跳至主要内容
临床试验/NCT01645033
NCT01645033已完成不适用

Computer-based Cognitive Behavioral Therapy for Risky Behaviors in Opioid Dependent Patients

Yale University2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2012年4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
63
试验地点
2
主要终点
Number of unprotected sexual occurrences, measured by an assessment, the HIV Risk-taking Behavior Scale (HRBS)

研究概览

简要总结

The purpose of this study is to determine if a computerized version of Cognitive Behavioral Therapy (CBT) can improve high-risk sexual behaviors in patients attending an outpatient methadone treatment clinic. This population is at high risk for contracting and spreading hepatitis and HIV. When added to their treatment as usual (TAU), the CBT session will increase the total exposure of clients to education about how to reduce risky sexual and needle use behaviors and provides real world examples. This study seeks to determine if the use of this CBT program is easily added into the clinical program and if patients are satisfied with its use.

The main hypothesis is that the use of computerized CBT in addition to treatment as usual will improve knowledge and reduce occurrences of unprotected sexual activity. The study will also look at patient and clinic costs related to the CBT intervention, drug use and retention/adherence.

详细描述

We plan to conduct a randomized pilot trial evaluating the feasibility and promise of computerized CBT as a single module targeting risky sexual behavior in a HIV/Hepatitis C virus(HCV) high risk population. In the context of a drug treatment program, we will randomize 60 methadone maintenance patients to either standard treatment as usual at the program (TAU) or TAU plus the HIV/HCV/STD risk reduction module of CBT4CBT("Stay Safe"). Participants will be assessed at baseline, one month and three month time points. The primary outcome measures will be knowledge regarding risk of infection and transmission of HIV/HCV/STD,self report assessment of risky sexual practices, retention in the study and client satisfaction with the module. Our specific aims are as follows:

  1. To determine the feasibility of integrating CBT4CBT/"Stay Safe" into this setting. Feasibility will be determined by completion of assessments at 1 and 3 month time points (retention) and satisfaction ratings by participants randomized to the computer module.
  2. Compare knowledge of HIV/HCV/STD transmission and its prevention before and after intervention. This will be assessed by percent correct answers on a quiz administered at each assessment.
  3. To evaluate changes in drug and sex risk behaviors by treatment. The primary outcome measure will be number of unprotected sexual encounters on self-assessment instruments for risky sexual behaviors.

We hypothesize that the single session of computer-based CBT will result in reduced risky sexual behaviors and increased knowledge of HIV/HCV/STD transmission with differences in retention by intervention. A successful outcome for this pilot project would result in an effect size of 0.30 or more on outcomes of risk behavior. This intervention will be compared to treatment as usual at the participating site, which currently consists of two group educational sessions on safety regarding risks of HIV/AIDS and hepatitis.

Preliminary Data- The case for computer-based behavioral treatments Computer-assisted therapies offer a relatively novel approach to the dissemination of Evidence Based Therapies (EBT) for behavioral interventions. Existing evidence points to their efficacy and cost-effectiveness. Computer-based interventions offer a number of attractive characteristics for use in primary care and substance treatment settings. Their low cost coupled with high consistency, accessibility and standardization are some associated advantages. Ease of implementation will be critical to reaching patients in remote and rural areas or in small medical offices as primary care providers become a mainstay of substance abuse treatment. Risky sexual behaviors can be targeted without the potential negative associations of face to face behavioral interventions for this highly sensitive domain and thus may be ideally modulated with computer-based therapies. Equivalency to counselor-based education for learning new health behaviors, cost-effectiveness, patient satisfaction and accessibility for illiterate patients are other advantages shown with computer-based therapy.

Computer-based CBT: Carroll et al. at Yale have developed an effective computer-based version of CBT, called "CBT4CBT" and have demonstrated its efficacy in reducing drug use and building coping skills.(38) The program makes extensive use of 'movies' as teaching tools: In each module, the user watches an individual confront a difficult situation relevant to that module's topic; after teaching the key skill through a variety of strategies, the 'movie' repeats but has a different ending because the characters implement the targeted coping skills. In developing CBT4CBT, we sought to develop an engaging version of CBT that could take advantage of the capacity of computer-based learning to convey information via a wide range of media (e.g., text, video, graphics, audio instruction, interactive exercises). The CBT4CBT program is highly user-friendly, requiring no previous experience with computers and minimal use of text-based material (i.e., minimal reading is required), and is highly interactive. In particular, we capitalize on the use of videotaped examples to allow users to actually see examples of individuals utilizing skills and strategies in a range of realistic situations. Viewers are able to watch real-life challenges acted out and safe behaviors modeled, while addressing negative or detrimental thought processes that predispose to unhealthy or risky behavior choices (e.g. making a decision to have sex without a condom). Viewer knowledge base is targeted by didactic portions and role playing is modeled by the actors. The module includes the opportunity for the client to print out and perform 'homework' worksheets, shown to be predictive for successful outcomes in CBT. The module allows for considerable control by the viewer, who can choose the speed of progression through the screens and has the capability to go back to previous screens for reviewing.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • mental capability to complete the study (as determined by MMSE, Mini Mental Status Exam score >25),
  • age 18 or older,
  • able to speak, read and understand English,
  • actively enrolled in methadone maintenance for intravenous drug use for 30 days or longer;
  • had unprotected vaginal or anal intercourse or oral sex within the past 6 months;
  • not pregnant or trying to become pregnant.

排除标准

  • have an untreated bipolar or schizophrenic disorder
  • are pregnant (by self-report) or trying to become pregnant (these may unduly influence behaviors of sexual activity)

结局指标

主要结局

Number of unprotected sexual occurrences, measured by an assessment, the HIV Risk-taking Behavior Scale (HRBS)

时间窗: 3 months (Number of unprotected sexual occurrences for the 28 days prior to completing an assessment, the HRBS)

Self-report of unprotected sexual occurrences for the previous 28 days will be recorded; measurements are obtained at baseline, 1 month and 3 months following randomization.

次要结局

  • Knowledge quiz score(measured as percent correct number of items on a knowledge quiz created for this study)(3 month followup (measured as percent correct number of items on a knowledge quiz created for this study))
  • Knowledge quiz score (measured as percent correct number of items on a knowledge quiz created for this study)(1 month followup (measured as percent correct number of items on a knowledge quiz created for this study))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验