Effects of Adding Motivational Interviewing to Antidepressant Treatment for Hispanic Adults With Depression

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00564278
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 217
• Location: 1
• Arms: 2
• Duration (Months): 66
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

This study will evaluate the effectiveness of adding motivational interviewing to antidepressant treatment for major depressive disorder in Hispanic adults.

Condition or Disease	Intervention/Treatment	Phase
Depression	Drug: Standard antidepressant therapy (SADT); Behavioral: Motivational antidepressant therapy (MADT)	N/A

Detailed Description

Depression is a serious illness that affects a person's mood, thoughts, and physical well-being. There are multiple types of depressive disorders, with major depressive disorder being one of the most common. The following symptoms may be signs of major depression: persistent feelings of anxiety, guilt, or hopelessness; irregular sleep and appetite patterns; lethargy; disinterest in previously enjoyed activities; excessive irritability and restlessness; suicidal thoughts; and inability to concentrate. Despite the widespread use of drug treatment for major depression in the United States, it continues to be underutilized in the Hispanic population. The retention rate in antidepressant therapy (ADT) among the Hispanic population is half that of the Caucasian population. It is believed that cultural factors and ambivalence toward seeking treatment interfere with ADT retention in Hispanic adults. Motivational antidepressant therapy (MADT) involves the use of motivational interviewing (MI) to discuss treatment with patients. This study will compare the effectiveness of culturally-specific MADT versus standard antidepressant therapy (SADT) in treating Hispanic adults with major depression.

Participants in this single-blind study will be randomly assigned to receive either MADT or SADT. A psychiatrist will conduct all medication visits and will recommend an initial antidepressant for each participant. Depending on treatment assignment, psychiatrists will use either the MADT or SADT approach in the medication visits. During the visits, participants will complete questionnaires, undergo vital sign measurements, and receive medication. Medication visits will occur weekly during the first two weeks, every 2 weeks for the next 6 weeks, and then on a monthly basis until the end of the study. In addition to visits with the psychiatrist, participants will complete 15-minute individual interviews with a clinician from the Hispanic Treatment Program. Individual interviews will take place every 2 weeks in the first month of treatment, monthly until the third month, and then every other month thereafter. The association between treatment, retention, and response will be assessed after 3 months of treatment. Preliminary outcome data will be obtained after 6 more months of continued treatment. After the end of treatment, participants may randomly be asked to participate in a small "focus group" to discuss personal experiences with study treatments.

Study Design

• Study Type: Interventional
• Actual Enrollment: 217 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Motivational Antidepressant Therapy for Hispanics
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard antidepressant therapy Participants will receive standard antidepressant therapy, including selecting among 9 FDA-approved antidepressants from several classes.	Drug: Standard antidepressant therapy (SADT); Treatment with medication will follow the Texas Medication Algorithm (TMA) for Depression. Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR), bupropion SR (Wellbutrin SR), duloxetine (Cymbalta), nortriptyline (Pamelor), and mirtazapine (Remeron).
Experimental: Motivational antidepressant therapy Participants will receive motivational antidepressant therapy, including selecting among the same list of 9 FDA-approved antidepressants from several classes as in the control arm.	Drug: Standard antidepressant therapy (SADT); Treatment with medication will follow the Texas Medication Algorithm (TMA) for Depression. Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR), bupropion SR (Wellbutrin SR), duloxetine (Cymbalta), nortriptyline (Pamelor), and mirtazapine (Remeron).; Behavioral: Motivational antidepressant therapy (MADT); The same medication treatment for depression will be offered and supplemented with techniques from motivational interviewing.

Outcome Measures

Primary Outcome Measures

1. Number of Days in ADT (Retention) [Measured at Months 3 and 9]

   A continuous measure of the total number of days in treatment, based on visit attendance. At each kept visit, patients will be credited as having been in treatment for the number of days since their last scheduled visit. For example, patients attending sessions on weeks 0, 1, and 12 would have been in treatment for 35 days (7 [week 0 to week 1] + 28 [week 8 to week 12]).

2. Mean of Depressive Symptoms Over 36-week Follow-up Using Hamilton Depression Scale -17-item Version (Symptoms) [HAMD-17 assessed at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.]

   Depressive symptoms were assessed using the 17-item standard clinician-administered version of the Hamilton Depression Scale (HAMD-17). We analyzed the HAMD-17 score, calculated as the sum of the individual items and ranging from 0 to 35 with higher numbers indicating more symptoms. HAMD-17 was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the HAMD-17 over 36 weeks using repeated measures.

3. Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment) [SDS at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.]

   Psychosocial functioning was assessed using the Sheehan Disability Scale (SDS), a self-report instrument composed of three visual analog subscales assessing degree of disruption caused by symptoms in three domains: work, social/leisure activities, and family/home life. We analyzed the 3 subscale scores for the 3 domains separately which ranged from 0 to 10 with higher scores indicating worse functioning. The SDS was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the SDS over 36 weeks using repeated measures.

4. Mean Perceived Quality of Life Over 36-week Follow-up Using Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) [QLESQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.]

   Quality of life was assessed using the 16-item Short Form of the Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ), a self-reported measure of quality of life in 8 domains that is sensitive to depressive symptom severity and treatment response. We analyzed the QLESQ total score as a percentage of the maximum possible score (ranging from 0-100) to facilitate comparisons across areas of functioning. It was calculated as such: % Max = (Raw score - minimum possible score) / (maximum possible score-minimum possible score) where raw score is the sum of the first 14 items. Higher numbers indicate better quality of life, greater enjoyment, and satisfaction. The QLESQ was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the QLESQ over 36 weeks using repeated measures.

Secondary Outcome Measures

1. Mean Patient Satisfaction Over 36-week Follow-up Using Client Satisfaction Questionnaire (CSQ) [CSQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.]

   Patient satisfaction was assessed using the 8-item Client Satisfaction Questionnaire (CSQ) which assesses patients' satisfaction with the services received. CSQ total score ranges from 8-32 with higher scores indicating greater satisfaction. The CSQ was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the CSQ over 36 weeks using repeated measures.

2. Proportion of Fully Adherent Days [Measured at each visit, up to 36 weeks]

   We used the Composite Adherence Score (CAS) described in our grant application to calculate medication adherence levels from all data sources (electronic caps [eCaps], pill count, self-report) and compare these across arms. Calculated via a statistically calibrated algorithm, the CAS relied first on eCaps data, secondarily on pill count, and the adherence questionnaire if eCaps data was missing due to an eCap malfunction. We calculated the number of the days the patient was fully adherent, number of days of partial adherence (e.g., opened the eCap fewer times than prescribed), or number of days of nonadherence when they did not take any prescribed pills. Patients who dropped out of the study and provided no further follow-up data were considered nonadherent for the remainder of the study period. We calculated the therapy-adherent period as a proportion of the total intended treatment period or proportion of days of full adherence, # of fully adherent days / # of days in treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Self-identifies as Hispanic

• Meets Diagnostic and Statistical Manual, 4th edition criteria for major depressive disorder (MDD)

• Score of 16 or higher on Hamilton Depression Scale (HAM-D17) at study entry

• Willing to abstain from other psychotropic medications not included in the Texas Medication Algorithm (TMA) for depression, as clinically indicated, for the duration of the study. Zolpidem for insomnia will be allowed.

• Fluency in English or Spanish

Exclusion Criteria:

• Acute suicidality

• History of schizophrenia, bipolar affective disorder, schizoaffective disorder, depression with psychotic features, or organic brain syndromes

• Alcohol or other substance abuse or dependence (except nicotine) within 6 months prior to study entry

• Clinically unstable medical disease, including narrow-angle glaucoma or increased intra-ocular pressure

• Systemic blood pressure of 140/90 mm Hg or less

• Liver function test values two times above the normal level

• Pregnant or breastfeeding

• Sexually active women not using an effective method of birth control

• Current or past history of seizure disorder (except febrile seizure in childhood)

• Receiving effective medication for MDD

• Unable to tolerate or unwilling to accept drug-free period of varying length: 1 week for benzodiazepines taken as needed; 2 weeks for buspirone, lithium, anticonvulsants, stimulants, barbiturates, opiates, and regular-use benzodiazepines (except clonazepam); and 5 weeks for clonazepam

• Received electroconvulsive therapy (ECT) within 3 months prior to study entry

• Parkinson's disease, dementia of any type, or cognitive impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute, 1051 Riverside Drive	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Roberto Lewis-Fernandez, MD, New York State Psychiatric Institute

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related info

Publications

None provided.

• Responsible Party: Roberto Lewis-Fernandez, Professor of Clinical Psychiatry, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT00564278
• Other Study ID Numbers: #5516/#6609R; R01MH077226; DSIR 82-SESC
• First Posted: Nov 27, 2007
• Last Update Posted: May 19, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Roberto Lewis-Fernandez, Professor of Clinical Psychiatry, New York State Psychiatric Institute: Hispanic Americans; Major Depressive Disorder; Antidepressant Therapy; Motivational Interviewing; Treatment Retention; Treatment Adherence
• Additional relevant MeSH terms: Depression; Depressive Disorder; Antidepressive Agents

Study Results

Participant Flow

Recruitment Details	The recruitment period extended from June 3, 2008 to Aug 14, 2013. Advertising was placed in local newspapers recruiting Hispanic adults to the trial, which took place in the Hispanic Treatment Program at the Psychiatric Institute, a research and clinical institute in Upper Manhattan affiliated with Columbia University.
Pre-assignment Detail	Of N=109 patients enrolled in SADT, 12 were pre-treatment drops (signed consent but did not return for a medication visit) and N=97 came to 1+ medication visit. Of N=108 patients enrolled in MADT, 10 were pre-treatment drops (signed consent but did not return for a medication visit) and N=98 participated in at least one medication visit.

Arm/Group Title	Standard Antidepressant Therapy	Motivational Antidepressant Therapy
Arm/Group Description	As per study criteria, the N=97 sample is our sample for data analysis. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline Hamilton Depression Scale-17 score of 16 or greater. Mean age was 43.41 (SD = 13.2).	As per study criteria, the N=98 sample is our sample for data analysis. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline Hamilton Depression Scale-17 score of 16 or greater. Mean age was 44.1 (SD = 12.3).
Period Title: Overall Study
STARTED	97	98
COMPLETED	50	56
NOT COMPLETED	47	42

Baseline Characteristics

Arm/Group Title	Standard Medication Therapy	Motivational Pharmacotherapy	Total
Arm/Group Description	N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater. Mean age was 43.4 with SD=13.2.	N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater. Mean age was 44.1 with SD=12.3.	Total of all reporting groups
Overall Participants	97	98	195
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	93 95.9%	92 93.9%	185 94.9%
>=65 years	4 4.1%	6 6.1%	10 5.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.4 (13.2)	44.1 (12.3)	43.8 (12.7)
Sex: Female, Male (Count of Participants)
Female	60 61.9%	62 63.3%	122 62.6%
Male	37 38.1%	36 36.7%	73 37.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	97 100%	98 100%	195 100%
Not Hispanic or Latino	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	97 100%	98 100%	195 100%

Outcome Measures

1. Primary Outcome

Title	Number of Days in ADT (Retention)
Description	A continuous measure of the total number of days in treatment, based on visit attendance. At each kept visit, patients will be credited as having been in treatment for the number of days since their last scheduled visit. For example, patients attending sessions on weeks 0, 1, and 12 would have been in treatment for 35 days (7 [week 0 to week 1] + 28 [week 8 to week 12]).
Time Frame	Measured at Months 3 and 9

Outcome Measure Data

Analysis Population Description

Patients who signed consent and attended at least one medication visit.

Arm/Group Title	Standard Antidepressant Therapy	Motivational Antidepressant Therapy
Arm/Group Description	N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.	N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
Measure Participants	97	98
Days in txt at 3 months	59.5 (30.65)	65.5 (24.6)
Days in txt at 9 months	148.7 (99.3)	164.1 (89.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Antidepressant Therapy, Motivational Antidepressant Therapy
	Comments	We also conducted an analysis using a Generalized Estimating Equations model adjusting for a number of covariates. We will conduct a three-part regression analysis assessing early/middle/late effects of MPT on retention. We will also conduct moderator analyses, as described in the original study grant, to determine whether there are specific patient groups for whom a significant difference in days in treatment is found.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.26
	Comments	All analyses presented are at 9 months.
	Method	t-test, 2 sided
	Comments	t(193) = -1.14, p=.26
Method of Estimation	Estimation Parameter	GEE model Beta
	Estimated Value	17.46
	Confidence Interval	(2-Sided) 95%; -16.61 to 51.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Mean of Depressive Symptoms Over 36-week Follow-up Using Hamilton Depression Scale -17-item Version (Symptoms)
Description	Depressive symptoms were assessed using the 17-item standard clinician-administered version of the Hamilton Depression Scale (HAMD-17). We analyzed the HAMD-17 score, calculated as the sum of the individual items and ranging from 0 to 35 with higher numbers indicating more symptoms. HAMD-17 was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the HAMD-17 over 36 weeks using repeated measures.
Time Frame	HAMD-17 assessed at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.

Outcome Measure Data

Analysis Population Description

All patients enrolled in both arms with available data at assessment time points.

Arm/Group Title	Standard Antidepressant Therapy	Motivational Antidepressant Therapy
Arm/Group Description	N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.	N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
Measure Participants	97	98
Mean (Standard Deviation) [units on a scale ranging from 0 to 35]	12.08 (7.17)	11.71 (7.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Antidepressant Therapy, Motivational Antidepressant Therapy
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mixed Model Beta for MADT vs SADT
	Estimated Value	-0.28
	Confidence Interval	(2-Sided) 95%; -1.57 to 1.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline depressive symptoms and time to assess the effect of MADT vs. SADT on mean depressive symptoms over follow-up.

3. Primary Outcome

Title	Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment)
Description	Psychosocial functioning was assessed using the Sheehan Disability Scale (SDS), a self-report instrument composed of three visual analog subscales assessing degree of disruption caused by symptoms in three domains: work, social/leisure activities, and family/home life. We analyzed the 3 subscale scores for the 3 domains separately which ranged from 0 to 10 with higher scores indicating worse functioning. The SDS was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the SDS over 36 weeks using repeated measures.
Time Frame	SDS at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.

Outcome Measure Data

Analysis Population Description

Patients with available data at assessment time points.

Arm/Group Title	Standard Antidepressant Therapy	Motivational Antidepressant Therapy
Arm/Group Description	N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.	N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
Measure Participants	97	98
Work	4.36 (3.44)	4.93 (3.41)
Social/leisure	4.87 (3.29)	5.44 (3.27)
Family/home life	4.55 (3.14)	5.05 (3.23)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Antidepressant Therapy, Motivational Antidepressant Therapy
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Work - Mixed Model Beta for MADT vs SADT
	Estimated Value	0.22
	Confidence Interval	(2-Sided) 95%; -0.50 to 0.95
	Parameter Dispersion	Type: Value:
	Estimation Comments	A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline work-related disability score and time to assess the effect of MADT vs. SADT on mean disability score in the work domain over follow-up.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Standard Antidepressant Therapy, Motivational Antidepressant Therapy
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Social-Mixed Model Beta for MADT vs SADT
	Estimated Value	0.22
	Confidence Interval	(2-Sided) 95%; -0.49 to 0.92
	Parameter Dispersion	Type: Value:
	Estimation Comments	A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline social-related disability score and time to assess the effect of MADT vs. SADT on mean disability score in the social domain over follow-up.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Standard Antidepressant Therapy, Motivational Antidepressant Therapy
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Family-Mixed Model Beta for MADT vs SADT
	Estimated Value	0.55
	Confidence Interval	(2-Sided) 95%; -0.08 to 1.18
	Parameter Dispersion	Type: Value:
	Estimation Comments	A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline family-related disability score and time to assess the effect of MADT vs. SADT on mean disability score in the family domain over follow-up.

4. Primary Outcome

Title	Mean Perceived Quality of Life Over 36-week Follow-up Using Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)
Description	Quality of life was assessed using the 16-item Short Form of the Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ), a self-reported measure of quality of life in 8 domains that is sensitive to depressive symptom severity and treatment response. We analyzed the QLESQ total score as a percentage of the maximum possible score (ranging from 0-100) to facilitate comparisons across areas of functioning. It was calculated as such: % Max = (Raw score - minimum possible score) / (maximum possible score-minimum possible score) where raw score is the sum of the first 14 items. Higher numbers indicate better quality of life, greater enjoyment, and satisfaction. The QLESQ was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the QLESQ over 36 weeks using repeated measures.
Time Frame	QLESQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.

Outcome Measure Data

Analysis Population Description

Patients with available data at assessment time points.

Arm/Group Title	Standard Antidepressant Therapy	Motivational Antidepressant Therapy
Arm/Group Description	N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.	N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
Measure Participants	97	98
Mean (Standard Deviation) [percentage of maximum possible score]	50.05 (18.59)	48.92 (19.50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Antidepressant Therapy, Motivational Antidepressant Therapy
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mixed Model Beta for MADT vs SADT
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95%; -3.61 to 3.64
	Parameter Dispersion	Type: Value:
	Estimation Comments	A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline QOL score and time to assess the effect of MADT vs. SADT on mean percent of quality of life over follow-up.

5. Secondary Outcome

Title	Mean Patient Satisfaction Over 36-week Follow-up Using Client Satisfaction Questionnaire (CSQ)
Description	Patient satisfaction was assessed using the 8-item Client Satisfaction Questionnaire (CSQ) which assesses patients' satisfaction with the services received. CSQ total score ranges from 8-32 with higher scores indicating greater satisfaction. The CSQ was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the CSQ over 36 weeks using repeated measures.
Time Frame	CSQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.

Outcome Measure Data

Analysis Population Description

Patients with available data at assessment time points.

Arm/Group Title	Standard Antidepressant Therapy	Motivational Antidepressant Therapy
Arm/Group Description	N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.	N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
Measure Participants	97	98
Mean (Standard Deviation) [units on a scale ranging from 8 to 32]	27.59 (3.38)	27.41 (3.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Antidepressant Therapy, Motivational Antidepressant Therapy
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mixed Model Beta for MADT vs SADT
	Estimated Value	-0.04
	Confidence Interval	(2-Sided) 95%; -0.74 to 0.66
	Parameter Dispersion	Type: Value:
	Estimation Comments	A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline patient satisfaction and time to assess the effect of MADT vs. SADT on mean patient satisfaction over follow-up.

6. Secondary Outcome

Title	Proportion of Fully Adherent Days
Description	We used the Composite Adherence Score (CAS) described in our grant application to calculate medication adherence levels from all data sources (electronic caps [eCaps], pill count, self-report) and compare these across arms. Calculated via a statistically calibrated algorithm, the CAS relied first on eCaps data, secondarily on pill count, and the adherence questionnaire if eCaps data was missing due to an eCap malfunction. We calculated the number of the days the patient was fully adherent, number of days of partial adherence (e.g., opened the eCap fewer times than prescribed), or number of days of nonadherence when they did not take any prescribed pills. Patients who dropped out of the study and provided no further follow-up data were considered nonadherent for the remainder of the study period. We calculated the therapy-adherent period as a proportion of the total intended treatment period or proportion of days of full adherence, # of fully adherent days / # of days in treatment.
Time Frame	Measured at each visit, up to 36 weeks

Outcome Measure Data

Analysis Population Description

All patients in both arms

Arm/Group Title	Standard Antidepressant Therapy	Motivational Antidepressant Therapy
Arm/Group Description	N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.	N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
Measure Participants	97	98
Mean (Standard Deviation) [Proportion of Fully Adherent days]	0.47 (0.34)	0.56 (0.32)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Antidepressant Therapy, Motivational Antidepressant Therapy
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mixed Model Beta for MADT vs SADT
	Estimated Value	9.14
	Confidence Interval	(2-Sided) 95%; 2.71 to 15.57
	Parameter Dispersion	Type: Value:
	Estimation Comments	A Generalized Linear Mixed Model was used with random intercept for clinician to model the effect of MPT vs. SADT on the mean proportion of fully adherent days over the study period. We used an exchangeable covariance structure.

Adverse Events

Time Frame	Time frame was duration of study: maximum of 36 weeks.
Arm/Group Title	Standard Antidepressant Therapy		Motivational Antidepressant Therapy
Arm/Group Description	Participants will receive standard antidepressant therapy. Standard antidepressant therapy (SADT): Treatment with medication will follow the Texas Medication Algorithm (TMA) for Depression. Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR), bupropion SR (Wellbutrin SR), duloxetine (Cymbalta), nortriptyline (Pamelor), and mirtazapine (Remeron).		Participants will receive motivational antidepressant therapy. Motivational antidepressant therapy (MADT): The same medication treatment for depression will be offered as in the SADT arm and supplemented with techniques from motivational interviewing.
All Cause Mortality
	Standard Antidepressant Therapy		Motivational Antidepressant Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Antidepressant Therapy		Motivational Antidepressant Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/97 (1%)		2/98 (2%)
Psychiatric disorders
Suicidal ideation	1/97 (1%)	1	0/98 (0%)	0
Manic episode	0/97 (0%)	0	2/98 (2%)	2
Other (Not Including Serious) Adverse Events
	Standard Antidepressant Therapy		Motivational Antidepressant Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/97 (3.1%)		5/98 (5.1%)
Musculoskeletal and connective tissue disorders
Neck stiffness or soreness	3/97 (3.1%)	3	5/98 (5.1%)	5

Limitations/Caveats

Focused only on Hispanics, so applicability to other populations unknown.

More Information

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.