Overview

This trial is active, not recruiting.

Condition major depression
Treatments guideline-based medical management, motivational interviewing for depression
Phase phase 1
Sponsor Denver Health and Hospital Authority
Start date April 2010
End date December 2012
Trial size 167 participants
Trial identifier NCT01114334, K23MH082997

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, outcomes assessor)
Primary purpose health services research
Arm
(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
guideline-based medical management GBMM
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.
(Experimental)
Motivational Interviews combined with guideline-based medical management for depression
guideline-based medical management GBMM
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.
motivational interviewing for depression MI with GBMM
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.

Primary Outcomes

Measure
Depression remission
time frame: 6, 12 and 36 weeks
Depression remission
time frame: 6, 12 and 36 weeks

Secondary Outcomes

Measure
Adherence to treatment with antidepressant medication
time frame: 6, 12, and 36 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Motivational Interviews Adapted to Improve Depression Treatment in Primary Care
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Denver Health and Hospital Authority.