Depression
Conditions
Keywords
Hispanic Americans, Major Depressive Disorder, Antidepressant Therapy, Motivational Interviewing, Treatment Retention, Treatment Adherence
Brief summary
This study will evaluate the effectiveness of adding motivational interviewing to antidepressant treatment for major depressive disorder in Hispanic adults.
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.
Interventions
DRUGStandard 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).
BEHAVIORALMotivational antidepressant therapy (MADT)
The same medication treatment for depression will be offered and supplemented with techniques from motivational interviewing.
Sponsors
National Institute of Mental Health (NIMH)
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days in ADT (Retention) | 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 of Depressive Symptoms Over 36-week Follow-up Using Hamilton Depression Scale -17-item Version (Symptoms) | 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. |
| Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment) | 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. |
| Mean Perceived Quality of Life Over 36-week Follow-up Using Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Proportion of Fully Adherent Days | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Standard Medication Therapy 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. | 97 |
| Motivational Pharmacotherapy 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. | 98 |
| Total | 195 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 35 | 33 |
| Overall Study | Physician Decision | 1 | 2 |
| Overall Study | Withdrawal by Subject | 11 | 7 |
Baseline characteristics
| Characteristic | Standard Medication Therapy | Motivational Pharmacotherapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 6 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 93 Participants | 92 Participants | 185 Participants |
| Age, Continuous | 43.4 years STANDARD_DEVIATION 13.2 | 44.1 years STANDARD_DEVIATION 12.3 | 43.8 years STANDARD_DEVIATION 12.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 97 Participants | 98 Participants | 195 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 97 participants | 98 participants | 195 participants |
| Sex: Female, Male Female | 60 Participants | 62 Participants | 122 Participants |
| Sex: Female, Male Male | 37 Participants | 36 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 97 | 5 / 98 |
| serious Total, serious adverse events | 1 / 97 | 2 / 98 |
Outcome results
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.
Time frame: SDS at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.
Population: Patients with available data at assessment time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Antidepressant Therapy | Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment) | Work | 4.36 Units on a scale ranging from 0-10 | Standard Deviation 3.44 |
| Standard Antidepressant Therapy | Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment) | Social/leisure | 4.87 Units on a scale ranging from 0-10 | Standard Deviation 3.29 |
| Standard Antidepressant Therapy | Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment) | Family/home life | 4.55 Units on a scale ranging from 0-10 | Standard Deviation 3.14 |
| Motivational Antidepressant Therapy | Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment) | Work | 4.93 Units on a scale ranging from 0-10 | Standard Deviation 3.41 |
| Motivational Antidepressant Therapy | Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment) | Social/leisure | 5.44 Units on a scale ranging from 0-10 | Standard Deviation 3.27 |
| Motivational Antidepressant Therapy | Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment) | Family/home life | 5.05 Units on a scale ranging from 0-10 | Standard Deviation 3.23 |
95% CI: [-0.5, 0.95]
95% CI: [-0.49, 0.92]
95% CI: [-0.08, 1.18]
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.
Time frame: HAMD-17 assessed at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.
Population: All patients enrolled in both arms with available data at assessment time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Antidepressant Therapy | Mean of Depressive Symptoms Over 36-week Follow-up Using Hamilton Depression Scale -17-item Version (Symptoms) | 12.08 units on a scale ranging from 0 to 35 | Standard Deviation 7.17 |
| Motivational Antidepressant Therapy | Mean of Depressive Symptoms Over 36-week Follow-up Using Hamilton Depression Scale -17-item Version (Symptoms) | 11.71 units on a scale ranging from 0 to 35 | Standard Deviation 7.31 |
95% CI: [-1.57, 1.01]
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.
Time frame: QLESQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.
Population: Patients with available data at assessment time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Antidepressant Therapy | Mean Perceived Quality of Life Over 36-week Follow-up Using Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) | 50.05 percentage of maximum possible score | Standard Deviation 18.59 |
| Motivational Antidepressant Therapy | Mean Perceived Quality of Life Over 36-week Follow-up Using Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) | 48.92 percentage of maximum possible score | Standard Deviation 19.5 |
95% CI: [-3.61, 3.64]
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 \[week 8 to week 12\]).
Time frame: Measured at Months 3 and 9
Population: Patients who signed consent and attended at least one medication visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Antidepressant Therapy | Number of Days in ADT (Retention) | Days in txt at 3 months | 59.5 Days in treatment | Standard Deviation 30.65 |
| Standard Antidepressant Therapy | Number of Days in ADT (Retention) | Days in txt at 9 months | 148.7 Days in treatment | Standard Deviation 99.3 |
| Motivational Antidepressant Therapy | Number of Days in ADT (Retention) | Days in txt at 3 months | 65.5 Days in treatment | Standard Deviation 24.6 |
| Motivational Antidepressant Therapy | Number of Days in ADT (Retention) | Days in txt at 9 months | 164.1 Days in treatment | Standard Deviation 89.2 |
Comparison: 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.p-value: 0.2695% CI: [-16.61, 51.53]t-test, 2 sided
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.
Time frame: CSQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.
Population: Patients with available data at assessment time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Antidepressant Therapy | Mean Patient Satisfaction Over 36-week Follow-up Using Client Satisfaction Questionnaire (CSQ) | 27.59 units on a scale ranging from 8 to 32 | Standard Deviation 3.38 |
| Motivational Antidepressant Therapy | Mean Patient Satisfaction Over 36-week Follow-up Using Client Satisfaction Questionnaire (CSQ) | 27.41 units on a scale ranging from 8 to 32 | Standard Deviation 3.39 |
95% CI: [-0.74, 0.66]
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.
Time frame: Measured at each visit, up to 36 weeks
Population: All patients in both arms
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Antidepressant Therapy | Proportion of Fully Adherent Days | 0.47 Proportion of Fully Adherent days | Standard Deviation 0.34 |
| Motivational Antidepressant Therapy | Proportion of Fully Adherent Days | 0.56 Proportion of Fully Adherent days | Standard Deviation 0.32 |
95% CI: [2.71, 15.57]