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Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Alejandro Interian, Ph.D., National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00356304
First received: July 21, 2006
Last updated: April 10, 2014
Last verified: April 2014
Results First Received: February 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Depression
Interventions: Behavioral: Motivational interviewing
Behavioral: Treatment as usual

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    Motivational Enhancement Therapy for Antidepressants   Treatment as Usual
STARTED   26   24 
COMPLETED   24   20 
NOT COMPLETED   2   4 



  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.
No text entered.

Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
   Motivational Enhancement Therapy for Antidepressants   Treatment as Usual   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   24   50 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.2  (10.8)   41  (13)   40.6  (11.8) 
Gender 
[Units: Participants]
     
Female   19   19   38 
Male   7   5   12 
Region of Enrollment 
[Units: Participants]
     
United States   26   24   50 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Medication Adherence, as Measured by Electronic Pill Container   [ Time Frame: Measured immediately post-treatment and at Months 2 and 5 months follow-ups ]
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Measure Type Primary
Measure Title Medication Adherence, as Measured by Electronic Pill Container
Measure Description 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  
Safety Issue No  

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.
We used an ITT with LOCF. These figures represent outcomes at 5 months.

Reporting Groups
  Description
Motivational Enhancement Therapy for Antidepressants No text entered.
Treatment as Usual No text entered.

Measured Values
   Motivational Enhancement Therapy for Antidepressants   Treatment as Usual 
Participants Analyzed 
[Units: Participants]
 26   24 
Medication Adherence, as Measured by Electronic Pill Container 
[Units: Percentage of Days]
Mean (Standard Error)
 58.76  (6.59)   34.7  (6.87) 


Statistical Analysis 1 for Medication Adherence, as Measured by Electronic Pill Container
Groups [1] All groups
Method [2] ANCOVA
P Value [3] <.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
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[2] Other relevant method information, such as adjustments or degrees of freedom:
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[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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2.  Secondary:   Beck Depression Inventory-II (BDI-II)   [ Time Frame: Measured at Month 5 ]

3.  Secondary:   Treatment Retention   [ Time Frame: Measured at Month 5 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Medication Attitudes   [ Time Frame: Measured at Month 5 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
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  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: Alejandro Interian, Principal Investigator
Organization: VA New Jersey Healthcare System
phone: 908-647-0180 ext 4617
e-mail: alejandro.interian@va.gov


Publications of Results:
Other Publications:

Responsible Party: Alejandro Interian, Ph.D., National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00356304     History of Changes
Other Study ID Numbers: K23MH074860 ( US NIH Grant/Contract Award Number )
DSIR 8K-RT
Study First Received: July 21, 2006
Results First Received: February 24, 2014
Last Updated: April 10, 2014
Health Authority: United States: Federal Government