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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00564278
First received: November 26, 2007
Last updated: February 11, 2016
Last verified: August 2014
Results First Received: August 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Health Services Research
Condition: Depression
Interventions: Drug: Standard antidepressant therapy (SADT)
Behavioral: Motivational antidepressant therapy (MADT)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period extended from June 3, 2008 to Aug 14, 2013. Advertising was placed in local newspapers recruiting Hispanic adults to the trial, which took place in the Hispanic Treatment Program at the Psychiatric Institute, a research and clinical institute in Upper Manhattan affiliated with Columbia University.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of N=109 patients enrolled in SADT, 12 were pre-treatment drops (signed consent but did not return for a medication visit) and N=97 came to 1+ medication visit. Of N=108 patients enrolled in MADT, 10 were pre-treatment drops (signed consent but did not return for a medication visit) and N=98 participated in at least one medication visit.

Reporting Groups
  Description
Standard Antidepressant Therapy As per study criteria, the N=97 sample is our sample for data analysis. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline Hamilton Depression Scale-17 score of 16 or greater. Mean age was 43.41 (SD = 13.2).
Motivational Antidepressant Therapy As per study criteria, the N=98 sample is our sample for data analysis. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline Hamilton Depression Scale-17 score of 16 or greater. Mean age was 44.1 (SD = 12.3).

Participant Flow:   Overall Study
    Standard Antidepressant Therapy   Motivational Antidepressant Therapy
STARTED   97   98 
COMPLETED   50   56 
NOT COMPLETED   47   42 
Lost to Follow-up                35                33 
Physician Decision                1                2 
Withdrawal by Subject                11                7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients who signed written informed consent and participated in baseline medication visit.

Reporting Groups
  Description
Standard Medication Therapy N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater. Mean age was 43.4 with SD=13.2.
Motivational Pharmacotherapy N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater. Mean age was 44.1 with SD=12.3.
Total Total of all reporting groups

Baseline Measures
   Standard Medication Therapy   Motivational Pharmacotherapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 97   98   195 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   93   92   185 
>=65 years   4   6   10 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.4  (13.2)   44.1  (12.3)   43.8  (12.7) 
Gender 
[Units: Participants]
     
Female   60   62   122 
Male   37   36   73 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   97   98   195 
Not Hispanic or Latino   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   97   98   195 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Days in ADT (Retention)   [ Time Frame: Measured at Months 3 and 9 ]

2.  Primary:   Mean of Depressive Symptoms Over 36-week Follow-up Using Hamilton Depression Scale -17-item Version (Symptoms)   [ Time Frame: HAMD-17 assessed at follow-up weeks 2, 4, 8, 12, 20, 28, and 36. ]

3.  Primary:   Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment)   [ Time Frame: SDS at follow-up weeks 2, 4, 8, 12, 20, 28, and 36. ]

4.  Primary:   Mean Perceived Quality of Life Over 36-week Follow-up Using Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)   [ Time Frame: QLESQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36. ]

5.  Secondary:   Mean Patient Satisfaction Over 36-week Follow-up Using Client Satisfaction Questionnaire (CSQ)   [ Time Frame: CSQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36. ]

6.  Secondary:   Proportion of Fully Adherent Days   [ Time Frame: Measured at each visit, up to 36 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Focused only on Hispanics, so applicability to other populations unknown.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Roberto Lewis-Fernandez, MD, Professor of Psychiatry CUMC - NYSPI
Organization: Columbia Univ Med Center and New York State Psychiatric Institute
phone: 646-774-8102
e-mail: rlewis@nyspi.columbia.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00564278     History of Changes
Other Study ID Numbers: #5516/#6609R
R01MH077226 ( US NIH Grant/Contract Award Number )
DSIR 82-SESC
Study First Received: November 26, 2007
Results First Received: August 6, 2015
Last Updated: February 11, 2016
Health Authority: United States: Federal Government