- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00564278
Effects of Adding Motivational Interviewing to Antidepressant Treatment for Hispanic Adults With Depression
Motivational Antidepressant Therapy for Hispanics
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- New York State Psychiatric Institute, 1051 Riverside Drive
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard antidepressant therapy
Participants will receive standard antidepressant therapy, including selecting among 9 FDA-approved antidepressants from several classes.
|
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.
|
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).
The same medication treatment for depression will be offered and supplemented with techniques from motivational interviewing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Days in ADT (Retention)
Time Frame: 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]).
|
Measured at Months 3 and 9
|
Mean of Depressive Symptoms Over 36-week Follow-up Using Hamilton Depression Scale -17-item Version (Symptoms)
Time Frame: 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. |
HAMD-17 assessed at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.
|
Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment)
Time Frame: 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.
|
SDS at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.
|
Mean Perceived Quality of Life Over 36-week Follow-up Using Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)
Time Frame: 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.
|
QLESQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Patient Satisfaction Over 36-week Follow-up Using Client Satisfaction Questionnaire (CSQ)
Time Frame: 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.
|
CSQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.
|
Proportion of Fully Adherent Days
Time Frame: 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.
|
Measured at each visit, up to 36 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Roberto Lewis-Fernandez, MD, New York State Psychiatric Institute
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #5516/#6609R
- R01MH077226 (U.S. NIH Grant/Contract)
- DSIR 82-SESC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
Clinical Trials on Standard antidepressant therapy (SADT)
-
Cota Inc.Hackensack Meridian Health; MYnd Analytics; Horizon Blue Cross Blue Shield of...Unknown
-
PD Dr. med. Thorsten MikoteitPsychiatrische Dienste Solothurn; Privatklinik WyssRecruitingDepressionSwitzerland
-
RANDCompleted
-
Sheppard Pratt Health SystemCentral Michigan UniversityWithdrawn1. Major Depressive DisorderUnited States
-
Charite University, Berlin, GermanyCompleted
-
Centre for Addiction and Mental HealthOntario Mental Health FoundationCompletedDepression | Major Depressive DisorderCanada
-
King's College LondonSouth London and Maudsley NHS Foundation TrustSuspendedDepressive Disorder, Major
-
Shanghai Zhongshan HospitalHuashan Hospital; Shanghai 10th People's Hospital; Ruijin Hospital; Shanghai East... and other collaboratorsActive, not recruiting
-
ShireCompletedMajor Depressive DisorderUnited States, Chile, Australia, Argentina, United Kingdom
-
Castilla-La Mancha Health ServiceComplejo Hospitalario La Mancha CentroCompletedSubacromial Impingement Syndrome | Vojta TherapySpain