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Skills Based Counseling for Adherence and Depression in HIV+ Methadone Patients - 1

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Steven A. Safren, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00218634
First received: September 20, 2005
Last updated: June 22, 2012
Last verified: June 2012
Results First Received: January 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Adherence
Depression
Heroin Dependence
Methadone
Motivational Interviewing
Substance-Related Disorders
Interventions: Behavioral: CBT-AD
Behavioral: ETAU

  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
First participants from methadone clinics, remainder from MGH or RIH clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants had to screen for study inclusion/exclusion criteria before randomization.

Reporting Groups
  Description
CBT-AD Cognitive behavioral therapy for adherence and depression
ETAU Enhanced Treatment as Usual

Participant Flow:   Overall Study
    CBT-AD   ETAU
STARTED   44   45 
COMPLETED   36   30 
NOT COMPLETED   8   15 
Lost to Follow-up                8                15 



  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.
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Reporting Groups
  Description
CBT-AD Cognitive behavioral therapy for adherence and depression
ETAU Enhanced Treatment as Usual
Total Total of all reporting groups

Baseline Measures
   CBT-AD   ETAU   Total 
Overall Participants Analyzed 
[Units: Participants]
 44   45   89 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   44   45   89 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.05  (7.34)   46.67  (7.05)   46.85  (7.15) 
Gender 
[Units: Participants]
     
Female   17   18   35 
Male   27   27   54 
Region of Enrollment 
[Units: Participants]
     
United States   44   45   89 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Medication Adherence at 3-month Follow-up Assessment   [ Time Frame: 3-month assessment ]

2.  Primary:   Percent Medication Adherence at 12-month Follow-up Assessment   [ Time Frame: 12-month follow-up assessment ]

3.  Secondary:   Clinician-assessed Depression Rating at 3 Month Follow-up Assessment   [ Time Frame: 3 month follow-up ]

4.  Secondary:   HIV Viral Load at 12-month Follow-up Assessment   [ Time Frame: 12-month follow-up assessment ]

5.  Secondary:   CD4+ Lymphocyte Count at 12-month Follow-up Assessment.   [ Time Frame: 12-month follow-up assessment ]

6.  Secondary:   Clinician-assessed Depression at 12-month Follow-up Assessment   [ Time Frame: 12-month follow-up assessment ]

7.  Secondary:   HIV Viral Load at 3-month Follow-up Assessment   [ Time Frame: 3-month assessment ]

8.  Secondary:   CD4+ Lymphocyte Count at 3-month Follow-up Assessment.   [ Time Frame: 3-month assessment ]


  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: Steven Safren
Organization: Mass General Hospital
phone: 617 724 0817
e-mail: ssafren@partners.org


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

Responsible Party: Steven A. Safren, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00218634     History of Changes
Other Study ID Numbers: NIDA-18603-1
R01DA018603 ( US NIH Grant/Contract Award Number )
Study First Received: September 20, 2005
Results First Received: January 3, 2012
Last Updated: June 22, 2012