N/A
N=195
Effects of Adding Motivational Interviewing to Antidepressant Treatment for Hispanic Adults With Depression
Depression
Bottom Line
View on ClinicalTrials.gov: NCT00564278 ↗Enrolled (actual)
195
Serious AEs
1.5%
Results posted
Mar 2016
Primary outcome: Primary: Number of Days in ADT (Retention) — 59.5; 65.5; 148.7; 164.1 Days in treatment — p=0.26
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard antidepressant therapy (SADT) (Drug); Motivational antidepressant therapy (MADT) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Days in ADT (Retention) |
59.5; 65.5; 148.7; 164.1 | 0.26 |
| PRIMARY Mean of Depressive Symptoms Over 36-week Follow-up Using Hamilton Depression Scale -17-item Version (Symptoms) |
12.08; 11.71 | — |
| PRIMARY Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment) |
4.36; 4.93; 4.87; 5.44; 4.55; 5.05 | — |
| PRIMARY Mean Perceived Quality of Life Over 36-week Follow-up Using Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) |
50.05; 48.92 | — |
| SECONDARY Mean Patient Satisfaction Over 36-week Follow-up Using Client Satisfaction Questionnaire (CSQ) |
27.59; 27.41 | — |
| SECONDARY Proportion of Fully Adherent Days |
0.47; 0.56 | — |
Summary
This study will evaluate the effectiveness of adding motivational interviewing to antidepressant treatment for major depressive disorder in Hispanic adults.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00564278). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.