跳至主要内容
临床试验/NCT00304915
NCT00304915已完成不适用

HIV Translating Initiatives for Depression Into Effective Solutions

VA Office of Research and Development6 个研究点 分布在 1 个国家目标入组 249 人开始时间: 2007年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
249
试验地点
6
主要终点
Percentage of Participants With Depression Treatment Response

研究概览

简要总结

This study is a randomized trial designed to test and refine a collaborative care model for treating depression in VA patients with HIV.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • current 9-item Patient Health Questionnaire (PHQ-9) score of 10 or more and
  • current treatment in the HIV clinic.

排除标准

  • 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.

结局指标

主要结局

Percentage of Participants With Depression Treatment Response

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (6)

Loading locations...

相似试验