Effects of Adding Motivational Interviewing to Antidepressant Treatment for Hispanic Adults With Depression

NCT00564278 | Completed Results

• 3 other identifiers: #5516/#6609RR01MH077226DSIR 82-SESC
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of adding motivational interviewing to antidepressant treatment for major depressive disorder in Hispanic adults.

Conditions

Depression

Keywords

Hispanic Americans; Major Depressive Disorder; Antidepressant Therapy; Motivational Interviewing; Treatment Retention; Treatment Adherence

Outcome Measures

Primary Outcomes (4)

• 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 \[week 8 to week 12\]).

  Measured at Months 3 and 9

• 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.

  HAMD-17 assessed at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.

• 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.

  SDS at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.

• 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.

  QLESQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.

Secondary Outcomes (2)

• 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.

• Proportion of Fully Adherent Days

  Measured at each visit, up to 36 weeks

Study Arms (2)

Standard antidepressant therapy

ACTIVE COMPARATOR

Participants will receive standard antidepressant therapy, including selecting among 9 FDA-approved antidepressants from several classes.

Drug: Standard antidepressant therapy (SADT)

Motivational antidepressant therapy

EXPERIMENTAL

Participants will receive motivational antidepressant therapy, including selecting among the same list of 9 FDA-approved antidepressants from several classes as in the control arm.

Drug: Standard antidepressant therapy (SADT); Behavioral: Motivational antidepressant therapy (MADT)

Interventions

Standard antidepressant therapy (SADT) DRUG

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).

Motivational antidepressant therapy; Standard antidepressant therapy

Motivational antidepressant therapy (MADT) BEHAVIORAL

The same medication treatment for depression will be offered and supplemented with techniques from motivational interviewing.

Motivational antidepressant therapy

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New York State Psychiatric Institute, 1051 Riverside Drive

New York, New York, 10032, United States

Location

Related Publications (1)

• Vargas SM, Cabassa LJ, Nicasio A, De La Cruz AA, Jackson E, Rosario M, Guarnaccia PJ, Lewis-Fernandez R. Toward a cultural adaptation of pharmacotherapy: Latino views of depression and antidepressant therapy. Transcult Psychiatry. 2015 Apr;52(2):244-73. doi: 10.1177/1363461515574159. Epub 2015 Mar 3.

  PMID: 25736422 DERIVED

Related Links

• Related info

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders; Health Behavior

Limitations and Caveats

Focused only on Hispanics, so applicability to other populations unknown.

Results Point of Contact

• Title: Roberto Lewis-Fernandez, MD, Professor of Psychiatry CUMC - NYSPI
• Organization: Columbia Univ Med Center and New York State Psychiatric Institute

rlewis@nyspi.columbia.edu

646-774-8102

Study Officials

• Roberto Lewis-Fernandez, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: November 26, 2007
• First Posted: November 27, 2007
• Study Start: February 1, 2008
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: May 19, 2021
• Results First Posted: March 10, 2016

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)