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Motivational Interviews for Depression in Primary Care

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ClinicalTrials.gov Identifier: NCT01114334
Recruitment Status : Completed
First Posted : May 3, 2010
Results First Posted : April 20, 2017
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Denver Health and Hospital Authority

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Health Services Research
Condition Major Depression
Interventions Behavioral: Guideline-Based Medical Management
Behavioral: Motivational Interviewing for Depression
Enrollment 168
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Motivational Interviewing With Guideline-Based Management Standard Management of Depression
Hide Arm/Group Description

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.

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.
Period Title: Overall Study
Started 88 80
Completed 67 58
Not Completed 21 22
Arm/Group Title Motivational Interviewing With Guideline-Based Management Standard Management of Depression Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 88 80 168
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 80 participants 168 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
82
  93.2%
75
  93.8%
157
  93.5%
>=65 years
6
   6.8%
5
   6.3%
11
   6.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 80 participants 168 participants
Female
60
  68.2%
58
  72.5%
118
  70.2%
Male
28
  31.8%
22
  27.5%
50
  29.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 80 participants 168 participants
Hispanic or Latino
34
  38.6%
25
  31.3%
59
  35.1%
Not Hispanic or Latino
54
  61.4%
55
  68.8%
109
  64.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 80 participants 168 participants
American Indian or Alaska Native
3
   3.4%
4
   5.0%
7
   4.2%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
27
  30.7%
32
  40.0%
59
  35.1%
White
29
  33.0%
31
  38.8%
60
  35.7%
More than one race
13
  14.8%
5
   6.3%
18
  10.7%
Unknown or Not Reported
16
  18.2%
8
  10.0%
24
  14.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 88 participants 80 participants 168 participants
88 80 168
1.Primary Outcome
Title Depression Remission
Hide Description 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.
Time Frame 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Guideline-based Medical Management Motivational Interview With GBMM
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 58 67
Measure Type: Number
Unit of Measure: participants
4 15
2.Secondary Outcome
Title Adherence to Treatment With Antidepressant Medication
Hide Description 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.
Time Frame 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Guideline-based Medical Management Motivational Interview With GBMM
Hide Arm/Group Description:

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

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.

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.

Overall Number of Participants Analyzed 80 88
Measure Type: Count of Participants
Unit of Measure: Participants
11
  13.8%
15
  17.0%
3.Secondary Outcome
Title Patient Health Questionnaire-9 Instrument for Assessing Depressive Symptoms
Hide Description 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.
Time Frame 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Guideline-based Medical Management Motivational Interview With GBMM
Hide Arm/Group Description:

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

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.

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.

Overall Number of Participants Analyzed 58 67
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
11.66
(10.33 to 13.00)
9.16
(7.87 to 10.46)
Time Frame Up to 36 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Guideline-based Medical Management Motivational Interview With GBMM
Hide Arm/Group Description

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

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.

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.

All-Cause Mortality
Guideline-based Medical Management Motivational Interview With GBMM
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Guideline-based Medical Management Motivational Interview With GBMM
Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)   0/88 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Guideline-based Medical Management Motivational Interview With GBMM
Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)   0/88 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Robert D. Keeley
Organization: Denver Health and University of Colorado Denver
Phone: 303-602-8270
Responsible Party: Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT01114334     History of Changes
Other Study ID Numbers: K23MH082997 ( U.S. NIH Grant/Contract )
First Submitted: April 29, 2010
First Posted: May 3, 2010
Results First Submitted: October 17, 2016
Results First Posted: April 20, 2017
Last Update Posted: June 6, 2018