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

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ClinicalTrials.gov Identifier: NCT00564278
Recruitment Status : Completed
First Posted : November 27, 2007
Results First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Health Services Research
Condition Depression
Interventions Drug: Standard antidepressant therapy (SADT)
Behavioral: Motivational antidepressant therapy (MADT)
Enrollment 217
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 Details 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
Hide 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
Reason Not Completed
Lost to Follow-up             35             33
Physician Decision             1             2
Withdrawal by Subject             11             7
Arm/Group Title Standard Medication Therapy Motivational Pharmacotherapy Total
Hide 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 Number of Baseline Participants 97 98 195
Hide Baseline Analysis Population Description
Patients who signed written informed consent and participated in baseline medication visit.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 98 participants 195 participants
<=18 years
0
   0.0%
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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants 98 participants 195 participants
43.4  (13.2) 44.1  (12.3) 43.8  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 98 participants 195 participants
Female
60
  61.9%
62
  63.3%
122
  62.6%
Male
37
  38.1%
36
  36.7%
73
  37.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 98 participants 195 participants
Hispanic or Latino
97
 100.0%
98
 100.0%
195
 100.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 97 participants 98 participants 195 participants
97 98 195
1.Primary Outcome
Title Number of Days in ADT (Retention)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who signed consent and attended at least one medication visit.
Arm/Group Title Standard Antidepressant Therapy Motivational Antidepressant Therapy
Hide 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.
Overall Number of Participants Analyzed 97 98
Mean (Standard Deviation)
Unit of Measure: Days in treatment
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)
Show Statistical Analysis 1 Hide 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
Comments [Not Specified]
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
Estimation Comments [Not Specified]
2.Primary Outcome
Title Mean of Depressive Symptoms Over 36-week Follow-up Using Hamilton Depression Scale -17-item Version (Symptoms)
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 97 98
Mean (Standard Deviation)
Unit of Measure: units on a scale ranging from 0 to 35
12.08  (7.17) 11.71  (7.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Antidepressant Therapy, Motivational Antidepressant Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
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
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)
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with available data at assessment time points.
Arm/Group Title Standard Antidepressant Therapy Motivational Antidepressant Therapy
Hide 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.
Overall Number of Participants Analyzed 97 98
Mean (Standard Deviation)
Unit of Measure: Units on a scale ranging from 0-10
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Antidepressant Therapy, Motivational Antidepressant Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
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
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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard Antidepressant Therapy, Motivational Antidepressant Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
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
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.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard Antidepressant Therapy, Motivational Antidepressant Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
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
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)
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with available data at assessment time points.
Arm/Group Title Standard Antidepressant Therapy Motivational Antidepressant Therapy
Hide 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.
Overall Number of Participants Analyzed 97 98
Mean (Standard Deviation)
Unit of Measure: percentage of maximum possible score
50.05  (18.59) 48.92  (19.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Antidepressant Therapy, Motivational Antidepressant Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
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
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)
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with available data at assessment time points.
Arm/Group Title Standard Antidepressant Therapy Motivational Antidepressant Therapy
Hide 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.
Overall Number of Participants Analyzed 97 98
Mean (Standard Deviation)
Unit of Measure: units on a scale ranging from 8 to 32
27.59  (3.38) 27.41  (3.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Antidepressant Therapy, Motivational Antidepressant Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
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
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in both arms
Arm/Group Title Standard Antidepressant Therapy Motivational Antidepressant Therapy
Hide 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.
Overall Number of Participants Analyzed 97 98
Mean (Standard Deviation)
Unit of Measure: Proportion of Fully Adherent days
0.47  (0.34) 0.56  (0.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Antidepressant Therapy, Motivational Antidepressant Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
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
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.
Time Frame Time frame was duration of study: maximum of 36 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Antidepressant Therapy Motivational Antidepressant Therapy
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Standard Antidepressant Therapy Motivational Antidepressant Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/97 (1.03%)      2/98 (2.04%)    
Psychiatric disorders     
Suicidal ideation  1 [1]  1/97 (1.03%)  1 0/98 (0.00%)  0
Manic episode  1 [2]  0/97 (0.00%)  0 2/98 (2.04%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, SideEffect Checklist
[1]
Pt developed suicidal ideation during trial. After phone eval, he was referred to psych ER, from where he was admitted to inpatient psychiatric unit. After discharge, pt requested study termination and follow-up in non-research outpatient unit.
[2]
Pt without clear history of bipolar disorder developed manic episode when started on antidepressant. Antidepressant was discontinued and appropriate mood stabilizers were initiated. Pt was terminated from the study and treated openly.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard Antidepressant Therapy Motivational Antidepressant Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/97 (3.09%)      5/98 (5.10%)    
Musculoskeletal and connective tissue disorders     
Neck stiffness or soreness  1  3/97 (3.09%)  3 5/98 (5.10%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, SideEffect Checklist
Focused only on Hispanics, so applicability to other populations unknown.
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: Roberto Lewis-Fernandez, MD, Professor of Psychiatry CUMC - NYSPI
Organization: Columbia Univ Med Center and New York State Psychiatric Institute
Phone: 646-774-8102
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00564278     History of Changes
Other Study ID Numbers: #5516/#6609R
R01MH077226 ( U.S. NIH Grant/Contract )
DSIR 82-SESC
First Submitted: November 26, 2007
First Posted: November 27, 2007
Results First Submitted: August 6, 2015
Results First Posted: March 10, 2016
Last Update Posted: March 10, 2016