity for MDD of at least 88%. Patients must have PHQ-9≥10 to ensure sufficient severity to warrant intervention.
• A new treatment episode is defined as no treatment with an antidepressant medication for emotional problems over the previous 90 days, nor evidence-based psychotherapy for depression.
• The subjects must have major depression as determined by diagnostic schedule.

You may not qualify if:

• Receipt of an antidepressant medication in the previous 90 days other than a low-dose TCA for pain or Trazodone for sleep (e.g. amitriptyline ≤ 50 mg a day or Trazodone ≤ 100 mg at night).
• Current interpersonal or cognitive behavioral psychotherapy that focuses on depression.
• Female subjects who are either pregnant or nursing.
• Subjects with drug or alcohol dependency or abuse (except for nicotine or caffeine) within the preceding 6 months.
• High risk for suicide.
• Inability to communicate in English.
• No personal telephone or homeless.
• Lifetime bipolar disorder.
• Psychosis.
• Subjects with a lifetime history of autism, mental retardation, or pervasive developmental disorders.
• Subjects with uncorrected hypothyroidism or hyperthyroidism.
• Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead

Study Sites (1)

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Robert D. Keeley
• Organization: Denver Health and University of Colorado Denver

robert.keeley@dhha.org

303-602-8270

Study Officials

• Robert D Keeley, MD MSPH

  Denver Health and University of Colorado, Department of Family Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster Randomized Clinical Trial

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: May 3, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 6, 2018
• Results First Posted: April 20, 2017

Record last verified: 2018-05

Locations

US (1)