Depression
Conditions
Keywords
Dysthymia, Major Depression, Hispanics, Latinos, Motivational Interviewing, Adherence
Brief summary
This study will determine the effectiveness of motivational interviewing in improving antidepressant medication adherence among Hispanics.
Detailed description
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.
Interventions
BEHAVIORALMotivational interviewing
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.
BEHAVIORALTreatment as usual
Participants will continue with their normal treatment regimen as usual.
Sponsors
National Institute of Mental Health (NIMH)
University of Medicine and Dentistry of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Self-identifies as Hispanic * DSM-IV diagnosis of any unipolar depressive disorder (i.e., MDD, dysthymia, or depressive disorder not otherwise specified) * Currently taking antidepressant medication
Exclusion criteria
* Clinically significant suicidal ideation * DSM-IV diagnosis of any substance-related disorder, bipolar disorder, or psychotic disorder/features within 12 months prior to study entry * Unstable general medical condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence, as Measured by Electronic Pill Container | Measured immediately post-treatment and at Months 2 and 5 months follow-ups | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Retention | Measured at Month 5 | — |
| Beck Depression Inventory-II (BDI-II) | Measured at Month 5 | 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. |
| Medication Attitudes | Measured at Month 5 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 26 |
| 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. | 24 |
| Total | 50 |
Baseline characteristics
| Characteristic | Motivational Enhancement Therapy for Antidepressants | Treatment as Usual | Total |
|---|---|---|---|
| Age, Continuous | 40.2 years STANDARD_DEVIATION 10.8 | 41 years STANDARD_DEVIATION 13 | 40.6 years STANDARD_DEVIATION 11.8 |
| Region of Enrollment United States | 26 participants | 24 participants | 50 participants |
| Sex: Female, Male Female | 19 Participants | 19 Participants | 38 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 24 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 |
Outcome results
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.
Time frame: Measured immediately post-treatment and at Months 2 and 5 months follow-ups
Population: We used an ITT with LOCF. These figures represent outcomes at 5 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Enhancement Therapy for Antidepressants | Medication Adherence, as Measured by Electronic Pill Container | 58.76 Percentage of Days | Standard Error 6.59 |
| Treatment as Usual | Medication Adherence, as Measured by Electronic Pill Container | 34.7 Percentage of Days | Standard Error 6.87 |
p-value: <0.05ANCOVA
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.
Time frame: Measured at Month 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Enhancement Therapy for Antidepressants | Beck Depression Inventory-II (BDI-II) | 16.75 units on a scale | Standard Error 2.7 |
| Treatment as Usual | Beck Depression Inventory-II (BDI-II) | 23.03 units on a scale | Standard Error 2.81 |
Secondary
Medication Attitudes
Time frame: Measured at Month 5
Secondary
Treatment Retention
Time frame: Measured at Month 5