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

Depression Clinical Trial

Official title:

Motivational Antidepressant Therapy for Hispanics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00564278
• Other study ID #: #5516/#6609R
• Secondary ID: R01MH077226DSIR
• Status: Completed
• Phase: N/A
• Start date: February 2008
• Est. completion date: August 2013

Study information

• Verified date: April 2021
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute, 1051 Riverside Drive	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Days in ADT (Retention)	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
Primary	Mean of Depressive Symptoms Over 36-week Follow-up Using Hamilton Depression Scale -17-item Version (Symptoms)	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.
Primary	Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment)	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.
Primary	Mean Perceived Quality of Life Over 36-week Follow-up Using Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)	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	Mean Patient Satisfaction Over 36-week Follow-up Using Client Satisfaction Questionnaire (CSQ)	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.
Secondary	Proportion of Fully Adherent Days	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

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