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临床试验/NCT03662529
NCT03662529已完成不适用

Neurobehavioral Measurement of Substance Users in an Outpatient Treatment Setting

Hunter Holmes Mcguire Veteran Affairs Medical Center2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2017年6月5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
发起方
入组人数
35
试验地点
2
主要终点
Rate of abstinence during final week of intensive outpatient therapy (IOP)

研究概览

简要总结

This study was an internal program effectiveness evaluation of the effects of a four-session weekly individualized cognitive therapy program (called the "Mind Freedom Plan" (MFP)) on substance use outcomes and substance abuse treatment retention in Veterans admitted to an intensive outpatient treatment program for substance abuse at the Richmond Veterans Administration Medical Center (RICVAMC). Substance use and treatment retention metrics of MFP-assigned Veterans were compared with those of Veterans assigned to typical case-management-oriented weekly individual sessions.

详细描述

This study was funded and launched as an internal program evaluation regarding the effects of a four-session weekly individualized cognitive therapy program called the "Mind Freedom Plan" (MFP) on substance use outcomes, impulsivity, and substance abuse treatment retention in veterans admitted to the intensive outpatient (treatment) program (IOP) for substance abuse at the Richmond Virginia Hunter Holmes McGuire Veterans Administration Medical Center (RICVAMC). Substance use and treatment retention outcomes were compared between veterans randomly assigned to the MFP versus treatment as usual (TAU), which consisted of typical case-management-oriented weekly individual sessions. Veteran participants were approached and consented within a week of admission to the RICVAMC IOP and randomly assigned to either an MFP or TAU practitioner. Assignment was constrained by practitioner new-patient availability in order to place veterans into individualized care sessions as soon as possible.

Participants completed self-reported and interview-based mood, personality and addiction severity assessments at study entry. After one month, participants were reassessed with psychometric symptomatology questionnaires, and also completed a 60-minute neurobehavioral testing session in a follow-up appointment. Subjects completed the Delis-Kaplan Executive Function System (DKEFS) Tower Test of planning ability, along with a delay-discounting decision-making task, a stop-signal task, and a go-nogo behavior inhibition task that used emotional and expressionless faces as stimuli.

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

  • Enrollment in the Substance Abuse Treatment Program - Intensive Outpatient Program
  • Currently meets criteria for an Alcohol or Substance Use Disorder per SUD clinic intake

排除标准

  • Unable to read and speak English
  • Currently active-duty military
  • Current engaged with legal involvement that is mandating the completion of the substance use program.

研究组 & 干预措施

Mind Freedom Plan therapy sessions

Experimental

The Four-Session Mind Freedom Plan (MFP) is cognitive behavioral therapy (CBT)-based, client-centered, manualized individual therapy that functions as part of intensive outpatient substance abuse treatment. The MFP model is based on efficacious brief interventions, with content and format driven from military veteran feedback. The four 60-minute MFP sessions were one-on-one private consultations with a therapist that were focused on identifying and changing unhealthy thinking and behavioral patterns as core elements of CBT, but with an emphasis on problem-solving, coping skills, goal setting, and psychosocial functioning. At each session, structured worksheets were utilized and homework was assigned to facilitate this CBT-based skill building.

干预措施: Four-Session Mind Freedom Plan (Behavioral)

Treatment as usual therapy

Active Comparator

The four 50-minute TAU sessions were one-on-one individual therapy sessions. Therapy was mostly supportive therapy with an emphasis problem solving on increasing veteran motivation. A discussion of the antecedents to relapse would take place if a relapse occurred and coping skills were discussed and reviewed. Veterans were also connected with community-level psychosocial supports as appropriate.

干预措施: Treatment as usual therapy (Behavioral)

结局指标

主要结局

Rate of abstinence during final week of intensive outpatient therapy (IOP)

时间窗: 21-28 Days

Chart review variable; abstinence in the final week of IOP was defined as urine drug screen (UDS) negative and no self-reported substance use by the final week of IOP. UDS results and self-reported substance use are documented in the patients' charts as part of standard care.

Percent of patients who completed the Substance Abuse Treatment Program (SATP) Intensive Outpatient Program (IOP).

时间窗: 28-Day

Chart review variable; SATP IOP patients are designated as completers vs non-completers by their IOP social worker. IOP treatment retention outcome is documented in the patients' charts as part of standard care.

次要结局

  • Drug use during outpatient therapy(1-28 Days)
  • Rapid-response impulsivity(28 Days)
  • Depression symptomatology(Pre-treatment baseline and 28 Days)
  • Quality of life as assessed by the Quality of Life Inventory (QoLI) total score.(Pre-treatment baseline and 28 Days)
  • Decision-based impulsivity(28 Days)
  • Problem-solving ability(28 Days)
  • Impulsive personality(Pre-treatment baseline and 28 Days)

研究者

发起方
Hunter Holmes Mcguire Veteran Affairs Medical Center
申办方类型
Fed
责任方
Principal Investigator
主要研究者

James Bjork

Neuroscientist

Hunter Holmes Mcguire Veteran Affairs Medical Center

研究点 (2)

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