Trial Outcomes & Findings for Motivational Interviews for Depression in Primary Care (NCT NCT01114334)

Last Updated: 2018-06-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

168 participants

Primary outcome timeframe

36 weeks

Results posted on

2018-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	Motivational Interviewing With Guideline-Based Management Intervention - MI with Standard Management of Depression The MI training approach included interactive learning for the core MI skills. An 8-hour classroom training on 7/25/09 consisted of a brief overview of MI, videos and discussion of core MI skills and "MI Spirit," as well as skill-building practice. At the providers' request, the research team distributed a pocket-sized, laminated treatment outline to MI trained providers for use at the point of service To optimize treatment integrity, 4-hour refresher sessions were offered after 4 and 12 months on 11/22/09 and 7/11/10. Over the first 14 months, the assistant trainer provided feedback via email and face-to face regarding audio-taped encounters (total two to four feedbacks per provider). In these sessions, the trainer also summarized MI skills demonstrated during the encounters and listed each patient's change talk statements. Providers were invited to respond and to choose which MI skill(s) they needed to improve.	Standard Management of Depression All providers randomized to either intervention or to control received a 1-hour slideshow and the "American Psychiatric Association Practice Guideline for the Treatment of Major Depressive Disorder" (APA depression guideline) (Gelenberg et al., 2010). The resources recommended antidepressant medications and psychotherapy as evidence-based treatments for depression.
Overall Study STARTED	88	80
Overall Study COMPLETED	67	58
Overall Study NOT COMPLETED	21	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Motivational Interviews for Depression in Primary Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Motivational Interviewing With Guideline-Based Management n=88 Participants Intervention - MI with Standard Management of Depression The MI training approach included interactive learning for the core MI skills. An 8-hour classroom training on 7/25/09 consisted of a brief overview of MI, videos and discussion of core MI skills and "MI Spirit," as well as skill-building practice. At the providers' request, the research team distributed a pocket-sized, laminated treatment outline to MI trained providers for use at the point of service To optimize treatment integrity, 4-hour refresher sessions were offered after 4 and 12 months on 11/22/09 and 7/11/10. Over the first 14 months, the assistant trainer provided feedback via email and face-to face regarding audio-taped encounters (total two to four feedbacks per provider). In these sessions, the trainer also summarized MI skills demonstrated during the encounters and listed each patient's change talk statements. Providers were invited to respond and to choose which MI skill(s) they needed to improve.	Standard Management of Depression n=80 Participants All providers randomized to either intervention or to control received a 1-hour slideshow and the "American Psychiatric Association Practice Guideline for the Treatment of Major Depressive Disorder" (APA depression guideline) (Gelenberg et al., 2010). The resources recommended antidepressant medications and psychotherapy as evidence-based treatments for depression.	Total n=168 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	82 Participants n=5 Participants	75 Participants n=7 Participants	157 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	58 Participants n=7 Participants	118 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	22 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	34 Participants n=5 Participants	25 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=5 Participants	55 Participants n=7 Participants	109 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	27 Participants n=5 Participants	32 Participants n=7 Participants	59 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	31 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	13 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	8 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment United States	88 participants n=5 Participants	80 participants n=7 Participants	168 participants n=5 Participants

PRIMARY outcome

Timeframe: 36 weeks

Population: We present clinical outcome (remission rate) at 36 weeks for all patient participants entering the study. 58 of 80 subjects assigned to Guideline-Based Medical Management, and 67 of 88 subjects assigned to Motivational Interview with Guideline-Based Medical Management had available data at 36 weeks (end of trial).

Outcome measures

Outcome measures
Measure	Guideline-based Medical Management n=58 Participants 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	Motivational Interview With GBMM n=67 Participants Motivational Interviews combined with guideline-based medical management for depression 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. 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
Depression Remission	4 participants	15 participants

SECONDARY outcome

Timeframe: 36 weeks

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. Minimally adequate persistence was defined as at least three 30-day fills of an antidepressant medication at a usual dose as defined in the American Psychiatric Association guideline without a 30-day gap in refills. The count of participants receiving minimally adequate persistence with antidepressant medication is reported for each study group.

Outcome measures

Outcome measures
Measure	Guideline-based Medical Management n=80 Participants 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	Motivational Interview With GBMM n=88 Participants Motivational Interviews combined with guideline-based medical management for depression 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. 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
Adherence to Treatment With Antidepressant Medication	11 Participants	15 Participants

SECONDARY outcome

Timeframe: 36 weeks

Depressive symptoms were measured with the Patient Health Questionnaire-9 (PHQ-9) instrument. The PHQ-9 is a nine item survey to assess depressive symptoms over the previous 2 weeks. The patient may answer "not at all" (scored as a 0) , "several days" (scored as a 1), "more than half the days" (scored as a 2), or "nearly every day" (scored as a 3) for each item. The range in total scores is from 0 (no depressive symptoms or best outcome) to 27 (severe depressive symptoms or worst outcome). For this randomized trial mean total scores are reported.

Outcome measures

Outcome measures
Measure	Guideline-based Medical Management n=58 Participants 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	Motivational Interview With GBMM n=67 Participants Motivational Interviews combined with guideline-based medical management for depression 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. 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
Patient Health Questionnaire-9 Instrument for Assessing Depressive Symptoms	11.66 units on a scale Interval 10.33 to 13.0	9.16 units on a scale Interval 7.87 to 10.46

Adverse Events

Guideline-based Medical Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Motivational Interview With GBMM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert D. Keeley

Denver Health and University of Colorado Denver

Phone: 303-602-8270

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place