HIV Translating Initiatives for Depression Into Effective Solutions (HI-TIDES)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00304915|
Recruitment Status : Completed
First Posted : March 20, 2006
Results First Posted : September 17, 2014
Last Update Posted : December 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV, Depression||Behavioral: Collaborative Care Interventions||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||249 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||HIV Translating Initiatives for Depression Into Effective Solutions|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||November 2016|
Experimental: Arm 1: Collaborative Care Intervention
HIV patients were screened for depression and the screener results were available to HIV clinicians. Depressed HIV patients received collaborative care intervention.
Behavioral: Collaborative Care Interventions
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.
No Intervention: Arm 2: Usual Care
HIV patients were screened for depression and the screener results were available to HIV clinicians. Depressed HIV patients received usual care.
- Percentage of Participants With Depression Treatment Response [ Time Frame: 6 months ]Depression symptom severity over the past two weeks was measured using the Hopkins Symptom Checklist (SCL-20). The SCL-20 includes the 13-item depression scale plus 7 depression-related items from the Hopkins Symptom Checklist-90-Revised. The items are scored from 0 to 4 and averaged to provide a mean depression severity score from 0 to 4. Depression treatment response at 6-months was defined as a 50% decrease in mean SCL-20 score compared to baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00304915
|United States, Arkansas|
|Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR|
|No. Little Rock, Arkansas, United States, 72114-1706|
|United States, Georgia|
|Atlanta VA Medical and Rehab Center, Decatur, GA|
|Decatur, Georgia, United States, 30033|
|United States, Texas|
|Michael E. DeBakey VA Medical Center, Houston, TX|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jeffrey M Pyne, MD||Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR|