HIV Translating Initiatives for Depression Into Effective Solutions (HI-TIDES)
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ClinicalTrials.gov Identifier: NCT00304915 |
Recruitment Status
:
Completed
First Posted
: March 20, 2006
Results First Posted
: September 17, 2014
Last Update Posted
: December 29, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV, Depression | Behavioral: Collaborative Care Interventions | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 249 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
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.
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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.
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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.
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- 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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- current 9-item Patient Health Questionnaire (PHQ-9) score of 10 or more and
- current treatment in the HIV clinic.
Exclusion Criteria:
- patients who do not have access to a telephone,
- patients with current suicidal ideation,
- patients with significant cognitive impairment as indicated by a score < 10 on the HIV Dementia Scale, and
- patients with a chart diagnosis of schizophrenia.

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 |
Additional Information:
Publications of Results:
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT00304915 History of Changes |
Other Study ID Numbers: |
MNT 05-152 |
First Posted: | March 20, 2006 Key Record Dates |
Results First Posted: | September 17, 2014 |
Last Update Posted: | December 29, 2016 |
Last Verified: | November 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Investigators can request IPD by contacting the PI. |
Keywords provided by VA Office of Research and Development:
HIV, depression patient care management patient care team |
Additional relevant MeSH terms:
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |