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临床试验/NCT01351454
NCT01351454已完成不适用

Behavioral Depression Treatment for African American HIV-infected Substance Users

University of North Carolina, Chapel Hill4 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2008年9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
61
试验地点
4
主要终点
Urinalysis

研究概览

简要总结

The objective of the current study is to test a novel, behavioral approach to treat depressive symptoms and improve HIV medication adherence and subsequent physical health outcomes among African American HIV-infected substance users residing in inner-city Washington, DC. This treatment will serve as a compliment to standard residential and follow-up outpatient substance use treatment, with the goal of reducing depressive symptoms and improving HIV medication adherence, physical health, and substance use outcomes.

详细描述

Approximately 37-50% of HIV positive individuals suffer from depression, which is associated with substance use, poor adherence to HIV medication, an increase in HIV risk behaviors, and subsequent poor health outcomes (e.g., Asch et al., 2003; Bing et al., 2001; Dew et al., 1997; Johnson, Rabkin, Lipsitz, Williams, & Remien, 1999). Additionally, depressed HIV positive substance users are at an even greater risk for poor medication adherence than non-substance users (Cook, Grey, & Burke-Miller, 2004). Notably, evidence indicates that HIV positive patients who receive treatment for depression exhibit significant improvements in HIV medication adherence and a reduction in risk behaviors that are directly relevant to their health and well being such as risky sexual behavior (e.g., Cook et al., 2006). Despite this link, few interventions targeting depression have been developed to meet the specific needs of HIV-infected substance users. This is especially evident for low income African American HIV positive substance users who often do not receive adequate treatment for any of these conditions due to poverty, lack of access to specialized treatment, low motivation, cognitive impairments, and a lack of coordination between medical, mental health, and substance abuse treatment providers (Calsyn et al., 2004). Thus, the objective of the present proposal is to test a novel, behavioral approach to treat depressive symptoms and improve HIV medication adherence and subsequent physical health outcomes among African American HIV infected substance users residing in inner-city Washington, DC. This treatment combines (1) LET'S ACT, a behavioral activation based treatment for depressed substance users (Daughters, Braun, Sargeant, Hopko, Blanco, & Lejuez, 2008), with (2) Life Steps, an HIV medication adherence intervention (Safren, Otto, & Worth, 1999). The purpose of this combined treatment will be to compliment standard residential and follow-up outpatient substance use treatment to specifically treat depressive symptoms with the additional goal of improving HIV medication adherence, substance use, and physical health outcomes. Participants will be randomly assigned to either treatment as usual (TAU) plus ACT HEALTHY or TAU plus Nondirective Therapy to test the efficacy of ACT HEALTHY. Treatment as usual for both groups consists of standard residential and outpatient substance abuse treatment. Based on the outcome of this preliminary trial, the ACT HEALTHY protocol will be further refined and readied for larger-scale clinical trials.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • between 18 and 65 years of age
  • HIV positive

排除标准

  • psychosis
  • the inability to give informed, voluntary, written consent to participate
  • reading ability [below 3rd grade level on the WRAT]

结局指标

主要结局

Urinalysis

时间窗: Urinalysis is assessed from residential discharged to a 12-month follow up period

Urinalysis is a biological measure of substance use.

MEMS

时间窗: MEMS is assessed from residential discharge to 12-month follow up period

The MEMS cap (AARDEX) is an electronic pill bottle designed to record HIV medication adherence.

Beck Depression Inventory (BDI-II; Beck et al., 1996)

时间窗: BDI-II will be evaluated from baseline to a 12-month follow up period

The Beck Depression Inventory is a 21-item self-report measure of depressive symptoms.

Time Line Follow Back (TLFB)

时间窗: TLFB will be assessed from baseline to a 12-month follow up period

The Time Line Follow Back is a self-report measure of drug and alcohol use.

Adherence to Anti-Retroviral Medications Questionnaire (ACTG; Chesney, Morin, & Sherr, 2000)

时间窗: ACTG will be assessed from baseline to 12-month follow up period

The ACTG is self-report measure of HIV medication adherence.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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