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Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression

This study has been completed.
Sponsor:
Collaborator:
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  
Number of Participants  
[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
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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 ]

2.  Secondary:   Beck Depression Inventory-II (BDI-II)   [ Time Frame: Measured at Month 5 ]
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Measure Type Secondary
Measure Title Beck Depression Inventory-II (BDI-II)
Measure Description

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.

Time Frame Measured at Month 5  
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.
No text entered.

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  
Number of Participants Analyzed  
[units: participants]
  26     24  
Beck Depression Inventory-II (BDI-II)  
[units: units on a scale]
Mean ± Standard Error
  16.75  ± 2.70     23.03  ± 2.81  

No statistical analysis provided for Beck Depression Inventory-II (BDI-II)



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: K23 MH074860, K23MH074860, 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