Motivational Antidepressant Therapy for Hispanics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- Mean of Depressive Symptoms Over 36-week Follow-up Using Hamilton Depression Scale -17-item Version (Symptoms)
研究概览
简要总结
This study will evaluate the effectiveness of adding motivational interviewing to antidepressant treatment for major depressive disorder in Hispanic adults.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard antidepressant therapy
Participants will receive standard antidepressant therapy, including selecting among 9 FDA-approved antidepressants from several classes.
干预措施: Standard antidepressant therapy (SADT) (Drug)
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.
干预措施: Standard antidepressant therapy (SADT) (Drug)
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.
干预措施: Motivational antidepressant therapy (MADT) (Behavioral)
结局指标
主要结局
Mean of Depressive Symptoms Over 36-week Follow-up Using Hamilton Depression Scale -17-item Version (Symptoms)
时间窗: 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.
Number of Days in ADT (Retention)
时间窗: 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 \[week 8 to week 12\]).
Mean Perceived Quality of Life Over 36-week Follow-up Using Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)
时间窗: 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.
Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment)
时间窗: 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.
次要结局
- Proportion of Fully Adherent Days(Measured at each visit, up to 36 weeks)
- 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.)
研究者
Roberto Lewis-Fernandez
Professor of Clinical Psychiatry
New York State Psychiatric Institute