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Motivational Interviews for Depression in Primary Care

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT01114334
First received: April 29, 2010
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Major Depression
Behavioral: Guideline-Based Medical Management
Behavioral: Motivational Interviewing for Depression
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Motivational Interviews Adapted to Improve Depression Treatment in Primary Care

Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome Measures:
  • Depression remission [ Time Frame: 6, 12 and 36 weeks ] [ Designated as safety issue: No ]
    The primary outcome is depression remission ascertained with the Patient Health Questionnaire-9. A score of less than 5 is considered to represent remission.

  • Depression remission [ Time Frame: 6, 12 and 36 weeks ] [ Designated as safety issue: No ]
    The primary outcome is depression remission ascertained with the Patient Health Questionnaire-9. A score of less than or equal to 5 is considered to represent remission.


Secondary Outcome Measures:
  • Adherence to treatment with antidepressant medication [ Time Frame: 6, 12, and 36 weeks ] [ Designated as safety issue: No ]
    Antidepressant Adherence will be measured with Computerized Pharmacy Records. Adherence will be operationalized as "non-persistence," or time to discontinuation. Non-persistence will be considered to have occurred if the days of medication supply from the previous prescription plus a 30-day grace period exceed the number of days between the previous prescription date and the current prescription fill date. Filling no prescriptions, 'initiation failure,' will be treated as non-persistence.


Enrollment: 167
Study Start Date: April 2010
Estimated Study Completion Date: May 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Guideline-based Medical Management

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
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.
Other Name: GBMM
Experimental: Motivational Interview with GBMM
Motivational Interviews combined with guideline-based medical management for depression
Behavioral: Guideline-Based Medical Management
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.
Other Name: GBMM
Behavioral: Motivational Interviewing for Depression
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.
Other Name: MI with GBMM

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. The subjects must have major depression as determined by diagnostic schedule.

Exclusion Criteria:

  1. 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).
  2. Current interpersonal or cognitive behavioral psychotherapy that focuses on depression.
  3. Female subjects who are either pregnant or nursing.
  4. Subjects with drug or alcohol dependency or abuse (except for nicotine or caffeine) within the preceding 6 months.
  5. High risk for suicide.\
  6. Inability to communicate in English.
  7. No personal telephone or homeless.
  8. Lifetime bipolar disorder.
  9. Psychosis.
  10. Subjects with a lifetime history of autism, mental retardation, or pervasive developmental disorders.
  11. Subjects with uncorrected hypothyroidism or hyperthyroidism.
  12. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114334

Locations
United States, Colorado
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
  More Information

No publications provided

Responsible Party: Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT01114334     History of Changes
Other Study ID Numbers: K23MH082997
Study First Received: April 29, 2010
Last Updated: March 27, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 27, 2014