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临床试验/NCT02707887
NCT02707887已完成不适用

Technology Enhanced Behavioral Activation Treatment for Substance Use

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
206
试验地点
2
主要终点
Timeline Followback (TLFB)

研究概览

简要总结

The purpose of this study is to:

  1. test the effect of a smartphone enhanced LETS ACT (LETS ACT-SE) on frequency of substance use
  2. use functional magnetic resonance imaging (fMRI) to test the relationship between neuromarkers of reward sensitivity on frequency of substance use.

详细描述

Comorbid substance use disorder (SUD) and depression is highly prevalent and associated with elevated rates of post treatment relapse to substance use, HIV risk behavior, and associated poor mental and physical health outcomes. Further, rates of substance use and depression disproportionately affect minority groups and those living in poverty. Although efficacious, the often complex, specialized nature of CBT poses problems in its integration into substance use treatment programs. Budget cuts for mental health and substance use treatment both nationally and in the state of North Carolina, reduce availability of publically funded treatment programs and staff to patient ratios. To address this limitation, a behavioral activation (BA) treatment, the Life Enhancement Treatment for Substance Use (LETS ACT), was developed to treat depressive symptoms among a predominantly African American sample of low income illicit drug users currently receiving residential substance use treatment. Collectively, two Stage I studies and 1 year follow-up data from the investigators Stage II R01DA026424 indicate that compared to a control condition, LETS ACT is associated with significantly better outcomes for treatment retention, post treatment abstinence, HIV sexual risk behavior, depressive symptoms, and environmental reward.

Although these strong outcomes suggest that LETS ACT may be ready for a Stage III dissemination trial, it is of note that there was a significant indirect effect of LETS ACT homework compliance on post treatment substance use and HIV sexual risk behavior via the theoretically proposed BA mechanism of action, environmental reward. In the context of limited access to care, these findings point to the need to identify cost-effective delivery-vehicles to increase treatment engagement outside of clinician sessions. Further, identifying neuroscience based biomarkers (neuromarkers) underlying key theoretical aspects of BA (i.e., reward sensitivity), and their relation to heterogeneity in BA treatment response among substance users with depression, are critical for the identification of accurately targeted interventions.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Between 18 and 55
  • •Meet criteria for DSM-V substance use disorder
  • •Elevated depressive symptoms (BDI ≥ 14)

排除标准

  • •Limited mental competency (MMSE < 23)
  • •Psychosis
  • •The use of psychotropic medication for < 3 months
  • •The inability to give informed, voluntary, written consent to participate

研究组 & 干预措施

LETS ACT

Active Comparator

The Life Enhancement Treatment for Substance Use (LETS ACT) involves the discussion of the treatment rationale, identification of values and goals in various life areas and activities in line with chosen life areas, and training for patients to identify their cycle of negative mood and behavior using forms to track their daily goals.

干预措施: LETS ACT (Behavioral)

LETS ACT-SE

Active Comparator

Participants assigned to the smartphone-enhanced LETS ACT (LETS ACT-SE) condition will be provided the exact same treatment as outlined in LETS ACT, except that LETS ACT-SE participants will record their daily goals using smartphone technology.

干预措施: LETS ACT-SE (Behavioral)

Treatment as Usual

Placebo Comparator

Patients are offered substance use group therapy including relapse prevention. They are also provided medical consultation on an ongoing basis as needed.

干预措施: Treatment as Usual (Behavioral)

LETS ACT-SE

Active Comparator

Participants assigned to the smartphone-enhanced LETS ACT (LETS ACT-SE) condition will be provided the exact same treatment as outlined in LETS ACT, except that LETS ACT-SE participants will record their daily goals using smartphone technology.

干预措施: Treatment as Usual (Behavioral)

LETS ACT

Active Comparator

The Life Enhancement Treatment for Substance Use (LETS ACT) involves the discussion of the treatment rationale, identification of values and goals in various life areas and activities in line with chosen life areas, and training for patients to identify their cycle of negative mood and behavior using forms to track their daily goals.

干预措施: Treatment as Usual (Behavioral)

结局指标

主要结局

Timeline Followback (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.

次要结局

  • Breathalyzer(Breathalyzer will be assessed from baseline to a 12-month follow up period.)
  • Behavioral Activation for Depression Scale (BADS)(BADS will be assessed from baseline to a 12-month follow up period.)
  • Reward Probability Index (RPI)(RPI will be assessed from baseline to a 12-month follow up period.)
  • Beck Depression Inventory-II (BDI-II)(BDI-II will be evaluated from baseline to a 12-month follow up period)
  • Daily Goals Form(Baseline to a 3-months post treatment.)
  • Texas Christian University (TCU) HIV/AIDS Risk Assessment Form(TCU will be assessed from baseline to a 12-month follow up period.)
  • Urinalysis(Urinalysis is assessed from post treatment to a 12-month follow up period)
  • Short Form Health Survey (SF-12)(SF-12 will be assessed from baseline to a 12-month follow up period.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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