- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00356304
Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression
Antidepressant Adherence Among Hispanics: A Motivational Interviewing Approach
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
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New Jersey
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New Brunswick, New Jersey, Förenta staterna, 08901
- University Behavioral Healthcare
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 2
Deltagarna kommer att få behandling som vanligt
|
Participants will continue with their normal treatment regimen as usual.
|
Experimentell: 1
Participants will receive motivational interviewing in addition to their antidepressant therapy
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Medication Adherence, as Measured by Electronic Pill Container
Tidsram: 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.
|
Measured immediately post-treatment and at Months 2 and 5 months follow-ups
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Treatment Retention
Tidsram: Measured at Month 5
|
Measured at Month 5
|
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Beck Depression Inventory-II (BDI-II)
Tidsram: 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. |
Measured at Month 5
|
Medication Attitudes
Tidsram: Measured at Month 5
|
Measured at Month 5
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Alejandro Interian, PhD, Rutgers, the State University of New Jersey
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- K23MH074860 (U.S.S. NIH-anslag/kontrakt)
- DSIR 8K-RT
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