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HIV Translating Initiatives for Depression Into Effective Solutions (HI-TIDES)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00304915
First received: March 16, 2006
Last updated: September 10, 2014
Last verified: September 2014
Results First Received: September 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV
Depression
Intervention: Behavioral: Collaborative Care Interventions

  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
Arm 1 Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in VA electronic medical record. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
Arm 2 Usual care arm. Usual care will include depression screening with the same 9-item Patient Health Questionnaire (PHQ-9) screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.

Participant Flow:   Overall Study
    Arm 1     Arm 2  
STARTED     123     126  
COMPLETED     105     110  
NOT COMPLETED     18     16  
Lost to Follow-up                 11                 11  
Death                 4                 5  
Withdrawal by Subject                 3                 0  



  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
Arm 1 Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
Arm 2 Usual care arm. Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  123     126     249  
Age  
[units: years]
Mean ± Standard Deviation
  49.8  ± 8.7     49.8  ± 10.5     49.8  ± 9.6  
Gender  
[units: participants]
     
Female     3     4     7  
Male     120     122     242  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     78     77     155  
White     45     49     94  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  



  Outcome Measures

1.  Primary:   Depression Severity   [ Time Frame: 6 months ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Jeff Pyne
Organization: Central Arkansas Veterans Healthcare System
phone: 501-257-1083
e-mail: jmpyne@uams.edu


Publications of Results:


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00304915     History of Changes
Other Study ID Numbers: MNT 05-152
Study First Received: March 16, 2006
Results First Received: September 10, 2014
Last Updated: September 10, 2014
Health Authority: United States: Federal Government