{"protocolSection":{"identificationModule":{"nctId":"NCT00564278","orgStudyIdInfo":{"id":"#5516/#6609R"},"secondaryIdInfos":[{"id":"R01MH077226","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01MH077226"},{"id":"DSIR 82-SESC"}],"organization":{"fullName":"New York State Psychiatric Institute","class":"OTHER"},"briefTitle":"Effects of Adding Motivational Interviewing to Antidepressant Treatment for Hispanic Adults With Depression","officialTitle":"Motivational Antidepressant Therapy for Hispanics"},"statusModule":{"statusVerifiedDate":"2021-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-02"},"primaryCompletionDateStruct":{"date":"2013-08","type":"ACTUAL"},"completionDateStruct":{"date":"2013-08","type":"ACTUAL"},"studyFirstSubmitDate":"2007-11-26","studyFirstSubmitQcDate":"2007-11-26","studyFirstPostDateStruct":{"date":"2007-11-27","type":"ESTIMATED"},"resultsFirstSubmitDate":"2015-08-06","resultsFirstSubmitQcDate":"2016-02-11","resultsFirstPostDateStruct":{"date":"2016-03-10","type":"ESTIMATED"},"lastUpdateSubmitDate":"2021-04-29","lastUpdatePostDateStruct":{"date":"2021-05-19","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Roberto Lewis-Fernandez","investigatorTitle":"Professor of Clinical Psychiatry","investigatorAffiliation":"New York State Psychiatric Institute"},"leadSponsor":{"name":"New York State Psychiatric Institute","class":"OTHER"},"collaborators":[{"name":"National Institute of Mental Health (NIMH)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This study will evaluate the effectiveness of adding motivational interviewing to antidepressant treatment for major depressive disorder in Hispanic adults.","detailedDescription":"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.\n\nParticipants 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."},"conditionsModule":{"conditions":["Depression"],"keywords":["Hispanic Americans","Major Depressive Disorder","Antidepressant Therapy","Motivational Interviewing","Treatment Retention","Treatment Adherence"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"HEALTH_SERVICES_RESEARCH","maskingInfo":{"masking":"SINGLE","whoMasked":["OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":217,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Standard antidepressant therapy","type":"ACTIVE_COMPARATOR","description":"Participants will receive standard antidepressant therapy, including selecting among 9 FDA-approved antidepressants from several classes.","interventionNames":["Drug: Standard antidepressant therapy (SADT)"]},{"label":"Motivational antidepressant therapy","type":"EXPERIMENTAL","description":"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.","interventionNames":["Drug: Standard antidepressant therapy (SADT)","Behavioral: Motivational antidepressant therapy (MADT)"]}],"interventions":[{"type":"DRUG","name":"Standard antidepressant therapy (SADT)","description":"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).","armGroupLabels":["Motivational antidepressant therapy","Standard antidepressant therapy"]},{"type":"BEHAVIORAL","name":"Motivational antidepressant therapy (MADT)","description":"The same medication treatment for depression will be offered and supplemented with techniques from motivational interviewing.","armGroupLabels":["Motivational antidepressant therapy"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"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\\]).","timeFrame":"Measured at Months 3 and 9"},{"measure":"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.\n\nWe calculated the model-estimated mean of the HAMD-17 over 36 weeks using repeated measures.","timeFrame":"HAMD-17 assessed at follow-up weeks 2, 4, 8, 12, 20, 28, and 36."},{"measure":"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.","timeFrame":"SDS at follow-up weeks 2, 4, 8, 12, 20, 28, and 36."},{"measure":"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.","timeFrame":"QLESQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36."}],"secondaryOutcomes":[{"measure":"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.","timeFrame":"CSQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36."},{"measure":"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.","timeFrame":"Measured at each visit, up to 36 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Self-identifies as Hispanic\n* Meets Diagnostic and Statistical Manual, 4th edition criteria for major depressive disorder (MDD)\n* Score of 16 or higher on Hamilton Depression Scale (HAM-D17) at study entry\n* 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.\n* Fluency in English or Spanish\n\nExclusion Criteria:\n\n* Acute suicidality\n* History of schizophrenia, bipolar affective disorder, schizoaffective disorder, depression with psychotic features, or organic brain syndromes\n* Alcohol or other substance abuse or dependence (except nicotine) within 6 months prior to study entry\n* Clinically unstable medical disease, including narrow-angle glaucoma or increased intra-ocular pressure\n* Systemic blood pressure of 140/90 mm Hg or less\n* Liver function test values two times above the normal level\n* Pregnant or breastfeeding\n* Sexually active women not using an effective method of birth control\n* Current or past history of seizure disorder (except febrile seizure in childhood)\n* Receiving effective medication for MDD\n* 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\n* Received electroconvulsive therapy (ECT) within 3 months prior to study entry\n* Parkinson's disease, dementia of any type, or cognitive impairment","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"79 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Roberto Lewis-Fernandez, MD","affiliation":"New York State Psychiatric Institute","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"New York State Psychiatric Institute, 1051 Riverside Drive","city":"New York","state":"New York","zip":"10032","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}}]},"referencesModule":{"references":[{"pmid":"25736422","type":"DERIVED","citation":"Vargas SM, Cabassa LJ, Nicasio A, De La Cruz AA, Jackson E, Rosario M, Guarnaccia PJ, Lewis-Fernandez R. Toward a cultural adaptation of pharmacotherapy: Latino views of depression and antidepressant therapy. Transcult Psychiatry. 2015 Apr;52(2):244-73. doi: 10.1177/1363461515574159. Epub 2015 Mar 3."}],"seeAlsoLinks":[{"label":"Related info","url":"https://nyculturalcompetence.org/"}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"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.","recruitmentDetails":"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.","groups":[{"id":"FG000","title":"Standard Antidepressant Therapy","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)."},{"id":"FG001","title":"Motivational Antidepressant Therapy","description":"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)."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"97"},{"groupId":"FG001","numSubjects":"98"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"50"},{"groupId":"FG001","numSubjects":"56"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"47"},{"groupId":"FG001","numSubjects":"42"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"35"},{"groupId":"FG001","numSubjects":"33"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"7"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Patients who signed written informed consent and participated in baseline medication visit.","groups":[{"id":"BG000","title":"Standard Medication Therapy","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."},{"id":"BG001","title":"Motivational Pharmacotherapy","description":"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."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"97"},{"groupId":"BG001","value":"98"},{"groupId":"BG002","value":"195"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"93"},{"groupId":"BG001","value":"92"},{"groupId":"BG002","value":"185"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"10"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"43.4","spread":"13.2"},{"groupId":"BG001","value":"44.1","spread":"12.3"},{"groupId":"BG002","value":"43.8","spread":"12.7"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"60"},{"groupId":"BG001","value":"62"},{"groupId":"BG002","value":"122"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"37"},{"groupId":"BG001","value":"36"},{"groupId":"BG002","value":"73"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"97"},{"groupId":"BG001","value":"98"},{"groupId":"BG002","value":"195"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"97"},{"groupId":"BG001","value":"98"},{"groupId":"BG002","value":"195"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","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\\]).","populationDescription":"Patients who signed consent and attended at least one medication visit.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Days in treatment","timeFrame":"Measured at Months 3 and 9","groups":[{"id":"OG000","title":"Standard Antidepressant Therapy","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."},{"id":"OG001","title":"Motivational Antidepressant Therapy","description":"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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"98"}]}],"classes":[{"title":"Days in txt at 3 months","categories":[{"measurements":[{"groupId":"OG000","value":"59.5","spread":"30.65"},{"groupId":"OG001","value":"65.5","spread":"24.6"}]}]},{"title":"Days in txt at 9 months","categories":[{"measurements":[{"groupId":"OG000","value":"148.7","spread":"99.3"},{"groupId":"OG001","value":"164.1","spread":"89.2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"We also conducted an analysis using a Generalized Estimating Equations model adjusting for a number of covariates.\n\nWe 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.","nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.26","pValueComment":"All analyses presented are at 9 months.","statisticalMethod":"t-test, 2 sided","statisticalComment":"t(193) = -1.14, p=.26","paramType":"GEE model Beta","paramValue":"17.46","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-16.61","ciUpperLimit":"51.53"}]},{"type":"PRIMARY","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.\n\nWe calculated the model-estimated mean of the HAMD-17 over 36 weeks using repeated measures.","populationDescription":"All patients enrolled in both arms with available data at assessment time points.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale ranging from 0 to 35","timeFrame":"HAMD-17 assessed at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.","groups":[{"id":"OG000","title":"Standard Antidepressant Therapy","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."},{"id":"OG001","title":"Motivational Antidepressant Therapy","description":"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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"98"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12.08","spread":"7.17"},{"groupId":"OG001","value":"11.71","spread":"7.31"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValueComment":"See Method of Estimation below.","paramType":"Mixed Model Beta for MADT vs SADT","paramValue":"-0.28","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.57","ciUpperLimit":"1.01","estimateComment":"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."}]},{"type":"PRIMARY","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.","populationDescription":"Patients with available data at assessment time points.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale ranging from 0-10","timeFrame":"SDS at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.","groups":[{"id":"OG000","title":"Standard Antidepressant Therapy","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."},{"id":"OG001","title":"Motivational Antidepressant Therapy","description":"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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"98"}]}],"classes":[{"title":"Work","categories":[{"measurements":[{"groupId":"OG000","value":"4.36","spread":"3.44"},{"groupId":"OG001","value":"4.93","spread":"3.41"}]}]},{"title":"Social/leisure","categories":[{"measurements":[{"groupId":"OG000","value":"4.87","spread":"3.29"},{"groupId":"OG001","value":"5.44","spread":"3.27"}]}]},{"title":"Family/home life","categories":[{"measurements":[{"groupId":"OG000","value":"4.55","spread":"3.14"},{"groupId":"OG001","value":"5.05","spread":"3.23"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValueComment":"See under Method of Estimation, below","paramType":"Work - Mixed Model Beta for MADT vs SADT","paramValue":"0.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.50","ciUpperLimit":"0.95","estimateComment":"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."},{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValueComment":"See under Method of Estimation below.","paramType":"Social-Mixed Model Beta for MADT vs SADT","paramValue":"0.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.49","ciUpperLimit":"0.92","estimateComment":"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."},{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValueComment":"See Method of Estimation below.","paramType":"Family-Mixed Model Beta for MADT vs SADT","paramValue":"0.55","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.08","ciUpperLimit":"1.18","estimateComment":"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."}]},{"type":"PRIMARY","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.","populationDescription":"Patients with available data at assessment time points.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage of maximum possible score","timeFrame":"QLESQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.","groups":[{"id":"OG000","title":"Standard Antidepressant Therapy","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."},{"id":"OG001","title":"Motivational Antidepressant Therapy","description":"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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"98"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"50.05","spread":"18.59"},{"groupId":"OG001","value":"48.92","spread":"19.50"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValueComment":"See Method of Estimation, below","paramType":"Mixed Model Beta for MADT vs SADT","paramValue":"0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.61","ciUpperLimit":"3.64","estimateComment":"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."}]},{"type":"SECONDARY","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.","populationDescription":"Patients with available data at assessment time points.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale ranging from 8 to 32","timeFrame":"CSQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.","groups":[{"id":"OG000","title":"Standard Antidepressant Therapy","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."},{"id":"OG001","title":"Motivational Antidepressant Therapy","description":"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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"98"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"27.59","spread":"3.38"},{"groupId":"OG001","value":"27.41","spread":"3.39"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValueComment":"See Method of Estimation below.","paramType":"Mixed Model Beta for MADT vs SADT","paramValue":"-0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.74","ciUpperLimit":"0.66","estimateComment":"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."}]},{"type":"SECONDARY","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.","populationDescription":"All patients in both arms","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Proportion of Fully Adherent days","timeFrame":"Measured at each visit, up to 36 weeks","groups":[{"id":"OG000","title":"Standard Antidepressant Therapy","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."},{"id":"OG001","title":"Motivational Antidepressant Therapy","description":"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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"98"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.47","spread":"0.34"},{"groupId":"OG001","value":"0.56","spread":"0.32"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValueComment":"See Method of Estimation below.","paramType":"Mixed Model Beta for MADT vs SADT","paramValue":"9.14","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.71","ciUpperLimit":"15.57","estimateComment":"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."}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Time frame was duration of study: maximum of 36 weeks.","eventGroups":[{"id":"EG000","title":"Standard Antidepressant Therapy","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).","seriousNumAffected":1,"seriousNumAtRisk":97,"otherNumAffected":3,"otherNumAtRisk":97},{"id":"EG001","title":"Motivational Antidepressant Therapy","description":"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.","seriousNumAffected":2,"seriousNumAtRisk":98,"otherNumAffected":5,"otherNumAtRisk":98}],"seriousEvents":[{"term":"Suicidal ideation","organSystem":"Psychiatric disorders","sourceVocabulary":"SideEffect Checklist","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"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.","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":97},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":98}]},{"term":"Manic episode","organSystem":"Psychiatric disorders","sourceVocabulary":"SideEffect Checklist","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"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.","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":97},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":98}]}],"otherEvents":[{"term":"Neck stiffness or soreness","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"SideEffect Checklist","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":97},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":98}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"Focused only on Hispanics, so applicability to other populations unknown."},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Roberto Lewis-Fernandez, MD, Professor of Psychiatry CUMC - NYSPI","organization":"Columbia Univ Med Center and New York State Psychiatric Institute","email":"rlewis@nyspi.columbia.edu","phone":"646-774-8102"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003863","term":"Depression"},{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D000074822","term":"Treatment Adherence and Compliance"}],"ancestors":[{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"},{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D015438","term":"Health Behavior"}]}},"hasResults":true}