HIV Translating Initiatives for Depression Into Effective Solutions (HI-TIDES)
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| ClinicalTrials.gov Identifier: NCT00304915 |
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Recruitment Status :
Completed
First Posted : March 20, 2006
Results First Posted : September 17, 2014
Last Update Posted : December 29, 2016
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Sponsor:
VA Office of Research and Development
Information provided by (Responsible Party):
VA Office of Research and Development
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Brief Summary:
This study is a randomized trial designed to test and refine a collaborative care model for treating depression in VA patients with HIV.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV, Depression | Behavioral: Collaborative Care Interventions | Not Applicable |
Background: Depression is the most common mental disorder in HIV infected patients. Despite the availability of efficacious treatments for depression, evidence suggests that it is under-diagnosed and under-treated in routine HIV care. To address this problem, the investigators will adapt and implement a collaborative stepped-care model for depression treatment in HIV clinics. This proposal builds on past success of the TIDES/WAVES programs used in VA primary care. The project (HI-TIDES or HIV Translating Initiatives for Depression into Effective Solutions) will implement the primary care collaborative care model for depression treatment in HIV clinics using evidence-based implementation strategies. Objectives: The objectives of this proposal are to: 1) Develop and evaluate the process of adapting, implementing, and sustaining collaborative care for depression in VA HIV clinics, 2) Compare the quality of depression care and the clinical effectiveness of HI-TIDES to usual care in the HIV clinics, and 3) Evaluate the cost-effectiveness of patients assigned to HI-TIDES relative to patients assigned to usual care in HIV clinics. Methods: The implementation framework for this proposal is primarily informed by the Rogers diffusion of innovation model, Simpson Transfer Model, and the PRECEDE model. The VA and American Psychiatric Association Practice Guidelines inform the stepped care collaborative model intervention as source documents for summarizing the evidence for depression treatment for the general population. An expert panel will be convened to rate the quality of available evidence for depression treatment in the context of HIV. Patients will be recruited from VA HIV clinics: Little Rock, Atlanta, and Houston. The intervention will be randomized at the level of the patient. The investigators expect to recruit a total of 140 intervention and 140 usual care patients. 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 the 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. A formative evaluation will occur during start-up and throughout the implementation of the intervention. A summative evaluation will document the effectiveness and cost-effectiveness of the intervention using an intent to treat analysis plan. Findings: No results at this time. Status: Start-up activities. Impact: The proposed study is highly relevant to the VA and the Veterans it serves for many reasons. First, the majority of VA patients with HIV are not seen in the primary care clinics and therefore will not benefit from VA's efforts in primary care settings to improve depression identification and treatment. Second, in addition to the negative outcomes of depression generally, depression in HIV patients is associated with additional negative outcomes including accelerated HIV disease progression, decreased immune system functioning, and premature death. Third, directly moving collaborative depression care from primary care clinics to HIV clinics is likely to fail for several reasons including the comorbidities associated with depressed HIV patient and the potential for drug-drug interactions. The proposed project will address these gaps and provide effectiveness and cost-effectiveness analyses to inform decisions about larger scale implementation of the HI-TIDES intervention.
| 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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Depression
MedlinePlus related topics:
HIV/AIDS
| Arm | Intervention/treatment |
|---|---|
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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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Primary Outcome Measures :
- 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
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
Locations
| 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 | |
Sponsors and Collaborators
VA Office of Research and Development
Investigators
| 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:
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HIV, depression patient care management patient care team |
Additional relevant MeSH terms:
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Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |