Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K23MH074860 | U.S. NIH Grant/Contract | View source | |
| DSIR 8K-RT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will determine the effectiveness of motivational interviewing in improving antidepressant medication adherence among Hispanics.
Depression is a serious mental illness characterized by symptoms that can interfere with a person's ability to work, study, eat, sleep, and enjoy activities that were once pleasurable. Studies have shown that people of Hispanic descent tend to underutilize mental health care services. Additionally, Hispanics have demonstrated lower compliance and completion rates for antidepressant treatment. This may be due to low socioeconomic status, lack of family financial support, and inadequate communication with mental health care providers. Motivational interviewing is a goal-oriented type of therapy that focuses on eliciting behavior change by identifying and mobilizing a person's values. This study will determine the effectiveness of culturally sensitive motivational interviewing in improving antidepressant medication adherence in Hispanics.
Participants in this 6-month, open-label study will be randomly assigned to receive either motivational interviewing in addition to their antidepressant therapy or treatment as usual. All participants will first attend a 45-minute screening visit, which will include questionnaires and an interview about psychiatric symptoms, medication attitudes, and medication adherence behavior. Participants will also receive an electronic medication container that will record how consistently medication is taken. Participants assigned to motivational interviewing will then attend two 1-hour sessions of motivational interviewing over 2 consecutive weeks, followed by a third session 8 weeks later. The group assigned to treatment as usual will not partake in motivational interviewing, but will continue to receive their normal care. All participants will return to the study site for follow-up assessments, which will include measures of antidepressant adherence, at Months 2 and 5.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Participants will receive motivational interviewing in addition to their antidepressant therapy |
|
| 2 | Active Comparator | Participants will receive treatment as usual |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational interviewing | Behavioral | Participants assigned to motivational interviewing will attend two 1-hour sessions of motivational interviewing over 2 consecutive weeks, followed by a third session 8 weeks later. Motivational interviewing is a type of counselling. Each session is of approximately 1 hour duration. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence, as Measured by Electronic Pill Container | Medication container caps (MEMS) recorded each instance where the antidepressant medication container was opened. An adherence index was derived the represented the percentage of days, within the medication period, where the container was opened. | Measured immediately post-treatment and at Months 2 and 5 months follow-ups |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Retention | Measured at Month 5 | |
| Beck Depression Inventory-II (BDI-II) | The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. Higher total scores indicate more severe depressive symptoms. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alejandro Interian, PhD | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Behavioral Healthcare | New Brunswick | New Jersey | 08901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18048562 | Background | Interian A, Martinez IE, Guarnaccia PJ, Vega WA, Escobar JI. A qualitative analysis of the perception of stigma among Latinos receiving antidepressants. Psychiatr Serv. 2007 Dec;58(12):1591-4. doi: 10.1176/ps.2007.58.12.1591. | |
| 20630257 | Background | Escobar JI, Cook B, Chen CN, Gara MA, Alegria M, Interian A, Diaz E. Whether medically unexplained or not, three or more concurrent somatic symptoms predict psychopathology and service use in community populations. J Psychosom Res. 2010 Jul;69(1):1-8. doi: 10.1016/j.jpsychores.2010.01.001. Epub 2010 Feb 16. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Motivational Enhancement Therapy for Antidepressants | Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic. |
| FG001 | Treatment as Usual | Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Motivational Enhancement Therapy for Antidepressants | Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Medication Adherence, as Measured by Electronic Pill Container | Medication container caps (MEMS) recorded each instance where the antidepressant medication container was opened. An adherence index was derived the represented the percentage of days, within the medication period, where the container was opened. | We used an ITT with LOCF. These figures represent outcomes at 5 months. | Posted | Mean | Standard Error | Percentage of Days | Measured immediately post-treatment and at Months 2 and 5 months follow-ups |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Motivational Enhancement Therapy for Antidepressants | Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alejandro Interian, Principal Investigator | VA New Jersey Healthcare System | 908-647-0180 | 4617 | alejandro.interian@va.gov |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D019263 | Dysthymic Disorder |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Treatment as usual | Behavioral | Participants will continue with their normal treatment regimen as usual. |
|
| Measured at Month 5 |
| Medication Attitudes | Measured at Month 5 |
| 23300127 | Result | Interian A, Lewis-Fernandez R, Gara MA, Escobar JI. A randomized-controlled trial of an intervention to improve antidepressant adherence among Latinos with depression. Depress Anxiety. 2013 Jul;30(7):688-96. doi: 10.1002/da.22052. Epub 2013 Jan 8. |
| BG001 | Treatment as Usual | Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Treatment Retention | Not Posted | Measured at Month 5 |
| Secondary | Beck Depression Inventory-II (BDI-II) | The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. Higher total scores indicate more severe depressive symptoms. | Posted | Mean | Standard Error | units on a scale | Measured at Month 5 |
|
|
|
| Secondary | Medication Attitudes | Not Posted | Measured at Month 5 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Treatment as Usual | Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study. | 0 | 24 | 0 | 24 |
Not provided
Not provided
| D001523 |
| Mental Disorders |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |